ACTIMMUNE Solution for injection Ref.[50763] Active ingredients: Interferon gamma-1b

2.1 Dosing Information

• 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

^* Note 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 (5.3, 5.4, 5.6)]:
  • 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 (6.2)].
  • Urinalysis

2.2 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 dose 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.

2.3 Dose Modification

• 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.

Central nervous system adverse reactions including decreased mental status, gait disturbance and dizziness have been observed, particularly in 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.

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.