ACTIMMUNE Solution for injection (2021)

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1. Indications and Usage

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 ...

2. Dosage and Administration

2.1 Dosing Information The recommended dosage of ACTIMMUNE administered subcutaneously, for the treatment of patients with CGD and SMO is shown in Table 1 below: Table 1: Recommended Dosage for ACTIMMUNE ...

3. Dosage Forms and Strengths

Injection: 100 mcg (2 million International Units) per 0.5 mL solution in a single-dose vial. ACTIMMUNE (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-dose vial for subcutaneous ...

4. 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.

5. Warnings and Precautions

5.1 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) ...

6. Adverse Reactions

The following adverse reactions are described below and elsewhere in the warnings and precautions section of the labeling: Cardiovascular Disorders [see Warnings and Precautions (5.1)] Neurologic ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of ACTIMMUNE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

6.3. Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical trials, 8 out of 33 ACTIMMUNE-treated patients developed non-neutralizing antibodies to interferon gamma-1b. No neutralizing ...

7. Drug Interactions

7.1 Myelosuppressive Agents When administering ACTIMMUNE in combination with other potentially myelosuppressive agents, monitor neutrophil and platelet counts [see Warnings and Precautions (5.3)] ...

8.1. Pregnancy

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 ...

8.2. Lactation

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 ...

8.3. Females and Males of Reproductive Potential

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 ...

8.4. Pediatric Use

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 ...

8.5. Geriatric Use

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 ...

10. Overdosage

Central nervous system adverse reactions including decreased mental status, gait disturbance and dizziness have been observed, particularly in patients receiving doses greater than 100 mcg/m2 ...

11. Description

ACTIMMUNE (Interferon gamma-1b), an interferon gamma, is a single-chain polypeptide containing 140 amino acids. Production of ACTIMMUNE is achieved by fermentation of a genetically engineered Escherichia ...

12.1. Mechanism of Action

Interferons bind to specific cell surface receptors and initiate a sequence of intracellular events that lead to the transcription of interferon-stimulated genes. The three major groups of interferons ...

12.3. Pharmacokinetics

Pharmacokinetic studies in patients with CGD have not been performed. The intravenous, intramuscular, and subcutaneous pharmacokinetics of ACTIMMUNE have been investigated in 24 healthy male subjects following ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: ACTIMMUNE has not been tested for its carcinogenic potential. Mutagenesis: Ames tests using five different tester strains of bacteria with and without metabolic activation ...

14. Clinical Studies

14.1 Effects in Chronic Granulomatous Disease (CGD) A randomized, double-blind, placebo-controlled trial of ACTIMMUNE (interferon gamma-1b) in patients with CGD, was performed to determine whether ACTIMMUNE ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

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 ...

17. Patient Counseling Information

Advise the patient and/or their parents or caregivers to read the FDA-approved patient labeling (Information for Patient/Caregiver). Inform patients and/or their parents or caregiver regarding the potential ...