My Treatment Diary Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket. People shown are not actual patients.
Important Contact Information My treatment center My emergency contacts Name Address Phone Name Home phone Cell phone My healthcare team Oncologist Address Phone Emergency phone Oncology nurse Phone Emergency phone Primary care doctor Address Phone Emergency phone Name Home phone Cell phone Name Home phone Cell phone Other contacts Pharmacy Phone Healthcare provider Address Phone Emergency phone Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
WHAT S INSIDE Indications & Important Safety Information... 4 How to Use This Diary... 10 Partnering With Your Healthcare Team... 12 Medicine Record... 16 Tracking Side Effects... 18 Side Effects of ABRAXANE...20 Understanding Blood Counts...26 My Treatment Tracker...30 Use this resource to keep important information in one place throughout your treatment with ABRAXANE. The information in this brochure does not take the place of talking with your doctor about your medical condition or your treatment. Be sure to talk with your healthcare team about any concerns or questions you may have. 3
Indications ABRAXANE is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer. ABRAXANE is a prescription medicine used to treat advanced non small cell lung cancer, in combination with carboplatin, in people who cannot be treated with surgery or radiation. ABRAXANE is a prescription medicine used to treat advanced pancreatic cancer, when used in combination with gemcitabine, as the first medicine you receive for advanced pancreatic cancer. Important Safety Information About ABRAXANE WARNING - LOW WHITE BLOOD CELL COUNT (NEUTROPENIA) Do not take ABRAXANE if your white blood cell count is below 1500 cells/mm 3 (neutropenia), since you may be more likely to get a serious infection. While taking ABRAXANE, you must get regular blood tests to check for any problems that could develop ABRAXANE contains albumin, a substance found in human blood. Do not substitute for or with other paclitaxel formulations 4 Please see Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Who should not receive ABRAXANE? Do not receive ABRAXANE if: your white blood cell count is below 1500 cells/mm 3 you have had a severe allergic reaction to ABRAXANE Serious side effects ABRAXANE may cause serious side effects, including: decreased blood counts. ABRAXANE can cause a severe decrease in neutrophils (a type of white blood cell important in fighting against bacterial infections) and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment Important Safety Information numbness, tingling, pain, or weakness in the hands or feet (neuropathy) severe infection (sepsis). If you receive ABRAXANE in combination with gemcitabine, infections can be severe and lead to death. Tell your doctor right away if you have a fever (temperature of greater than 100.4 F) or develop signs of infection lung or breathing problems. If you receive ABRAXANE in combination with gemcitabine, lung or breathing problems may be severe and can lead to death. Tell your doctor right away if you have a sudden onset of persistent dry cough or shortness of breath allergic (hypersensitivity) reactions, which could be severe and sometimes fatal, have been reported with ABRAXANE 5
Other risks Treatment with ABRAXANE can make liver problems worse. If you have liver problems, your starting dose of ABRAXANE should be lowered or withheld ABRAXANE contains albumin (human), a product of human blood Risks to pregnancy If you are pregnant or become pregnant, ABRAXANE can harm your unborn baby. You should not become pregnant while taking ABRAXANE. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving ABRAXANE If you are a man, you should not father a child during your treatment with ABRAXANE. ABRAXANE can harm the unborn baby of your partner Other possible side effects The most common side effects of ABRAXANE include: hair loss numbness, tingling, pain, or weakness in the hands or feet abnormal heart beat 6 Please see Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
tiredness joint and muscle pain changes in your liver function tests rash low red blood cell count (anemia). Red blood cells carry oxygen to your body tissues. Tell your doctor if you feel weak, tired, or short of breath nausea and vomiting infections. If you have a fever (temperature of greater than 100.4 F) or other signs of infection, tell your doctor right away diarrhea loss of body fluid (dehydration) swelling in the hands or feet Other side effects include vision problems, decreased appetite, kidney problems, constipation, and difficulty breathing In some patients receiving ABRAXANE, severe heart and blood vessel side effects have occurred. These included chest pain, heart attack, fluid under the skin, blood clots in the veins or lungs, high blood pressure, stroke, and heart failure 7
Other important safety information about ABRAXANE You should contact your doctor if you have signs or symptoms of vomiting, diarrhea, dehydration, cough, or breathing difficulties that do not go away, or signs of an allergic reaction. Tell your doctor if you have any other medical conditions Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). You should be monitored by your doctor or nurse during and after you receive ABRAXANE to make sure no problems occur at the injection site. In some cases, these problems occurred 7 to 10 days after the medicine was injected It is not known whether ABRAXANE interacts with other drugs, so be sure to tell your doctor about any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements you are taking Since it is not known if ABRAXANE passes into human milk, you should discuss with your doctor if you should receive ABRAXANE or breastfeed It is not known if ABRAXANE is safe or effective in children ABRAXANE has not been adequately studied in people with severe kidney problems These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088. 8 Please see Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
