ACTIMMUNE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ACTIMMUNE (ACTIMMUNE).
Interferon gamma-1b binds to interferon gamma receptors, modulating immune responses by enhancing macrophage oxidative metabolism, antigen presentation, and cytokine production, and inhibiting viral replication.
| Metabolism | Primarily renal catabolism; no significant hepatic metabolism via CYP450 enzymes. |
| Excretion | Renal (primarily); minimal biliary/fecal |
| Half-life | Terminal elimination half-life: 25-35 minutes after subcutaneous administration; prolonged with renal impairment |
| Protein binding | >90% |
| Volume of Distribution | Approximately 0.2-0.5 L/kg indicating limited extravascular distribution |
| Bioavailability | Subcutaneous: >90% |
| Onset of Action | Subcutaneous: 2-4 hours for pharmacodynamic effects (e.g., neopterin increase) |
| Duration of Action | Pharmacodynamic effects persist for 24-48 hours; dosing schedule is 3 times weekly |
50 mcg/m² (1 million IU/m²) subcutaneously three times weekly
| Dosage form | VIAL |
| Renal impairment | No dose adjustment recommended for renal impairment; not studied in ESRD |
| Liver impairment | No specific guidelines; caution in severe hepatic impairment |
| Pediatric use | 50 mcg/m² (1 million IU/m²) subcutaneously three times weekly; may be increased to 100 mcg/m² (2 million IU/m²) if tolerated |
| Geriatric use | No specific dose adjustment; use with caution due to increased risk of adverse effects (e.g., flu-like symptoms, CNS effects) |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ACTIMMUNE (ACTIMMUNE).
| Breastfeeding | Unknown if interferon gamma-1b is excreted in human milk. M/P ratio not established. Caution recommended; consider developmental and health benefits of breastfeeding along with mother's clinical need and potential adverse effects on the infant. |
| Teratogenic Risk | Interferon gamma-1b is a biologic response modifier. Animal studies are insufficient; in pregnant cynomolgus monkeys, doses up to 100 mcg/kg/day (approximately 20 times human dose) did not reveal teratogenicity, but embryo-fetal loss rates were increased. There are no adequate human studies. Risk cannot be ruled out; use only if potential benefit justifies potential risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to interferon gamma or any component","Patients with known autoimmune hepatitis or severe hepatic disease"]
| Precautions | ["May exacerbate underlying autoimmune disorders (e.g., multiple sclerosis, rheumatoid arthritis)","Increased risk of hepatic enzyme elevations; monitor liver function","May cause bone marrow suppression (leukopenia, thrombocytopenia)","Cardiac toxicity (arrhythmias, myocardial ischemia) in patients with pre-existing cardiac disease","May alter mental status, especially in elderly","Increased risk of capillary leak syndrome"] |
| Food/Dietary | No known food interactions. |
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| Fetal Monitoring | Monitor maternal complete blood counts, hepatic function, and renal function periodically. Fetal growth and well-being should be monitored via ultrasound if used during pregnancy. Observe for maternal flu-like symptoms and signs of infection. |
| Fertility Effects | No controlled studies on fertility. In animal studies, no impairment of fertility was observed at doses up to 20 times the human dose. Effects on human fertility are unknown. |
| Clinical Pearls |
| Monitor for flu-like symptoms; premedicate with acetaminophen. Contraindicated in autoimmune hepatitis. Do not administer to patients with known hypersensitivity to interferon-gamma or any product component. |
| Patient Advice | Report any signs of infection or bleeding. · Inject subcutaneously as directed; rotate injection sites. · Common side effects include fever, headache, and fatigue. · Do not freeze; store in refrigerator. · Inform doctor if pregnant or breastfeeding. |