Actimmune

What Is Actimmune?

Actimmune (interferon gamma 1 b) is a specific interferon made from human proteins used to prevent infections in people with a condition called Chronic Granulomatous Disease. Actimmune is also used to treat a congenital bone disorder called osteopetrosis.

What Are Side Effects of Actimmune?

Common side effects of Actimmune include injection site reactions (pain/swelling/redness), diarrhea, upset stomach, nausea, vomiting, problems with memory or concentration, weakness, tired feeling, lack of coordination, muscle or joint pain, or headache. Flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches may occur, especially when you first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use.

Dosage for Actimmune

The recommended dosage of Actimmune for the treatment of patients with Chronic Granulomatous Disease and severe, malignant osteopetrosis is 50 mcg/m2 (1 million IU/m2) for patients whose body surface area is greater than 0.5 m2 and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m2.

What Drugs, Substances, or Supplements Interact with Actimmune?

Other drugs may affect Actimmune. Tell your doctor all medications and supplements you use.

Actimmune During Pregnancy or Breastfeeding

Actimmune is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Actimmune (interferon gamma 1 b) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Actimmune Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• confusion, hallucinations;
• a seizure (convulsions);
• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding; or
• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Your doses may be delayed or reduced if you have certain side effects.

Common side effects may include:

• fever, chills;
• diarrhea;
• headache;
• feeling tired;
• rash; or
• redness or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Actimmune (Interferon Gamma 1 b)

 

Actimmune Professional Information

SIDE EFFECTS

The following adverse reactions are described below and elsewhere in the warnings and precautions section of the labeling:

• Cardiovascular Disorders [see WARNINGS AND PRECAUTIONS]
• Neurologic Disorders [see WARNINGS AND PRECAUTIONS]
• Bone Marrow Toxicity [see WARNINGS AND PRECAUTIONS]
• Hepatic Toxicity [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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 CGD during a clinical trial in the United States and Europe.

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

Table 2: Adverse Reactions Occurring in 2 % or Greater of CGD Patients Receiving ACTIMMUNE in Clinical Trials

Adverse Reactions	Percent of Patients
	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

Similar safety data were observed in 34 patients with SMO.

The clinical and laboratory toxicity associated with multiple dose studies of ACTIMMUNE is dose, route and schedule-dependent.

The most common adverse reactions include constitutional symptoms such as fever, headache, chills, myalgia or fatigue which may decrease in severity as treatment continues.

Less Common Adverse Reactions

The following adverse reactions are assessed as potentially related to ACTIMMUNE (interferon gamma-1b) therapy:

Blood and Lymphatic System—neutropenia (reversible), febrile neutropenia, leukopenia, and thrombocytopenia.

Cardiovascular— angina pectoris, arrhythmia, atrial fibrillation, atrioventricular block, cardiac failure (including congestive cardiac failure), tachyarrhythmia, heart block, (acute) myocardial infarction, myocardial ischemia, syncope, and tachycardia.

Gastrointestinal—abdominal pain, dyspepsia, gastrointestinal bleeding, granulomatous colitis, hepatic insufficiency, and pancreatitis, including pancreatitis with fatal outcome.

General Disorders and Administration Site Conditions—asthenia, chest pain/discomfort, influenza-like illness/flu-like symptoms, injection site hemorrhage, injection site pain, malaise, rigors, and weakness.

Hepatobiliary Disorders—hepatic insufficiency and hepatomegaly.

Immunological—hypersensitivity, increased autoantibodies, lupus-like syndrome (including systemic lupus erythematosus-flares and drug-induced lupus erythematosus), and Stevens-Johnson syndrome.

Infections and Infestations—upper respiratory tract infection.

Investigations—blood alkaline phosphatase increased, liver function tests abnormal/ elevation of hepatic enzymes, increased triglycerides, and weight decreased.

Metabolic—hyponatremia, hypokalemia, hyperglycemia, and hypertriglyceridemia.

Musculoskeletal—back pain, clubbing, and muscle spasms.

Nervous System—dizziness (excluding vertigo), gait disturbance, headache, Parkinsonian symptoms, convulsion/seizure (including grand mal convulsions), and transient ischemic attacks.

Psychiatric—confusion, depression, disorientation, hallucinations, mental status changes, and mental status decreased.

Pulmonary—tachypnea, bronchospasm, pulmonary edema, and interstitial pneumonitis.

Renal—acute renal failure (which may be reversible) and, proteinuria.

Skin and Subcutaneous Tissue Disorders—atopic dermatitis, (exacerbation of) dermatomyositis, transient cutaneous rash, and urticaria.

Vascular Disorder—deep venous thrombosis, hypotension, pulmonary embolism.

Abnormal Laboratory Test Values: Elevations of ALT and AST have been observed [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during post approval use of ACTIMMUNE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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 postmarketing 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 postmarketing safety database clinically significant adverse reactions 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.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical trials, 8 out of 33 ACTIMMUNE-treated patients developed non-neutralizing antibodies to interferon gamma-1b. No neutralizing antibodies to ACTIMMUNE have been detected in patients. In a Phase 1 study, none of the 38 ACTIMMUNE-treated healthy volunteers developed non-neutralizing antibodies to interferon gamma-1b.

The detection of antibody formation, including neutralizing antibody, in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ACTIMMUNE with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Actimmune (Interferon Gamma 1 b)