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How to use this diary Dealing with cancer treatment can be challenging. Knowing what to expect from ABRAXANE, understanding how treatment may affect you, and taking steps to get organized can help you be a more active partner in your care. You can learn more about how ABRAXANE works and what to expect when starting treatment by reading the brochure Your Guide to Treatment With ABRAXANE included in your starter kit. This diary provides tips and tools to help you stay organized and become more aware of how treatment with ABRAXANE may affect you. Important contact information: On the inside front cover, you will find space to write down important contact information for your healthcare team and people you can call on to support you when you need help or have an emergency Taking an active role: On pages 12-15, you will find tips on how to get the help you need from your healthcare team to help with your symptoms and address your concerns Medicine record: On page 17, you will find a space to list all the medicines you are taking Blood count log: On pages 28-29 is a log you can use to keep track of results from your blood tests 10 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Keeping track of your symptoms and medical appointments: On page 30, you will find instructions for using the treatment tracker (beginning on page 34). The calendar pages provided give you space to describe how you are feeling over the course of a month. Bringing this information to your doctor visits can help you remember to mention any symptoms that may be new, worrisome, or getting worse. You can also use these pages to keep track of appointments related to your cancer treatment and other activities you have planned On the inside back cover is a pocket you can use to store copies of your test results and other information you receive from your healthcare team Remember, the information presented here does not take the place of talking with your doctor about your medical condition or your treatment. Be sure to talk with your healthcare team about any concerns or questions you may have. ABRAXANE is a type of chemotherapy that may help slow or prevent the growth of cancer cells. ABRAXANE may also affect normal cells. This may cause side effects. Information about the possible side effects of ABRAXANE can be found on pages 20-25. Working closely with your healthcare team may help you cope with the physical and emotional changes you may experience. 11
Partnering with your healthcare team When you are living with advanced or metastatic (meh-tuh-sta-tik) cancer, you may have symptoms that are caused by your disease or other health problems. Symptoms may also be caused by the side effects of the treatment you are taking for your cancer. These symptoms and side effects may be hard for you to cope with on your own. It is important to know that your doctor, nurse, and other healthcare providers may have tips to help you cope with your symptoms and side effects. In fact, your care team is the best source for medical advice. This can include advice on: Protecting yourself from infections or injury Coping with hair loss and skin changes Stretching, strengthening, or soothing sore muscles and painful joints Balancing activity with rest so that you have more energy for daily tasks Making dietary changes to improve your appetite or control nausea, vomiting, or diarrhea Maintaining a healthy weight and exercising safely Taking medicines to help prevent, treat, or relieve rashes, low blood counts, nausea, or pain 12 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
What your healthcare team needs to know In order for your care team to help you, you have to speak up about how you are feeling. The more specific you can be, the better. To help you when you have side effects, your healthcare team needs to know: When your symptoms occur and how long they last How much they bother you (see instructions for rating your symptoms on page 31) Whether they affect your daily routine or activities If you took any medicines to treat your symptoms If you have any questions or concerns Reporting your symptoms as soon as you notice them may help keep them from getting worse. See page 22 to learn about symptoms and side effects that you should report to your doctor right away while you are taking ABRAXANE. Taking an Active Role Use the tools in this treatment diary to keep track of your medicines, describe your symptoms and side effects, and write down questions to ask your doctor. This can help you get the expert advice you need while you are receiving ABRAXANE. 13
Keeping track of your appointments The calendar pages in the last section of this diary (My Treatment Tracker) can help you keep track of appointments related to your cancer treatment. Keeping this important information in one place may help you remember when you are scheduled for chemotherapy, doctor visits, and tests. It may also help you plan activities for the days when you expect to feel best. Month JUNE SUNDAY MONDAY TUESDAY WEDNESDAY 1 2 Blood test 9:30 AM Bring Treatment Diary 3 4 8 9 10 11 Lunch with Jim 15 16 17 18 22 23 24 25 29 30 14 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
To use the calendar that begins on page 34, fill in the days of the month as shown in the sample below. Then write down: 4 The time of each appointment and what it s for 4 How you are getting to your appointment or who is going with you 4 What you want to bring with you 4 Activities you have planned THURSDAY FRIDAY SATURDAY 11:00 AM Lisa picks me up for 11:30 AM infusion 5 6 Anna s dance recital 7 12 13 14 19 20 21 Dr. Fine 2:00 PM 26 27 28 15
Medicine record In the spaces to the right, write down: The name(s) of your chemotherapy medicine(s) When you will start treatment How often you will have infusions You may also want to keep a record of other medicines you may be taking (such as antinausea medicines). Talk with your doctor if you have questions about your treatment plan. 16 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Chemotherapy medicines Name Start date How often ABRAXANE Other medicines Name What it s for Dose/How often Medicine Record 17
