Avonex, INN- Interferon Beta-1A

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 AVONEX 30µg (Interferon beta-1a) Flip-off presentation 1. NAME OF THE MEDICINAL PRODUCT AVONEX 30 µg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AVONEX (Interferon beta-1a) contains a 30 µg (6 million IU) dose of Interferon beta-1a per vial. Using the World Health Organisation (WHO) natural interferon beta standard, Second International Standard for Interferon, Human Fibroblast (Gb-23-902-531), 30 µg of AVONEX contains 6 million IU of antiviral activity. The activity against other standards is not known. 3. PHARMACEUTICAL FORM AVONEX (Interferon beta-1a) is a powder and solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications AVONEX (Interferon beta-1a) is indicated for the treatment of ambulatory patients with relapsing multiple sclerosis (MS) characterized by at least 2 recurrent attacks of neurologic dysfunction (relapses) over the preceding 3-year period without evidence of continuous progression between relapses. AVONEX slows the progression of disability and decreases the frequency of relapses. AVONEX is also indicated for the treatment of patients who have experienced a single demyelinating event with an active inflammatory process if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1). AVONEX should be discontinued in patients who develop progressive multiple sclerosis. 4.2 Posology and method of administration The recommended dosage of AVONEX (Interferon beta-1a) for the treatment of relapsing MS is 30 µg injected (1 ml solution) IM once a week (see 6.6 Instructions for use and handling and disposal) and no additional benefit has been shown by administering a higher dose (60µg) once a week. Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. There is no experience with AVONEX in patients aged 16 years or less. Therefore, AVONEX should not be used in children. The IM injection site should be varied each week (see 5.3 Preclinical safety data). Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with AVONEX administration. These symptoms are usually present during the first few months of treatment. 2 At the present time, it is not known for how long patients should be treated. Patients should be clinically evaluated after 2 years of treatment and longer-term treatment should be decided on an individual basis by the treating physician. Treatment should be discontinued if the patient develops chronic progressive multiple sclerosis. 4.3 Contraindications AVONEX (Interferon beta-1a) is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human serum albumin or any other component of the formulation. AVONEX is contraindicated in pregnant patients (also see 4.6 Use during pregnancy and lactation), patients with severe depressive disorders and/or suicidal ideation and in epileptic patients with a history of seizures not adequately controlled by treatment. 4.4 Special warnings and special precautions for use Patients should be informed of the most common adverse events associated with interferon beta administration, including symptoms of the flu-like syndrome (see 4.8 Undesirable effects). These symptoms tend to be most prominent at the initiation of therapy and decrease in frequency and severity with continued treatment. AVONEX, as other interferons, should be used with caution in patients with depression or other mood disorders, conditions that are common with multiple sclerosis. Depression has been reported in association with AVONEX use and it may occur at any time during treatment. Patients treated with AVONEX should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician. Patients exhibiting depression should be monitored closely during therapy with AVONEX and treated appropriately. Cessation of therapy should be considered. Caution should be exercised when administering AVONEX to patients with pre-existing seizure disorder. For patients without a pre-existing seizure disorder who develop seizures during therapy with AVONEX, an etiologic basis should be established and appropriate anti-convulsant therapy instituted prior to resuming AVONEX treatment. Caution should be used and close monitoring considered when administering AVONEX to patients with severe renal and hepatic failure and to patients with severe myelosuppression. Hepatic injury including elevated serum hepatic enzyme levels, hepatitis, autoimmune hepatitis and hepatic failure has been reported with Interferon beta in post-marketing. In some patients a recurrence of elevated serum levels of hepatic enzymes has occurred upon AVONEX rechallenge. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential of additive effects from multiple drugs or other hepatotoxic agents (e.g., alcohol) has not been determined. Patients should be monitored for signs of hepatic injury and caution exercised when interferons are used concomitantly with other drugs associated with hepatic injury. Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX. Symptoms of the flu-like syndrome associated with AVONEX therapy may prove stressful to patients with underlying cardiac conditions. Patients should be advised about the abortifacient potential of interferon beta (see 4.6 Use during pregnancy and lactation and 5.3 Preclinical safety data). Laboratory abnormalities are associated with the use of interferons. Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete and differential white blood cell counts, platelet counts, and blood chemistry, including liver function tests, are recommended during AVONEX therapy. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. 3 Patients may develop antibodies to AVONEX. The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies). Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a reduction of clinical efficacy. It is estimated that the plateau for the incidence of neutralising antibody formation is reached after 12 months of treatment. Data from patients treated up to two years with AVONEX suggests that approximately 8% develop neutralising antibodies. The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products. 4.5 Interaction with other medicinal products and other forms of interaction No formal drug interaction studies have been conducted with AVONEX (Interferon beta-1a) in humans. The interaction of AVONEX with corticosteroids or ACTH has not been studied systematically. The clinical studies indicate that multiple sclerosis patients can receive AVONEX and corticosteroids or ACTH during relapses. Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals. The effect of high-dose AVONEX administration on P450-dependent metabolism in monkeys was evaluated and no changes in liver metabolizing capabilities were observed. Caution should be exercised when AVONEX is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g., antiepileptics and some classes of antidepressants. 4.6 Pregnancy and lactation Because of the potential hazards to the foetus, AVONEX (Interferon beta-1a) is contraindicated in pregnancy. There are no studies of Interferon beta-1a in pregnant women. At high doses, in rhesus monkeys, abortifacient effects were observed. It cannot be excluded that such effects will be observed in humans. Fertile women receiving AVONEX should take appropriate contraceptive measures. Patients planning for pregnancy and those becoming pregnant should be informed of the potential hazards and AVONEX should be discontinued. Nursing Mothers It is not known whether AVONEX is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made either to discontinue nursing or to discontinue AVONEX therapy. 4.7 Effects on ability to drive and use machines AVONEX has minor influence on the ability to drive and use machines (see 4.8 “Undesirable effects”) 4.8 Undesirable effects The highest incidence of adverse reactions associated with AVONEX therapy is related to flu syndrome. The most commonly reported symptoms of the flu syndrome are myalgia, fever, chills, sweating, asthenia, headache and nausea. Symptoms of the flu syndrome tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment. Transient neurological symptoms that may mimic MS exacerbations may occur following injections. Transient episodes of hypertonia and/or severe muscular weakness

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