The following information is designed to support the appropriate prescribing, administration and monitoring of Amfexa 5mg Tablets.

Transcription

1 A physician s guide to prescribing Amfexa 5mg Tablets (dexamfetamine sulphate) Dear Doctor, The following information is designed to support the appropriate prescribing, administration and monitoring of Amfexa 5mg Tablets. Amfexa is a newly launched, branded preparation of dexamfetamine sulphate. Each Amfexa tablet contains 5 mg of dexamfetamine sulphate. The tablets are white round, cloverleaf-shaped tablets with a notched, cross-scored line on the top-side and a cross-scored line on the rear side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Flynn Pharma Ltd. Medical Information by medinfo@flynnpharma.com or by telephone Amfexa is indicated as part of a comprehensive treatment programme for attentiondeficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate treatment is considered clinically inadequate. 1 A comprehensive treatment programme typically includes psychological, educational and social measures. 1 Diagnosis should be made according to DSM-5 criteria or the guidelines in ICD-10 and should be based on a comprehensive multidisciplinary evaluation of the patient. 1 Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine must be based on a very thorough assessment of the severity and chronicity of the child s symptoms in relation to the child s age and potential for abuse, misuse or diversion. 1 Treatment should be under the supervision of a specialist in childhood and/or adolescent behavioural disorders. 1 Current NICE guidance (Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in children, young people and adults; CG72, 2008) indicates that dexamfetamine should be considered in children and young people whose ADHD is unresponsive to a maximum tolerated dose of methylphenidate or atomoxetine. 2 Please consider and use the following information, checklists and advice in addition to the information contained within the Summary of Product Characteristics (SmPC) when initiating, monitoring or ceasing use of Amfexa: Checklist 1: Checklist before prescribing Amfexa 5mg Tablets Checklist 2: Checklist for monitoring of ongoing therapy with Amfexa 5mg Tablets Consideration when ending treatment with Amfexa 5mg Tablets

2 Dexamfetamine is a schedule 2 controlled substance and as such clinicians should be aware of the current legislation and requirements associated with the prescribing of controlled substances. Key prescription requirements include; Name and address of the patient Age (if under 12 years) Dose Form of the medicine (tablet, capsules etc) Strength Total quantity (in both words and numbers) Signature Date (controlled drug prescriptions are only valid for 28 days from appropriate date) Prescriber s address Prescriber type Treatment period Instalment direction More detailed information is available from the Royal Pharmaceutical Society (Medicines, Ethics and Practice section). 3 Potential abuse, dependency, misuse or diversion of dexamfetamine by the patient should be carefully evaluated at every visit. 1 Should you require any further information relating to the use, supply or prescribing of Amfexa please contact Flynn Pharma by phone or by medinfo@flynnpharma.com. Yours faithfully, The Medical Department Flynn Pharma References: 1. Amfexa SmPC, May Accessed October NICE CG72, Accessed October Royal Pharmaceutical Society (Medicines, Ethics and Practice section). Accessed October, 2015

3 Checklist 1: checklist before prescribing Amfexa 5mg Tablets It is recommended that this checklist be used in conjunction with the SmPC for Amfexa 5mg Tablets (which can be accessed at As outlined in the SmPC in more detail, there are some specific concurrent conditions where the use of Amfexa 5mg Tablets is contraindicated. In addition, there are some conditions which require specific special warnings and precautions when Amfexa is used; these include some cardiovascular, cerebrovascular and neuropsychiatric disorders. 1 Blood pressure and pulse should be recorded on a centile chart at each dose adjustment and then at least every 6 months Height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every dose adjustment and then at least every 6 months and at every visit Potential abuse, dependency, misuse or diversion of dexamfetamine by the patient should be carefully evaluated at every visit. 1 Additional information can be found in the SmPC, the specific section of the SmPC to refer to is indicated by the red numbers in the checklist. As you work through the checklist, it may also be useful for you to discuss the Amfexa 5mg Tablets patient information leaflet (PIL) with your patient and their parent(s) or guardian(s) which can be accessed here

4 Date of assessment: Name: Date of birth: Gender: Age: Patients with any of the following conditions, comorbidities and/or co-medications should not receive Amfexa 5mg Tablets : Contraindications 4.3 The following are contraindicated: Evaluated Hypersensitivity to the active substance or any of the excipients listed in section 6.1 Hypersensitivity or idiosyncracy to sympathomimetic amines Glaucoma Phaeochromocytoma Symptomatic cardiovascular disease, structural cardiac abnormalities and/or moderate or severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels). Advanced arteriosclerosis. During or within 14 days after treatment with a monoamine oxidase inhibitor (MAOI) Hyperthyroidism or thyrotoxicosis Severe depression, anorexia nervosa/anorexic disorders, suicidal ideation, hyperexcitability, psychotic symptoms, severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled), schizophrenia, psychopathic/borderline personality disorder Gilles de la Tourette syndrome or similar dystonias Cerebrovascular disorders (cerebral aneurysm, vascular abnormalities including vasculitis or stroke) Porphyria History of drug abuse or alcohol abuse Special warnings and precautions for use (4.4) Before progressing with dexamfetamine treatment, please consider the following prior to treatment with Amfexa 5mg Tablets: Family history Family history of sudden cardiac or unexplained death or malignant arrhythmia Family history of tics or Tourette s syndrome Family history of suicide, bipolar disorder, and depression Evaluated