What causes the side effects of chemotherapy? Cancer cells divide quickly and grow out of control. In people with advanced or metastatic cancer, these fast-growing cells may spread to other parts of the body. By stopping cells from dividing, some chemotherapies, like ABRAXANE, may help slow or prevent the growth of cancer cells. And because many chemotherapies are given systemically which means that they travel through the bloodstream they can reach cells in many part of the body, including cancer cells. Chemotherapies like ABRAXANE may also affect healthy cells that grow quickly. These include blood cells as well as cells in the hair, skin, mouth, and digestive tract. Damage to these cells can cause side effects. ABRAXANE may also affect organs such as the kidneys, liver, and heart. Be sure to tell your doctor if you have other medical conditions. Some of the side effects of ABRAXANE can be serious. A list of possible side effects of ABRAXANE can be found on pages 20-25. When taking ABRAXANE, you may experience side effects described in this treatment diary as well as others not listed here. It is not possible to know how you will react to treatment with ABRAXANE, but it is important to know what you may expect. If you have questions about your treatment, talk with your doctor. 18 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Tracking Side Effects Why it s important to keep track of side effects Keeping track of how you feel throughout your treatment with ABRAXANE may make it easier for you to describe your symptoms to your healthcare team. Since side effects are different for each person, it is important to make your doctor and nurse aware of how treatment is affecting you. This will help them give you the best possible advice on how you might cope with any side effects you may experience. 19
ABRAXANE may cause serious side effects Possible side effect Decreased blood counts: Severe drop in neutrophils (NOO-troh-fils), white blood cells (WBCs) that help fight infection Severe drop in platelets (PLAYT-lets) (PLT) that help control bleeding What you may notice If ABRAXANE causes a drop in your WBC count (neutropenia [noo-troh-pee-nee-uh]), you are at greater risk of getting an infection. Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment. If ABRAXANE causes a drop in your PLT count, you may bleed or bruise more easily Neuropathy (noor-ah-puh-thee) Numbness, tingling, pain, or weakness in your hands or feet Severe infection, or sepsis (SEP-sis) If you receive ABRAXANE in combination with gemcitabine for advanced pancreatic cancer, you may develop an infection that can be severe and lead to death. Tell your doctor right away if you have fever (temperature greater than 100.4 F) or develop signs of infection 20 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Possible side effect Lung or breathing problems What you may notice If you receive ABRAXANE in combination with gemcitabine for advanced pancreatic cancer, you may develop lung or breathing problems that may be severe and can lead to death. Tell your doctor right away if you have a sudden onset of persistent dry cough or shortness of breath Allergic reactions, which could be severe and sometimes fatal, have been reported with ABRAXANE Trouble breathing Skin irritations, such as itching or hives Stuffy or runny nose Sneezing Swelling of the neck, lips, tongue, or throat These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or nurse. 21
Know when to call the doctor The treatment tracker on pages 34-45 allows you to keep track of your symptoms over the course of 6 months. But some symptoms that may occur during treatment with ABRAXANE should be reported to your doctor right away or within 24 hours of when you first notice them. Call your doctor right away if you have: A fever of greater than 100.4 F or other signs of infection, such as chills, sore throat, cough, redness, or swelling Signs of an allergic reaction, such as trouble breathing, itching, hives, or swelling of the neck, lips, tongue, or throat Weakness, tiredness, or shortness of breath, especially if it is new or worse than before Nausea that makes it hard to eat or drink or lasts for more than 24 hours and doesn t go away with the medicines you ve been given Diarrhea that lasts for more than 24 hours and doesn t go away with the medicines you ve been given Other side effects to share with your doctor: Numbness, tingling, pain, or weakness in your hands or feet Vomiting Signs of dehydration, such as dry mouth, thirst, dizziness, or having less urine than usual 22 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Ask your doctor if there are other symptoms that should be reported right away. 23
Most common side effects of ABRAXANE Possible side effect Hair loss What you may notice Your hair may start to fall out after you start treatment You may lose hair on your head (scalp, eyebrows, eyelashes) and body Neuropathy You may have numbness, tingling, pain, or weakness in your hands or feet You may feel clumsy or have trouble buttoning your clothes Tiredness Joint and muscle pain Rash You may feel very weary or worn out, even after you rest Your joints or muscles may feel weak or achy You may notice small or large spots on your skin that are flat or raised Your skin may burn or be itchy, red, peeling, or hot Anemia (low red blood cell counts) You may feel short of breath, weak, dizzy, or very tired You may look pale Nausea and vomiting You may feel sick to your stomach or have the urge to throw up You may have no appetite or have trouble keeping food down Infections You may run a fever, your skin may feel hot, and your body may ache 24 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Possible side effect Infections (continued) Diarrhea Dehydration What you may notice You may have other signs of infection, such as chills, sore throat, cough, redness, or swelling You may have loose, watery stools, cramps, bloating, or a sudden urge to have a bowel movement Vomiting, diarrhea, or fever may make it hard for you to keep enough fluid in your body Your mouth may feel dry or sticky You may feel thirsty, dizzy, or very weak Your skin may tent, or stay up, when lightly pinched You may have less urine than usual or it may look dark Swelling (usually in the legs or feet) Your hands, arms, legs, or feet may feel puffy, swollen, or tender Other side effects Other side effects that may occur with ABRAXANE Abnormal heart beat Changes in your liver function tests Vision problems Injection site reactions Decreased appetite Kidney problems Constipation Difficulty breathing 25
