Extavia Side Effects

Generic name: interferon beta-1b

Note: This document contains side effect information about interferon beta-1b. Some of the dosage forms listed on this page may not apply to the brand name Extavia.

Some side effects of Extavia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to interferon beta-1b: subcutaneous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking interferon beta-1b (the active ingredient contained in Extavia) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using interferon beta-1b and call your doctor at once if you have any of these serious side effects:

• depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;

• bruising, swelling, oozing, or skin changes where the injection was given;

• weight changes, pounding heartbeats, feeling too hot or cold;

• fever, chills, body aches, flu symptoms; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of interferon beta-1b may include:

• weakness;

• headache;

• muscle pain or weakness;

• sleep problems (insomnia);

• stomach pain;

• swelling in your hands or feet;

• skin rash; or

• irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to interferon beta-1b: subcutaneous powder for injection

General

The most frequently reported side effects were lymphopenia, injection site reaction, asthenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, rash, insomnia, abdominal pain, and pain. The most commonly reported side effects resulting in clinical intervention (e.g., discontinuation of interferon beta-1b (the active ingredient contained in Extavia) dosage adjustment, or the need for treatment of side effect symptom with concomitant medication) were depression, flu-like symptom complex, injection site reactions, leukopenia, elevated liver enzymes, asthenia, hypertonia, and myasthenia.

Hematologic

Very common (10% or more): Decreased lymphocyte count (less than 1500/mm3; 86%), leukopenia (18%), decreased white blood cell count (less than 3000/mm3; 13%), decreased absolute neutrophil count (less than 1500/mm3; 13%)
Common (1% to 10%): Lymphadenopathy (6%)
Rare (less than 0.1%): Thrombotic microangiopathy (at least 1 patient)
Postmarketing reports: Anemia, thrombocytopenia

Local

"Injection site reaction" includes all side effects occurring at the injection site (except injection site necrosis), which include injection site inflammation, injection site pain, injection site hypersensitivity, injection site mass, injection site edema, injection site reaction, injection site hemorrhage, and injection site atrophy.

About 69% of patients experienced injection site reactions during the first 3 months of therapy with the incidence decreasing to about 40% at the end of the trials.

Injection site necrosis generally occurred within the first 4 months of therapy, but has been reported over 1 year after start of therapy during postmarketing experience. The necrotic lesions usually had a diameter of 3 cm or less, but larger areas have been observed. The necrosis typically extended to subcutaneous fat only, but has extended to fascia overlying muscle. In some lesions where biopsy results were available, vasculitis has been observed.

Very common (10% or more): Injection site reaction (78%), injection site inflammation (42%), injection site pain (16%)
Common (1% to 10%): Injection site necrosis (4%), injection site hypersensitivity (4%), injection site mass (2%), injection site edema (2%)
Frequency not reported: Injection site hemorrhage, injection site atrophy, nonspecific reactions, severe necrotic lesions, injection site vasculitis

Other

The incidence of flu-like symptom complex decreased to 10% at the end of clinical trials. The median duration was 7.5 days in one study.

Development of fatal capillary leak syndrome has been associated with the administration of cytokines to patients with a preexisting monoclonal gammopathy.

Very common (10% or more): Flu-like symptom complex (denotes flu syndrome and/or a combination of at least 2 side effects from fever, chills, myalgia, malaise, sweating; 57%), asthenia (53%), pain (42%), fever (31%), chills (21%), peripheral edema (12%)
Common (1% to 10%): Chest pain (9%), malaise (6%)
Postmarketing reports: Fatal capillary leak syndrome

Psychiatric

Frequency not reported: Depression, suicidal ideation, suicide attempts, suicide, nervousness
Postmarketing reports: Anxiety, confusion, emotional lability, psychotic symptoms

During clinical studies, 3 suicides and 8 suicide attempts were reported among 1532 patients treated with interferon beta-1b compared to 1 suicide and 4 suicide attempts among 965 patients on placebo.

Nervous system

Seizures have been temporally associated with beta interferons in clinical trials and during postmarketing experience. It is not known if such events were due to primary seizure disorder, effects of multiple sclerosis alone, use of beta interferons, other possible precipitants of seizures (e.g., fever), or to some combination of these.

Sudden hearing loss, which was reversible within 7 to 14 days of drug discontinuation, has been reported.

Very common (10% or more): Headache (50%), insomnia (21%), incoordination (17%)
Frequency not reported: Somnolence, seizures, sudden reversible hearing loss
Postmarketing reports: Convulsion, dizziness

Musculoskeletal

In a study of 124 multiple sclerosis patients, myalgia and myasthenia were reported in 44% and 13% of the patients, respectively.

