INDICATIONS AND USAGE
ACTIMMUNE® (Interferon gamma-1b) is indicated:
Helping your patients begin treatment
Amgen is committed to getting patients and families the help they need to obtain ACTIMMUNE.
Learn more about the patient support program, Horizon By Your Side.
Download the Patient Enrollment Form
Starts the prescribing process to help your patients receive ACTIMMUNE
Download Letter of Medical Necessity Template
Letter of Medical Necessity (SMO)
A customizable letter template for HCPs who are submitting a Prior Authorization (PA) for specific ACTIMMUNE SMO patient cases seeking payor access.
Horizon By Your Side is a patient support program for patients prescribed ACTIMMUNE.
The dedicated members of the Horizon By Your Side team provide personalized service to SMO patients so they can have support and injection training with ACTIMMUNE.
Clinical Nurse Educators (CNE) work directly with individual patients to answer non-medical, logistical questions and provide support upon enrollment. Additionally, the CNE educates about navigating insurance processes and accessing treatment on your patient’s behalf. The CNE has the expertise and tools to support the patient by educating on patient benefits, prior authorization requirements, payor policies, and coding and claim submissions.
These services are offered to ACTIMMUNE patients upon enrollment with the Patient Enrollment Form (PEF) and completed patient consent. The services are built around 3 components: connect, coordinate, and champion.
The Horizon By Your Side team helps:
CONNECT: Your patient will be paired with a Clinical Nurse Educator who can provide tools and resources to help your patient manage their day-to-day challenges.
COORDINATE: The Horizon By Your Side team can help patients address financial barriers by researching their insurance benefits, explaining insurance options, and connecting them to financial assistance if eligible.
CHAMPION: The Clinical Nurse Educator will serve as a dedicated personal resource and main point of contact for your patient’s ongoing non-medical needs. To learn more, call 1 (844) 469-4297 or visit www.horizonbyyourside.com/ACTIMMUNE/hcp.
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.