For Healthcare Professionals For Patients and Caregivers Important Safety Information Medication Guide ACTIMMUNE.com

HOW WE CAN HELPThere Are Many Ways the Amgen By Your Side Team Helps Your Patients

Amgen By Your Side is a support program for patients prescribed ACTIMMUNE® (Interferon gamma-1b). After your patient has enrolled, they will be paired with a dedicated support partner, called a Clinical Nurse Educator (CNE). Their CNE can be a partner, providing nonmedical education to help them navigate their unique treatment experience — including information on insurance, financial support options, important appointment-related information, and other patient support services.

What Amgen By Your Side Can Do to Support Your Patients

  • Educate them on the results of their benefits investigation and review their insurance coverage
  • Help them understand potential out-of-pocket costs and financial support options
  • Educate you and your staff on insurance processes, including specific payor requirements for their Amgen medication and examples
  • Provide education to you and your staff about product coding and billing
  • Share additional resources that may be helpful as your patient gets started

What Your Office Needs to Do on Behalf of Your Patients

  • Complete and submit the payor insurance paperwork for the product on behalf of your patient
  • Collect and directly provide appropriate medical documentation to insurance company
  • Work with patients to connect with their specialty pharmacy to schedule the shipment of their medicine so they avoid running out of supply

The Amgen By Your Side team may include:

Case Managers work on behalf of the patient and interact with the doctor’s office to confirm insurance information is accurate and to inform the office on insurance criteria for the submission of a prior authorization.

In addition, a Case Manager:

  • May reach out to the doctor’s office after a prescriber initiates enrollment and inquire about missing information on the enrollment form
  • Has the expertise and knowledge to educate the doctor’s office on payor policies and insurance criteria for access to Amgen products
  • Works closely with Specialty Pharmacies to ensure all required information is received for the timely delivery of Amgen products to your patients

The CNE is a dedicated support partner that helps investigate, explain, and educate on the steps of the treatment experience. They are your patient’s point of contact and champion while your patient is accomplishing their treatment goals.

Learn more about contacting a CNE and why your patient should connect with one

Once you decide ACTIMMUNE is right for your patient, you can initiate their enrollment in Amgen By Your Side

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, 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; reduce dose or discontinue
    • Myelosuppression, or receiving other potentially myelosuppressive agents; consider dose reduction or discontinuation of therapy
    • 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 accompanying Full Prescribing Information for complete safety information.

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, 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; reduce dose or discontinue
    • Myelosuppression, or receiving other potentially myelosuppressive agents; consider dose reduction or discontinuation of therapy
    • 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 accompanying Full Prescribing Information for complete safety information.