5 Patient s history and physical exam Baseline evaluation of patient s cardiovascular status, including blood pressure and heart rate. Concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms and accurate recording of pre-treatment height and weight on a growth chart Cardiovascular (view section 4.4) History of cardiovascular disease Known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities or increased blood pressure or heart rate Underlying medical condition which might be compromised by increases in blood pressure or heart rate Psychiatric/neurological disorders (view section 4.4) Pre-existing psychotic or manic symptoms Pre-existing psychiatric disorders Aggressive or hostile behaviour Motor or verbal tics or Tourette s syndrome Anxiety, agitation or tension Depressive symptoms (screen for risk for bipolar disorder by detailed psychiatric history including family history of suicide, bipolar disorder and depression Bipolar disorder Presence of epilepsy. Epileptic patients with history of seizures, prior EEG abnormalities in absence of seizures History of drug dependency or abuse of CNS stimulants History of drug misuse or diversion of CNS stimulants Other medical conditions such as (view section 4.4) Known intolerance to excipients Known renal or hepatic insufficiency Presence of leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders Pregnancy (view section 4.6) Breast feeding (view section 4.6) Potential drug-drug interactions (view section 4.5) Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower the absorption of amfetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amfetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amfetamines Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase the absorption of amfetamines, thereby decreasing urinary excretion and therefore potentiate the actions of amfetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amfetamine molecule, thereby decreasing urinary excretion and therefore potentiate the actions of amfetamines. Clonidine Coumarin anticoagulants

6 Anticonvulsants Antidepressants Antihistamines adrenergic blockers Lithium Alpha-methyltyrosine Haloperidol Disulfiram Vasopressors Antihypertensive drugs Noradrenaline Morphine Meperidine MAO-inhibitors halogenated narcotics Phenothiazines Alcohol Record any additional information here:

7 Checklist 2: checklist for monitoring of ongoing therapy with Amfexa 5mg Tablets As outlined in the SmPC in more detail, growth, psychiatric and cardiovascular status should be regularly monitored. Blood pressure and pulse should be recorded on a centile chart at each dose adjustment and then at least every 6 months Height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every dose adjustment and then at least every 6 months and at every visit Potential abuse, dependency, misuse or diversion of dexamfetamine by the patient should be carefully evaluated at every visit. This checklist should be used in conjunction with the SmPC for Amfexa 5mg Tablets ( Additional information can be found in the SmPC. The specific section of the SmPC to refer to is indicated by the number in red.

8 Date of assessment: Name: Date of birth: Gender: Age: Carefully review the following systems as indicated below at each adjustment of dose and at followup visits at least every 6 months: Evaluated General medical findings (view section 4.4) Document height, body weight and appetite Consider discontinuation of Dexamfetamine if growth is below expectations Document blood pressure and heart rate Document any indication of abuse, dependency, off-label use, misuse or diversion of Amphetamine It is important for clinicians to monitor symptoms and prescription refills for evidence of misuse or diversion of ADHD medication. It is also helpful to have an open discussion about stimulant diversion and misuse with patients and parents so that students can be prepared if they are approached by peers to sell or misuse medications and so that parents can remain vigilant in monitoring medications Pregnancy (view section 4.6) Evaluate benefit/risk if pregnant New cardiovascular findings Palpitations Exceptional chest pain Unexplained syncope Dyspnoea Other symptoms suggestive of cardiac disease Refer for a specialist cardiac evaluation New neurological findings Severe headache, numbness, weakness or paralysis, impairment of coordination, vision, speech, language or memory Any of above conditions may suggest cerebral vasculitis: stop Dexamfetamine (view section 4.4) Seizure frequency increase or new-onset seizures Amphetamine should be discontinued (view section 4.4) New psychiatric findings or worsening thereof (view section 4.4) Psychotic or manic symptoms Consider discontinuation of Dexamfetamine Suicidal ideation or behaviour Consider treatment of underlying of psychiatric condition, re-evaluate benefit/risk, consider discontinuation of Dexamfetamine Aggressive and hostile behaviour Consider the need for adjustment of treatment: verify that the dose is appropriate and that the medication is being administered as prescribed. If so, discontinue the stimulant; stimulant medications can be discontinued abruptly, without tapering. Referral to a qualified mental health specialist or psycho-pharmacologist may be warranted to assess for bipolar disorder or a thought disorder

9 Anxiety, agitation or tension Consider the need for adjustment of treatment Depressive symptoms Consider the need for adjustment of treatment Motor or verbal tics or worsening thereof Consider the need for adjustment of treatment: Conduct a drug trial at different doses, including no medication, to be sure that tics are drug-related; if tics abate on no medication, reconsider the risks and benefits of treatment with the patient and family Growth Patient not growing or gaining weight or height as expected Consider interruption of treatment or discontinuation of treatment if growth is below expectations. Treatment duration (view section 4.2 and 4.4) No improvement in symptoms after appropriate dosage adjustment over a 1-month period is observed Consider discontinuation of Dexametamine Patient is being treated continuously for >12 months Consider interruption of treatment: The duration of pharmacologic therapy is highly individualized. Ongoing evaluation of the risks and benefits of medication is necessary for each patient Record any additional information here:

10 Considerations when ending treatment with Amfexa 5mg Tablets To prevent unsupervised termination of medication, the procedures for a trial period off medicine should be discussed routinely with patients. Regular assessment and monitoring of behaviour through formal ratings appears to decrease the rate of unsupervised termination of medications. After years of medication, it is reasonable to offer children and adolescents who have had stable improvement in ADHD symptoms and target behaviours a trial off of medication to determine whether medication is still necessary. Such a trial should be undertaken with close monitoring of core symptoms and function at home, school, and in the community Careful supervision is required during dexamfetamine withdrawal, since this may unmask depression as well as chronic hyperactivity. Some patients may require long-term follow-up. If you have any questions relating to this mediation please contact Flynn Pharma Ltd medinfo@flynnpharma.com