- ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD).
- ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).
DOSAGE AND ADMINISTRATION
The recommended dosage of ACTIMMUNE administered subcutaneously, for the treatment of patients with CGD and SMO is shown in Table 1 below:
Table 1: Recommended Dosage
for ACTIMMUNE for the Treatment of Patients with CGD and SMO
|Body Surface Area (m²)||Dose (mcg/m²)||Dose (International Units/m²)a||Frequency|
|Greater than 0.5 m²||50 mcg/m²||1 million International Units/m²||Three times weekly (For example, Monday, Wednesday and Friday)|
|Equal to or less than 0.5 m²||1.5 mcg/kg/dose||-||Three times weekly (For example, Monday, Wednesday and Friday)|
|aNote that the above activity is expressed in International Units (1 million International Units/50 mcg). This is equivalent to what was previously expressed as units (1.5 million units/50 mcg).|
- Prior to the beginning of treatment and at three-month intervals during treatment the following laboratory tests are recommended for all patients on ACTIMMUNE (interferon gamma-1b) therapy[see WARNINGS AND PRECAUTIONS] :
Important Administration Instructions
- The optimum sites of subcutaneous injection are the right and left deltoid and anterior thigh.
- ACTIMMUNE can be administered by a physician, nurse, family member or patient when appropriately counseled 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. ACTIMMUNE is a clear, colorless solution.
- ACTIMMUNE is for a single use only. Discard any unused portion. ACTIMMUNE does not contain a preservative.
- ACTIMMUNE should not be mixed with other drugs in the same syringe.
- Administer ACTIMMUNE using either sterilized glass or plastic disposable syringes.
- If severe reactions occur, the dosage should be reduced by 50 percent or therapy should be interrupted until the adverse reaction abates.
- Safety and efficacy has not been established for ACTIMMUNE given in doses greater or less than the recommended dose of 50 mcg/m² . Higher doses (i.e., greater than 50 mcg/m²) are not recommended. The minimum effective dose of ACTIMMUNE has not been established.
Dosage Forms And Strengths
Injection: 100 mcg (2 million International Units) per 0.5 mL solution in a single-use vial. ACTIMMUNE (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection.
ACTIMMUNE (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection. Each vial permits the extraction of up to 0.5 mL of ACTIMMUNE with additional volume to facilitate solution withdrawal. Each 0.5 mL of ACTIMMUNE contains: 100 mcg (2 million International Units) of interferon gamma-1b.
|42238-111-12||Cartons of 12 vials|
Storage And Handling
Store vials in the refrigerator at 2 to 8 °C (36 °F – 46 °F). Do Not Freeze. Avoid excessive or vigorous agitation. Do Not Shake. An unused vial of ACTIMMUNE can be stored at room temperature up to 12 hours prior to use. Discard vials if not used within the 12 hour period. Do not return to the refrigerator.
Manufactured by: Horizon Pharma Ireland Ltd. Dublin, Ireland. Distributed by: HZNP USA Inc. Roswell, GA 30076. Revised: Aug 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/12/2015
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