Betaferon Adverse Reactions

Summary of the safety profile: At the beginning of treatment adverse reactions are common but in general they subside with further treatment. The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions. Injection site reactions occurred frequently after administration of Betaferon. Redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8.0 million IU) Betaferon treatment.
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (see Dosage & Administration). Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory drugs. The incidence of injection site reactions may be reduced by the use of an autoinjector.
Tabulated list of adverse reactions: The following adverse event listing is based on reports from clinical trials (Table 3, adverse events and laboratory abnormalities) and from the post-marketing surveillance (Table 4, frequencies - where known-based on pooled clinical trials (very common ≥ 1/10, common ≥ 1/100 to <1/10, uncommon ≥ 1/1000 to <1/100, rare ≥ 1/10,000 to <1/1,000, very rare <1/10,000)) of Betaferon use. Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed. (See Tables 3A and 3B.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions. (See Table 4.)

Click on icon to see table/diagram/image

The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Pulmonary arterial hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products. Events were reported at various time points including up to several years after starting treatment with interferon beta.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the local reporting system.