Drug: Actimmune

ACTIMMUNE® (Interferon gamma-1 b), a biologic response modifier, is a single-chain polypeptide containing 140 amino acids. Production of ACTIMMUNE (interferon gamma 1 b) is achieved by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the human protein. Purification of the product is achieved by conventional column chromatography. ACTIMMUNE (interferon gamma 1 b) is a highly purified sterile solution consisting of non-covalent dimers of two identical 16,465 dalton monomers; with a specific activity of 20 million International Units (IU)/mg (2x106 IU per 0.5 mL) which is equivalent to 30 million units/mg. ACTIMMUNE (interferon gamma 1 b) is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection. Each 0.5 mL of ACTIMMUNE contains: 100 mcg (2 million IU) of Interferon gamma-1 b formulated in 20 mg mannitol, 0.36 mg sodium succinate, 0.05 mg polysorbate 20 and Sterile Water for Injection. Note that the above activity is expressed in International Units (1 million IU/50mcg). This is equivalent to what was previously expressed as units (1.5 million U/50mcg).

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The following data on adverse reactions are based on the subcutaneous administration of ACTIMMUNE (interferon gamma 1 b) 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 (interferon gamma 1 b)
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 (interferon gamma 1 b) and placebo treated patients, respectively. Similar safety data were observed in 34 patients with severe malignant osteopetrosis. ACTIMMUNE (interferon gamma 1 b) 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 1 b) (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-hepatic insufficiency, gastrointestinal bleeding, and pancreatitis, including pancreatitis with fatal outcome. Hematologic-deep venous thrombosis and pulmonary embolism. Immunological- increased autoantibodies, lupus-like syndrome. Metabolic- hyponatremia, hyperglycemia and hypertriglyceridemia. 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 (see WARNINGS and PRECAUTIONS: Laboratory Tests). No neutralizing antibodies to ACTIMMUNE (interferon gamma 1 b) have been detected in any Chronic Granulomatous Disease patients receiving ACTIMMUNE (interferon gamma 1 b) . Post-Marketing Experience Children with CGD less than 3 years of age Data on the safety and activity of ACTIMMUNE (interferon gamma 1 b) 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 (interferon gamma 1 b) 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 (interferon gamma 1 b) therapy. In 6 of the 10 patients receiving ACTIMMUNE (interferon gamma 1 b) 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 (interferon gamma 1 b) 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 (interferon gamma 1 b) 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 (interferon gamma 1 b) treatment and did not recur with rechallenge. In the post-marketing safety database clinically significant adverse events observed during ACTIMMUNE (interferon gamma 1 b) 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. Read the Actimmune (interferon gamma 1 b) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

The recommended dosage of ACTIMMUNE (interferon gamma 1 b) 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. Note that the above activity is expressed in International Units (1 million IU/50mcg). This is equivalent to what was previously expressed as units (1.5 million U/50mcg). Injections should be administered subcutaneously three times weekly (for example, Monday, Wednesday, Friday). The optimum sites of injection are the right and left deltoid and anterior thigh. ACTIMMUNE (interferon gamma 1 b) can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The formulation does not contain a preservative. A vial of ACTIMMUNE (interferon gamma 1 b) is suitable for a single use only. The unused portion of any vial should be discarded. Higher doses are not recommended. Safety and efficacy has not been established for ACTIMMUNE (interferon gamma 1 b) given in doses greater or less than the recommended dose of 50 mcg/m2. The minimum effective dose of ACTIMMUNE (interferon gamma 1 b) has not been established. ACTIMMUNE (interferon gamma 1 b) should not be mixed with other drugs in the same syringe. Dose modification If severe reactions occur, the dosage should be reduced by 50 percent or therapy should be interrupted until the adverse reaction abates. ACTIMMUNE (interferon gamma 1 b) may be administered using either sterilized glass or plastic disposable syringes.

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interactions between ACTIMMUNE (interferon gamma 1 b) and other drugs have not been fully evaluated. Caution should be exercised when administering ACTIMMUNE (interferon gamma 1 b) in combination with other potentially myelosuppressive agents (see WARNINGS). Preclinical studies in rodents using species-specific interferon-gamma have demonstrated a decrease in hepatic microsomal cytochrome P-450 concentrations. This could potentially lead to a depression of the hepatic metabolism of certain drugs that utilize this degradative pathway. Read the Actimmune Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

ACTIMMUNE (interferon gamma 1 b) is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease. ACTIMMUNE (interferon gamma 1 b) is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis.

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ACTIMMUNE (interferon gamma 1 b) is contraindicated in patients who develop or have known hypersensitivity to interferon-gamma, E. coli derived products, or any component of the product. Last reviewed on RxList: 2/19/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Central nervous system adverse reactions including decreased mental status, gait disturbance and dizziness have been observed, particularly in cancer patients receiving doses greater than 100 mcg/m2/day by intravenous or intramuscular administration. These abnormalities were reversible within a few days upon dose reduction or discontinuation of therapy. Reversible neutropenia, elevation of hepatic enzymes and of triglycerides, and thrombocytopenia have also been observed.

