PRODUCT MONOGRAPH. Pr ADCETRIS. Brentuximab vedotin. Antineoplastic agent

Size: px
Start display at page:

Download "PRODUCT MONOGRAPH. Pr ADCETRIS. Brentuximab vedotin. Antineoplastic agent"

Transcription

1 PRODUCT MONOGRAPH Pr ADCETRIS Brentuximab vedotin Lyophilized powder for reconstitution with 10.5 ml of sterile Water for Injection, USP 50 mg Antineoplastic agent ADCETRIS, indicated for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and for the treatment of patients with systemic anaplastic large cell lymphoma (salcl) after failure of at least one multi-agent chemotherapy regimen, has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for ADCETRIS, please refer to Health Canada s Notice of Compliance with conditions drug products website: Seattle Genetics, Inc , 30 th Drive S.E. Bothell, WA Date of Approval: May 15, 2015 Date of Revision: February 11, 2015 Canadian importer/distributor: GMD Distribution Inc. 1215B North Service Road W Oakville, ON, L6M 2W2 Submission Control No: ADCETRIS Product Monograph Page 1 of 45

2 This product has been approved under the Notice of Compliance with Conditions (NOC/c) policy for one or all of its indicated uses. What is a Notice of Compliance with Conditions (NOC/c)? An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Products approved under Health Canada s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame. What will be different about this Product Monograph? The following Product Monograph will contain boxed text at the beginning of each major section clearly stating the nature of the market authorization. Sections for which NOC/c status holds particular significance will be identified in the left margin by the symbol NOC/c. These sections may include, but are not limited to, the following: - Indications and Clinical Uses; - Action; - Warnings and Precautions; - Adverse Reactions; - Dosage and Administration; and - Clinical Trials. ADCETRIS Product Monograph Page 2 of 45

3 Adverse Drug Reaction Reporting and Re-Issuance of the Product Monograph Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada s Health Product Safety Information Division at The Product Monograph will be re-issued in the event of serious safety concerns previously unidentified or at such time as the sponsor provides the additional data in support of the product s clinical benefit. Once the latter has occurred, and in accordance with the NOC/c policy, the conditions associated with market authorization will be removed. ADCETRIS Product Monograph Page 3 of 45

4 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION... 5 SUMMARY PRODUCT INFORMATION... 5 DESCRIPTION... 5 INDICATIONS AND CLINICAL USE... 6 CONTRAINDICATIONS... 6 WARNINGS AND PRECAUTIONS... 7 ADVERSE REACTIONS DRUG INTERACTIONS DOSAGE AND ADMINISTRATION OVERDOSAGE ACTION AND CLINICAL PHARMACOLOGY STORAGE AND STABILITY SPECIAL HANDLING INSTRUCTIONS DOSAGE FORMS, COMPOSITION AND PACKAGING PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION CLINICAL TRIALS DETAILED PHARMACOLOGY TOXICOLOGY REFERENCES PART III: CONSUMER INFORMATION ADCETRIS Product Monograph Page 4 of 45

5 Pr ADCETRIS Brentuximab vedotin ADCETRIS, indicated for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and for the treatment of patients with systemic anaplastic large cell lymphoma (salcl) after failure of at least one multi-agent chemotherapy regimen, has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the nature of the authorization. PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Intravenous infusion Pharmaceutical Form/Strength Lyophilized powder, 50 mg Clinically Relevant Nonmedicinal Ingredients None. For a complete listing see Dosage Forms, Composition and Packaging section. DESCRIPTION ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) consisting of three components: 1) the chimeric IgG1 antibody cac10, specific for human CD30, 2) the potent microtubule-disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable linker that covalently attaches MMAE to cac10. The biological activity of brentuximab vedotin results from a multi-step process. Binding of the ADC to CD30 on the cell surface initiates internalization of the ADC-CD30 complex, which then traffics to the lysosomal compartment. Within the cell, MMAE is released via proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest, and results in apoptotic death of the CD30-expressing tumor cell. ADCETRIS Product Monograph Page 5 of 45

6 NOC/c INDICATIONS AND CLINICAL USE ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate indicated for: The treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates; The treatment of patients with systemic anaplastic large cell lymphoma (salcl) after failure of at least one multi-agent chemotherapy regimen. The indications were authorized based on promising response rates demonstrated in single-arm trials (see CLINICAL TRIALS). No data demonstrate increased survival with ADCETRIS. ADCETRIS should only be administered by a qualified healthcare professional experienced in the use of antineoplastic therapy. Geriatrics ( 65 years of age): The safety and efficacy of ADCETRIS have not been established in the geriatric population. Pediatrics (<18 years of age): The safety and efficacy of ADCETRIS have not been established in the pediatric population. NOC/c CONTRAINDICATIONS Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary toxicity. ADCETRIS is contraindicated for patients who have or have had progressive multifocal leukoencephalopathy (PML) (See WARNINGS AND PRECAUTIONS, Progressive Multifocal Leukoencephalopathy). ADCETRIS Product Monograph Page 6 of 45

7 Serious Warnings and Precautions Clinically significant and/or life-threatening adverse events include: JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death (see WARNINGS AND PRECAUTIONS, Progressive Multifocal Leukoencephalopathy) Stevens-Johnson syndrome and toxic epidermal necrolysis (see WARNINGS AND PRECAUTIONS, Dermatologic) Serious and opportunistic infections (see WARNINGS AND PRECAUTIONS, Infections) Acute pancreatitis (see WARNINGS AND PRECAUTIONS, Gastrointestinal) NOC/c WARNINGS AND PRECAUTIONS General Infusion reactions Immediate and delayed infusion-related reactions, as well as anaphylaxis, have been reported. Monitor patients during infusion. Symptoms of an infusion reaction include chills, nausea, cough, and itching within 2 days after a dose. Symptoms of a severe infusion reaction include wheezing, difficulty breathing, hives, itching, and swelling. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an infusion-related reaction occurs, the infusion should be interrupted and appropriate medical management instituted. Patients who have experienced a prior infusion-related reaction should be premedicated for subsequent infusions. Premedication may include acetaminophen, an antihistamine and a corticosteroid. Cardiac Ventricular Repolarization QT shortening was observed in CD30-positive patients treated with brentuximab vedotin. The clinical significance of QT shortening is unknown. Dermatologic Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal outcomes, have been reported with ADCETRIS. The symptoms of SJS and TEN include unexplained widespread skin pain, blisters on the skin and mucous membranes, hives, tongue swelling, a red or purple skin rash that spreads, or unexplained shedding of the skin. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy. ADCETRIS Product Monograph Page 7 of 45

8 Gastrointestinal Acute pancreatitis, including fatal outcomes, has been reported in patients treated with ADCETRIS. Consider the diagnosis of acute pancreatitis for patients presenting with new or worsening abdominal pain. Hold ADCETRIS for any suspected case of acute pancreatitis and discontinue if a diagnosis of acute pancreatitis is confirmed. Hematologic Anemia: Grade 3 or 4 anemia can occur with ADCETRIS. Neutropenia: Neutropenia was very common in the pivotal trials for HL and salcl occurring in 55 (54%) and 37 (64%) patients, respectively. Complete blood counts should be monitored prior to each dose of ADCETRIS and more frequent monitoring should be considered for patients with Grade 3 or 4 neutropenia. Prolonged ( 1 week) severe neutropenia and febrile neutropenia can occur with ADCETRIS. If Grade 3 or 4 neutropenia develops, manage by growth factor support, dose delays, reductions or discontinuations (see DOSAGE AND ADMINISTRATION). Thrombocytopenia: Prolonged ( 1 week) severe thrombocytopenia can occur with ADCETRIS. If Grade 3 or 4 thrombocytopenia develops, monitor closely and consider platelet transfusions or dose delays. Hepatotoxicity Hepatotoxicity, predominantly in the form of asymptomatic, mild to moderate transient elevations in alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), has been reported in patients receiving ADCETRIS. Hyperglycemia Hyperglycemia has been reported during clinical trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. If hyperglycemia develops, monitor the patient s serum glucose and administer anti-diabetic treatment as appropriate. Immune The efficacy and safety of, and ability to generate a primary or anamnestic response to immunization with live attenuated or inactivated vaccines during or following ADCETRIS treatment have not been established; therefore, patients should be observed for failure to respond to a vaccine. The risks and benefits of vaccinating patients with live attenuated, or inactivated, vaccines during or following ADCETRIS therapy should be considered. ADCETRIS Product Monograph Page 8 of 45

