Actimmune Side Effects

Generic Name: interferon gamma-1b

Please note - some side effects for Actimmune may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Actimmune - for the Consumer

Actimmune

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actimmune:

Diarrhea; fatigue; flu-like symptoms (eg, low-grade fever, chills, general body discomfort); headache; joint pain; muscle pain; nausea; pain, redness, or swelling at the injection site; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Actimmune:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dizziness; fainting; fast or irregular heartbeat; high or persistent fever; mood or mental changes; seizures; signs of infection (eg, chills, persistent sore throat); stomach pain; trouble walking; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Actimmune Side Effects - for the Professional

Actimmune

The following data on adverse reactions are based on the subcutaneous administration of Actimmune  at a dose of 50 mcg/m2, three times weekly, in patients with Chronic Granulomatous Disease (CGD) during an investigational trial in the United States and Europe.

The most common adverse events observed in patients with CGD are shown in the following table:

		Percent of Patients
Clinical Toxicity		Actimmune CGD (n=63)		Placebo CGD (n=65)
Fever		52		28
Headache		33		9
Rash		17		6
Chills		14		0
Injection site erythema or tenderness		14		2
Fatigue		14		11
Diarrhea		14		12
Vomiting		13		5
Nausea		10		2
Myalgia		6		0
Arthralgia		2		0
Injection site pain		0		2

Miscellaneous adverse events which occurred infrequently in patients with CGD and may have been related to underlying disease included back pain (2 percent versus 0 percent), abdominal pain (8 percent versus 3 percent) and depression (3 percent versus 0 percent) for Actimmune  and placebo treated patients, respectively.

Similar safety data were observed in 34 patients with severe malignant osteopetrosis.

Actimmune  has also been evaluated in additional disease states in studies in which patients have generally received higher doses (>100 mcg/m2/three times weekly) administered by intramuscular or subcutaneous injection, or intravenous infusion. All of the previously described adverse reactions which occurred in patients with Chronic Granulomatous Disease have also been observed in patients receiving higher doses. Adverse reactions not observed in patients with Chronic Granulomatous Disease but reported in patients receiving Actimmune  (Interferon gamma-1b) in other studies include: Cardiovascular—hypotension, syncope, tachyarrhythmia, heart block, heart failure, and myocardial infarction. Central Nervous System—confusion, disorientation, gait disturbance, Parkinsonian symptoms, seizure, hallucinations, and transient ischemic attacks. Gastrointestinal—dyspepsia, hepatic insufficiency, gastrointestinal bleeding, and pancreatitis, including pancreatitis with fatal outcome. General Disorders and Administration Site Conditions—malaise, injection site hemorrhage. Hematologic—deep venous thrombosis and pulmonary embolism. Immunological—increased autoantibodies, lupus-like syndrome. Metabolic—hyponatremia, hyperglycemia and hypertriglyceridemia. Musculoskeletal—clubbing, muscle spasms. Pulmonary—tachypnea, bronchospasm, and interstitial pneumonitis. Renal—reversible renal insufficiency. Other—chest discomfort, exacerbation of dermatomyositis.

Abnormal Laboratory Test Values:  Elevations of ALT and AST, neutropenia, thrombocytopenia, and proteinuria have been observed.

No neutralizing antibodies to Actimmune  have been detected in any Chronic Granulomatous Disease patients receiving Actimmune.

Post-Marketing Experience

Children with CGD less than 3 years of age:
Data on the safety and activity of Actimmune  in 37 patients under the age of 3 years was pooled from four uncontrolled post-marketing studies. The rate of serious infections per patient-year in this uncontrolled group was similar to the rate observed in the Actimmune  treatment groups in controlled trials. Developmental parameters (height, weight and endocrine maturation) for this uncontrolled group conformed to national normative scales before and during Actimmune  therapy.

In 6 of the 10 patients receiving Actimmune  therapy before age one year 2-fold to 25-fold elevations from baseline of AST and/or ALT were observed. These elevations occurred as early as 7 days after starting treatment. Treatment with Actimmune  was interrupted in all 6 of these patients and was restarted at a reduced dosage in 4. Liver transaminase values returned to baseline in all patients and transaminase elevation recurred in one patient upon Actimmune  rechallenge. An 11-fold alkaline phosphatase elevation and hypokalemia in one patient and neutropenia (ANC=525 cells/mm3) in another patient resolved with interruption of Actimmune  treatment and did not recur with rechallenge.

In the post-marketing safety database clinically significant adverse events observed during Actimmune  therapy in children under the age of three years (n=14) included: two cases of hepatomegaly, and one case each of Stevens-Johnson syndrome, granulomatous colitis, urticaria, and atopic dermatitis.

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Side Effects by Body System - for Healthcare Professionals

General

General flu-like side effects have been reported most frequently. These have included fever (52%), headache (33%), chills (14%), fatigue (14%), myalgia (6%), and arthralgia (2%). Chest discomfort has been reported.

Gastrointestinal

Gastrointestinal side effects have been reported frequently. These have included diarrhea (14%), vomiting (13%), and nausea (10%). Gastrointestinal bleeding has been reported rarely.

Dermatologic

Dermatologic side effects have included rash (17%).

Local

Local side effects have included erythema or tenderness at the site of injection (14%).

Cardiovascular

Cardiovascular side effects have been reported rarely. These have included hypotension, syncope, tachyarrhythmia, heart block, heart failure, and myocardial infarction.

Nervous system

Nervous system side effects have been reported rarely. These have included confusion, disorientation, gait disturbance, Parkinsonian symptoms, seizure, hallucinations, and transient ischemic attacks.

Respiratory

Respiratory side effects have included tachypnea, bronchospasm, and interstitial pneumonitis.

Hematologic

Hematologic side effects have been reported rarely. These have included deep venous thrombosis and pulmonary embolism.

Renal

Renal side effects have included renal insufficiency which was reversible.

Metabolic

Metabolic side effects have included hyponatremia, hyperglycemia, and hypertriglyceridemia.

Immunologic

Immunologic side effects have included increased autoantibodies and lupus-like syndrome.

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