Keeping track of your blood counts Your doctor will check your blood cell counts during your treatment with ABRAXANE and after you have stopped your treatment. Your blood cell counts will be checked before each infusion with a blood test called a complete blood count (CBC). The CBC measures the total number of different types of blood cells and other parts of the blood. You may also have other blood tests. Monitoring your blood cell counts helps show if you are at risk for side effects such as anemia, fatigue, or infections. The results of your blood tests can also help show if your doctor needs to change or delay your next dose. The chart on this page and the next page shows common blood tests that you may receive during treatment with ABRAXANE. Be sure to ask your doctor to explain the results of your CBC and other blood tests. You can track your blood counts in the chart on pages 28-29. Or, you may use the back pocket of this diary to store your blood test results. The normal range for blood counts is used as a guideline. Talk to your doctor about what your counts mean. It is not always necessary to treat blood cell counts that are not in the normal range. Your doctor will consider many factors when deciding if treatment is necessary. What is counted What it does Normal range* Complete Blood Count (CBC) Red blood cells (RBC) Hemoglobin (Hgb) Carry oxygen from your lungs to the rest of your body Iron-rich part of the RBC that carries oxygen to the tissues Men: 5 to 6 million cells/mcl (cells per microliter) Women: 4 to 5 million cells/mcl Men: 14 to 17 gm/dl (grams per deciliter) Women: 12 to 15 gm/dl 26 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
What is counted What it does Normal range* Complete Blood Count (CBC) Hematocrit (Hct) White blood cells (WBC) Absolute neutrophil count (ANC) Platelets (PLT) Other Blood Tests Aspartate aminotransferase (AST) [also called serum glutamic-oxaloacetic transaminase (SGOT)] Total bilirubin (TBIL) Measures the percentage of blood made of red blood cells Help fight infections Measures a type of white blood cell that is important in fighting infections Control bleeding and help blood clot Measures the level of a certain enzyme in the blood to check how well your liver is working Checks how well the liver is working by measuring the level of a yellowish substance in the blood that is broken down by the liver *Normal ranges may vary from one lab to another. Men: 41% to 50% Women: 36% to 44% 4,500 to 10,000 cells/mcl 2,500 to 6,000 cells/mcl 140,000 to 450,000 cells/mcl 10 to 34 IU/L (international units per liter) 0.3 to 1.9 mg/dl (milligrams per deciliter) Understanding Blood Counts Your normal ranges may not fall within this chart. Talk to your doctor about what normal is for you. 27
Blood count log Use this form to keep track of your blood counts. Begin by recording your blood counts before you start treatment with ABRAXANE. Then, on the days that you have blood work, write down the test results in the space provided. You may not have all of these tests performed every time you have your blood drawn, or even at all. Date RBC Hgb Hct WBC 6/2 4.4 11.0 33% 6,200 If you receive printouts of your test results, ask your doctor or nurse to show you how to read them. You can also use the back pocket of this diary to store the results of your blood tests. 28 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Key Red blood cells RBC Hemoglobin Hgb Hematocrit Hct White blood cells WBC Absolute neutrophil count ANC Platelets PLT Aspartate aminotransferase AST (SGOT) Total bilirubin TBIL ANC PLT AST (SGOT) TBL 4,500 178,000 24 1.1 29
Keeping track of your symptoms The treatment tracker that starts on page 34 lists the most common symptoms you may experience with ABRAXANE. Some of these symptoms may be caused by side effects of your treatment. You may also have side effects that you do not feel but will show up on blood tests. You may have only some of these symptoms. Or you may have other symptoms that are not listed. You can use the boxes on the calendar pages to write down any symptoms or side effects you may experience. Before filling in the calendar pages, you may want to make copies for later use. Each blank sheet covers a 1-month period. Complete a new sheet for each month that you are in treatment. Try to get in the habit of writing down symptoms or side effects as soon as you notice them. You can also use the calendar pages to help you keep track of your medical appointments and other activities you have planned. 30 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
How to fill out your treatment tracker Start by filling in the month at the top, as shown in the sample on the next page. Read the list of symptoms. For each symptom you notice, think about how much it is affecting you, on a scale of 0-3: 0 1 2 3 Not at all A little Quite a bit A great deal (NONE) (MILD) (MODERATE) (SEVERE) For example, if you have been feeling tired, ask yourself how it has affected your daily routine. If you have been able to do most of your activities but get tired more quickly, you might rate that a 1. If you are so tired that you are spending most of the day in bed, your tiredness would be more severe, so you might rate that a 3. My Treatment Tracker 31
Bring your treatment diary with you when you visit the doctor. But do not wait until you see the doctor if you have a symptom that is severe (rated a 3 ) or troubling. Don t hesitate to reach out to your healthcare team to find out what you may be able to do. Month JUNE SUNDAY MONDAY TUESDAY WEDNESDAY 1 2 Blood test 9:30 AM Bring Treatment Diary 3 4 8 9 10 11 Tired 3 Tired 3 Tired 2 Lunch with Jim 15 16 17 18 Numbness in hands 1 Numbness in hands 1 Numbness in hands 1 22 23 24 25 29 30 32 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
Rating Scale 0 Not at all (NONE) 1 A little (MILD) 2 Quite a bit (MODERATE) 3 A great deal (SEVERE) THURSDAY FRIDAY SATURDAY 11:00 AM Lisa picks me up for 11:30 AM infusion Dr. Fine 2:00 PM 5 12 19 26 Nausea 2 6 13 20 27 7 Nausea 1. Anna s dance recital 14 21 28 Possible Symptoms Numbness, tingling, pain, or weakness in your hands or feet Hair loss Tiredness Joint and muscle pain Rash Shortness of breath Dizziness Nausea Vomiting Decreased appetite Fever, body aches, chills, sore throat, cough, redness, or swelling Diarrhea Dry mouth, thirst, dizziness, or less urine than usual Swelling in the hands, legs, or feet 33
My Treatment Tracker Month SUNDAY MONDAY TUESDAY WEDNESDAY 34 It is important to speak up and share your concerns with your healthcare team. Every question you have is worth asking.
