Avonex Prefilled Syringe Side Effects

Generic Name: interferon beta-1a

Note: This page contains information about the side effects of interferon beta-1a. Some of the dosage forms included on this document may not apply to the brand name Avonex Prefilled Syringe.

Not all side effects for Avonex Prefilled Syringe may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to interferon beta-1a: kit, solution

In addition to its needed effects, some unwanted effects may be caused by interferon beta-1a (the active ingredient contained in Avonex Prefilled Syringe). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking interferon beta-1a:

More common
  • Black, tarry stools
  • chest pain
  • chills
  • cough
  • diarrhea
  • fever
  • flu-like symptoms
  • headache
  • joint pain
  • muscle aches
  • nausea
  • pain
  • painful or difficult urination
  • shortness of breath
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain
  • clumsiness or unsteadiness
  • convulsions (seizures)
  • decreased hearing
  • difficulty with swallowing
  • dizziness
  • fainting
  • feeling of warmth
  • hives or itching
  • mood changes, especially with thoughts of suicide
  • muscle spasms
  • pain or discharge from the vagina
  • pelvic discomfort, aching, or heaviness
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness, swelling, or tenderness at the injection site
  • runny or stuffy nose
  • skin lesions
  • sneezing
  • sore throat
  • speech problems
  • swelling of the face, lips, or eyelids
  • troubled breathing
Rare
  • Earache
  • general feeling of discomfort or illness
  • loss of appetite
  • painful blisters on trunk of body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
Incidence not known
  • Bleeding gums
  • blood in the urine or stools
  • bloody nose
  • chest discomfort
  • confusion
  • constipation
  • dark urine
  • decreased urine output
  • depressed mood
  • dilated neck veins
  • dry skin and hair
  • extreme fatigue
  • fast, irregular, or pounding heartbeat
  • feeling cold
  • general tiredness and weakness
  • hair loss
  • heavier menstrual periods
  • high fever
  • irregular breathing
  • light-colored stools
  • loss of bladder control
  • mental depression
  • mood or other mental changes
  • muscle cramps and stiffness
  • nausea or vomiting
  • nervousness
  • pale skin
  • persistent loss of appetite
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue
  • redness, blistering, peeling, or loosening of the skin
  • sensitivity to heat
  • skin rash
  • slowed heartbeat
  • sudden loss of consciousness
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swelling of the mouth or throat
  • tightness in the chest
  • tightness in the throat
  • upper right abdominal or stomach pain or tenderness
  • weight gain or loss
  • yellow eyes and skin

Some of the side effects that can occur with interferon beta-1a may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Heartburn
  • indigestion
  • sour stomach
Less common
  • Hair loss
  • trouble sleeping

For Healthcare Professionals

Applies to interferon beta-1a: intramuscular kit, intramuscular powder for injection, subcutaneous kit, subcutaneous solution

General

In general, the use of interferon beta-1a (the active ingredient contained in Avonex Prefilled Syringe) in patients with multiple sclerosis is limited. It is probable that rarely occurring adverse effects may not have been reported to date.

The most commonly reported adverse effects associated with Avonex(R) have included influenza-like and other symptoms occurring within hours to days after an injection. Symptoms have included muscle aches, fever, chills, fatigue, headache, nausea, and vomiting. The most common side effects resulting in clinical intervention (e.g., treatment discontinuation or need for treatment due to adverse effects) were influenza-like symptoms and depression.

The most commonly reported serious side effects associated with Rebif(R) have included psychiatric disorders including depression and suicidal ideation or attempt. The most common side effects have included injection site disorders, influenza-like symptoms (headache, fatigue, fever, rigors, chest pain, back pain, myalgia), abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities. The most common side effects resulting in clinical intervention (e.g., treatment discontinuation or need for treatment due to adverse effects) were injection site disorders, influenza-like symptoms, depression, and elevated liver enzymes.

Nervous system

In a placebo-controlled study, four patients receiving interferon beta-1a (the active ingredient contained in Avonex Prefilled Syringe) experienced a seizure, while none receiving placebo experienced a seizure. Three of four patients had no prior seizure history. However, a causal relationship with interferon beta-1a has not been confirmed.

Seizures and extrapyramidal symptoms were reported in a 21-year-old man with a history of Tourette's syndrome and Asperger's syndrome, who was recently diagnosed with multiple sclerosis. Generalized tonic-clonic seizures occurred on days 14 and 34 following the start of therapy with interferon beta-1a 30 mcg per week. Given this patient's other neurologic conditions require a drug regimen with multiple pharmacodynamic properties, it was difficult to establish causality. A new drug regimen without interferon beta-1a has prevented seizure activity and controlled his symptoms of Tourette's syndrome.