9 A higher incidence of infusion-related reactions was observed in patients who developed persistently positive antibodies than in those who did not. The effect of anti-brentuximab vedotin antibodies on efficacy and safety has not been established. Infections Serious and opportunistic infections such as pneumonia, bacteremia, sepsis/septic shock (including fatal outcomes), herpes zoster, Pneumocystis jiroveci pneumonia, and oral candidiasis have been reported in patients treated with ADCETRIS. Symptoms of infection include fever ( 38 C), sore throat, difficulty breathing, painful sores (ulcers) around the mouth and/or anus, or pain on urination. Patients should be carefully monitored during treatment for the emergence of possible bacterial, fungal, or viral infections. Neurologic Peripheral Neuropathy ADCETRIS treatment can cause a peripheral neuropathy that may be sensory or motor in nature. ADCETRIS-induced peripheral neuropathy is typically cumulative. In the pivotal HL and salcl clinical trials, 56 (55%) and 33 (59%) patients, respectively, experienced peripheral neuropathy (any grade). Of these, 34/56 (61%) HL patients and 16/33 (48%) salcl patients had complete resolution and 14/56 (25%) HL patients and 10/33 (30%) salcl patients showed some resolution or improvement. The remainder continued to have symptoms of peripheral neuropathy at the end of the treatment or during the follow-up period. Symptoms of peripheral sensory neuropathy include burning sensation, pain, numbness and tingling (feeling of pins and needles) of hands and/or feet. Symptoms of motor neuropathy include weakness and difficulty walking. Patients experiencing new or worsening peripheral neuropathy may require a delay, change in dose, or discontinuation of ADCETRIS (see DOSAGE AND ADMINISTRATION). Progressive multifocal leukoencephalopathy JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with ADCETRIS. Contributing factors may include prior therapies and underlying disease that may cause immunosuppression. Consider the diagnosis of PML in any patient presenting with new-onset signs and symptoms of central nervous system abnormalities. These symptoms include confusion or problems thinking, loss of balance or problems walking, difficulty speaking, decreased strength or weakness on one side of the body, blurred vision or loss of vision. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture or brain biopsy. Hold ADCETRIS dosing for any suspected case of PML and discontinue ADCETRIS dosing if a diagnosis of PML is confirmed. ADCETRIS Product Monograph Page 9 of 45

10 Pulmonary Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary toxicity. In a clinical trial that studied ADCETRIS with bleomycin as part of a combination regimen, the rate of non-infectious pulmonary toxicity was higher than the historical incidence reported with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Patients typically reported cough and dyspnea. Interstitial infiltration and/or inflammation were observed on radiographs and computed tomographic imaging of the chest. Most patients responded to corticosteroids. One patient in the clinical trial experienced fatal lung toxicity. Cases of pulmonary toxicity have been reported in patients receiving single-agent ADCETRIS. Although a causal association with single-agent ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately. Tumor Lysis Syndrome Tumor lysis syndrome may occur. Patients with rapidly proliferating tumor and high tumor burden may be at increased risk of tumor lysis syndrome. Symptoms of tumor lysis syndrome include nausea, vomiting, edema (swelling), shortness of breath, heart rhythm disturbances, and acute renal failure. Monitor closely and take appropriate measures. Special Populations Pregnant Women There are no adequate and well-controlled studies performed with ADCETRIS in pregnant women. However, based on its mechanism of action and findings in animals, ADCETRIS can cause fetal harm when administered to a pregnant woman. Brentuximab vedotin caused embryofetal toxicities including increased early resorption, post-implantation loss, decreased numbers of live fetuses, and external malformations (i.e., umbilical hernias and malrotated hindlimbs) in animals at maternal exposures that were similar to human exposures at the recommended doses for patients with HL and salcl. Brentuximab vedotin and MMAE were both shown to cross the placenta in this study (see Part II, Developmental and Reproductive Toxicity). For women of childbearing potential, precautions should be taken to avoid pregnancy and at least two contraceptive methods should be used while taking ADCETRIS and for 6 months after completing therapy. If pregnancy occurs, the physician should be immediately informed. ADCETRIS should not be administered to pregnant women unless the possible benefits to the mother outweigh the risks to the fetus. If this drug is used during pregnancy, or if the patient ADCETRIS Product Monograph Page 10 of 45

11 becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. See the fertility section below pertaining to advice for women whose male partners are being treated with ADCETRIS. Nursing Women It is not known whether brentuximab vedotin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ADCETRIS a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Fertility It is not known if ADCETRIS will affect human spermatogenesis. In non-clinical studies, brentuximab vedotin resulted in testicular toxicity which was partially resolved 16-weeks post last dose administration. Therefore, due to this potential risk, men should be advised not to impregnate their partner during treatment with ADCETRIS. Men of reproductive potential should use an appropriate method of barrier contraception throughout treatment with ADCETRIS and for at least 6 months after completing therapy (see Developmental and Reproductive Toxicity: Impairment of Fertility). Pediatrics (<18 years of age) The safety and efficacy of ADCETRIS have not been established in the pediatric population. Clinical trials of ADCETRIS included only 9 pediatric patients and this number is not sufficient to determine whether they respond differently than adult patients (see ACTION AND CLINICAL PHARMACOLOGY). Geriatrics ( 65 years of age) The safety and efficacy of ADCETRIS have not been established in the geriatric population. Clinical trials of ADCETRIS included 17 geriatric patients and this number is not sufficient to determine whether they respond differently than younger patients (see ACTION AND CLINICAL PHARMACOLOGY). Renal impairment The kidney is a route of excretion for MMAE. MMAE exposure is increased in patients with severe renal impairment (creatinine clearance <30 ml/min) (see ACTION AND CLINICAL PHARMACOLOGY). Hepatic impairment The liver is a route of clearance for MMAE. MMAE exposure is increased in patients with hepatic impairment (see ACTION AND CLINICAL PHARMACOLOGY). ADCETRIS Product Monograph Page 11 of 45

12 Monitoring and Laboratory Tests Complete blood counts should be monitored prior to each dose of ADCETRIS and more frequent monitoring should be considered for patients with Grade 3 or 4 neutropenia or thrombocytopenia. NOC/c ADVERSE REACTIONS Adverse Drug Reaction Overview ADCETRIS was studied as monotherapy in 160 patients in two phase II trials. Across both trials, the most common adverse reactions ( 20%), regardless of causality, were peripheral sensory neuropathy, fatigue, nausea, diarrhea, anemia, pyrexia, upper respiratory tract infection, neutropenia, vomiting and cough. The most common adverse reactions occurring in at least 2 patients in either trial, regardless of causality, using the NCI Common Toxicity Criteria Version 3.0, are shown in Table 1. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. ADCETRIS was studied in 102 patients with HL and 58 patients with salcl in single arm pivotal, phase II trials in which the recommended starting dose and schedule was 1.8 mg/kg intravenously every 3 weeks for a maximum of 16 cycles. Median durations of treatment were 27 weeks (range, 3 to 56 weeks) and 23.5 weeks (range, 3 to 75 weeks) for the HL and salcl studies, respectively (see Clinical Trials section). The treatment-emergent adverse reactions that occurred in 20% of HL patients were: leukopenia (61%), neutropenia (54%), peripheral sensory neuropathy (52%), upper respiratory tract infection (47%), fatigue (46%), nausea (42%), diarrhea (36%), anemia (33%), pyrexia (29%), thrombocytopenia (28%), lymphopenia (24%), vomiting (22%), and cough (21%). Grade 3 treatment-emergent adverse reactions that occurred in more than 2% of patients included neutropenia (15%), peripheral sensory neuropathy (9%), anemia (8%), thrombocytopenia (7%), lymphopenia (7%), leukopenia (6%), and peripheral motor neuropathy (4%). Grade 4 treatmentemergent adverse reactions included neutropenia (6%), thrombocytopenia (2%), anemia (2%), abdominal pain (1%) and lymphopenia (1%). ADCETRIS Product Monograph Page 12 of 45

