actimmune

For subcutaneous use only ( 2.1 ) The recommended dose is 50 mcg/m 2 for patients whose body surface area is greater than 0.5 m 2 and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m 2 three times weekly. ( 2.1 ) Monitor hematology, blood chemistries and urinalysis prior to the beginning of treatment and at 3-month intervals. ( 2.1 ) If severe reactions occur, reduce dose by 50 percent or discontinue therapy until the adverse reaction abates. ( 2.3 ) 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 (m 2 ) Dose (mcg/m 2 ) Dose (International Units/m 2 ) 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). Frequency Greater than 0.5 m 2 50 mcg/m 2 1 million International Units/m 2 Three times weekly (For example, Monday, Wednesday and Friday) Equal to or less than 0.5 m 2 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…

The following adverse reactions are described below and elsewhere in the warnings and precautions section of the labeling: Cardiovascular Disorders [see Warnings and Precautions (5.1) ] Neurologic Disorders [see Warnings and Precautions (5.2) ] Bone Marrow Toxicity [see Warnings and Precautions (5.3) ] Hepatic Toxicity [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Renal Toxicity [see Warnings and Precautions (5.6) ] Common adverse reactions (incidence rate 2% or greater) for ACTIMMUNE include fever, headache, rash, chills, injection site erythema or tenderness, fatigue, diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc.at 1 800 77 AMGEN (1 800 772 6436)or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following data on adverse reactions are based on the subcutaneous administration of ACTIMMUNE at a dose of 50 mcg/m 2 , three times weekly, in patients with CGD during a clinical trial in the United States and Europe. The most common adverse reactions observed in patients with CGD are shown in the following…

ACTIMMUNE is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, E. coli derived products, or any component of the product. Known hypersensitivity to interferon gamma, E. coli derived products, or any component of the product ( 4 )

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/m 2 /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.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Concomitant use of drugs with neurotoxic, hematotoxic or cardiotoxic effects may increase the toxicity of interferons. ( 7.2 ) Avoid simultaneous administration of ACTIMMUNE with other heterologous serum protein or immunological preparations (e.g., vaccines). ( 7.3 ) 7.1 Myelosuppressive Agents When administering ACTIMMUNE in combination with other potentially myelosuppressive agents, monitor neutrophil and platelet counts [see Warnings and Precautions (5.3) ] . 7.2 Drugs with Neurotoxic, Hematoxic or Cardiotoxic Effects The concurrent use of drugs having neurotoxic (including effects on the central nervous system), hematotoxic, or cardiotoxic effects may increase the toxicity of interferons in these systems. It is theoretically possible that hepatotoxic and/or nephrotoxic drugs might have an effect on the clearance of ACTIMMUNE. 7.3 Immunological Preparations Simultaneous administration of ACTIMMUNE with other heterologous serum protein preparations or immunological preparations (e.g., vaccines) should be avoided due to the risk of an unexpected, or amplified, immune response. 7.4 Effects on Cytochrome P-450 Pathways Preclinical studies in rodents using species-specific interferon gamma have demonstrated a decrease in hepatic microsomal cytochrome P-450 concentrations. This could potentially lead to a depression of the hepatic metabolism of certain drugs that utilize this degradative pathway.