Extavia (interferon beta-1b)

No dosing information is available for this tab.

Administer by IM, or subcutaneous injection depending on the specific preparation.

Interferon beta-1a is commercially available as a once-weekly IM injection (Avonex(R)) or a 3-times-weekly subcutaneous injection (Rebif(R)). Interferon beta-1b is commercially available as a subcutaneous alternate-day injection (Betaseron(R), Extavia(R)); the 2 currently available interferon beta-1b preparations are identical except for some packaging components (e.g., needle size).

Subcutaneous administration of interferon beta is associated with higher rates of injection site reactions than IM administration. Interferon beta prefilled syringes and auto-injectors are for single use only; do not re-use.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies have not been performed to date with interferon beta.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Avonex(R) and Rebif(R) are contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin, or any other component of the formulation.

*Betaseron(R) and Extavia(R) are contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Interferon beta-1a (Avonex(R)): The most common adverse reactions (>=5%) in clinical studies were flu-like symptoms including chills, fever, myalgia, and asthenia.

Interferon beta-1a (Rebif(R)): The most common adverse reactions in controlled clinical trials were injection site disorders, influenza-like symptoms, abdominal pain, depression, elevation of liver enzymes, and hematologic abnormalities.

Interferon beta-1b (Betaseron(R)): The most common adverse reactions (>=5%) in clinical studies were injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia.

Interferon beta-1b (Extavia(R)): The most common adverse reactions (>=5%) in clinical studies were injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Although safety and efficacy of interferon beta in pediatric patients have not been established, the drug has been used with variable results for the management of childhood onset MS. In the PARADIGMS trial, a double-dummy randomized trial comparing fingolimod to interferon beta-1a by weekly intramuscular injection, fingolimod was superior to interferon in reducing relapsing rates. In another study that included a limited number of patients, treatment failure rates in children 10.5-17 years of age who received interferon beta-1a or beta-1b were higher than those reported in well-controlled studies in adults, but these results may be attributed to the selection of children with severe forms of childhood onset MS (i.e., with numerous relapses) or other unknown factors. Adverse effects reported when interferon beta was used in children were similar to those reported in adults.

There are no well-controlled studies in pregnant women; however, available data, including prospective observational studies, have generally not identified a drug-associated risk of major birth defects with the use of interferon beta during pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta in pregnancy have been inconsistent. In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion at doses greater than those used clinically; however, it is unclear whether, as a class of products, administration of interferon beta therapies to pregnant animals at doses greater than those used clinically results in an increased rate of abortion. Use interferon beta during pregnancy only if the potential benefits justify the possible risks to the fetus.

A population-based cohort study collected data from 1996--2014 in Finland and from 2005-2014 in Sweden for 2,831 pregnancy outcomes in women with MS. In 797 of the pregnancies, women were exposed to only interferon beta; no evidence for an increased risk of birth defects was identified in comparison of women with MS exposed to interferon beta, and women with MS that were not exposed to any non-steroid therapies within the study. Increased risk of miscarriage or ectopic pregnancy was not observed; however, data for these outcomes may have been incomplete, making interpretation of the findings more difficult.

Two smaller cohort studies that collected data on women exposed to interferon beta during pregnancy found that a decrease in mean birth weight may be associated with interferon beta exposure during pregnancy; however, this finding has not been replicated in larger observational studies. Additionally, two small studies observed an increased rate of miscarriage, with only one study determining the findings to be statistically significant. In a small cohort study, an increased risk of preterm birth was observed following exposure to interferon beta.

Limited data suggest that interferon beta-1a distributes into human milk. There are no data on the presence of interferon beta-1b in human milk. It is not known whether interferon beta has any effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for interferon beta and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Clinical studies of interferon beta did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger patients. In general, dosage of interferon beta should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly also should be considered.

Clinical studies of interferon beta did not include sufficient numbers of patients >=65 years of age and older to determine whether geriatric patients respond differently than younger patients.