13 The treatment-emergent adverse reactions that occurred in 20% of systemic ALCL patients were: neutropenia (64%), leukopenia (52%), peripheral sensory neuropathy (52%), nausea (40%), fatigue (38%), pyrexia (34%), anemia (33%), diarrhea (29%), upper respiratory tract infection (28%), lymphopenia (26%), rash (24%), thrombocytopenia (24%), and constipation (22%). Grade 3 treatment-emergent adverse reactions that occurred in more than 3% of patients included neutropenia (16%), peripheral sensory neuropathy (16%), lymphopenia (10%), thrombocytopenia (9%), anemia (7%) and peripheral motor neuropathy (7%). Grade 4 treatmentemergent adverse reactions included neutropenia (9%), thrombocytopenia (5%), fatigue, leukopenia, lymphopenia, pain in extremity, and pain (1 patient, 2% each). Table 1: Commonly Reported (at least 2 patients in either trial) Adverse Reactions System Organ Class Preferred Term HL Total N = 102 n (%) of patients Any Grade 3 Grade 4 Grade salcl Total N = 58 n (%) of patients Any Grade 3 Grade 4 Grade Blood and lymphatic system disorders a Leukopenia 62 (61) 6 (6) - 30 (52) 2 (3) 1 (2) Neutropenia 55 (54) 15 (15) 6 (6) 37 (64) 9 (16) 5 (9) Anemia 34 (33) 8 (8) 2 (2) 19 (33) 4 (7) - Thrombocytopenia 29 (28) 7 (7) 2 (2) 14 (24) 5 (9) 3 (5) Lymphopenia 24 (24) 7 (7) 1 (1) 15 (26) 6 (10) 1 (2) Lymphadenopathy 11 (11) (10) - - Nervous system disorders Peripheral sensory neuropathy b 53 (52) 9 (9) - 30 (52) 9 (16) - Headache 19 (19) (19) 1 (2) - Peripheral motor neuropathy c 16 (16) 4 (4) - 5 (9) 4 (7) - Dizziness 11 (11) (16) - - Memory impairment 1 (1) (5) - - Dysgeusia 2 (2) (2) - - Restless legs syndrome 3 (3) Syncope 2 (2) 2 (2) - 1 (2) - 1 (2) Lethargy (3) - - Somnolence (3) - - General disorders and administration site conditions Fatigue 47 (46) 2 (2) - 22 (38) 2 (3) 1 (2) Pyrexia 30 (29) 2 (2) - 20 (34) 1 (2) - Chills 13 (13) (14) - - Pain 7 (7) (10) - 1 (2) Edema peripheral 4 (4) (14) - - ADCETRIS Product Monograph Page 13 of 45

14 System Organ Class Preferred Term HL Total N = 102 n (%) of patients Any Grade 3 Grade 4 Grade salcl Total N = 58 n (%) of patients Any Grade 3 Grade 4 Grade Asthenia 4 (4) 1 (1) - 5 (9) - - Chest discomfort 3 (3) Influenza like illness 2 (2) (2) - - Non-cardiac chest pain 3 (3) 1 (1) Edema 2 (2) (2) - - Malaise 2 (2) Gastrointestinal disorders Nausea 43 (42) (40) 1 (2) - Diarrhea 37 (36) 1 (1) - 17 (29) 2 (3) - Vomiting 22 (22) (17) 2 (3) - Abdominal pain 17 (17) 1 (1) 1 (1) 5 (9) 1 (2) - Constipation 16 (16) (22) 1 (2) - Dyspepsia 5 (5) (9) - - Abdominal pain upper 6 (6) 1 (1) - 2 (3) - - Abdominal distension 4 (4) (5) - - Stomatitis 4 (4) (3) - - Dry mouth 4 (4) (2) - - Oral pain (9) - - Flatulence 3 (3) (2) - - Gastroesophageal reflux disease 1 (1) (5) - - Hemorrhoids 1 (1) (5) - - Toothache 2 (2) (3) - - Dysphagia 1 (1) (3) 1 (2) - Epigastric discomfort 3 (3) Gastritis 3 (3) Hematemesis 3 (3) 1 (1) Hiatus hernia 3 (3) Infections and infestations Upper respiratory tract 48 (47) (28) - - infection d Bronchitis 9 (9) (5) - - Urinary tract infection 6 (6) 1 (1) - 3 (5) 2 (3) - Herpes zoster 7 (7) (2) - - ADCETRIS Product Monograph Page 14 of 45

15 System Organ Class Preferred Term HL Total N = 102 n (%) of patients Any Grade 3 Grade 4 Grade salcl Total N = 58 n (%) of patients Any Grade 3 Grade 4 Grade Folliculitis (9) - - Influenza 5 (5) Pneumonia 4 (4) 1 (1) - 1 (2) 1 (2) - Herpes simplex 3 (3) (2) - - Candidiasis 3 (3) Cellulitis 1 (1) (3) 1 (2) - Ear infection 1 (1) (3) - - Fungal infection 3 (3) Fungal skin infection 2 (2) (2) - - Septic shock 1 (1) - 1 (1) 2 (3) 1 (2) - Oral candidiasis (3) - - Paronychia 2 (2) Pyelonephritis 2 (2) 2 (2) Respiratory, thoracic and mediastinal disorders Cough 21 (21) (17) - - Dyspnea 13 (13) 1 (1) - 11 (19) 1 (2) - Oropharyngeal pain 11 (11) (7) - - Productive cough 6 (6) (5) - - Nasal congestion 6 (6) (2) - - Epistaxis 2 (2) (3) - - Dyspnea exertional 2 (2) (2) - - Pneumonitis 3 (3) 1 (1) 1 (1) Pulmonary embolism 2 (2) - 2 (2) 1 (2) 1 (2) - Rhinorrhoea 1 (1) (3) - - Dysphonia 2 (2) Hemoptysis 2 (2) 1 (1) Lung disorder 2 (2) Pneumothorax 2 (2) 1 (1) Throat tightness 2 (2) Skin and subcutaneous tissue disorders Rash 14 (14) (24) - - ADCETRIS Product Monograph Page 15 of 45

16 System Organ Class Preferred Term HL Total N = 102 n (%) of patients Any Grade 3 Grade 4 Grade salcl Total N = 58 n (%) of patients Any Grade 3 Grade 4 Grade Pruritus 16 (16) (19) - - Alopecia 13 (13) (14) - - Night sweats 12 (12) (7) - - Dry skin 4 (4) (10) - - Hyperhidrosis 6 (6) (2) - - Rash pruritic 3 (3) (7) - - Rash erythematous 4 (4) (3) - - Erythema 4 (4) (2) - - Rash maculo-papular 4 (4) (2) - - Dermatitis (7) 1 (2) - Ecchymosis 2 (2) (2) - - Rash papular 2 (2) (2) 1 (2) - Skin lesion 1 (1) (3) - - Urticaria 2 (2) (2) - - Rash macular 2 (2) Skin exfoliation (3) - - Musculoskeletal and connective tissue disorders Myalgia 17 (17) (16) 1 (2) - Arthralgia 19 (19) (9) - - Back pain 14 (14) (9) 1 (2) - Pain in extremity 10 (10) (14) 1 (2) 1 (2) Muscle spasms 9 (9) (14) 1 (2) - Neck pain 6 (6) (9) 1 (2) - Bone pain 8 (8) 1 (1) - 2 (3) - - Groin pain 4 (4) (9) - - Musculoskeletal pain 5 (5) (7) 1 (2) - Musculoskeletal chest pain 3 (3) (2) - - Flank pain 2 (2) Psychiatric disorders Insomnia 14 (14) (16) - - Anxiety 11 (11) 2 (2) - 4 (7) - - Depression 8 (8) (7) 1 (2) - Confusional state 1 (1) (5) 1 (2) - ADCETRIS Product Monograph Page 16 of 45

