AVONEX is indicated for the treatment of: adult patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials this was characterised as two or more acute exacerbations (relapses) in the preceding three years without evidence of continuous progression between relapses. AVONEX slows the progression of disability and decreases the frequency of relapses. adult patient

AVONEX 30MCG/0.5ML Solution for injection Pre-filled syringe: Roztwór do wstrzykiwań 30 mcg/0,5 ml (6 mln j.m.)

The highest incidence of adverse reactions associated with AVONEX therapy is related to flu-like symptoms. The most common flu-like symptoms are myalgia, fever, chills, sweating, asthenia, headache, and nausea. Dose titration of AVONEX at treatment initiation has been shown to reduce the severity and frequency of flu-like symptoms. These symptoms tend to be most prominent at the

Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or to any of the excipients of this product listed in section 6.1. Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).

AVONEX 30MCG/0.5ML Solution for injection Pre-filled syringe

Q: Warnings?

Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. AVONEX should be administered with caution to patients with previous or current depressive disorders, particularly those with a history of suicidal ideation (see section 4.3). Depression and suicidal ideation are kno

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

AVONEX 30MCG/0.5ML Solution for injection Pre-filled syringe — Description, Dosage, Side Effects | PillsCard

Pharmacotherapeutic group: Interferons, ATC code: L03AB07. Interferons constitute a family of naturally occurring proteins produced by eukaryotic cells in response to viral infection or other biological inducers.‍‍‍‍‍‍‍‍‍‍‍‍‍ Interferons are cytokines that mediate antiviral, antiproliferative, and immunomodulatory activity. Three major forms of interferons have been distinguished to date: alfa, beta, and gamma. Interferons alfa and beta are classified as Type I interferons, while interferon gamma is designated as Type II. These interferons have partially overlapping but clearly distinguishable biological activities. They also likely differ in their site of synthesis within the cell. Interferon beta is produced by various cell types, including fibroblasts and macrophages. Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated proteins forming a complex with a single carbohydrate moiety linked to a nitrogen atom. Glycosylation is known to alter the stability, activity, biodistribution, and elimination half-life of various active substances. How glycosylation modifies the effects of interferon beta is not yet fully understood. Mechanism of action AVONEX exerts its effects through binding to specific receptors on the surface of human cells. This binding initiates a complex cascade of intracellular events, which then lead to the expression of a range of interferon-induced gene products and markers. These include MHC Class I antigen, 2'/5'-oligoadenylate synthetase, β2-microglobulin, and neopterin. Levels of some of these products were measured in the serum and cellular fractions of blood collected from patients treated with AVONEX. Following a single intramuscular dose of AVONEX, serum concentrations of these products remained elevated for a minimum of four days and a maximum of one week. Whether the mechanism of action of AVONEX in the treatment of MS is mediated by the same pathways as the biological effects described above is not yet known, given the incompletely understood pathophysiology of multiple sclerosis. Clinical efficacy and safety The efficacy of lyophilised AVONEX in the treatment of multiple sclerosis was demonstrated in a placebo-controlled study involving 301 patients (AVONEX, n=158; placebo, n=143) with relapsing forms of the disease characterised by at least two exacerbations during the preceding 3 years, or at least one exacerbation per year prior to enrolment if disease duration was less than 3 years. Patients with an EDSS score of 1.0 to 3.5 at entry were enrolled in the clinical study. Due to the study design, individual patients were followed for varying durations. Of the patients treated with AVONEX, 150 completed one year and 85 completed two years of the study. The cumulative percentage of patients who progressed in disability by the end of year two (by Kaplan-Meier life-table analysis) was 35% in patients receiving placebo and 22% in those treated with AVONEX. Disability progression was defined as an increase of 1 point on the Expanded Disability Status Scale (EDSS) sustained for a minimum of six months. A one-third annual reduction in relapse rate was also demonstrated. This clinical effect was observed only after more than one year of treatment. A double-blind, randomised dose-comparison study in 802 patients with relapsing multiple sclerosis (AVONEX 30 micrograms n=402, AVONEX 60 micrograms n=400) showed no statistically significant difference or trend in clinical or routine MRI parameters between the 30 microgram and 60 microgram doses. The effect of AVONEX was also demonstrated in a randomised, double-blind study of 383 patients diagnosed with MS (AVONEX n=193, placebo n=190) who had experienced a first demyelinating event associated with at least two compatible MRI lesions. A reduction in the risk of developing a second attack was observed in the AVONEX-treated group. An effect on MRI parameters was also noted. The estimated risk of developing a further event was 50% at three years and 39% at two years in the placebo group, and 35% (three years), 21% (two years) in the AVONEX group. In a subsequent analysis, patients with a baseline MRI showing at least one Gd-enhancing lesion and nine T2 lesions had a two-year risk of a second event of 56% in the placebo group and 21% in the AVONEX-treated group. Nevertheless, even in this high-risk subgroup, the impact of early treatment with AVONEX is unknown, as the study was designed to determine time to a further event rather than to monitor long-term disease outcome. Moreover, there is currently no clearly established definition of a high-risk patient and a more conservative approach is accepted, requiring at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan at least three months after the initial scan. In any case, treatment should be considered only for those patients classified as high risk. Paediatric population Limited efficacy/safety data on AVONEX administered intramuscularly at a dose of 15 micrograms once weekly (n=8) compared with placebo (n=8) in patients followed for 4 years showed similar results to adults, although EDSS scores increased over the 4-year follow-up period, suggesting disease progression. No direct comparison with doses currently recommended for adults is available. AVONEX 30 micrograms/0.5 ml solution for injection was studied as an active comparator in 2 controlled clinical trials in paediatric patients aged 10 years to less than 18 years with relapsing-remitting multiple sclerosis (see section 4.2). In an open-label, randomised, actively controlled study, 150 participants were randomly assigned in a 1:1 ratio to treatment with dimethyl fumarate administered orally at 240 mg twice daily, or AVONEX administered at 30 μg once weekly by intramuscular injection (i.m.) for 96 weeks. In the ITT population, treatment with dimethyl fumarate compared with AVONEX resulted in a higher proportion of patients free from new or newly enlarging T2 hyperintense lesions at week 96 compared with baseline [12.8% versus 2.8%]. In a double-blind, double-dummy, actively controlled study, 215 participants were randomly assigned to receive either oral fingolimod (0.5 mg once daily or 0.25 mg once daily for patients weighing ≤ 40 kg) or intramuscular AVONEX 30 μg once weekly for up to 24 months. The primary endpoint, adjusted annualised relapse rate (ARR) at week 96, was significantly lower in patients treated with fingolimod (0.122) compared with patients receiving AVONEX (0.675), representing a relative reduction in ARR of 81.9% (p <0.001). Overall, the safety profile in patients receiving AVONEX in the two clinical trials was qualitatively consistent with the safety profile previously observed in adult patients.

