Actimmune
(Interferon Gamma-1b)Dosage & Administration
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Actimmune Prescribing Information
- 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).
- For subcutaneous use only ()
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)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 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
- The recommended dose is 50 mcg/m2 for patients whose body surface area is greater than 0.5 m2 and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m2 three times weekly. ()
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)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 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
- Monitor hematology, blood chemistries and urinalysis prior to the beginning of treatment and at 3-month intervals. ()
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)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 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
- If severe reactions occur, reduce dose by 50 percent or discontinue therapy until the adverse reaction abates. ()
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.
Injection: 100 mcg (2 million International Units) per 0.5 mL solution in a single-dose vial. ACTIMMUNE (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-dose vial for subcutaneous injection.
Based on animal data, may cause fetal harm. (
There are no adequate and well-controlled studies in pregnant women. ACTIMMUNE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
ACTIMMUNE has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. A study in pregnant primates treated with subcutaneous doses 2 – 100 times the human dose failed to demonstrate teratogenic activity for ACTIMMUNE.
Female mice treated subcutaneously with recombinant murine IFN-interferon gamma (rmuIFN-gamma) at 280 times the maximum recommended clinical dose of ACTIMMUNE from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. The clinical significance of this finding observed following treatment of mice with rmuIFN-gamma is uncertain. For lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity or teratogenicity in preclinical studies.
ACTIMMUNE is contraindicated in patients who develop or have known hypersensitivity to interferon gamma,
- Cardiovascular Disorders: Pre-existing cardiac conditions may be exacerbated. ()
5.1 Cardiovascular DisordersAcute and transient "flu-like" symptoms such as fever and chills induced by ACTIMMUNE at doses of 250 mcg/m2/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 administration of ACTIMMUNE. Acetaminophen may also be used to ameliorate these effects.
- Neurologic Disorders: Reduce dose or discontinue if decreased mental status, gait disturbance, dizziness occur. ()
5.2 Neurologic DisordersDecreased mental status, gait disturbance and dizziness have been observed, particularly in patients receiving ACTIMMUNE doses greater than 250 mcg/m2/day (greater than 10 times the weekly recommended dose). Most of these abnormalities were reversible within a few days upon dose reduction or discontinuation of therapy. Monitor patients when administering ACTIMMUNE to patients with seizure disorders or compromised central nervous system function.
- Bone Marrow Toxicity: Monitor for neutropenia and thrombocytopenia particularly when administering ACTIMMUNE in combination with other potentially myelosuppressive agents. ()
5.3 Bone Marrow ToxicityReversible neutropenia and thrombocytopenia that can be severe and may be dose related have been observed during ACTIMMUNE therapy. Monitor neutrophil and platelet counts in patients with myelosuppression during treatment with ACTIMMUNE.
- 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 Hepatic ToxicityRepeated administration of ACTIMMUNE to patients with advanced hepatic disease may result in accumulation of interferon gamma-1b. Frequent assessment of liver function in these patients is recommended.
Elevations of aspartate transaminase (AST) and/or alanine transaminase (ALT) (up to 25-fold) have been observed during ACTIMMUNE therapy. The incidence appeared to be higher in patients less than 1 year of age compared to older children. The transaminase elevations were reversible with reduction in dosage or interruption of ACTIMMUNE treatment. Patients begun on ACTIMMUNE before age one year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified
[see Dosage and Administration (2.3)]. - Hypersensitivity Reactions:If serious hypersensitivity reactions occur, discontinue and institute appropriate medical therapy. ()
5.5 Hypersensitivity ReactionsIsolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE. If such an acute reaction develops the drug should be discontinued immediately and appropriate medical therapy instituted. Transient cutaneous rashes have occurred in some patients following injection of ACTIMMUNE that have necessitated treatment interruption.
- Renal Toxicity: Monitor renal function regularly when administering ACTIMMUNE to patients with severe renal insufficiency ()
5.6 Renal ToxicityMonitor renal function regularly when administering ACTIMMUNE in patients with severe renal insufficiency because the possibility exists that with repeated administration, accumulation of interferon gamma-1b may occur. Renal toxicity has been reported in patients receiving ACTIMMUNE.