17 System Organ Class Preferred Term HL Total N = 102 n (%) of patients Any Grade 3 Grade 4 Grade salcl Total N = 58 n (%) of patients Any Grade 3 Grade 4 Grade Mental status changes 1 (1) (3) - 1 (2) Panic attack 2 (2) Metabolism and nutrition disorders Decreased appetite 11 (11) (16) 1 (2) - Hyperglycemia 6 (6) 4 (4) - 3 (5) 1 (2) - Hypokalemia 2 (2) 1 (1) - 5 (9) 2 (3) - Dehydration 3 (3) (5) 1 (2) - Hypomagnesemia 2 (2) (5) - - Fluid overload (3) 1 (2) - Hypophosphatemia (3) 1 (2) - Investigations Weight decreased 6 (6) (14) 2 (3) - Weight increased 2 (2) (3) - - Alanine aminotransferase increased 2 (2) 1 (1) - 1 (2) - 1 (2) Transaminases increased 1 (1) 1 (1) - 2 (3) 1 (2) - Vascular disorders Hot flush 5 (5) (5) - - Hypotension 2 (2) (3) - - Flushing 2 (2) (2) - - Hypertension 2 (2) 1 (1) - 1 (2) 1 (2) - Deep vein thrombosis (3) 2 (3) - Neoplasms benign, malignant and unspecified (including cysts and polyps) Hodgkin's disease recurrent 7 (7) 1 (1) Tumor flare 1 (1) (9) - 1 (2) Anaplastic large cell lymphoma t- and null-cell types recurrent (5) - - Diffuse large b-cell lymphoma 2 (2) Mycosis fungoides (3) 2 (3) - Cardiac disorders Tachycardia 2 (2) (5) - - Bradycardia 1 (1) (3) - 1 (2) Eye disorders Cataract 2 (2) (2) - - Dry eye 2 (2) (2) - - ADCETRIS Product Monograph Page 17 of 45

18 System Organ Class Preferred Term HL Total N = 102 n (%) of patients Any Grade 3 Grade 4 Grade salcl Total N = 58 n (%) of patients Any Grade 3 Grade 4 Grade Vision blurred 1 (1) (3) 1 (2) - Ocular hyperemia (3) - - Injury, poisoning and procedural complications Contusion 2 (2) (2) - - Excoriation (5) - - Arthropod bite 2 (2) Ear and labyrinth disorders Deafness (3) - - Ear congestion (3) - - Renal and urinary disorders Dysuria (3) - - Reproductive system and breast disorders Erectile dysfunction 2 (2) Vaginal hemorrhage 2 (2) a includes adverse reactions and laboratory abnormalities b includes peripheral sensory neuropathy, paresthesia, neuralgia, hyperesthesia, hypoesthesia, and burning sensation c includes peripheral motor neuropathy, demyelinating polyneuropathy, muscular weakness, and polyneuropathy d includes terms upper respiratory tract infection, sinusitis, nasopharyngitis, rhinitis, viral upper respiratory tract infection, and acute sinusitis Infusion reactions Two cases of anaphylaxis were reported in phase 1 trials. There were no Grade 3 or 4 infusionrelated reactions reported in the pivotal trials, however, Grade 1 or 2 infusion-related reactions were reported for 12 HL patients (12%) and 5 salcl patients (9%). The adverse reactions that were associated with infusion-related reactions in HL patients were chills (5%), nausea (4%), dyspnoea (4%), pruritus (4%), cough (3%), erythema (2%), flushing (2%), throat tightness (2%) and in 1 patient each, dizziness, pyrexia, rash, vomiting, back pain, dyspepsia, dysphagia, hypoaesthesia facial, oropharyngeal pain, and urticaria. The adverse reactions that were associated with infusion-related reactions in salcl patients were chills, nausea, dizziness, pyrexia, rash, vomiting, diarrhea and local neck swelling each of which occurred in 1 patient. ADCETRIS Product Monograph Page 18 of 45

19 Cardiac Adverse Reactions In the phase 2 salcl trial, four patients experienced serious cardiac adverse events. Of these, one patient with a history of severe cardiac disease experienced a myocardial infarction while on study therapy. The potential cardiac toxicity of ADCETRIS is unknown, and patients with significant pre-existing cardiac conditions should be monitored closely. Serious adverse reactions In the HL pivotal trial, serious adverse reactions, regardless of causality, were reported in 25 (25%) of patients receiving ADCETRIS. In the salcl pivotal trial, serious adverse reactions, regardless of causality, were reported in 25 (43%) of patients receiving ADCETRIS. The serious adverse reactions experienced by 2 HL patients were abdominal pain, pulmonary embolism, demyelinating polyneuropathy, pneumonitis, pneumothorax, pyelonephritis, and pyrexia. The serious adverse reactions experienced by at least 2 salcl patients were ALCL recurrent in 3 patients, and septic shock, supraventricular arrhythmia, pain in extremity, and urinary tract infection each in 2 patients. Other important serious adverse reactions reported in patients receiving ADCETRIS included one case of Stevens-Johnson syndrome in an HL patient and one case of tumor lysis syndrome in an salcl patient. Dose modifications Adverse reactions that led to dose reductions in at least 2 HL patients included peripheral sensory neuropathy (10%). Adverse reactions that led to dose delays in at least 2 HL patients included neutropenia (16%), peripheral sensory neuropathy (13%), thrombocytopenia (4%), upper respiratory tract infection, alanine aminotransferase increased, herpes zoster, influenza, lymphadenopathy and pyelonephritis (2%). Adverse reactions that led to dose reductions in at least 2 salcl patients included peripheral sensory neuropathy (10%). Adverse reactions that led to dose delays in at least 2 salcl patients included peripheral sensory neuropathy (14%), neutropenia (12%), and thrombocytopenia (5%). Discontinuations Adverse reactions that led to treatment discontinuation in at least 2 patients with HL were peripheral sensory neuropathy (6%), peripheral motor neuropathy (3%) and Hodgkin s disease recurrent (2%). The adverse reaction that led to treatment discontinuation in patients with salcl was peripheral sensory neuropathy (12%). ADCETRIS Product Monograph Page 19 of 45

20 Deaths In the HL pivotal trial, there were no deaths within 30 days of the last study treatment. In the salcl pivotal trial, 6 deaths occurred within 30 days of the last study treatment and were due to ALCL recurrent (3 patients), acute myocardial infarction and acute renal failure not related to disease (both in 1 patient), respiratory failure secondary to progressive salcl (1 patient) and sudden death (1 patient). Immunogenicity Patients with HL and salcl in the pivotal trials (see Clinical Trials section) were tested for antibodies to brentuximab vedotin every 3 weeks using a sensitive electrochemiluminescent immunoassay. Seven (7) % of patients in these trials developed persistently positive antibodies (positive test at more than 2 timepoints) and 27% of patients developed transiently positive antibodies (positive test at one or two timepoints). One additional patient who tested positive at baseline had persistently positive antibodies. Two patients with persistently positive antibodies experienced adverse events consistent with infusion reactions that led to discontinuation of treatment. Of 59 patients with ATA-positive samples, 31% were negative for the presence of neutralizing antibodies, 63% had at least one sample that was positive for the presence of neutralizing antibodies, and the remainder were of unknown status. A higher incidence of infusion-related reactions was associated with patients who had positive antibodies than those who did not. The effect of anti-brentuximab vedotin antibodies on efficacy and safety has not been established. Less Common Clinical Trial Adverse Drug Reactions (1 patient in either trial) Blood and lymphatic system disorders: anemia of chronic disease, coagulopathy, idiopathic thrombocytopenic purpura, lymph node pain, macrocytosis Cardiac disorders: acute myocardial infarction, arrhythmia supraventricular, atrial fibrillation, atrioventricular block complete, cyanosis Ear and labyrinth disorders: ear discomfort, ear pain, otorrhoea, tinnitus, vertigo, vestibular disorder Endocrine disorders: Addison s disease, hypogonadism, hypothyroidism ADCETRIS Product Monograph Page 20 of 45

PATIENT MEDICATION INFORMATION

PATIENT MEDICATION INFORMATION READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Pr CYRAMZA ramucirumab Read this carefully before you receive CYRAMZA (pronounced "si ram - ze"). This leaflet is a

More information

Dallas Neurosurgical and Spine Associates, P.A Patient Health History

Dallas Neurosurgical and Spine Associates, P.A Patient Health History Dallas Neurosurgical and Spine Associates, P.A Patient Health History DOB: Date: Reason for your visit (Chief complaint): Past Medical History Please check corresponding box if you have ever had any of

More information

IMPORTANT DRUG WARNING Regarding Mycophenolate-Containing Products

IMPORTANT DRUG WARNING Regarding Mycophenolate-Containing Products Dear Healthcare Provider: Mycophenolate REMS (Risk Evaluation and Mitigation Strategy) has been mandated by the FDA (Food and Drug Administration) due to postmarketing reports showing that exposure to

