No

Biological Response Modulator

Reduce frequency and severity of serious infections associated with chronic granulomatous disease; delay time to disease progression in patients with severe, malignant osteopetrosis

C

Hypersensitivity to interferon gamma, E. coli derived proteins, or any component

Patients with pre-existing cardiac disease, seizure disorders, CNS disturbances, or myelosuppression should be carefully monitored; long-term effects on growth and development are unknown; safety and efficacy in children < 1 year of age have not been established in patients with chronic granulomatous disease.

Based on 50 mcg/m² dose administered three times weekly for chronic granulomatous disease

Central nervous system: Fever (52%), headache (33%), chills (14%), fatigue (14%)

Dermatologic: Rash (17%)

Gastrointestinal: Diarrhea (14%), vomiting (13%)

1% to 10%:

Central nervous system: Depression (3%)

Gastrointestinal: Nausea (10%), abdominal pain (8%)

Neuromuscular & skeletal: Myalgia (6%), arthralgia (2%), back pain (2%)

Other myelosuppressive agents; may decrease cytochrome P-450 concentrations leading to increased serum concentrations of drugs metabolized by this pathway

Store in refrigerator. Do not freeze. Do not shake. Discard if left unrefrigerated for >12 hours.

Absorption: Slowly absorbed from I.M. and S.C. injection

Half-life: Elimination:

I.V.: 38 minutes

I.M., S.C.: 3-6 hours

Time to peak plasma concentration:

I.M.: 4 hours (1.5 ng/mL)

S.C.: 7 hours (0.6 ng/mL)

If severe reactions occur, modify dose (50% reduction) or therapy should be discontinued until adverse reactions improve.

BSA less than or equal to 0.5 m²: 1.5 mcg/kg/dose 3 times/week

BSA >0.5 m²: 50 mcg/m² (1 million int. units/m²) 3 times/week

Severe, malignant osteopetrosis: Children >1 year: S.C.:

BSA less than or equal to 0.5 m²: 1.5 mcg/kg/dose 3 times/week

BSA >0.5 m²: 50 mcg/m² (1 million int. units/m²) 3 times/week

CBC with differential, platelets, LFTs, electrolytes, BUN, creatinine, and urinalysis prior to therapy and at 3-month intervals

Sedation is common; may rarely cause depression

May cause leukopenia; use caution with clozapine and carbamazepine; concurrent use with psychotropics may produce additive sedation

No information available to require special precautions

No effects or complications reported

Use as directed; do not change the dosage or schedule of administration without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience flu-like syndrome (acetaminophen may help or can administer dose at bedtime); nausea, vomiting, or loss of appetite (frequent small meals, frequent mouth care, sucking lozenges, or chewing gum may help); drowsiness, dizziness, agitation, or abnormal thinking (use caution when driving or engaging in tasks requiring alertness until response to drug is known). Report unusual bruising or bleeding; persistent abdominal disturbances; unusual fatigue; muscle pain or tremors; chest pain or palpitations; swelling of extremities; visual disturbances; pain, swelling, or redness at injection site; or other unusual symptoms. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Single-dose vials only: discard unused portion; do not shake

Injection: 100 mcg [2 million int. units]