Important Safety Information and Indications

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

In patients who develop or have known hypersensitivity to interferon gamma-1b, E.
coli -derived products, or any component of the product

WARNINGS AND PRECAUTIONS

ACTIMMUNE should be used with caution in patients with:

Pre-existing cardiac conditions, including ischemia, congestive heart failure, or arrhythmia

Seizure disorders or compromised central nervous system function

Myelosuppression or receiving other potentially myelosuppressive agents

Severe renal insufficiency

Age <1 year

Monitoring:

Before starting ACTIMMUNE and every 3 months during treatment, hematologic tests, blood chemistries, and urinalysis are recommended for all patients

Patients begun on ACTIMMUNE before the age of 1 year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified

Monitor renal function regularly when administering ACTIMMUNE in patients with severe renal insufficiency; accumulation of interferon gamma-1b may occur with repeated administration. Renal toxicity has been reported in patients receiving ACTIMMUNE

USE IN SPECIFIC POPULATIONS

ACTIMMUNE should be used during pregnancy only if the potential benefit to the patient outweighs the potential risk to the fetus

It is not known if ACTIMMUNE is excreted in human milk, so either ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the patient

In younger patients, long-term effects of ACTIMMUNE on fertility are not known

In animal studies, both male and female fertility was negatively impacted by doses significantly higher than the maximum clinical dose

DRUG INTERACTIONS

Concomitant use of drugs with neurotoxic, hematotoxic, or cardiotoxic effects may increase the toxicity of interferons

Avoid simultaneous administration of ACTIMMUNE with other heterologous serum protein or immunological preparations (eg, vaccines)

ADVERSE REACTIONS

The most common adverse experiences occurring with ACTIMMUNE therapy are “flu-like” symptoms such as fever, headache, chills, myalgia, or fatigue, which may decrease in severity as treatment continues, and may be minimized by bedtime administration of ACTIMMUNE. Acetaminophen may be used to prevent or partially alleviate the fever and headache

Isolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE

Reversible neutropenia, thrombocytopenia, and elevations of AST and/or ALT have been observed during ACTIMMUNE therapy

At doses 10 times greater than the weekly recommended dose, ACTIMMUNE may exacerbate pre-existing cardiac conditions, or may cause reversible neurological effects such as decreased mental status, gait disturbance, and dizziness

INDICATIONS AND USAGE

ACTIMMUNE® (Interferon gamma-1b) is indicated:

For reducing the frequency and severity of serious infections associated with chronic granulomatous disease

For delaying time to disease progression in patients with severe, malignant osteopetrosis

Please see Full Prescribing Information for additional safety information.

Reference: ACTIMMUNE (Interferon gamma-1b) [prescribing information] Amgen.

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