Dosing Information

• The recommended dosage of ACTIMMUNE administered subcutaneously, for the treatment of patients with CGD and SMO is shown in Table 1 below:

• 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

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.

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.