Interferon-gamma

Interferon-gamma
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Interferon-gamma is an immunological agent that is FDA approved for the treatment of serious infections associated with Chronic Granulomatous Disease and delaying time to disease progression in patients with severe, malignant osteopetrosis.. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

The recommended dosage of ACTIMMUNE for the treatment of patients with Chronic Granulomatous Disease and severe, malignant osteopetrosis is 50 mcg/m2 (1 million IU/m2) for patients whose body surface area is greater than 0.5 m2 and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m2. Note that the above activity is expressed in International Units (1 million IU/50mcg). This is equivalent to what was previously expressed as units (1.5 million U/50mcg). Injections should be administered subcutaneously three times weekly (for example, Monday, Wednesday, Friday). The optimum sites of injection are the right and left deltoid and anterior thigh. ACTIMMUNE can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The formulation does not contain a preservative. A vial of ACTIMMUNE is suitable for a single use only. The unused portion of any vial should be discarded. Higher doses are not recommended. Safety and efficacy has not been established for ACTIMMUNE given in doses greater or less than the recommended dose of 50 mcg/m2. The minimum effective dose of ACTIMMUNE has not been established. ACTIMMUNE should not be mixed with other drugs in the same syringe.

• Dose Modification: If severe reactions occur, the dosage should be reduced by 50 percent or therapy should be interrupted until the adverse reaction abates.
• ACTIMMUNE may be administered using either sterilized glass or plastic disposable syringes.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Interferon-gamma in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Interferon-gamma in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Interferon-gamma FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Interferon-gamma in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Interferon-gamma in pediatric patients.

Contraindications

ACTIMMUNE is contraindicated in patients who develop or have known hypersensitivity to interferon-gamma, E. coli derived products, or any component of the product.

Warnings

Cardiovascular Disorders

Acute and transient flu-like symptoms such as fever and chills induced by ACTIMMUNE at doses of 250 mcg/m2/day (greater than 10 times the weekly recommended dose) or higher may exacerbate pre-existing cardiac conditions. ACTIMMUNE should be used with caution in patients with pre-existing cardiac conditions, including ischemia, congestive heart failure or arrhythmia.

Neurologic Disorders

Decreased mental status, gait disturbance and dizziness have been observed, particularly in patients receiving ACTIMMUNE doses greater than 250 mcg/m2/day (greater than 10 times the weekly recommended dose). Most of these abnormalities were mild and reversible within a few days upon dose reduction or discontinuation of therapy. Caution should be exercised when administering ACTIMMUNE to patients with seizure disorders or compromised central nervous system function.

Bone Marrow Toxicity

Reversible neutropenia and thrombocytopenia that can be severe and may be dose related have been observed during ACTIMMUNE therapy. Caution should be exercised when administering ACTIMMUNE to patients with myelosuppression.

Hepatic Toxicity

Elevations of AST and/or ALT (up to 25-fold) have been observed during ACTIMMUNE therapy. The incidence appeared to be higher in patients less than 1 year of age compared to older children. The transaminase elevations were reversible with reduction in dosage or interruption of ACTIMMUNE treatment. Patients begun on ACTIMMUNE before age one year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Interferon-gamma Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Interferon-gamma Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Interferon-gamma Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Interferon-gamma in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Interferon-gamma in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Interferon-gamma during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Interferon-gamma in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Interferon-gamma in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Interferon-gamma in geriatric settings.

Gender

There is no FDA guidance on the use of Interferon-gamma with respect to specific gender populations.

Race

There is no FDA guidance on the use of Interferon-gamma with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Interferon-gamma in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Interferon-gamma in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Interferon-gamma in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Interferon-gamma in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Interferon-gamma Administration in the drug label.

Monitoring

There is limited information regarding Interferon-gamma Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Interferon-gamma and IV administrations.

Overdosage

There is limited information regarding Interferon-gamma overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

There is limited information regarding Interferon-gamma Mechanism of Action in the drug label.

Structure

There is limited information regarding Interferon-gamma Structure in the drug label.

Pharmacodynamics

There is limited information regarding Interferon-gamma Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Interferon-gamma Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Interferon-gamma Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Interferon-gamma Clinical Studies in the drug label.

How Supplied

There is limited information regarding Interferon-gamma How Supplied in the drug label.

Storage

There is limited information regarding Interferon-gamma Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Interferon-gamma Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Interferon-gamma interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Interferon-gamma Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Interferon-gamma Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Interferon, gamma
Interferon gamma, line representation
Identifiers
Symbols	IFNG ; IFG; IFI
External IDs	Template:OMIM5 Template:MGI HomoloGene: 55526
Gene ontology Molecular function Template:GNF GO Template:GNF GO Template:GNF GO Cellular component Template:GNF GO Template:GNF GO Biological process Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO Template:GNF GO
RNA expression pattern
More reference expression data
Orthologs
Template:GNF Ortholog box
Species	Human	Mouse
Entrez	n/a	n/a
Ensembl	n/a	n/a
UniProt	n/a	n/a
RefSeq (mRNA)	n/a	n/a
RefSeq (protein)	n/a	n/a
Location (UCSC)	n/a	n/a
PubMed search	n/a	n/a