More information

Teriflunomide (Aubagio) 14mg once daily tablet

Teriflunomide (Aubagio) 14mg once daily tablet Teriflunomide (Aubagio) 14mg once daily tablet Exceptional healthcare, personally delivered Your Consultant Neurologist has suggested that you may benefit from treatment with Teriflunomide. The decision

More information

INITIATING ORAL AUBAGIO (teriflunomide) THERAPY

INITIATING ORAL AUBAGIO (teriflunomide) THERAPY FOR YOUR PATIENTS WITH RELAPSING FORMS OF MS INITIATING ORAL AUBAGIO (teriflunomide) THERAPY WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY Severe liver injury including fatal liver failure has been

More information

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. [new-ka la]

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. [new-ka la] READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Pr NUCALA [new-ka la] mepolizumab lyophilized powder for subcutaneous injection Read this carefully before you start

More information

VAERS_ID SYMPTOM1 SYMPTOMVERSION1 SYMPTOM2 SYMPTOMVERSION2 SYMPTOM3 SYMPTOMVERSION3 SYMPTOM4 SYMPTOMVERSION4 SYMPTOM5 SYMPTOMVERSION5 131806

VAERS_ID SYMPTOM1 SYMPTOMVERSION1 SYMPTOM2 SYMPTOMVERSION2 SYMPTOM3 SYMPTOMVERSION3 SYMPTOM4 SYMPTOMVERSION4 SYMPTOM5 SYMPTOMVERSION5 131806 VAERS_ID SYMPTOM1 SYMPTOMVERSION1 SYMPTOM2 SYMPTOMVERSION2 SYMPTOM3 SYMPTOMVERSION3 SYMPTOM4 SYMPTOMVERSION4 SYMPTOM5 SYMPTOMVERSION5 131806 Arthritis 8.10 Dizziness 8.10 Hypertension 8.10 Sinusitis 8.10

More information

Package leaflet: Information for the patient. Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab

Package leaflet: Information for the patient. Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab Package leaflet: Information for the patient Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab This medicine is subject to additional monitoring. This will allow quick identification

More information

Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis

Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis A service of the U.S. National Institutes of Health Trial record 1 of 1 for: CICL670A2202 Previous Study Return to List Next Study Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload

More information

PATIENT HEALTH QUESTIONNAIRE Radiation Oncology (Patient Label)

PATIENT HEALTH QUESTIONNAIRE Radiation Oncology (Patient Label) REVIEWED DATE / INITIALS SAFETY: Are you at risk for falls? Do you have a Pacemaker? Females; Is there a possibility you may be pregnant? ALLERGIES: Do you have any allergies to medications? If, please

More information

calendar Your treatment for VELCADE (bortezomib) For the treatment of patients with multiple myeloma

calendar Your treatment for VELCADE (bortezomib) For the treatment of patients with multiple myeloma For the treatment of patients with multiple myeloma Your treatment calendar for VELCADE (bortezomib) VELCADE (bortezomib) is approved for the treatment of patients with multiple myeloma (a cancer of the

More information

3% Sodium Chloride Injection, USP 5% Sodium Chloride Injection, USP

3% Sodium Chloride Injection, USP 5% Sodium Chloride Injection, USP PRESCRIBING INFORMATION 3% Sodium Chloride Injection, USP 5% Sodium Chloride Injection, USP IV Fluid and Electrolyte Replenisher Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision:

More information

White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other.

White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other. Nausicalm Cyclizine hydrochloride Ph. Eur. 50 mg Presentation White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other. Uses Actions The active ingredient-cyclizine

More information

MANAGEMENT OF COMMON SIDE EFFECTS of INH (Isoniazid), RIF (Rifampin), PZA (Pyrazinamide), and EMB (Ethambutol)

MANAGEMENT OF COMMON SIDE EFFECTS of INH (Isoniazid), RIF (Rifampin), PZA (Pyrazinamide), and EMB (Ethambutol) MANAGEMENT OF COMMON SIDE EFFECTS of INH (Isoniazid), RIF (Rifampin), PZA (Pyrazinamide), and EMB (Ethambutol) 1. Hepatotoxicity: In Active TB Disease a. Background: 1. Among the 4 standard anti-tb drugs,

More information

Eastern Health MS Service. Tysabri Therapy. Information for People with MS and their Families

Eastern Health MS Service. Tysabri Therapy. Information for People with MS and their Families Eastern Health MS Service Tysabri Therapy Information for People with MS and their Families The Eastern Health MS Service has developed this information for you as a guide through what will happen to you

More information

Teriflunomide is the active metabolite of Leflunomide, a drug employed since 1994 for the treatment of rheumatoid arthritis (Baselt, 2011).

Teriflunomide is the active metabolite of Leflunomide, a drug employed since 1994 for the treatment of rheumatoid arthritis (Baselt, 2011). Page 1 of 10 ANALYTE NAME AND STRUCTURE TERIFLUNOMIDE Teriflunomide TRADE NAME Aubagio CATEGORY Antimetabolite TEST CODE PURPOSE Therapeutic Drug Monitoring GENERAL RELEVANCY BACKGROUND sclerosis. The

More information

LEMTRADA REMS Education Program for Prescribers

LEMTRADA REMS Education Program for Prescribers For Prescribers LEMTRADA REMS Education Program for Prescribers This education program includes information about: The LEMTRADA REMS Program requirements Serious risks of autoimmune conditions, infusion

More information

Early Access to Medicines Scheme Treatment protocol Information for patients

Early Access to Medicines Scheme Treatment protocol Information for patients Early Access to Medicines Scheme Treatment protocol Information for patients Introduction The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed

More information

Interpretation of Laboratory Values

Interpretation of Laboratory Values Interpretation of Laboratory Values Konrad J. Dias PT, DPT, CCS Overview Electrolyte imbalances Renal Function Tests Complete Blood Count Coagulation Profile Fluid imbalance Sodium Electrolyte Imbalances

More information

Human Normal Immunoglobulin Solution for Intravenous Infusion.

Human Normal Immunoglobulin Solution for Intravenous Infusion. CONSUMER MEDICINE INFORMATION (CMI) OCTAGAM Human Normal Immunoglobulin Solution for Intravenous Infusion. OCTAGAM is available in single use bottles of 20 ml, 50 ml, 100 ml and 200 ml. OCTAGAM contains

More information

Severe rheumatoid arthritis (a disease that causes inflammation of the joints),where MabThera is given intravenously together with methotrexate.

Severe rheumatoid arthritis (a disease that causes inflammation of the joints),where MabThera is given intravenously together with methotrexate. EMA/614203/2010 EMEA/H/C/000165 EPAR summary for the public rituximab This is a summary of the European public assessment report (EPAR) for. It explains how the Committee for Medicinal Products for Human

More information

IMPORTANT: PLEASE READ

IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION combined hepatitis A (inactivated) and hepatitis B (recombinant) vaccine This leaflet is part III of a three-part "Product Monograph" published when was approved for sale

More information

See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2016 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR

See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2016 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN (mitotane)

More information

Core Safety Profile. Pharmaceutical form(s)/strength: 50mg tablets IE/H/PSUR/0028/002 Date of FAR: 17.07.2013

Core Safety Profile. Pharmaceutical form(s)/strength: 50mg tablets IE/H/PSUR/0028/002 Date of FAR: 17.07.2013 Core Safety Profile Active substance: Naltrexone Hydrochloride Pharmaceutical form(s)/strength: 50mg tablets P-RMS: IE/H/PSUR/0028/002 Date of FAR: 17.07.2013 4.2 Posology and method of administration

More information

Sixth pandemic pharmacovigilance weekly update

Sixth pandemic pharmacovigilance weekly update 13 January 2010 EMA/21345/2010 Patient Health Protection This update has been prepared by the European Medicines Agency to provide a summary of the adverse drug reactions reported after the use of centrally

More information

Preoperative Laboratory and Diagnostic Studies

Preoperative Laboratory and Diagnostic Studies Preoperative Laboratory and Diagnostic Studies Preoperative Labratorey and Diagnostic Studies The concept of standardized testing in all presurgical patients regardless of age or medical condition is no

More information

Oxford University Hospitals. NHS Trust. Department of Neurology Natalizumab (Tysabri) for Multiple Sclerosis. Information for patients