⚠️ Warnings

Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. AVONEX should be administered with caution to patients with previous or current depressive disorders, particularly those with a history of suicidal ideation (see section 4.3).‍‍‍‍‍‍‍‍‍‍‍‍‍ Depression and suicidal ideation are known to occur at an increased frequency in patients with multiple sclerosis and in association with interferon use. Patients must be advised to immediately report any symptoms of depression or suicidal ideation to their treating physician. Such patients must be closely monitored during treatment and treated appropriately. Discontinuation of therapy with AVONEX should also be considered (see also sections 4.3 and 4.8). AVONEX should be administered with caution to patients with a history of seizures, to those being treated with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8). AVONEX should be administered with caution and close monitoring in patients with severe renal and hepatic insufficiency and in patients with severe myelosuppression. Thrombotic microangiopathy (TMA): Cases of thrombotic microangiopathy, manifesting as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta-containing products. Events were reported at various time points during treatment and may occur from several weeks to several years after starting treatment with interferon beta. Early clinical features include thrombocytopenia, new-onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function. Laboratory findings suggestive of TMA include decreased platelet count, elevated serum lactate dehydrogenase (LDH) levels due to haemolysis, and schistocytes (fragmented red blood cells) on a blood smear. Therefore, if clinical features of TMA are observed, further testing of platelet count, serum LDH, blood smears, and renal function is recommended. If TMA is diagnosed, treatment should be initiated promptly (considering plasma exchange) and immediate discontinuation of AVONEX is recommended. Nephrotic syndrome: Cases of nephrotic syndrome with various underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN), and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta-containing products. Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta. Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria, and impaired renal function, is recommended, especially in patients at higher risk of renal disease. Prompt treatment of nephrotic syndrome is required, and discontinuation of treatment with AVONEX should be considered. Hepatic injury including elevated serum hepatic enzymes, autoimmune hepatitis, hepatitis, and hepatic failure has been reported in association with interferon beta use during post-marketing surveillance (see section 4.8). In some cases, these reactions occurred during concomitant use of other medicinal products associated with hepatic injury. The potential for additive effects of multiple medicinal products or other hepatotoxic substances (e.g. alcohol) has not been established. Patients should be monitored for signs of hepatic injury and caution is required when interferons are used concomitantly with other medicinal products associated with hepatic injury. Patients with cardiac disease, such as angina pectoris, congestive heart failure, or arrhythmia, must be closely monitored during treatment with AVONEX for potential worsening of these clinical conditions. Flu-like symptoms associated with treatment may place additional stress on patients with underlying cardiac disease, leading to worsening of their condition. Changes in laboratory test values are associated with interferon administration. Therefore, in addition to the standard tests 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 treatment with AVONEX. In patients with myelosuppression, more frequent monitoring of complete and differential white blood cell counts and platelet counts is advisable. Patients may develop antibodies to AVONEX. Antibodies in some patients may reduce the activity of interferon beta-1a in vitro (neutralising antibodies). Neutralising antibodies may reduce the in vivo biological effects of AVONEX with potential reduction of clinical efficacy. Peak incidence of neutralising antibody formation has been found to occur at 12 months of treatment. Data from patients treated with AVONEX for three years indicate that approximately 5 to 8% of them develop neutralising antibodies. The use of different assays to detect serum antibodies to interferons limits the ability to compare antigenicity between different products. Cases of injection site necrosis have been reported during the post-marketing period (see section 4.8). To minimise the risk of injection site reactions, patients should be instructed to use aseptic injection technique and to rotate injection sites with each dose. The self-injection procedure by patients should be periodically reviewed, especially when injection site reactions have occurred. If patients experience any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, they should be advised to consult their physician. The decision whether to discontinue therapy following a single site of necrosis depends on the extent of the necrosis. Patients who continue treatment with AVONEX after experiencing injection site necrosis should avoid injecting into the affected area until it has fully healed. If multiple lesions occur, the injection site should be changed or treatment discontinued until healing occurs.

AVONEX 30MCG/0.5ML Solution for injection Pre-filled syringe

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