Version May 2024
Note: Dosing expressed in mcg; 50 mcg is equivalent to 1 million units (50 mcg/m2 is equivalent to 1 million units/m2).
Chronic granulomatous disease: SUBQ: 50 mcg/m2 (1 million units/m2) 3 times weekly; maximum dose: 50 mcg/m2
Malignant osteopetrosis (severe): SUBQ: 50 mcg/m2 (1 million units/m2) 3 times weekly; maximum dose: 50 mcg/m2
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling; drug accumulation may occur in patients with severe renal insufficiency.
There are no dosage adjustments provided in the manufacturer’s labeling; drug accumulation may occur in patients with advanced hepatic disease. If severe transaminase elevations occur during treatment, interrupt and reduce the dose upon resolution.
If severe reactions occur, reduce dose by 50% or therapy should be interrupted until adverse reaction abates.
Refer to adult dosing.
Note: Dosing expressed in mcg; 50 mcg is equivalent to 1 million units (50 mcg/m2 is equivalent to 1 million units/m2).
Chronic granulomatous disease: Children and Adolescents: SUBQ:
Body surface area (BSA) ≤0.5 m2: 1.5 mcg/kg/dose 3 times weekly; maximum dose: 50 mcg/m2
BSA >0.5 m2: 50 mcg/m2 (1 million units/m2) 3 times weekly; maximum dose: 50 mcg/m2
Malignant osteopetrosis (severe): Infants, Children, and Adolescents: SUBQ:
Body surface area (BSA) ≤0.5 m2: 1.5 mcg/kg/dose 3 times weekly; maximum dose: 50 mcg/m2
BSA >0.5 m2: 50 mcg/m2 (1 million units/m2) 3 times weekly; maximum dose: 50 mcg/m2
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: Infants, Children, and Adolescents: If severe reactions occur, reduce dose by 50% or therapy should be interrupted until adverse reaction abates.
There are no dosage adjustments provided in the manufacturer’s labeling; drug accumulation may occur in patients with severe renal insufficiency.
There are no dosage adjustments provided in the manufacturer’s labeling; drug accumulation may occur in patients with advanced hepatic disease. If severe transaminase elevations occur during treatment, interrupt and reduce the dose upon resolution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Based on 50 mcg/m2 dose administered 3 times weekly for chronic granulomatous disease
>10%:
Central nervous system: Fever (52%), headache (33%), chills (14%), fatigue (14%)
Dermatologic: Rash (17%)
Gastrointestinal: Diarrhea (14%), vomiting (13%)
Local: Injection site erythema or tenderness (14%)
1% to 10%:
Central nervous system: Depression (3%)
Gastrointestinal: Nausea (10%), abdominal pain (8%)
Neuromuscular & skeletal: Myalgia (6%), arthralgia (2%), back pain (2%)
<1%, postmarketing, and/or case reports: Alkaline phosphatase elevated, atopic dermatitis, granulomatous colitis, hepatomegaly, hypersensitivity reactions, hypokalemia, neutropenia, Stevens-Johnson syndrome
Additional adverse reactions noted at doses >100 mcg/m2 administered 3 times weekly: ALT increased, AST increased, autoantibodies increased, bronchospasm, chest discomfort, confusion, dermatomyositis exacerbation, disorientation, DVT, gait disturbance, GI bleeding, hallucinations, heart block, heart failure, hepatic insufficiency, hyperglycemia, hypertriglyceridemia, hyponatremia, hypotension, interstitial pneumonitis, lupus-like syndrome, MI, neutropenia, pancreatitis (may be fatal), Parkinsonian symptoms, PE, proteinuria, renal insufficiency (reversible), seizure, syncope, tachyarrhythmia, tachypnea, thrombocytopenia, TIA
Hypersensitivity to interferon gamma, E. coli derived products, or any component of the formulation
Concerns related to adverse effects:
• Bone marrow suppression: Dose-related reversible neutropenia and thrombocytopenia (may be severe) have been reported; use caution in patients with myelosuppression.
• CNS effects: Neurologic disorders (ie, decreased mental status, gait disturbances, dizziness) have been noted at the higher doses (>250 mcg/m2/day); most of these abnormalities were reversible within a few days after dose reduction or discontinuation. Use with caution in patients with a history of seizure disorder or compromised CNS function.
• Flu-like symptoms: Acute and transient flu-like symptoms (eg, fever, headache, chills, myalgia, fatigue) have been noted at the higher doses (>250 mcg/m2/day) and may exacerbate preexisting cardiovascular disorders; some of the flu-like symptoms may be minimized by bedtime administration.
• Hepatotoxicity: Elevations of AST and/or ALT (up to 25-fold) have been observed and were reversible with dose reduction or interruption of treatment. Incidence may be increased in children <1 year; perform monthly liver function assessments in this age group; modify dosage if severe elevations of liver enzyme develop.
• Hypersensitivity reactions: Acute serious hypersensitivity reactions have been reported (case reports); transient cutaneous rashes may occur; treatment interruption may be necessary. Discontinue therapy immediately if an acute reaction occurs.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with preexisting cardiovascular disease, including ischemia, heart failure, or arrhythmia. In a scientific statement from the American Heart Association, interferon has been determined to be an agent that may either cause reversible direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate/major) (AHA [Page 2016]).
• Hepatic function impairment: Drug accumulation may occur in patients with advanced hepatic disease.
• Renal function impairment: Drug accumulation may occur in patients with severe renal insufficiency; renal toxicity has been reported.
Dosage form specific issues:
• Latex: The vial stopper may contain dry natural rubber and may cause allergic reactions.
Actimmune Injection, solution: 100 mcg (2 million units) per 0.5 mL (50 mcg is equivalent to 1 million units)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous [preservative free]:
Actimmune: 2,000,000 units/0.5 mL (0.5 mL)
No
Solution (Actimmune Subcutaneous)
2000000 units/0.5 mL (per 0.5 mL): $6,513.68
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SubQ: Administer by SubQ injection into the right and left deltoid or anterior thigh. Consider premedication with acetaminophen and/or bedtime administration to minimize adverse reactions (eg, flu-like symptoms). Do not mix with other drugs in the same syringe.
SubQ: Administer by SubQ injection into the right and left deltoid or anterior thigh. Consider premedication with acetaminophen and/or bedtime administration to minimize adverse reactions (eg, flu-like symptoms). Do not mix with other drugs in the same syringe.
Chronic granulomatous disease: Reduction in the frequency and severity of serious infections associated with chronic granulomatous disease
Malignant osteopetrosis (severe): To delay time to disease progression in patients with severe, malignant osteopetrosis
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Zidovudine: Interferons may enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Risk C: Monitor therapy
Adverse events have been observed in animal reproduction studies.
It is not known if interferon gamma 1b is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
CBC with differential, platelets, LFTs (monthly in children <1 year), electrolytes, BUN, creatinine, and urinalysis prior to therapy and at 3-month intervals
Interferon gamma participates in immunoregulation by enhancing the oxidative metabolism of macrophages; it also enhances antibody dependent cellular cytotoxicity, activates natural killer cells and has a role in the expression of Fc receptors and major histocompatibility antigens.
Absorption: IM, SubQ: >89%
Half-life elimination: IM: ~3 hours, SubQ: ~6 hours
Time to peak, plasma: IM: ~4 hours (1.5 ng/mL); SubQ: ~7 hours (0.6 ng/mL)
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