Source: http://www.rxlist.com

ACTIMMUNE (interferon gamma 1 b) (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single- use vial for subcutaneous injection. Each 0.5 mL of ACTIMMUNE (interferon gamma 1 b) contains: 100 mcg (2 million lU) of Interferon gamma-1b, formulated in 20 mg mannitol, 0.36 mg sodium succinate, 0.05 mg polysorbate 20 and Sterile Water for Injection. Single vial (NDC 64116-011-01)
Cartons of 12 (NDC 64116-011-12) Stability and Storage Vials of ACTIMMUNE (interferon gamma 1 b) must be placed in a 2-8°C (36-46°F) refrigerator immediately upon receipt to ensure optimal retention of physical and biochemical integrity. DO NOT FREEZE. Avoid excessive or vigorous agitation. DO NOT SHAKE. An unentered vial of ACTIMMUNE (interferon gamma 1 b) should not be left at room temperature for a total time exceeding 12 hours prior to use. Vials exceeding this time period should not be returned to the refrigerator; such vials should be discarded. Do not use beyond the expiration date stamped on the vial. Manufactured by: InterMune, Inc. Brisbane, CA 94005. U.S. Revised - January 2007. FDA Rev date: 1/26/2007 Last reviewed on RxList: 2/19/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Isolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE (interferon gamma 1 b) . If such an acute, reaction develops the drug should be discontinued immediately and appropriate medical therapy instituted. Transient cutaneous rashes have occurred in some patients following injection but have rarely necessitated treatment interruption. Laboratory Tests In addition to those tests normally required for monitoring patients with Chronic Granulomatous Disease and osteopetrosis, the following laboratory tests are recommended for all patients on ACTIMMUNE (Interferon gamma-1 b) therapy prior to the beginning of and at three month intervals during treatment (see WARNINGS: Bone Marrow and Hepatic Toxicity).
  • Hematologic tests - including complete blood counts, differential and platelet counts
  • Blood chemistries - including renal and liver function tests. In patients less than 1 year of age, liver function tests should be measured monthly (see ADVERSE REACTIONS: Post-Marketing Experience).
  • Urinalysis
Carcinogenesis, Mutagenesis and Impairment of Fertility Carcinogenesis: ACTIMMUNE (interferon gamma 1 b) has not been tested for its carcinogenic potential. Mutagenesis: Ames tests using five different tester strains of bacteria with and without metabolic activation revealed no evidence of mutagenic potential. ACTIMMUNE (interferon gamma 1 b) was tested in a micronucleus assay for its ability to induce chromosomal damage in bone marrow cells of mice following two intravenous doses of 20 mg/kg. No evidence of chromosomal damage was noted. Impairment of Fertility: Female cynomolgus monkeys treated with daily subcutaneous doses of 30 or 150 mcg/kg ACTIMMUNE (interferon gamma 1 b) (approximately 20 and 100 times the human dose) exhibited irregular menstrual cycles or absence of cyclicity during treatment. Similar findings were not observed in animals treated with 3 mcg/kg ACTIMMUNE (interferon gamma 1 b) . Female mice receiving recombinant murine IFN-gamma (rmulFN-gamma) at 32 times the maximum recommended clinical dose of ACTIMMUNE (interferon gamma 1 b) for 4 weeks via intramuscular injection exhibited an increased incidence of atretic ovarian follicles. Male cynomolgus monkeys treated intravenously for 4 weeks with 8 times the maximum recommended clinical dose of ACTIMMUNE (interferon gamma 1 b) exhibited decreased spermatogenesis. The impact of this finding on fertility is not known. Male mice receiving rmulFN-gamma at 32 times the maximum recommended clinical dose of ACTIMMUNE (interferon gamma 1 b) for 4 weeks via intramuscular injection exhibited decreased spermatogenesis. Male mice treated subcutaneously with rmulFN-gamma from shortly after birth through puberty, with 280 times the maximum recommended clinical dose of ACTIMMUNE (interferon gamma 1 b) exhibited profound yet reversible decreases in sperm counts and fertility, and an increase in the number of abnormal sperm. The clinical significance of these findings observed following treatment of mice with rmulFN-gamma is uncertain. Pregnancy Teratogenic Effects: Pregnancy Category C. ACTIMMUNE (interferon gamma 1 b) has shown an increased incidence of abortions in primates when given in doses approximately 100 times the human dose. A study in pregnant primates treated with subcutaneous doses 2-100 times the human dose failed to demonstrate teratogenic activity for ACTIMMUNE (interferon gamma 1 b) .              Female mice treated subcutaneously with rmulFN-gamma at 280 times the maximum recommended clinical dose of ACTIMMUNE (interferon gamma 1 b) from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. The clinical significance of this finding observed following treatment of mice with rmulFN-gamma is uncertain. There are no adequate and well-controlled studies in pregnant women. ACTIMMUNE (interferon gamma 1 b) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether ACTIMMUNE (interferon gamma 1 b) is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ACTIMMUNE (interferon gamma 1 b) , a decision should be made whether to discontinue nursing or to discontinue the drug, dependent upon the importance of the drug to the mother. Last reviewed on RxList: 2/19/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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