Sudden hearing loss and tinnitus have been associated with interferon beta (the specific interferon beta was not identified in the case report). Ototoxic effects resolved 7 to 14 days after discontinuation of the drug.

Transient neurological symptoms were of limited duration, temporally related to the injections, and most prominent at the initiation of therapy. In some cases, these symptoms were associated with influenza-like syndrome.

Very common (10% or more): Headache (up to 70%), dizziness (up to 15%)
Common (1% to 10%): Hypertonia (up to 7%), seizures (up to 5%), abnormal coordination (up to 5%), migraine (up to 5%)
Frequency not reported: Sleep difficulty, muscle spasm, paresthesia, myasthenia, extrapyramidal symptoms, sudden hearing loss, tinnitus
Postmarketing reports: Rebif(R): Seizures, transient neurological symptoms (i.e., hypoesthesia, muscle spasm, paresthesia, musculoskeletal stiffness, difficulty walking) that mimic multiple sclerosis exacerbations

Other

A register nurse reported to the manufacturer that a 48-year-old female patient with stage 4 non-small cell lung cancer with metastases discontinued Avonex(R) due to chills, shaking, and difficulty breathing following injection. The registered nurse reported the lung cancer was not related to Avonex(R); however, causality for the other events was not assessed. Avonex(R) was discontinued prior to the patient's death due to lung cancer.

Very common (10% or more): Influenza-like symptoms (up to 59%), fatigue (up to 41%), fever (up to 28%), asthenia (up to 24%), pain (up to 23%), chills/rigors (up to 19%)
Common (1% to 10%): Chest pain (up to 8%), abdominal pain (up to 8%), infection (up to 7%), malaise (up to 5%), toothache (up to 3%)
Rare (less than 0.1%): Avonex(R): Chills and shaking following injection (at least 1 case)

Psychiatric

Very common (10% or more): Depression (up to 25%)
Common (1% to 10%): Somnolence (up to 5%)
Frequency not reported: Suicidal ideation, suicide attempt, suicide, anhedonia, psychotic thoughts, mood disturbances, hypersexuality, aggressive behavior, panic attacks
Postmarketing reports: Avonex(R): Depression, suicidal ideation, development of new or worsening of other preexisting psychiatric disorders (including psychosis); Rebif(R): Suicide

Data from the SPECTRIMS (Secondary Progressive Efficacy Trial of Interferon beta-1a in MS) study suggest that depression is not a side effect of interferon beta-1a.

A case reported to the manufacturer pertained to a 62-year-old female patient on Avonex(R) for multiple sclerosis who was hospitalized for 2 to 3 days due to attempting suicide by overdosing on alprazolam. Treatment is unknown and the patient recovered. Avonex(R) therapy was not discontinued. Upon follow-up, the patient's neurologist confirmed hospitalization due to suicide attempt, but indicated she had overdosed on Valium (R). No further information was provided and the neurologist did not assess causality.

Local

Injection site reactions were reported more frequently by patients receiving Rebif(R) than in patients receiving Avonex(R) (83% vs. 28%, p less than 0.001) during the EVIDENCE Trial (EVidence of Interferon Dose-response: European North American Comparative Efficacy) where efficacy and safety of interferon beta-1a (the active ingredient contained in Avonex Prefilled Syringe) (Rebif[R]) 44 mcg subcutaneously three times weekly was compared against interferon beta-1a (Avonex[R]) 30 mcg intramuscularly once weekly in patients with relapsing-remitting multiple sclerosis (n=667).

Very common (10% or more): Injection site reaction (up to 92%), inflammation at site of subcutaneous injection (up to 52%)
Common (1% to 10%): Injection site pain (up to 8%), injection site inflammation (up to 6%), injection site necrosis (up to 4%)
Frequency not reported: Subcutaneous injection sites: Injection site necrosis, injection site atrophy, injection site edema, injection site hemorrhage
Postmarketing reports: Avonex(R): Rare cases of injection site abscess or cellulitis requiring surgical intervention; Rebif(R): Injection site abscesses, injection site infections (including cellulitis and necrosis requiring debridement, systemic antibiotic treatment, and/or grafting)

Hematologic

Very common (10% or more): Leukopenia (up to 36%), lymphadenopathy (up to 12%)
Common (1% to 10%): Thrombocytopenia (up to 8%), injection site ecchymosis (up to 6%), anemia (up to 5%)
Postmarketing reports: Avonex(R): Decreased peripheral blood counts in all cell lines (including rare pancytopenia, thrombocytopenia); Rebif(R): Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), pancytopenia

Altered leukocyte counts were reported more frequently by patients receiving Rebif(R) than in patients receiving Avonex(R) (11% vs. 5%, p=0.003) during the EVIDENCE Trial (EVidence of Interferon Dose-response: European North American Comparative Efficacy) where efficacy and safety of interferon beta-1a (Rebif[R]) 44 mcg subcutaneously three times weekly was compared against interferon beta-1a (Avonex[R]) 30 mcg intramuscularly once weekly in patients with relapsing-remitting multiple sclerosis (n=667).

