Interferon Gamma

Interferons are potent cytokines that possess antiviral, immunomodulating and antiproliferative actions. The interferons bind to specific cell-surface receptors that initiate a series of intracellular events, induction of certain enzymes, inhibition of cell-proliferation, and enhancement of immune activities. it-1b is a parenteral recombinant DNA drug that is essentially identical to natural gamma interferon. Interferon Gamma is chemically and pharmacologically distinct from interferon alfa or interferon beta. Recombinant it-1b is derived from genetically engineered Escherichia coli and is currently used in the treatment of chronic granulomatous disease, an inherited disorder of phagocytic oxidative metabolism. it-1b was approved by the FDA in December 1990. I

Interferon Gamma is primarily indicated in conditions like Chronic granulomatous disease, Malignant Osteopetrosis, and can also be given in adjunctive therapy as an alternative drug of choice in Adjunct in the treatment of opioid dependence, Leishmaniasis, Lepromatous leprosy, Oncological indications.

Interferon Gamma is contraindicated in conditions like Hypersensitivity.

The severe or irreversible adverse effects of Interferon Gamma, which give rise to further complications include Bronchospasm, Pancreatitis, Neutropenia, Hyponatremia, Interstitial pneumonitis, Hypoglycemia, Hepatic insufficiency, Renal insufficiency. Interferon Gamma produces potentially life-threatening effects which include Myocardial infarction, GI bleeding, Pulmonary embolism, Heart failure. which are responsible for the discontinuation of Interferon Gamma therapy. The signs and symptoms that are produced after the acute overdosage of Interferon Gamma include Ataxia, Dizziness, Clouding of consciousness. The symptomatic adverse reactions produced by Interferon Gamma are more or less tolerable and if they become severe, they can be treated symptomatically, these include Headache, Fatigue, Nausea, Vomiting, Fever, Myalgia, Chills, Parkinsonism, Arthralgia, Syncope, Tachypnea.

Acute and transient flu-like syndrome or constitutional symptoms (e.g., chills, fever) that are associated with daily dosages ≥250 mcg/m 2 (>10 times the weekly recommended dosage) may exacerbate preexisting cardiac conditions. Use with caution in patients with preexisting cardiac disease (e.g., arrhythmia, CHF, symptoms of ischemia). Possible seizures, decreased mental status, dizziness, and gait disturbance, particularly at daily dosages >250 mcg/m 2 (>10 times the weekly recommended dosage). Use with caution in patients with known seizure disorders or compromised CNS function. Possibly severe, reversible, dose-limiting neutropenia and thrombocytopenia reported rarely. Use with caution in patients with myelosuppression and in those receiving drugs that may be myelosuppressive. Monitor blood cell and differential counts and platelet counts prior to initiating interferon gamma-1b and at 3-month intervals during therapy. Proteinuria reported rarely. Perform urinalysis and monitor appropriate blood chemistry tests prior to initiating interferon gamma-1b and at 3-month intervals during therapy. Possibly substantial (up to 25-fold) elevations of AST and/or ALT reported; children <1 year of age most at risk (see Pediatric Use under Cautions). Reversible with dosage reduction or interruption of therapy. Perform liver function tests prior to initiating interferon gamma-1b and at monthly (for children <1 year of age) or 3-month intervals during therapy. If severe hepatic enzyme elevations occur, modify dosages. (See Dosage under Dosage and Administration.) If acute, serious hypersensitivity reactions occur, discontinue immediately and initiate appropriate therapy. Category C. Not known whether interferon gamma-1b is distributed into milk; discontinue nursing or the drug. Increased risk of elevations of AST and/or ALT in children <1 year of age. May occur as early as 7 days after starting treatment. (See Hepatic Effects under Cautions.) Possibly reversible alkaline phosphatase elevation and hypokalemia.

Acute and transient flu-like syndrome or constitutional symptoms (e.g., chills, fever) that are associated with daily dosages ≥250 mcg/m 2 (>10 times the weekly recommended dosage) may exacerbate preexisting cardiac conditions. Use with caution in patients with preexisting cardiac disease (e.g., arrhythmia, CHF, symptoms of ischemia). Possible seizures, decreased mental status, dizziness, and gait disturbance, particularly at daily dosages >250 mcg/m 2 (>10 times the weekly recommended dosage). Use with caution in patients with known seizure disorders or compromised CNS function. Possibly severe, reversible, dose-limiting neutropenia and thrombocytopenia reported rarely. Use with caution in patients with myelosuppression and in those receiving drugs that may be myelosuppressive. Monitor blood cell and differential counts and platelet counts prior to initiating interferon gamma-1b and at 3-month intervals during therapy. Proteinuria reported rarely. Perform urinalysis and monitor appropriate blood chemistry tests prior to initiating interferon gamma-1b and at 3-month intervals during therapy. Possibly substantial (up to 25-fold) elevations of AST and/or ALT reported; children <1 year of age most at risk (see Pediatric Use under Cautions). Reversible with dosage reduction or interruption of therapy. Perform liver function tests prior to initiating interferon gamma-1b and at monthly (for children <1 year of age) or 3-month intervals during therapy. If severe hepatic enzyme elevations occur, modify dosages. (See Dosage under Dosage and Administration.) If acute, serious hypersensitivity reactions occur, discontinue immediately and initiate appropriate therapy. Category C. Not known whether interferon gamma-1b is distributed into milk; discontinue nursing or the drug. Increased risk of elevations of AST and/or ALT in children <1 year of age. May occur as early as 7 days after starting treatment. (See Hepatic Effects under Cautions.) Possibly reversible alkaline phosphatase elevation and hypokalemia.

1.5 mcg/kg/dose (1.5 (1.5)) As recommended. SC — For patients whose body surface area is less than 0.5 m2. 50 mcg/m2 (50 (50)) As recommended. SC — For patients whose body surface area is greater than 0.5 m2.

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

No formal drug interaction studies to date.

Inj (reconstituted soln) Store at room temperature. Use within 12 hrs if kept at room temperature. SC Inj Store in refrigerator. Do not Freeze.