INDICATIONS AND USAGE
ACTIMMUNE® (Interferon gamma-1b) is indicated:
For US Healthcare Professionals
What is severe malignant osteopetrosis
(SMO)?
What is severe malignant osteopetrosis (SMO)?
Severe malignant osteopetrosis (SMO) is a congenital disorder that results in impaired bone remodeling.1 It is sometimes referred to as marble bone disease or malignant infantile osteopetrosis (MIOP). Severe malignant osteopetrosis is a severe form of malignant osteopetrosis.1,2 SMO:
- Is a dysfunction of osteoclasts that leads to abnormal increase in bone mass and narrowing of space inside the bones where bone marrow is formed
- Presents in children within the first year of life and frequently within the first 3 months
Safety and Tolerability
Learn about common side effects of
ACTIMMUNE and how to manage them
Symptoms of SMO
Learn more about the
indicators of SMO
Support and Resources
See provider and patient materials
available for download
References: 1. Stark Z, Savarirayan R. Osteopetrosis. Orphanet J Rare Dis. 2009;4:5. 2. Wilson CJ, Vellodi A. Autosomal recessive osteopetrosis: diagnosis, management, and outcome. Arch Dis Child. 2000;83(5):449-452.
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.