Oxford University Hospitals. NHS Trust. Department of Neurology Natalizumab (Tysabri) for Multiple Sclerosis. Information for patients Oxford University Hospitals NHS Trust Department of Neurology Natalizumab (Tysabri) for Multiple Sclerosis Information for patients page 2 What is Natalizumab and what is it used for? Natalizumab is an

More information

Disease Modifying Therapies for MS

Disease Modifying Therapies for MS Disease Modifying Therapies for MS The term disease-modifying therapy (DMT) means a drug that can modify or change the course of a disease. In other words a DMT should be able to reduce the number of attacks

More information

BILLING AND CODING INFORMATION

BILLING AND CODING INFORMATION Effective April 1, 2016, C-Code for Portrazza: C9475, Injection, necitumumab, 1 mg BILLING AND CODING INFORMATION INDICATION Portrazza (necitumumab) is an epidermal growth factor receptor (EGFR) antagonist

More information

NEW PATIENT HISTORY QUESTIONNAIRE. Physician Initials Date PATIENT INFORMATION

NEW PATIENT HISTORY QUESTIONNAIRE. Physician Initials Date PATIENT INFORMATION NEW PATIENT HISTORY QUESTIONNAIRE Physician Initials Date PATIENT INFORMATION JHH# DOB# AGE HOME PH CELL PH DAY PH EMAIL Who is your REFERRING PHYSICIAN? (The doctor who referred you to Johns Hopkins Neurology.)

More information

Breast Cancer. Breast Cancer Page 1

Breast Cancer. Breast Cancer Page 1 Breast Cancer Summary Breast cancers which are detected early are curable by local treatments. The initial surgery will give the most information about the cancer; such as size or whether the glands (or

More information

What You Need to Know About LEMTRADA (alemtuzumab) Treatment: A Patient Guide

What You Need to Know About LEMTRADA (alemtuzumab) Treatment: A Patient Guide For Patients What You Need to Know About LEMTRADA (alemtuzumab) Treatment: A Patient Guide Patients: Your doctor or nurse will go over this patient guide with you. It is important to ask any questions

More information

Special pediatric considerations are noted when applicable, otherwise adult provisions apply.

Special pediatric considerations are noted when applicable, otherwise adult provisions apply. DRUG NAME: Eribulin SYNONYM(S): Eribulin mesylate COMMON TRADE NAME(S): HALAVEN CLASSIFICATION: antimicrotubule agent Special pediatric considerations are noted when applicable, otherwise adult provisions

More information

PHENYLEPHRINE HYDROCHLORIDE INJECTION USP

PHENYLEPHRINE HYDROCHLORIDE INJECTION USP PRESCRIBING INFORMATION PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10 mg/ml Sandoz Canada Inc. Date of Preparation: September 1992 145 Jules-Léger Date of Revision : January 13, 2011 Boucherville, QC, Canada

More information

This regimen has low emetogenic potential refer to local protocol None required routinely. Baseline results valid for 7 days. Results valid for 72 hrs

This regimen has low emetogenic potential refer to local protocol None required routinely. Baseline results valid for 7 days. Results valid for 72 hrs Regimen : Ipilimumab for Advanced Melanoma ICD10 code Codes pre-fixed with C43. Indication Regimen detail Ipilimumab is recommended as an option for treating advanced (unresectable or metastatic) melanoma

More information

Breast Pathway Group FEC 60 (Fluorouracil / Epirubicin / Cyclophosphamide) in Early Breast Cancer in Elderly / Frail

Breast Pathway Group FEC 60 (Fluorouracil / Epirubicin / Cyclophosphamide) in Early Breast Cancer in Elderly / Frail Breast Pathway Group FEC 60 (Fluorouracil / Epirubicin / Cyclophosphamide) in Early Breast Cancer in Elderly / Frail Indication: Neoadjuvant or adjuvant therapy for elderly and frail patients with breast

More information

A guide to the accelerated elimination procedure

A guide to the accelerated elimination procedure A guide to the accelerated elimination procedure Prescribing information and information on adverse event reporting can be found on the last page. What is the accelerated elimination procedure? An accelerated

More information

MEDICATION GUIDE. PROCRIT (PRO KRIT) (epoetin alfa)

MEDICATION GUIDE. PROCRIT (PRO KRIT) (epoetin alfa) MEDICATION GUIDE PROCRIT (PROKRIT) (epoetin alfa) Read this Medication Guide: before you start PROCRIT. if you are told by your healthcare provider that there is new information about PROCRIT. if you are

More information

UNDERSTANDING HAIR THINNING/HAIR LOSS

UNDERSTANDING HAIR THINNING/HAIR LOSS UNDERSTANDING HAIR THINNING/HAIR LOSS INDICATION AUBAGIO (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. IMPORTANT SAFETY INFORMATION WARNING: HEPATOTOXICITY

More information

MEDICATION GUIDE REMICADE (Rem-eh-kaid) (infliximab) Read the Medication Guide that comes with REMICADE before you receive the first treatment, and

MEDICATION GUIDE REMICADE (Rem-eh-kaid) (infliximab) Read the Medication Guide that comes with REMICADE before you receive the first treatment, and MEDICATION GUIDE REMICADE (Rem-eh-kaid) (infliximab) Read the Medication Guide that comes with REMICADE before you receive the first treatment, and before each time you get a treatment of REMICADE. This

More information

Clinical Presentation (Preclerkship; Year 1 & 2)

Clinical Presentation (Preclerkship; Year 1 & 2) Clinical Presentation (Preclerkship; Year 1 & 2) Definition of a Clinical Presentation A clinical presentation must: Represent a common or important way in which a patient, group of patients, community

More information

QUESTIONS TO ASK MY DOCTOR

QUESTIONS TO ASK MY DOCTOR Be a part of the treatment decision by asking questions QUESTIONS TO ASK MY DOCTOR FOR PATIENTS WITH ADVANCED STOMACH OR GASTROESOPHAGEAL JUNCTION (GEJ) CANCER CYRAMZA (ramucirumab) is used alone or in

More information

Tests / Procedures Date Where was procedure done?

Tests / Procedures Date Where was procedure done? New Patient Worksheet For Appointment Scheduled with: Date: Time: Personal Information (Please PRINT and complete all sections) Patient Name Date of Birth Address Gender M F City St E-mail Zip Phone Cell

More information

Enhancing the Child s Voice in Clinical Care and Research

Enhancing the Child s Voice in Clinical Care and Research Enhancing the Child s Voice in Clinical Care and Research Bryce B. Reeve, Ph.D. Associate Professor, Health Policy and Management Member, Lineberger Comprehensive Cancer Center bbreeve@email.unc.edu Standardized,

More information

Multiple sclerosis disease-modifying drugs second line treatments

Multiple sclerosis disease-modifying drugs second line treatments Great Ormond Street Hospital for Children NHS Foundation Trust: Information for Families Multiple sclerosis disease-modifying drugs second line treatments The following information should be read in conjunction

More information

Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI)

Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI) Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI) Highlights from Prescribing Information - the link to the full text PI is as follows: http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf

More information

I B2.4. Design of the patient information leaflet for VariQuin

I B2.4. Design of the patient information leaflet for VariQuin (English translation of official Dutch version) I B2.4. Design of the patient information leaflet for VariQuin Information for the Patient: Read this package leaflet carefully when you have some time to

More information

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

RISK EVALUATION AND MITIGATION STRATEGY (REMS) Initial REMS Approval: 9/2010 Most Recent Modification: 05/2015 0.5mg capsules Sphingosine 1-phosphate Receptor Modulator Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936 RISK

More information

In non-hodgkin s lymphoma, MabThera is used to treat two types of the disease, both of which affect B-lymphocytes:

In non-hodgkin s lymphoma, MabThera is used to treat two types of the disease, both of which affect B-lymphocytes: EMA/614203/2010 EMEA/H/C/000165 EPAR summary for the public rituximab This is a summary of the European public assessment report (EPAR) for. It explains how the Committee for Medicinal Products for Human

More information

Summary of the risk management plan (RMP) for Ofev (nintedanib)

Summary of the risk management plan (RMP) for Ofev (nintedanib) EMA/738120/2014 Summary of the risk management plan (RMP) for Ofev (nintedanib) This is a summary of the risk management plan (RMP) for Ofev, which details the measures to be taken in order to ensure that

More information

Summary of the risk management plan (RMP) for Accofil (filgrastim)

Summary of the risk management plan (RMP) for Accofil (filgrastim) EMA/475472/2014 Summary of the risk management plan (RMP) for Accofil (filgrastim) This is a summary of the risk management plan (RMP) for Accofil, which details the measures to be taken in order to ensure

More information

SOUTH TAMPA MULTIPLE SCLEROSIS CENTER

SOUTH TAMPA MULTIPLE SCLEROSIS CENTER SOUTH TAMPA MULTIPLE SCLEROSIS CENTER PATIENT/CARE GIVER QUESTIONNAIRE DEMOGRAPHIC INFORMATION Patient's Name: City: State: Zip Code: Phone: Marital Status: Spouse/Care Giver Name: Phone (H) (W) Occupation:

More information

ACTEMRA (tocilizumab) injection, for intravenous use injection, for subcutaneous use Initial U.S. Approval: 2010

ACTEMRA (tocilizumab) injection, for intravenous use injection, for subcutaneous use Initial U.S. Approval: 2010 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA. ACTEMRA (tocilizumab)

More information

Attached from the following page is the press release made by BMS for your information.