A study of 19 patients with primary progressive multiple sclerosis reported frequent and clinically significant increase in spasticity that appeared approximately 2 months after start of interferon beta-1b (the active ingredient contained in Extavia)

Very common (10% or more): Hypertonia (40%), myalgia (23%)
Frequency not reported: Increase in spasticity, leg cramps, myasthenia
Postmarketing reports: Arthralgia

Dermatologic

A case of sarcoid-like dermatitis was reported in a 57-year-old white man diagnosed with multiple sclerosis. The cutaneous eruption that developed 2 months after initiation of interferon beta-1b (the active ingredient contained in Extavia) therapy histologically resembled sarcoidal granulomas, but without distinctive features of true sarcoidosis.

A case of cutaneous necrosis in a 38-year-old woman diagnosed with relapsing-remitting multiple sclerosis was believed to be a result of an immunological response to the improperly dissolved lyophilized drug. The patient was rechallenged with the drug, after introducing changes to the way she reconstituted the drug, without any reports of scars.

Very common (10% or more): Rash (21%)
Common (1% to 10%): Skin disorder (10%)
Frequency not reported: Contact dermatitis, erythema nodosum, exfoliative dermatitis, furunculosis, hirsutism, leukoderma, lichenoid dermatitis, maculopapular rash, psoriasis, seborrhea, benign skin neoplasm, skin carcinoma, skin hypertrophy, skin necrosis, skin ulcer, vesiculobullous lesions, sarcoid-like dermatitis, septal panniculitis
Postmarketing reports: Alopecia, pruritus, skin discoloration, urticaria

Gastrointestinal

Very common (10% or more): Abdominal pain (16%)
Frequency not reported: Constipation, dyspepsia
Postmarketing reports: Diarrhea, nausea, pancreatitis, vomiting

Hepatic

Very common (10% or more): Elevated alanine aminotransferase (SGPT greater than 5 times baseline; 12%)
Common (1% to 10%): Elevated aspartate aminotransferase (SGOT greater than 5 times baseline; 4%), asymptomatic elevation of serum transaminases
Rare (less than 0.1%): Severe hepatic injury (including cases of hepatic failure [some due to autoimmune hepatitis])
Frequency not reported: Elevated liver enzymes
Postmarketing reports: Hepatitis, elevated gamma-glutamyltransferase

During clinical trials, elevations of SGPT and SGOT to greater than 5 times baseline levels led to dose reduction or treatment discontinuation in some patients.

Genitourinary

Very common (10% or more): Urinary urgency (11%)
Common (1% to 10%): Metrorrhagia (9%), impotence (8%)
Frequency not reported: Menstrual disorders/irregularities, severe vaginal bleeding, dysmenorrhea, prostatic disorder, urinary frequency
Postmarketing reports: Menorrhagia

A 19-year-old white woman diagnosed with multiple sclerosis experienced severe vaginal bleeding when her dose of interferon beta-1b was increased, 1 month from the start of therapy, from 4 to 8 million international units.

Cardiovascular

Common (1% to 10%): Hypertension (6%)
Frequency not reported: Peripheral vascular disorder, congestive heart failure (CHF), cardiomyopathy with CHF, worsening of CHF
Postmarketing reports: Cardiomyopathy, palpitations, tachycardia, vasodilatation

CHF, cardiomyopathy, and cardiomyopathy with CHF have been reported in patients without known predisposition to such events, and without establishment of other known etiologies. In some cases, these events were temporally related to interferon beta-1b. Recurrence upon rechallenge was observed in some patients.

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis/anaphylactic reactions
Frequency not reported: Other allergic reactions (including dyspnea, bronchospasm, tongue edema, skin rash, urticaria)

Respiratory

Common (1% to 10%): Dyspnea (6%)
Postmarketing reports: Bronchospasm

Metabolic

Postmarketing reports: Increased triglycerides, anorexia, decreased weight, increased weight

Immunologic

The development of antibodies against interferon beta has been reported, often as early as 3 months after the start of treatment. The antibodies may bind to and block the beneficial effect of interferon beta in multiple sclerosis. The overall clinical significance is unknown.

Neutralizing antibodies formation occurred after the 24-week treatment in 95% of patients treated with natural interferon beta compared to 27% of patients treated with recombinant interferon beta.

Results of a prospective study suggest that several autoimmune events may occur during interferon beta treatment of multiple sclerosis and recommends the close monitoring of thyroid, liver function, and autoantibodies.

Frequency not reported: Development of antibodies against interferon beta

Endocrine

Postmarketing reports: Hypothyroidism, hyperthyroidism, thyroid dysfunction

Renal

Rare (less than 0.1%): Subacute renal failure due to thrombotic microangiopathy (at least 1 patient)
Postmarketing reports: Hemolytic uremic syndrome, nephrotic syndrome with minimal histologic changes of the glomerulus

Hemolytic uremic syndrome and nephrotic syndrome with minimal histologic changes of the glomerulus have been reported during postmarketing experience. Upon withdrawal of interferon beta therapy these side effects subsided.

A 53-year-old female with multiple sclerosis developed subacute renal failure due to thrombotic microangiopathy following 8 years of therapy with interferon beta-1b.

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