Dosing and uses of Actimmune (interferon gamma 1b)
Adult dosage forms and strengths
injectable solution
- 100mcg/0.5mL (single-dose vial)
- 50mcg = 1 million units/m²
Chronic Granulomatous Disease
Indicated to reduce frequency and severity of infections associated with chronic granulomatous disease
BSA >0.5 m²: 50 mcg/m² SC 3 times/week
BSA ≤0.5 m²: 1.5 mcg/kg SC 3 times/week
Malignant Osteopetrosis
Indicated to delay time to progression for severe malignant osteopetrosis
BSA >0.5 m²: 50 mcg/m² SC 3 times/week
BSA ≤0.5 m²: 1.5 mcg/kg SC 3 times/week
Orphan Designations
Friedriech's ataxia
Renal cell carcinoma
Sponsor
- Horizon Pharma Ireland Limited; Adelaide Chambers; Dublin 8; IRELAND
Administration
Optimum sites are right and left deltoid, anterior thigh
If severe reactions occur, reduce dose by 50 percent or discontinue therapy until the adverse reaction abates
Monitor
CBC, blood chemistries, urinalysis: q3month
Pediatric dosage forms and strengths
injectable solution
- 100mcg/0.5mL (single-dose vial)
- 50mcg = 1 million units/m²
Chronic Granulomatous Disease
BSA >0.5 m²: 50 mcg/m² SC 3 times/week
BSA <0.5 m²: 1.5 mcg/kg SC 3 times/week
Actimmune (interferon gamma 1b) adverse (side) effects
>10%
Fever (52%)
Headache (33%)
Rash (17%)
Chills (14%)
Diarrhea (14%)
Injection site erythema/tenderness (14%)
Vomiting (13%)
Nausea (10%)
1-10%
Arthralgia
Myalgia
Warnings
Contraindications
Hypersensitivity to interferon gamma or E. coli-derived products
Cautions
Immunocompromised patients
Potential for hepatotoxicity
If severe reactions occur, decrease dose 50% or withhold until side effects subside
Caution in cardiovascular disease; pre-existing cardiac conditions may be exacerbated
Reduce dose or discontinue if decreased mental status, gait disturbance, dizziness occur
Monitor for neutropenia and thrombocytopenia particularly when administering in combination with other potentially myelosuppressive agents
Reduce dose or discontinue to reverse severe elevations of aspartate transaminase (AST) and/or alanine transaminase (ALT); monitor liver function monthly in patients <1 year old
If serious hypersensitivity reactions occur, discontinue and institute appropriate medical therapy
Monitor renal function regularly when administering therapy to patients with severe renal insufficiency
Refrigerate vials-do not freeze or shake
The stopper of the glass vial contains natural rubber (a derivative of latex) which may cause allergic reactions
May cause flu-like symptoms
No preservatives-discard unused portions
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known whether excreted in breast milk, discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Actimmune (interferon gamma 1b)
Mechanism of action
Recombinant human interferon gamma-1b, cytokine that confers greater resistance to microbial pathogens and regulates immune processes
Pharmacokinetics
Absorption: 89% (SC, IM)
Half-life: 38 min (IV); 3 hr (IM); 5.9 hr (SC)
Peak plasma time: 4 hr (IM); 7 hr (SC)
