ACTIMMUNE- interferon gamma-1b injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INTERFERON GAMMA-1B (UNII: 21K6M2I7AG) (INTERFERON GAMMA-1B - UNII:21K6M2I7AG)

Available from:

Horizon Therapeutics USA, Inc.

INN (International Name):

Interferon gamma-1b

Composition:

Interferon gamma-1b 100 ug in 0.5 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). - ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, E. coli derived products, or any component of the product. Risk Summary There are no adequate and well-controlled studies in pregnant women. ACTIMMUNE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data ACTIMMUNE has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. A study in pregnant primates treated with subcutaneous doses 2 – 100 times the human dose failed to demonstrate teratogenic activity for ACTIMMUNE. Female mice treated subcutaneously with recombinant murine IFN-interferon gamma (rmuIFN-gamma) at 280 times the maximum recommended clinical dose of ACTIMMUNE from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. The clinical significance of this finding observed following treatment of mice with rmuIFN-gamma is uncertain. For lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity or teratogenicity in preclinical studies. Risk Summary It is not known whether ACTIMMUNE is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ACTIMMUNE, a decision should be made whether to discontinue nursing or to discontinue the drug, dependent upon the importance of the drug to the mother. Infertility Based on the information available, it cannot be excluded that the presence of higher levels of interferon gamma may impair male fertility and that in certain cases of female infertility increased levels of interferon gamma may have played a role [see Nonclinical Toxicology (13.1) ]. In younger patients, the long-term effect on fertility is also not known. The safety and effectiveness of ACTIMMUNE has been established in pediatric patients aged 1 year and older in CGD patients and 1 month and older in SMO patients [see Clinical Studies (14)]. There are no data available for pediatric patients below the age of 1 month. Clinical studies of ACTIMMUNE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Product summary:

ACTIMMUNE (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-dose vial for subcutaneous injection. Each vial permits the extraction of up to 0.5 mL of ACTIMMUNE with additional volume to facilitate solution withdrawal. Each 0.5 mL of ACTIMMUNE contains: 100 mcg (2 million International Units) of interferon gamma-1b. Store vials in the refrigerator at 2 to 8 °C (36 °F – 46 °F). Do Not Freeze. Avoid excessive or vigorous agitation. Do Not Shake . An unused vial of ACTIMMUNE can be stored at room temperature up to 12 hours prior to use. Discard vials if not used within the 12 hour period. Do not return to the refrigerator.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ACTIMMUNE- INTERFERON GAMMA-1B INJECTION, SOLUTION
HORIZON THERAPEUTICS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACTIMMUNE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACTIMMUNE.
ACTIMMUNE (INTERFERON GAMMA-1B) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
ACTIMMUNE is an interferon gamma indicated for:
Reducing the frequency and severity of serious infections associated
with Chronic Granulomatous
Disease (CGD) (1)
Delaying time to disease progression in patients with severe,
malignant osteopetrosis (SMO) (1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only (2.1)
The recommended dose is 50 mcg/m for patients whose body surface area
is greater than 0.5 m and
1.5 mcg/kg/dose for patients whose body surface area is equal to or
less than 0.5 m three times
weekly. (2.1)
Monitor hematology, blood chemistries and urinalysis prior to the
beginning of treatment and at 3-
month intervals. (2.1)
If severe reactions occur, reduce dose by 50 percent or discontinue
therapy until the adverse reaction
abates. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mcg (2 million International Units) of Interferon
gamma-1b in 0.5 mL solution in a single-
dose vial. (3)
CONTRAINDICATIONS
Known hypersensitivity to interferon gamma, _E. coli_ derived
products, or any component of the product (4)
WARNINGS AND PRECAUTIONS
_Cardiovascular Disorders_: Pre-existing cardiac conditions may be
exacerbated. (5.1)
_Neurologic Disorders_: Reduce dose or discontinue if decreased mental
status, gait disturbance,
dizziness occur. (5.2)
_Bone Marrow Toxicity_: Monitor for neutropenia and thrombocytopenia
particularly when administering
ACTIMMUNE in combination with other potentially myelosuppressive
agents. (5.3)
_Hepatic Toxicity_: Reduce dose or discontinue to reverse severe
elevations of aspartate transaminase
(AST) and/or alanine transaminase (ALT); monitor liver function
monthly in patients less than 1 year old.
(