INDICATIONS AND USAGE
ACTIMMUNE® (Interferon gamma-1b) is indicated:
Resources for your patients
Horizon By Your Side (HBYS) is a support program for patients prescribed ACTIMMUNE. Our dedicated team partners with your patient to provide nonclinical, personalized support so they can start and continue treatment as you prescribe. Each patient’s access journey is unique and our team is prepared to help navigate the entire process, including:
- Patient Enrollment
- Benefits Investigation
- Prior Authorization
- Payor Appeal
The team at Horizon By Your Side can help identify coverage policies early in the access process to help ensure maximum efficiency.
Clinical Nurse Educator (CNE)
The CNE is a dedicated support partner that helps investigate, explain, and educate on each step of the treatment experience. They are your patient’s point of contact and constant champion in helping accomplish their treatment goals.
Horizon Case Manager
Managers work on behalf of the patient and interact with the doctor’s office to ensure insurance information is accurate and to inform the office on insurance criteria for the submission of a prior authorization. These comprehensive services are free of charge to your patient.
Dedicated one-on-one support
Clinical Nurse Educators (CNEs), like Shannon, provide patients with nonmedical education to help them navigate their unique treatment experience—including information on insurance, financial assistance options, important appointment-related information, and other patient support services.
Our mission is to connect, coordinate, and champion your patient at the most important steps along the way:
CONNECT: Your patient will be connected to one person dedicated to partnering with them throughout their treatment experience.
COORDINATE: Your patient will receive educational support on insurance, financial assistance options, and more.
CHAMPION: Your patient’s dedicated partner will empower them to be confident self-advocates for maintaining treatment goals.
Horizon By Your Side
Call us Monday–Friday 9 AM–8 PM (EST) 1-855-4MY-HBYS
Email us at HPSACT@horizontherapeutics.com
Use the downloads below to help your patients and families living with chronic granulomatous disease (CGD). The information covers everything from tips for staying on treatment to explaining CGD in patient-friendly terms.
CGD Facts
Lists easy-to-understand information about CGD to help patients, friends, family, and school staff learn more about the disease.
Family Testing Guide
A guide to explain risks of CGD to family members and the importance of testing.
Injection Training Guide
Provides injection reminders and shows patients how to measure the dose, choose the injection site, and store ACTIMMUNE.
Managing Side Effects
Provides tips for patients to minimize common side effects, including advice on reducing symptoms like fever and headache.
Give your Spanish-speaking patients and their families the tools they need to help get started and stay on ACTIMMUNE treatment for chronic granulomatous disease (CGD).
Chronic Granulomatous Disease Brochure (Spanish)
Learn more about chronic granulomatous disease, including signs, symptoms, medicines that help treat it, and more.
Injection Training Guide (Spanish)
Provides injection reminders and shows patients how to measure the dose, choose the injection site, and store ACTIMMUNE.
Managing Side Effects (Spanish)
Provides tips for patients to minimize common side effects, including advice on reducing symptoms like fever and headache.
CGD TRAQ Brochure (Spanish)
An easy-to-use process and practical advice for teens who are ready to transition to self-care.
TRAQ, Transition Readiness Assessment Questionnaire.
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.