Rating Scale 0 Not at all (NONE) 1 A little (MILD) 2 Quite a bit (MODERATE) 3 A great deal (SEVERE) THURSDAY FRIDAY SATURDAY Possible Symptoms Numbness, tingling, pain, or weakness in your hands or feet Hair loss Tiredness Joint and muscle pain Rash Shortness of breath Dizziness Nausea Vomiting Decreased appetite Fever, body aches, chills, sore throat, cough, redness, or swelling Diarrhea Dry mouth, thirst, dizziness, or less urine than usual Swelling in the hands, legs, or feet 35
My Treatment Tracker Month SUNDAY MONDAY TUESDAY WEDNESDAY 36 Plan activities to look forward to and mark them on your calendar. And try to pace yourself so you have energy for the things you really want to do.
Rating Scale 0 Not at all (NONE) 1 A little (MILD) 2 Quite a bit (MODERATE) 3 A great deal (SEVERE) THURSDAY FRIDAY SATURDAY Possible Symptoms Numbness, tingling, pain, or weakness in your hands or feet Hair loss Tiredness Joint and muscle pain Rash Shortness of breath Dizziness Nausea Vomiting Decreased appetite Fever, body aches, chills, sore throat, cough, redness, or swelling Diarrhea Dry mouth, thirst, dizziness, or less urine than usual Swelling in the hands, legs, or feet 37
My Treatment Tracker Month SUNDAY MONDAY TUESDAY WEDNESDAY 38 Connect with other patients in person, by phone, or online. Sharing your feelings or hearing from others who are facing similar issues may help you feel less alone.
Rating Scale 0 Not at all (NONE) 1 A little (MILD) 2 Quite a bit (MODERATE) 3 A great deal (SEVERE) THURSDAY FRIDAY SATURDAY Possible Symptoms Numbness, tingling, pain, or weakness in your hands or feet Hair loss Tiredness Joint and muscle pain Rash Shortness of breath Dizziness Nausea Vomiting Decreased appetite Fever, body aches, chills, sore throat, cough, redness, or swelling Diarrhea Dry mouth, thirst, dizziness, or less urine than usual Swelling in the hands, legs, or feet 39
My Treatment Tracker Month SUNDAY MONDAY TUESDAY WEDNESDAY 40 Don t be shy about asking for financial support if you need it. There are many resources that may be able to help you find ways to pay for care or other expenses while you are in treatment.
Rating Scale 0 Not at all (NONE) 1 A little (MILD) 2 Quite a bit (MODERATE) 3 A great deal (SEVERE) THURSDAY FRIDAY SATURDAY Possible Symptoms Numbness, tingling, pain, or weakness in your hands or feet Hair loss Tiredness Joint and muscle pain Rash Shortness of breath Dizziness Nausea Vomiting Decreased appetite Fever, body aches, chills, sore throat, cough, redness, or swelling Diarrhea Dry mouth, thirst, dizziness, or less urine than usual Swelling in the hands, legs, or feet 41
My Treatment Tracker Month SUNDAY MONDAY TUESDAY WEDNESDAY 42 Know how to get in touch with your healthcare team when the office is closed. And find out whom to contact to get answers to questions that come up between visits.
Rating Scale 0 Not at all (NONE) 1 A little (MILD) 2 Quite a bit (MODERATE) 3 A great deal (SEVERE) THURSDAY FRIDAY SATURDAY Possible Symptoms Numbness, tingling, pain, or weakness in your hands or feet Hair loss Tiredness Joint and muscle pain Rash Shortness of breath Dizziness Nausea Vomiting Decreased appetite Fever, body aches, chills, sore throat, cough, redness, or swelling Diarrhea Dry mouth, thirst, dizziness, or less urine than usual Swelling in the hands, legs, or feet 43
My Treatment Tracker Month SUNDAY MONDAY TUESDAY WEDNESDAY 44 Take steps to support your health. Ask your healthcare team for advice on eating a well-balanced diet, exercising safely, and maintaining a healthy weight.
Rating Scale 0 Not at all (NONE) 1 A little (MILD) 2 Quite a bit (MODERATE) 3 A great deal (SEVERE) THURSDAY FRIDAY SATURDAY Possible Symptoms Numbness, tingling, pain, or weakness in your hands or feet Hair loss Tiredness Joint and muscle pain Rash Shortness of breath Dizziness Nausea Vomiting Decreased appetite Fever, body aches, chills, sore throat, cough, redness, or swelling Diarrhea Dry mouth, thirst, dizziness, or less urine than usual Swelling in the hands, legs, or feet 45
Notes 46 Please see Important Safety Information on pages 4-9, and Patient Information and full Prescribing Information, including Boxed WARNING, in the back pocket.
