INDICATIONS AND USAGE
ACTIMMUNE® (Interferon gamma-1b) is indicated:
Prescriber and practice resources available to you
Download these resources to learn more about chronic granulomatous disease (CGD) and help your patients get access to treatment.
Patient Enrollment Form
Download the form, complete it with your patient, sign it, and submit by fax or email.
ACTIMMUNE Annotated Patient Enrollment Form
After prescribing ACTIMMUNE, initiate the process to enroll your patient in Horizon By Your Side.
X-Linked Chronic Granulomatous Disease (CGD)
Review the case histories of 2 male patients with X-linked CGD and how they found success with adherence.
Autosomal Recessive Chronic Granulomatous Disease (CGD)
Review the case histories of 2 female patients with autosomal recessive CGD and their journeys to treatment with ACTIMMUNE.
Protect HSCT Discussion Guide
Review the implications of infections leading up to hematopoietic stem cell transplantation (HSCT) and how ACTIMMUNE may help.
Chronic Granulomatous Disease: An Updated Experience
See updated data from a cohort of patients being followed since 1985 and review newly recognized manifestations of CGD.
ACTIMMUNE Coding Flashcard
A resource providing relevant NDC, ICD-10-CM and HCPCS codes for payor claims submissions.
ACTIMMUNE Letter of Medical Necessity (CGD)
A customizable letter template for HCPs who are submitting a Prior Authorization (PA) for specific ACTIMMUNE CGD patient cases seeking payor access.
ACTIMMUNE Prior Authorization Checklist
Provides a checklist of the common criteria that may be requested for ACTIMMUNE.
ACTIMMUNE Payor Appeal Letter Checklist and Tips
Provides a checklist and tips that may be useful when creating an appeal letter after a prior authorization request is denied by your patient's health plan.
ACTIMMUNE Payor Appeal Letter Template
A customizable letter template for HCPs who are submitting an appeal for specific ACTIMMUNE patient cases that were denied Prior Authorization (PA).
ACTIMMUNE Payor Access Roadmap
A resource to help educate healthcare providers about patient access and coverage.
ACTIMMUNE 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.
Video Library
The Role of NADPH Oxidase in the Immune Response and CGD
Learn how a mutation in any of the 5 NADPH oxidase component genes can lead to life-threatening infections.
The Importance of Genetic Testing for CGD
See how 1 patient’s diagnosis of CGD led to answers for an entire family.
Recognition and Management of Autosomal Recessive CGD
Review the case history of a patient with autosomal recessive CGD.
Why ACTIMMUNE for Your Patient With CGD
See how ACTIMMUNE reduces the frequency and severity of CGD-associated infections.
Stay informed about ACTIMMUNE and CGD
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.