Actimmune

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

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