Attached from the following page is the press release made by BMS for your information. July 22, 2015 CheckMate -025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early (PRINCETON, NJ, July 20, 2015) Bristol-Myers Squibb Company (NYSE:BMY) announced

More information

Keeping track of your MS relapse symptoms. record your experience. share with your doctor.

Keeping track of your MS relapse symptoms. record your experience. share with your doctor. FROM RELAPSE TO RELIEF Keeping track of your MS relapse symptoms record your experience. share with your doctor. Tracking your MS relapse symptoms No matter what MS relapse treatment you re on or considering,

More information

Importer / Manufacturer: MSD (THAILAND) LTD./ Merck & Co.,Inc., West Point, Pennsylvania 19486 SUMMARY OF PRODUCT CHARACTERISTICS

Importer / Manufacturer: MSD (THAILAND) LTD./ Merck & Co.,Inc., West Point, Pennsylvania 19486 SUMMARY OF PRODUCT CHARACTERISTICS Registration No. 1C 68/47(NC) Importer / Manufacturer: MSD (THAILAND) LTD./ Merck & Co.,Inc., West Point, Pennsylvania 19486 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL PRODUCT VARIVAX [Varicella

More information

Review Of Systems. 1. General Weight Weight 1 year ago Maximum weight When Height Fatigue/Weakness Y P N Fever/Chills Y P N

Review Of Systems. 1. General Weight Weight 1 year ago Maximum weight When Height Fatigue/Weakness Y P N Fever/Chills Y P N Review Of Systems Y N P a condition you have now a condition you have NEVER had a condition you have had in the past Responses and Comments: 1. General Weight Weight 1 year ago Maximum weight When Height

More information

What Medical Emergencies Should a Dental Office be Prepared to Handle?

What Medical Emergencies Should a Dental Office be Prepared to Handle? What Medical Emergencies Should a Dental Office be Prepared to Handle? Gary Cuttrell, DDS, JD, University of NM Division of Dental Services Santiago Macias, MD, First Choice Community Healthcare Dentists

More information

Liver Disease & Hepatitis Program Providers: Brian McMahon, MD, Steve Livingston, MD, Lisa Townshend, ANP. Primary Care Provider:

Liver Disease & Hepatitis Program Providers: Brian McMahon, MD, Steve Livingston, MD, Lisa Townshend, ANP. Primary Care Provider: Liver Disease & Hepatitis Program Providers: Brian McMahon, MD, Steve Livingston, MD, Lisa Townshend, ANP Primary Care Provider: If you are considering hepatitis C treatment, please read this treatment

More information

Medication Guide TASIGNA (ta-sig-na) (nilotinib) Capsules

Medication Guide TASIGNA (ta-sig-na) (nilotinib) Capsules Medication Guide TASIGNA (ta-sig-na) (nilotinib) Capsules Read this Medication Guide before you start taking Tasigna and each time you get a refill. There may be new information. This information does

More information

Candida Questionnaire and Score Sheet. If you d like to know if your health problems are yeast connected, take this comprehensive questionnaire.

Candida Questionnaire and Score Sheet. If you d like to know if your health problems are yeast connected, take this comprehensive questionnaire. Anne Baker CN, LE Nourish Holistic Nutrition Therapy Coach www.nourishholisticnutrition.com nourishnutriton@comcast.net 248 891 5215 Candida Questionnaire and Score Sheet If you d like to know if your

More information

EXHIBIT H SETTLEMENT ELIGIBILITY CRITERIA. a) pharmacy records reflecting the dispensing of Bextra and/or Celebrex to the Class Member; or

EXHIBIT H SETTLEMENT ELIGIBILITY CRITERIA. a) pharmacy records reflecting the dispensing of Bextra and/or Celebrex to the Class Member; or EXHIBIT H SETTLEMENT ELIGIBILITY CRITERIA 1. PRODUCT IDENTIFICATION DOCUMENTATION In order to be eligible for compensation under the Settlement Agreement, each Claimant must provide evidence of the Class

More information

5.07.09. Aubagio. Aubagio (teriflunomide) Description

5.07.09. Aubagio. Aubagio (teriflunomide) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.07.09 Subject: Aubagio Page: 1 of 6 Last Review Date: December 5, 2014 Aubagio Description Aubagio (teriflunomide)

More information

VAD Chemotherapy Regimen for Multiple Myeloma Information for Patients

VAD Chemotherapy Regimen for Multiple Myeloma Information for Patients VAD Chemotherapy Regimen for Multiple Myeloma Information for Patients The Regimen contains: V = vincristine (Oncovin ) A = Adriamycin (doxorubicin) D = Decadron (dexamethasone) How Is This Regimen Given?

More information

POINCIANA INTERNAL MEDICINE PA. Patient Name: Social Security Number: Date of Birth: / / Sex: M/F (Circle One) Married/Single/Divorced/Widow Address:

POINCIANA INTERNAL MEDICINE PA. Patient Name: Social Security Number: Date of Birth: / / Sex: M/F (Circle One) Married/Single/Divorced/Widow Address: Patient Name: Social Security Number: Date of Birth: / / Sex: M/F (Circle One) Married/Single/Divorced/Widow Address: (Street) (City/State/Zip) Home Phone: ( ) E Mail Address: Would you be interested in

More information

Stepping toward a different treatment option LEARN WHAT ACTHAR CAN DO FOR YOU

Stepping toward a different treatment option LEARN WHAT ACTHAR CAN DO FOR YOU FOR MS RELAPSES Stepping toward a different treatment option LEARN WHAT ACTHAR CAN DO FOR YOU As a person with multiple sclerosis (MS), you know firsthand the profound impact MS relapses can have on your

More information

BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA)

BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA) BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA) Protocol Code Tumour Group Contact Physician UBRAVKAD Breast Dr Stephen Chia ELIGIBILITY:

More information

MEDICAL HISTORY AND SCREENING FORM

MEDICAL HISTORY AND SCREENING FORM MEDICAL HISTORY AND SCREENING FORM The purpose of preventive exams is to screen for potential health problems and provide education to promote optimal health. It is best practice for chronic health problems

More information

See 17 for PATIENT COUNSELING INFORMATION. Revised: 11/2015

See 17 for PATIENT COUNSELING INFORMATION. Revised: 11/2015 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CANCIDAS safely and effectively. See full prescribing information for CANCIDAS. CANCIDAS (caspofungin

More information

MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules. What is the most important information I should know about POMALYST?

MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules. What is the most important information I should know about POMALYST? MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules What is the most important information I should know about POMALYST? Before you begin taking POMALYST, you must read and agree to all of

More information

CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early

CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early April 21, 2015 CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early Opdivo Demonstrates Superior Overall Survival Compared to Docetaxel in Patients with Previously-Treated

More information

PATIENT HISTORY FORM

PATIENT HISTORY FORM PATIENT HISTORY FORM If you are new to the office, have not been seen in over one (1) year, or are returning for a new problem, please complete this form in full. If there have been any changes since your

More information

Key Facts about Influenza (Flu) & Flu Vaccine

Key Facts about Influenza (Flu) & Flu Vaccine Key Facts about Influenza (Flu) & Flu Vaccine mouths or noses of people who are nearby. Less often, a person might also get flu by touching a surface or object that has flu virus on it and then touching

More information

Disease Modifying Therapies for MS

Disease Modifying Therapies for MS Disease Modifying Therapies for MS The term disease-modifying therapy means a drug that can modify or change the course of a disease. In other words a DMT should be able to reduce the number of attacks

More information

Patient Medication Guide Brochure

Patient Medication Guide Brochure Patient Medication Guide Brochure 1 MEDICATION GUIDE TASIGNA (ta-sig-na) (nilotinib) Capsules Read this Medication Guide before you start taking TASIGNA and each time you get a refill. There may be new

More information

b. Distinguish between different venues of senior residence c. Advocate the necessity of geriatrics as a true specialty

b. Distinguish between different venues of senior residence c. Advocate the necessity of geriatrics as a true specialty 1. Introduction/ Getting to know our Seniors a. Identify common concepts and key terms used when discussing geriatrics b. Distinguish between different venues of senior residence c. Advocate the necessity

More information

Southwest General Surgical Associates General & Vascular Surgery 8230 Walnut Hill Lane Suite 408 Dallas, TX 75231 Phone-214)369-5432 Fax-214)369-5591

Southwest General Surgical Associates General & Vascular Surgery 8230 Walnut Hill Lane Suite 408 Dallas, TX 75231 Phone-214)369-5432 Fax-214)369-5591 Southwest General Surgical Associates General & Vascular Surgery 8230 Walnut Hill Lane Suite 408 Dallas, TX 75231 Phone-214)369-5432 Fax-214)369-5591 Andres U. Katz, M.D. Richard S. Anderson, M.D. G. Thomas

More information

MEDICATION GUIDE. ACTEMRA (AC-TEM-RA) (tocilizumab) Solution for Intravenous Infusion

MEDICATION GUIDE. ACTEMRA (AC-TEM-RA) (tocilizumab) Solution for Intravenous Infusion MEDICATION GUIDE ACTEMRA (AC-TEM-RA) (tocilizumab) Solution for Intravenous Infusion ACTEMRA (AC-TEM-RA) (tocilizumab) Injection, Solution for Subcutaneous Administration Read this Medication Guide before

More information

Billing and Coding Guide

Billing and Coding Guide Billing and Coding Guide INDICATIONS Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to or have had unsatisfactory

More information

Reference ID: 3793488

Reference ID: 3793488 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABRAXANE safely and effectively. See full prescribing information for ABRAXANE. ABRAXANE for Injectable

More information

ABVD Chemotherapy Regimen for Hodgkin s Disease

ABVD Chemotherapy Regimen for Hodgkin s Disease ABVD Chemotherapy Regimen for Hodgkin s Disease The Regimen Contains: A: doxorubicin (Adriamycin ) B: Bleomycin (Blenoxane ) V: Vinblastine (Velban ) D: Dacarbazine (DTIC-Dome ) How Is This Regimen Given?

More information

Full name DOB Age Address Email Phone numbers (H) (W) (C) Emergency contact Phone

Full name DOB Age Address Email Phone numbers (H) (W) (C) Emergency contact Phone DEMOGRAPHIC INFORMATION Full name DOB Age Address Email Phone numbers (H) (W) (C) Emergency contact Phone CARE INFORMATION Primary care physician: Address Phone Fax Referring physician: Specialty Address

More information

Patient Group Direction Hospital: Bristol Royal Infirmary Department: UHBristol Thrombosis Service University Hospitals Bristol NHS Foundation Trust.

Patient Group Direction Hospital: Bristol Royal Infirmary Department: UHBristol Thrombosis Service University Hospitals Bristol NHS Foundation Trust. Patient Group Direction Hospital: Bristol Royal Infirmary Department: UHBristol Thrombosis Service University Hospitals Bristol NHS Foundation Trust. This Patient Group Direction (PGD) has been written

More information

Transient Hypogammaglobulinemia of Infancy. Chapter 7

Transient Hypogammaglobulinemia of Infancy. Chapter 7 Transient Hypogammaglobulinemia of Infancy Chapter 7 An unborn baby makes no IgG (antibody) and only slowly starts producing it after birth. However, starting at about the sixth month of pregnancy, the

More information

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational Clinical Trial Results Database Page 2 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Psoriasis Approved Indication investigational Clinical Trial Results Database Page 3 Study

More information

* Sections or subsections omitted from the full prescribing information are not listed

* Sections or subsections omitted from the full prescribing information are not listed HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RECLAST safely and effectively. See full prescribing information for RECLAST. Reclast (zoledronic

More information

The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in May 2013.

The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in May 2013. The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in May 2013 Havrix 720 Junior 1 NAME OF THE MEDICINAL PRODUCT Havrix 720 Junior 2 QUALITATIVE

More information

Summary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole)

Summary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole) EMA/303592/2015 Summary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole) This is a summary of the risk management plan (RMP) for Aripiprazole Pharmathen, which details the measures

More information

Inpatient Rotations Goals and Objectives Third and Fourth Years

Inpatient Rotations Goals and Objectives Third and Fourth Years Inpatient Rotations Goals and Objectives Third and Fourth Years Faculty: Members of the LSU Department of Pediatrics Goal: To develop competency in caring for, and supervising care of, infants, children,

More information

ZOVIRAX Cold Sore Cream

ZOVIRAX Cold Sore Cream Data Sheet ZOVIRAX Cold Sore Cream Aciclovir 5% w/w Presentation Topical cream Indications ZOVIRAX Cold Sore Cream is indicated for the treatment of Herpes simplex virus infections of the lips and face

More information

E/M LEVEL WORKSHEET. Category. Subcategory (if applicable) (new/established, etc.)

E/M LEVEL WORKSHEET. Category. Subcategory (if applicable) (new/established, etc.) E/M LEVEL WORKSHEET STEP 1 : IDENTIFY THE CATEGORY AND SUBCATEGORY OF SERVICE Carefully read the documentation. Using the Table of Contents, identify the appropriate category/subcategory. Category Subcategory

More information

LOEWENBERG SCHOOL OF NURSING LOEWENBERG SCHOOL OF NURSING HEALTH EXAMINATION FORM (FORM 003)

LOEWENBERG SCHOOL OF NURSING LOEWENBERG SCHOOL OF NURSING HEALTH EXAMINATION FORM (FORM 003) SECTION I: To be completed by STUDENT: Name: DOB: Address: Phone (H): Phone (C): Health History: Please complete the following information: Recent weight loss or gain Fatigue, fever, sweats Difficulty

More information

Disability Evaluation Under Social Security

Disability Evaluation Under Social Security Disability Evaluation Under Social Security Revised Medical Criteria for Evaluating Endocrine Disorders Effective June 7, 2011 Why a Revision? Social Security revisions reflect: SSA s adjudicative experience.

More information

If you have any concerns about being given this vaccine, ask your doctor or pharmacist.

If you have any concerns about being given this vaccine, ask your doctor or pharmacist. PNEUMOVAX 23 Pneumococcal Vaccine Single Dose Vial/Pre-filled Syringe What is in this leaflet This leaflet answers some common questions about PNEUMOVAX 23. It does not contain all the available information.

More information

Commonly Asked Questions About Chronic Hepatitis C

Commonly Asked Questions About Chronic Hepatitis C Commonly Asked Questions About Chronic Hepatitis C From the American College of Gastroenterology 1. How common is the hepatitis C virus? The hepatitis C virus is the most common cause of chronic viral

More information

The Family Library. Understanding Diabetes

The Family Library. Understanding Diabetes The Family Library Understanding Diabetes What is Diabetes? Diabetes is caused when the body has a problem in making or using insulin. Insulin is a hormone secreted by the pancreas and is needed for the

More information

Progress in MS: Current and Emerging Therapies

Progress in MS: Current and Emerging Therapies Progress in MS: Current and Emerging Therapies Presented by: Dr. Kathryn Giles, MD MSc FRCPC The MS Society gratefully acknowledges the grant received from Biogen Idec Canada, which makes possible the

More information

Medication Guide EQUETRO (ē-kwĕ-trō) (carbamazepine) Extended-Release Capsules

Medication Guide EQUETRO (ē-kwĕ-trō) (carbamazepine) Extended-Release Capsules Medication Guide EQUETRO (ē-kwĕ-trō) (carbamazepine) Extended-Release Capsules Read this Medication Guide before you start taking EQUETRO and each time you get a refill. There may be new information. This

More information