This brochure is intended for US audiences only. ABRAXANE is a registered trademark of Celgene Corporation. 2015 Celgene Corporation 09/15 US-ABR140126(1)
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 Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) Initial U.S. Approval: 2005 WARNING: NEUTROPENIA See full prescribing information for complete boxed warning. Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3. (4) It is recommended that frequent peripheral blood cell counts be performed to monitor the occurrence of bone marrow suppression. (4, 5.1, 6.1, 6.2, 6.3) DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. -------------------------- RECENT MAJOR CHANGES -------------------------- Dosage and Administration (2.4, 2.8) 12/2014 Dosage and Administration (2.7) 07/2015 Warnings and Precautions, Hepatic Impairment (5.6) 12/2014 -------------------------- INDICATIONS AND USAGE ---------------------------- ABRAXANE is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (1.1) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. (1.2) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. (1.3) ----------------------- DOSAGE AND ADMINISTRATION ---------------------- Metastatic Breast Cancer: Recommended dosage of ABRAXANE is 260 mg/m 2 intravenously over 30 minutes every 3 weeks. (2.1) Non-Small Cell Lung Cancer: Recommended dosage of ABRAXANE is 100 mg/m 2 intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after ABRAXANE. (2.2) Adenocarcinoma of the Pancreas: Recommended dosage of ABRAXANE is 125 mg/m 2 intravenously over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle; administer gemcitabine on Days 1, 8 and 15 of each 28-day cycle immediately after ABRAXANE. (2.3) Do not administer ABRAXANE to any patient with AST > 10 x ULN or bilirubin > 5 x ULN. Do not administer ABRAXANE to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. For diseases other than metastatic adenocarcinoma of the pancreas, reduce starting dose in patients with moderate to severe hepatic impairment. (2.4) Dose Reductions: Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities. (2.5) Use caution when handling cytotoxic drugs. Closely monitor the infusion site for extravasation and infiltration. No premedication is required prior to administration. (2.6) --------------------- DOSAGE FORMS AND STRENGTHS -------------------- For injectable suspension: lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-use vial for reconstitution. (3) ------------------------------ CONTRAINDICATIONS ----------------------------- Neutrophil counts of < 1,500 cells/mm 3. (4) Severe hypersensitivity reaction to ABRAXANE. (4) ----------------------- WARNINGS AND PRECAUTIONS ---------------------- ABRAXANE causes myelosuppression. Monitor CBC and withhold and/or reduce the dose as needed. (5.1) Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. (5.2) Sepsis occurred in patients with or without neutropenia who received ABRAXANE in combination with gemcitabine; interrupt ABRAXANE and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm 3, then resume treatment at reduced dose levels. (5.3) Pneumonitis occurred with the use of ABRAXANE in combination with gemcitabine; permanently discontinue treatment with ABRAXANE and gemcitabine. (5.4) Severe hypersensitivity reactions with fatal outcome have been reported. Do not re-challenge with this drug. (5.5) Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment; therefore administer with caution. (5.6) ABRAXANE contains albumin derived from human blood, which has a theoretical risk of viral transmission. (5.7) Fetal harm may occur when administered to a pregnant woman. Advise women of childbearing potential to avoid becoming pregnant while receiving ABRAXANE. (5.8) Advise men not to father a child while on ABRAXANE. (5.9) ------------------------------ ADVERSE REACTIONS ----------------------------- The most common adverse reactions ( 20%) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea. (6.1) The most common adverse reactions ( 20%) in NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue. (6.2) The most common ( 20%) adverse reactions of ABRAXANE in adenocarcinoma of the pancreas are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. (6.3) To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------------ DRUG INTERACTIONS ------------------------------ Use caution when concomitantly administering ABRAXANE with inhibitors or inducers of either CYP2C8 or CYP3A4. (7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 07/2015 Reference ID: 3793488 1
FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: NEUTROPENIA 1 INDICATIONS AND USAGE 1.1 Metastatic Breast Cancer 1.2 Non-Small Cell Lung Cancer 1.3 Adenocarcinoma of the Pancreas 2 DOSAGE AND ADMINISTRATION 2.1 Metastatic Breast Cancer 2.2 Non-Small Cell Lung Cancer 2.3 Adenocarcinoma of the Pancreas 2.4 Dosage in Patients with Hepatic Impairment 2.5 Dose Reduction/Discontinuation Recommendations 2.6 Preparation and Administration Precautions 2.7 Preparation for Intravenous Administration 2.8 Stability 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hematologic Effects 5.2 Nervous System 5.3 Sepsis 5.4 Pneumonitis 5.5 Hypersensitivity 5.6 Hepatic Impairment 5.7 Albumin (Human) 5.8 Use in Pregnancy 5.9 Use in Men 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience in Metastatic Breast Cancer 6.2 Clinical Trials Experience in Non-Small Cell Lung Cancer 6.3 Clinical Trials Experience in Adenocarcinoma of the Pancreas 6.4 Postmarketing Experience with ABRAXANE and other Paclitaxel Formulations 6.5 Accidental Exposure 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Patients with Hepatic Impairment 8.7 Patients with Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Metastatic Breast Cancer 14.2 Non-Small Cell Lung Cancer 14.3 Adenocarcinoma of the Pancreas 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 16.3 Handling and Disposal 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the Full Prescribing Information are not listed. Reference ID: 3793488 2
