Adult Dosing
Chronic granulomatous disease and severe malignant osteopetrosis
- Body surface area >0.5 m2: 50 mcg/m2 (1 million IU/m2) SC 3 times/wk
- Body surface area
0.5 m2: 1.5 mcg/kg/dose SC 3 times/wk - Max: 50 mcg/m2
- In case of severe adverse reactions, reduce the dose by 50% or interrupt therapy until the adverse event subsides
Notes:- Optimum sites for injecting interferon gamma-1b are the right and left deltoid and anterior thigh
- This formulation contains no preservative; each vial is intended for single use only
Pediatric Dosing
Chronic granulomatous disease and severe malignant osteopetrosis
- Body surface area >0.5 m2: 50 mcg/m2 (1 million IU/m2) SC 3 times/wk
- Body surface area 0.5 m2: 1.5 mcg/kg/dose SC 3 times/wk
- Max: 50 mcg/m2
- In case of severe adverse reactions, reduce the dose by 50% or interrupt therapy until the adverse event subsides
Notes:- Optimum sites for injecting interferon gamma-1b are the right and left deltoid and anterior thigh
- This formulation contains no preservative; each vial is intended for single use only
[Outline]
See Supplemental Patient Information
- Doses of 250 mcg/m2/day (greater than 10 times the weekly recommended dose) or higher may induce acute and transient "flu-like" symptoms such as fever and chills, which may exacerbate preexisting cardiac conditions. This product should be used with caution in patients with preexisting cardiac conditions
- Decreased mental status, gait disturbance, and dizziness have occurred, especially in patients receiving interferon gamma-1b at doses >250 mcg/m2/day. Most of these conditions are usually reversible within a few days upon dose reduction or discontinuation of therapy. Should be used with caution in patients with seizure disorders or compromised CNS function
- Reversible neutropenia and thrombocytopenia, which can be severe and may be dose related have been observed during therapy. Should be used with caution in patients with myelosuppression or those receiving other myelosuppressive agents
- Increased AST and/or ALT (up to 25-fold) have been observed during therapy. Such incidences appear to be higher in patients <1 year of age compared to older children. Transaminase elevations were reversible with dose reduction or interruption of therapy. Hepatic functions should be assessed monthly in patients <1 yr of age receiving this therapy. Dose modification is recommended if severe elevations of hepatic enzymes develop
- Rare incidences of acute serious hypersensitivity reactions have been reported in patients receiving therapy. Discontinue therapy immediately and institute appropriate medical therapy in such patients
- It is recommended to conduct hematologic tests (including CBC, differential and platelet counts), blood chemistries (including renal and liver function tests) and urinalysis in patients on therapy prior to initiating therapy and at 3-month intervals during treatment
Supplemental Patient Information
- Provide thorough instructions on appropriate use of the product if home use is determined to be desirable by the physician
- Advise patients to use acetaminophen to prevent or partially alleviate fever and headache
Pregnancy Category:C
Breastfeeding: No data available on the use of interferon gamma-1b during lactation; however, interferon alfa (a closely related drug) is excreted in milk in very low amounts. Any interferon in breastmilk is probably destroyed in the infant's GI tract and not absorbed, except perhaps in neonates. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 28 July 2011). As per manufacturer's data, it is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the possibility of serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
