Hznp Usa, Inc.

Hznp Usa, Inc. Drugs

• Ibuprofen
  

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  Ibuprofen

  

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  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 Body Surface Area (m2) Dose (mcg/m2) Dose (International Units/m2)* Frequency * 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). 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) 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 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.

  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.

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