Musculoskeletal

Very common (10% or more): Myalgia (up to 29%), back pain (up to 25%), skeletal pain (up to 15%)
Common (1% to 10%): Arthralgia (up to 9%)

Hepatic

Symptoms of liver dysfunction appeared from 1 to 6 months following the initiation of therapy.

Fulminant liver failure occurring 7 weeks after the start of Rebif(R) therapy that required a liver transplantation has been reported in a patient who was also receiving nefazodone.

Asymptomatic elevation of hepatic transaminases has been reported, and in some patients has occurred upon rechallenge with Avonex(R).

Asymptomatic abnormalities of liver enzymes have been reported more frequently in patients receiving Rebif(R) compared with the patients receiving Avonex(R) (18% vs. 10%, p=0.002) during the EVIDENCE Trial (EVidence of Interferon Dose-response: European North American Comparative Efficacy) where efficacy and safety of interferon beta-1a (the active ingredient contained in Avonex Prefilled Syringe) (Rebif[R]) 44 mcg subcutaneously three times weekly was compared against interferon beta-1a (Avonex[R]) 30 mcg intramuscularly once weekly in patients with relapsing-remitting multiple sclerosis (n=667).

Very common (10% or more): Elevated SGPT (up to 27%), elevated SGOT (up to 17%)
Common (1% to 10%): Abnormal hepatic function (up to 9%), bilirubinemia (up to 3%)
Frequency not reported: Jaundice, symptoms of liver dysfunction
Postmarketing reports: Avonex(R): Hepatic injury (including hepatic failure, elevated serum hepatic enzyme levels); Rebif(R): Rare cases of severe liver dysfunction (including hepatic failure requiring liver transplantation)

Gastrointestinal

Very common (10% or more): Nausea (up to 23%), abdominal pain (up to 22%)
Common (1% to 10%): Dry mouth (up to 5%)
Frequency not reported: Gastrointestinal upset (i.e., nausea, diarrhea, dyspepsia)

Cardiovascular

CHF, cardiomyopathy, and cardiomyopathy with CHF have been reported in patients without prior known history to these events. In some cases recurrence was observed upon rechallenge.

Common (1% to 10%): Vasodilation (up to 2%)
Postmarketing reports: Avonex(R): Congestive heart failure (CHF), cardiomyopathy, cardiomyopathy with CHF

Hypersensitivity

Frequency not reported: Anaphylaxis, other allergic reactions (including dyspnea, orolingual edema, skin rash, urticaria)

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 14%), sinusitis (up to 14%)
Common (1% to 10%): Bronchitis (up to 8%)
Rare (less than 0.1%): Avonex(R): Difficulty breathing following injection (at least 1 case)

A register nurse reported to the manufacturer that a 48-year-old female patient with stage 4 non-small cell lung cancer with metastases discontinued Avonex(R) due to chills, shaking, and difficulty breathing following injection. The registered nurse reported the lung cancer was not related to Avonex(R); however, causality for the other events was not assessed. Avonex(R) was discontinued prior to the patient's death due to lung cancer.

Genitourinary

Very common (10% or more): Urinary tract infection (up to 17%)
Common (1% to 10%): Micturition frequency (up to 7%), urinary incontinence (up to 4%), abnormal urine constituents (up to 3%)
Rare (less than 0.1%): Menstrual disorders (at least 1 case)
Postmarketing reports: Avonex(R): Menorrhagia, metrorrhagia

Ocular

A 48-year-old female with relapsing-remitting multiple sclerosis experienced retinopathy coincident with interferon beta-1a (the active ingredient contained in Avonex Prefilled Syringe) therapy. Five months prior to presenting with blurry vision in the inferonasal quadrant of her right eye, the patient began interferon beta-1a 44 mcg subcutaneously three times per week. Dilated fundus examination showed cotton wool spots in the maculae of each eye. Therapy with interferon beta-1a was discontinued. Six weeks later a follow-up fundoscopic examination showed complete resolution of her cotton wool spots. Four years later, she remained without any symptoms and without recurrence of retinal findings.

