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Actimmune (Interferon Gamma-1B) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease.

ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis.

DOSAGE AND ADMINISTRATION

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. 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 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 is suitable for a single dose only. The unused portion of any vial should be discarded.

Higher doses are not recommended. Safety and efficacy has not been established for ACTIMMUNE given in doses greater or less than the recommended dose of 50 mcg/m2. The minimum effective dose of ACTIMMUNE has not been established.

DOSE MODIFICATION

If severe reactions occur, the dosage should be modified (50 percent reduction) or therapy should be discontinued until the adverse reaction abates.

ACTIMMUNE may be administered using either sterilized glass or plastic disposable syringes.

HOW SUPPLIED

ACTIMMUNE (Interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-dose vial for subcutaneous injection. Each 0.5 mL of ACTIMMUNE contains: 100 mcg (2 million IU) 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 must be placed in a 2-8°C (36-46°F) refrigerator immediately upon receipt to insure optimal retention of physical and biochemical integrity. DO NOT FREEZE. Avoid excessive or vigorous agitation. DO NOT SHAKE. An unentered vial of ACTIMMUNE 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.

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