FULL PRESCRIBING INFORMATION ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) WARNING: NEUTROPENIA Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm 3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE [see Contraindications (4), Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2, 6.3)]. Note: An albumin form of paclitaxel may substantially affect a drug s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. 1 INDICATIONS AND USAGE 1.1 Metastatic Breast Cancer ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1.2 Non-Small Cell Lung Cancer ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. 1.3 Adenocarcinoma of the Pancreas ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. 2 DOSAGE AND ADMINISTRATION 2.1 Metastatic Breast Cancer After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for ABRAXANE is 260 mg/m 2 administered intravenously over 30 minutes every 3 weeks. 2.2 Non-Small Cell Lung Cancer The recommended dose of ABRAXANE is 100 mg/m 2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin on Day 1 of each 21 day cycle immediately after ABRAXANE [see Clinical Studies (14.2)]. 2.3 Adenocarcinoma of the Pancreas The recommended dose of ABRAXANE is 125 mg/m 2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. Administer gemcitabine immediately after ABRAXANE on Days 1, 8 and 15 of each 28-day cycle [see Clinical Studies (14.3)]. 2.4 Dosage in Patients with Hepatic Impairment For patients with mild hepatic impairment (total bilirubin greater than ULN and less than or equal to 1.5 x ULN and aspartate aminotransferase [AST] less than or equal to 10 x ULN), no dose adjustments are required, regardless of indication. Do not administer ABRAXANE to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. Do not administer ABRAXANE to patients with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN regardless of indication as these patients have not been studied. Recommendations for dosage adjustment for the first course of therapy are shown in Table 1. Reference ID: 3793488 3
Table 1: Recommendations for Starting Dose in Patients with Hepatic Impairment SGOT (AST) Levels Bilirubin Levels ABRAXANE Dose a MBC NSCLC c Pancreatic c Adenocarcinoma Mild < 10 x ULN AND > ULN to 1. 5 x ULN 260 mg/m 2 100 mg/m 2 125 mg/m 2 Moderate < 10 x ULN AND > 1.5 to 3 x ULN 200 mg/m 2 b 80 mg/m 2 b not recommended Severe < 10 x ULN AND > 3 to 5 x ULN 200 mg/m 2 b 80 mg/m 2 b not recommended > 10 x ULN OR > 5 x ULN not recommended not recommended not recommended MBC = Metastatic Breast Cancer; NSCLC = Non-Small Cell Lung Cancer. a Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance. b A dose increase to 260 mg/m 2 for patients with metastatic breast cancer or 100 mg/m 2 for patients with non-small cell lung cancer in subsequent courses should be considered if the patient tolerates the reduced dose for two cycles. c Patients with bilirubin levels above the upper limit of normal were excluded from clinical trials for pancreatic or lung cancer. 2.5 Dose Reduction/Discontinuation Recommendations Metastatic Breast Cancer Patients who experience severe neutropenia (neutrophils less than 500 cells/mm 3 for a week or longer) or severe sensory neuropathy during ABRAXANE therapy should have dosage reduced to 220 mg/m 2 for subsequent courses of ABRAXANE. For recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m 2. For Grade 3 sensory neuropathy hold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses of ABRAXANE [see Contraindications (4), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)]. Non-Small Cell Lung Cancer Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm 3 and platelet count is at least 100,000 cells/mm 3 [see Contraindications (4), Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. In patients who develop severe neutropenia or thrombocytopenia withhold treatment until counts recover to an absolute neutrophil count of at least 1500 cells/mm 3 and platelet count of at least 100,000 cells/mm 3 on Day 1 or to an absolute neutrophil count of at least 500 cells/mm 3 and platelet count of at least 50,000 cells/mm 3 on Days 8 or 15 of the cycle. Upon resumption of dosing, permanently reduce ABRAXANE and carboplatin doses as outlined in Table 2. Withhold ABRAXANE for Grade 3-4 peripheral neuropathy. Resume ABRAXANE and carboplatin at reduced doses (see Table 2) when peripheral neuropathy improves to Grade 1 or completely resolves [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)]. Table 2: Permanent Dose Reductions for Hematologic and Neurologic Adverse Drug Reactions in NSCLC Adverse Drug Reaction Occurrence Weekly ABRAXANE Dose (mg/m 2 ) Every 3-Week Carboplatin Dose (AUC mg min/ml) Neutropenic Fever (ANC less than 500/mm 3 with fever >38 C) OR Delay of next cycle by more than 7 days for ANC less than 1500/mm 3 OR ANC less than 500/mm 3 for more than 7 days First 75 4.5 Second 50 3 Third Discontinue Treatment First 75 4.5 Second Discontinue Treatment First 75 4.5 Severe sensory Neuropathy Grade 3 or 4 Second 50 3 Third Discontinue Treatment Reference ID: 3793488 4
