INDICATIONS AND USAGE
ACTIMMUNE® (Interferon gamma-1b) is indicated:
ACTIMMUNE efficacy
ACTIMMUNE significantly reduced the total number of serious infections* in patients with chronic granulomatous disease (CGD)1,2
Most patients in the clinical trial also received prophylactic antibiotics.
ACTIMMUNE significantly reduced risk of serious infections* in patients with CGD1,2
Treatment effect of ACTIMMUNE is seen early and maintained for the duration of the study.
ACTIMMUNE delivers efficacy across various patient types
In subgroup analyses, ACTIMMUNE was beneficial regardless of age or type of CGD inheritance.1,2
†Not statistically significant, P > 0.05
ACTIMMUNE significantly reduced inpatient hospitalization days compared with placebo1,2
Treatment with ACTIMMUNE resulted in 33% shorter average length of stay in patients who did need to be hospitalized‡
‡32 days in the ACTIMMUNE group vs 48 days in the placebo group; P = 0.02.
ACTIMMUNE helped keep patients free of serious infections* for up to 12 months2
More than twice as many patients treated with ACTIMMUNE remained free of serious infection for up to 12 months compared with patients treated with placebo.
77%
were free of serious infection for up to the 12 months of the study§
30%
of patients who received placebo (P = 0.0006)
*Serious infection is defined as a clinical event requiring hospitalization and/or intravenous antibiotics.
§Mean duration of ACTIMMUNE treatment was 8.9 months.
Stay informed about ACTIMMUNE and CGD
References: 1. ACTIMMUNE (Interferon gamma-1b) [prescribing information] Horizon. 2. The International Chronic Granulomatous Disease Cooperative Study Group. A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease. N Engl J Med. 1991;324(8):509-516.
Approved Uses and Important Safety Information
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
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
Please see Full Prescribing Information for additional safety information.
Approved Uses and Important Safety Information
Approved Uses and Important Safety Information
Approved Uses and Important Safety Information
Approved Uses and Important Safety Information
INDICATIONS AND USAGE
ACTIMMUNE® (Interferon gamma-1b) is indicated:
Approved Uses and Important Safety Information
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
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
Please see Full Prescribing Information for additional safety information.