Plegridy · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-096856 · has-adverse-reaction-information · PDF-Seite 8

Summary of safety profile The most common adverse drug reactions (ADR) (at a higher incidence than placebo) for Peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks were injection site erythema, influenza like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia. The most commonly reported adverse reaction leading to discontinuation in patients treated with peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks was influenza-like illness (<1%). Tabulated list of adverse reactions via subcutaneous route of administration In clinical studies, a total of 1,468 patients received peginterferon beta-1a SC for up to 278 weeks with an overall exposure equivalent of 4,217 person -years. 1,285 patients received at least 1 year, 1,124 patients have received at least 2 years, 947 patients received at least 3 years, and 658 patients received at least 4 years of treatment with peginterferon beta-1a. The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study. Table 2 summarises ADRs (incidence above placebo and with a reasonable possibility of causality) from 512 patients treated with peginterferon beta-1a 125 micrograms SC every 2 weeks and 500 patients who received placebo for up to 48 weeks and post-marketing data. The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class. The incidence of the adverse reactions below are expressed according to the following categories: - Very common (≥1/10) - Common (≥1/100 to <1/10) - Uncommon (≥1/1,000 to <1/100) 8 - Rare (≥1/10,000 to <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available data) Table 2: Tabulated summary of adverse drug reactions MedDRA system organ class Adverse reaction Frequency category Blood and lymphatic system Thrombocytopenia Uncommon disorders Thrombotic microangiopathy Rare including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome* Immune system disorders Angioedema

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HOS-096852 · has-contraindication-information · PDF-Seite 5

- Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the excipients listed in section 6.1. - Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).

HOS-096851 · has-indication-information · PDF-Seite 3

Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).

HOS-096854 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed. The clinical studies indicate that multiple sclerosis patients can receive peginterferon beta-1a and corticosteroids during relapses. Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals. Caution should be exercised when peginterferon beta-1a 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. some classes of antiepileptics and antidepressants.

HOS-096855 · has-pregnancy-information · PDF-Seite 7

Pregnancy A large amount of data (more than 1,000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy. However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use 7 was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed. Experience with exposure during the second and third trimester is very limited. Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion. The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far. If clinically needed, the use of peginterferon beta-1ay may be considered during pregnancy. Breast-feeding Limited information available on the transfer of interferon beta-1a/peginterferon beta-1a into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1a/peginterferon beta-1a excreted in human milk are negligible. No harmful effects on the breastfed newborn/infant are anticipated. Peginterferon beta-1a can be used during breast-feeding. Fertility There are no data on the effects of peginterferon beta-1a on human fertility. In animals, anovulatory effects were observed at very high doses (see section 5.3). No information is available on the effects of peginterferon beta-1a on male fertility in animals.

HOS-096853 · has-warning-information · PDF-Seite 5

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hepatic injury Elevated serum hepatic transaminase levels, hepatitis, autoimmune hepatitis and rare cases of severe hepatic failure have been reported with interferon beta medicinal products. Elevations in hepatic enzymes have been observed with the use of peginterferon beta-1a. Patients should be monitored for signs of hepatic injury (see section 4.8). Depression Peginterferon beta-1a should be administered with caution to patients with previous depressive disorders (see section 4.3). Depression occurs with increased frequency in the multiple sclerosis population and in association with interferon use. Patients 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 and treated appropriately. Cessation of therapy with peginterferon beta-1a should be considered (see section 4.8). Hypersensitivity reactions Serious hypersensitivity reactions including cases of anaphylaxis have been reported as a rare complication of treatment with interferon beta, including peginterferon beta-1a. Patients should be advised to discontinue treatment with peginterferon beta-1a and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity. Treatment with peginterferon beta-1a should not be restarted (see section 4.8). Injection site reactions Injection site reactions, including injection site necrosis, have been reported with the use of subcutaneous interferon beta. To minimise the risk of injection site reactions patients should be instructed in the use of an aseptic injection technique. The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred. If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor. One patient treated with peginterferon beta-1a in clinical trials experienced an injection site necrosis with SC peginterferon beta-1a. Whether to discontinue therapy following a single site of necrosis is dependent on the extent of necrosis (see section 4.8).

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