Adenocarcinoma of the Pancreas Dose level reductions for patients with adenocarcinoma of the pancreas, as referenced in Tables 4 and 5, are provided in Table 3. Table 3: Dose Level Reductions for Patients with Adenocarcinoma of the Pancreas Dose Level ABRAXANE (mg/m 2 ) Gemcitabine (mg/m 2 ) Full dose 125 1000 1 st dose reduction 100 800 2 nd dose reduction 75 600 If additional dose reduction required Discontinue Discontinue Recommended dose modifications for neutropenia and thrombocytopenia for patients with adenocarcinoma of the pancreas are provided in Table 4. Table 4: Dose Recommendation and Modifications for Neutropenia and/or Thrombocytopenia at the Start of a Cycle or within a Cycle for Patients with Adenocarcinoma of the Pancreas Cycle Day ANC (cells/mm 3 ) Platelet count (cells/mm 3 ) ABRAXANE / Gemcitabine Day 1 < 1500 OR < 100,000 Delay doses until recovery Day 8 500 to < 1000 OR 50,000 to < 75,000 Reduce 1 dose level < 500 OR < 50,000 Withhold doses Day 15: If Day 8 doses were reduced or given without modification: 500 to < 1000 OR 50,000 to < 75,000 Reduce 1 dose level from Day 8 < 500 OR < 50,000 Withhold doses Day 15: If Day 8 doses were withheld: 1000 OR 75,000 Reduce 1 dose level from Day 1 500 to < 1000 OR 50,000 to < 75,000 Reduce 2 dose levels from Day 1 < 500 OR < 50,000 Withhold doses ANC = Absolute Neutrophil Count Recommended dose modifications for other adverse drug reactions in patients with adenocarcinoma of the pancreas are provided in Table 5. Table 5: Dose Modifications for Other Adverse Drug Reactions in Patients with Adenocarcinoma of the Pancreas Adverse Drug Reaction ABRAXANE Gemcitabine Febrile Neutropenia: Grade 3 or 4 Withhold until fever resolves and ANC 1500; resume at next lower dose level Peripheral Neuropathy: Grade 3 or 4 Withhold until improves to Grade 1; resume at next lower dose level No dose reduction Cutaneous Toxicity: Grade 2 or 3 Gastrointestinal Toxicity: Grade 3 mucositis or diarrhea Reduce to next lower dose level; discontinue treatment if toxicity persists Withhold until improves to Grade 1; resume at next lower dose level 2.6 Preparation and Administration Precautions ABRAXANE is a cytotoxic drug and, as with other potentially toxic paclitaxel compounds, caution should be exercised in handling ABRAXANE. The use of gloves is recommended. If ABRAXANE (lyophilized cake or reconstituted suspension) contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure to paclitaxel, events may include tingling, burning and redness. If ABRAXANE contacts mucous membranes, the membranes should be flushed thoroughly with water. Reference ID: 3793488 5
Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration. Limiting the infusion of ABRAXANE to 30 minutes, as directed, reduces the likelihood of infusion-related reactions [see Adverse Reactions (6.4)]. Premedication to prevent hypersensitivity reactions is generally not needed prior to the administration of ABRAXANE. Premedication may be needed in patients who have had prior hypersensitivity reactions to ABRAXANE. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be re-challenged with this drug [see Warnings and Precautions (5.5)]. 2.7 Preparation for Intravenous Administration ABRAXANE is supplied as a sterile lyophilized powder for reconstitution before use. AVOID ERRORS, READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION. 1. Aseptically, reconstitute each vial by injecting 20 ml of 0.9% Sodium Chloride Injection, USP. 2. Slowly inject the 20 ml of 0.9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the sterile syringe to direct the solution flow onto the INSIDE WALL OF THE VIAL. 3. DO NOT INJECT the 0.9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this will result in foaming. 4. Once the injection is complete, allow the vial to sit for a minimum of 5 minutes to ensure proper wetting of the lyophilized cake/powder. 5. Gently swirl and/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake/powder occurs. Avoid generation of foam. 6. If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides. Each ml of the reconstituted formulation will contain 5 mg/ml paclitaxel. The reconstituted suspension should be milky and homogenous without visible particulates. If particulates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use. Discard the reconstituted suspension if precipitates are observed. Discard any unused portion. Calculate the exact total dosing volume of 5 mg/ml suspension required for the patient and slowly withdraw the dosing volume of the reconstituted suspension from the vial(s) into a syringe: Dosing volume (ml)=total dose (mg)/5 (mg/ml). Inject the appropriate amount of reconstituted ABRAXANE into an empty, sterile intravenous bag [plasticized polyvinyl chloride (PVC) containers, PVC or non-pvc type intravenous bag]. The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer ABRAXANE infusions. The use of medical devices containing silicone oil as a lubricant (ie, syringes and intravenous bags) to reconstitute and administer ABRAXANE may result in the formation of proteinaceous strands. Visually inspect the reconstituted ABRAXANE suspension in the intravenous bag prior to administration. Discard the reconstituted suspension if proteinaceous strands, particulate matter or discoloration are observed. 2.8 Stability Unopened vials of ABRAXANE are stable until the date indicated on the package when stored between 20ºC to 25ºC (68ºF to 77ºF) in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Stability of Reconstituted Suspension in the Vial Reconstituted ABRAXANE in the vial should be used immediately, but may be refrigerated at 2ºC to 8ºC (36ºF to 46ºF) for a maximum of 24 hours if necessary. If not used immediately, each vial of reconstituted suspension should be replaced in the original carton to protect it from bright light. Discard any unused portion. Stability of Reconstituted Suspension in the Infusion Bag The suspension for infusion when prepared as recommended in an infusion bag should be used immediately, but may be refrigerated at 2 C to 8 C (36 F to 46 F) and protected from bright light for a maximum of 24 hours. The total combined refrigerated storage time of reconstituted ABRAXANE in the vial and in the infusion bag is 24 hours. This may be followed by storage in the infusion bag at ambient temperature (approximately 25 C) and lighting conditions for a maximum of 4 hours. Reference ID: 3793488 6