A 23-year-old male was diagnosed with multiple sclerosis. About 4 months later, following peripheral vision loss in his left eye, he was started on oral prednisone (short course) and subcutaneous interferon beta-1a. His visual symptoms improved. Three months later peripheral vision loss in his right eye developed, but resolved following a week of prednisone. Signs of retinopathy were found during testing 15 months after interferon beta-1a was started. After additional tests, the diagnosis was changed to Susac syndrome and interferon beta-1a was discontinued. Two weeks after the drug was stopped, the patient showed dramatic improvement of the retinopathy, suggesting interferon beta-1a may have exacerbated the retinal findings of Susac syndrome.

Very common (10% or more): Rebif(R): Abnormal vision (up to 13%)
Common (1% to 10%): Avonex(R): Eye disorder (4%); Rebif(R): Xerophthalmia (up to 3%)
Rare (less than 0.1%): Retinopathy (at least 1 case), exacerbation of Susac syndrome retinopathy (at least 1 case)
Postmarketing reports: Rebif(R): Retinal vascular disorders (i.e., retinopathy, cotton wool spots or obstruction of retinal artery or vein)

Dermatologic

A 30-year-old woman developed severe widespread urticaria within 30 minutes of her second dose of interferon beta-1a (the active ingredient contained in Avonex Prefilled Syringe) The patient had suspended therapy with interferon beta-1a due to pregnancy, and reinitiated her treatment 18 months later. Patient underwent prick and intradermal tests with 0.03 mL of the drug diluted in normal saline, starting with a concentration of 1:1000. She had a positive response to the most diluted concentration of the drug.

A 24-year-old female with multiple sclerosis experienced a 12-month history of subcutaneous nodules coincident with Rebif(R) therapy. These lesions became apparent during the early stages of pregnancy at which time she was taking a break from therapy. Prior to pregnancy, she had received 3 years of subcutaneous treatment, requiring injections of Rebif(R) 44 mcg three times weekly. The site of injection had included the thighs, abdomen, upper arms, and buttocks, although her preferred site of injection was the abdomen. The examination showed multiple 5 to 10 mm diameter firm subcutaneous nodules in a bandlike distribution across the lower abdomen, below the umbilicus. The subcutaneous nodules stayed palpable after 18 months. No further cutaneous adverse events developed once the site of injection was rotated without preference.

Common (1% to 10%): Erythematous rash (up to 7%), maculopapular rash (up to 5%), alopecia (up to 4%)
Rare (less than 0.1%): Severe urticaria (at least 1 case), calcified subcutaneous nodules (at least 1 case), psoriasis (at least 1 case), periungual and nail alterations (at least 1 case)
Postmarketing reports: Avonex(R): Rash (including vesicular rash); Rebif(R): Erythema multiforme, Stevens-Johnson syndrome, increased sweating

Immunologic

Very common (10% or more): Rebif(R): Detection of serum neutralizing antibodies (NAb) (up to 31%)
Common (1% to 10%): Avonex(R): Detection of serum NAb (up to 5%)
Rare (less than 0.1%): Exacerbation or induction of severe dermatomyositis (at least 1 case), subacute cutaneous lupus erythematosus (at least 1 case)
Postmarketing reports: Avonex(R): Autoimmune disorders of multiple target organs (including idiopathic thrombocytopenia, hyperthyroidism, hypothyroidism, rare cases of autoimmune hepatitis); Rebif(R): Drug-induced lupus erythematosus, autoimmune hepatitis

The clinical significance of the presence of NAb is unknown. A small preliminary study suggests that switching these patients to alternate interferon beta preparations may not be clinically beneficial.

Subacute cutaneous lupus erythematosus was confirmed in a 43-year-old white man with a long history of multiple sclerosis. He had received interferon beta-1a 3 million international units weekly for 5 months and listed no family history of autoimmune diseases.

Autoimmune hepatitis in a 38-year-old female treated with Avonex(R) has been reported to occur after 24 months of treatment.

Neutralizing antibodies developed in up to 31% receiving Rebif(R) and up to 5% of patients receiving Avonex(R) during the EVIDENCE Trial (EVidence of Interferon Dose-response: European North American Comparative Efficacy) where efficacy and safety of interferon beta-1a (Rebif[R]) 44 mcg subcutaneously three times weekly was compared against interferon beta-1a (Avonex[R]) 30 mcg intramuscularly once weekly in patients with relapsing-remitting multiple sclerosis (n=667).

Endocrine

Common (1% to 10%): Thyroid disorder (up to 6%)

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