General MedicationsSUBCUTANEOUSHigh Alert

ACTIMMUNE

INTERFERON GAMMA-1B

Standard Dose

2 DOSAGE AND ADMINISTRATION 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 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/m 2 . Higher doses (i.e., greater than 50 mcg/m 2 ) are not recommended. The minimum effective dose of ACTIMMUNE has not been established.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD).

Summary

Indications and usage 1 INDICATIONS AND USAGE 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).

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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). ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) ( 1 ) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO) ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION 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 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/m 2 . Higher doses (i.e., greater than 50 mcg/m 2 ) are not recommended. The minimum effective dose of ACTIMMUNE has not been established. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Cardiovascular Disorders : Pre-existing cardiac conditions may be exacerbated. ( 5.1 ) Neurologic Disorders : Reduce dose or discontinue if decreased mental status, gait disturbance, dizziness occur. ( 5.2 ) Bone Marrow Toxicity : Monitor for neutropenia and thrombocytopenia particularly when administering ACTIMMUNE in combination with other potentially myelosuppressive agents. ( 5.3 ) Hepatic Toxicity : Reduce dose or discontinue to reverse severe elevations of aspartate transaminase (AST) and/or alanine transaminase (ALT); monitor liver function monthly in patients less than 1 year old. ( 5.4 ) Hypersensitivity Reactions: If serious hypersensitivity reactions occur, discontinue and institute appropriate medical therapy. ( 5.5 ) Renal Toxicity : Monitor renal function regularly when administering ACTIMMUNE to patients with severe renal insufficiency ( 5.6 ) 5.1 Cardiovascular Disorders Acute and transient "flu-like" symptoms such as fever and chills induced by ACTIMMUNE at doses of 250 mcg/m 2 /day (greater than 10 times the weekly recommended dose) or higher may exacerbate pre-existing cardiac conditions. Patients with pre-existing cardiac conditions, including ischemia, congestive heart failure or arrhythmia on ACTIMMUNE should be monitored for signs/symptoms of exacerbation. Some of the "flu-like" symptoms may be minimized by bedtime ad

Monitoring

• 5 WARNINGS AND PRECAUTIONS Cardiovascular Disorders : Pre-existing cardiac conditions may be exacerbated.
• ( 5.1 ) Neurologic Disorders : Reduce dose or discontinue if decreased mental status, gait disturbance, dizziness occur.
• ( 5.2 ) Bone Marrow Toxicity : Monitor for neutropenia and thrombocytopenia particularly when administering ACTIMMUNE in combination with other potentially myelosuppressive agents.
• ( 5.3 ) Hepatic Toxicity : Reduce dose or discontinue to reverse severe elevations of aspartate transaminase (AST) and/or alanine transaminase (ALT); monitor liver function monthly in patients less than 1 year old.

Interaction Notes

• 7 DRUG INTERACTIONS 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.