ACTIMMUNE® helps protect patients with CGD from serious infections

People with chronic granulomatous disease (CGD) are more likely to get serious, repeat, and often life-threatening infections. ACTIMMUNE® contains a protein called interferon gamma. It is almost the same as the protein the body makes naturally as it fights infections. That’s why ACTIMMUNE®, taken along with prescribed antifungal and antibiotic medicines, plays an important role in helping to protect people from serious infections. This means less time in the hospital and more time for you to do the things you enjoy.

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ACTIMMUNE® helps you lower the risk of serious infections

Compared with people who did not take ACTIMMUNE®, people who took ACTIMMUNE® had a lower risk of getting infections. They didn’t have as many serious infections and went to the hospital much less. If they did go to the hospital, they spent 33% less time there.

Don’t use ACTIMMUNE® if you are allergic to interferon gamma, E coli–derived products, or any of the ingredients contained in ACTIMMUNE®.

Helping you lower the risk of infections

ACTIMMUNE® has been proven to result in a:

CGD Treatment Stats 1 Icon

decrease in
serious
infections

CGD Treatment Stats 2 Icon

lower risk of
serious
infection

CGD Treatment Stats 3 Icon

decrease in
days in
the hospital

Select Safety Information

The most common side effects with ACTIMMUNE® are flu-like symptoms, which may decrease in severity as use of ACTIMMUNE continues. Flu-like symptoms include:

  • Fever
  • Headache
  • Chills
  • Muscle pain
  • Fatigue (tiredness)

Taking ACTIMMUNE® at bedtime may also help reduce some of these symptoms. Acetaminophen (for example, Tylenol®) may be helpful in preventing fever and headache.

If you develop a serious reaction, stop treatment right away. Call your doctor or seek medical help. Tell your doctor if you have any allergies to interferon gamma or E coli–derived products, a cardiac condition (such as irregular heartbeat, heart failure, or decreased blood flow to your heart), history of seizures or other neurologic disorders, or reduced bone marrow function. If you are pregnant or plan to become pregnant or plan to nurse, you should talk to your doctor.

*An infection is serious if you have to go to the hospital and get intravenous (IV) antibiotics.

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Important Safety Information

What is ACTIMMUNE® (Interferon gamma-1b) used for?

ACTIMMUNE® is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body's ability to fight infections effectively. CGD is often treated (though not cured) with antibiotics, antifungals, and ACTIMMUNE.

ACTIMMUNE is also used to slow the worsening of severe, malignant osteopetrosis (SMO). SMO is a genetic disorder that affects normal bone formation and is usually diagnosed in the first few months after birth.

When should I not take ACTIMMUNE?

Don't use ACTIMMUNE if you are allergic to interferon-gamma, E coli derived products, or any ingredients contained in the product.

What warnings should I know about ACTIMMUNE?

At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions.

ACTIMMUNE may cause decreased mental status, walking disturbances, and dizziness, particularly at very high doses. These symptoms are usually reversible within a few days upon dose reduction or discontinuation of therapy.

Bone marrow function may be suppressed with ACTIMMUNE, and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced.

Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than 1 year old. Your doctor should monitor your liver function every 3 months, and monthly in children under 1 year.

In rare cases, ACTIMMUNE can cause severe allergic reactions and/or rash. If you experience a serious reaction to ACTIMMUNE, discontinue it immediately and contact your doctor or seek medical help.

What should I tell my healthcare provider?

Be sure to tell your doctor about all the medications you are taking.

Tell your doctor if you:

  • are pregnant or plan to become pregnant or plan to nurse
  • have a cardiac condition such as irregular heartbeat, heart failure, or decreased blood flow to your heart
  • have a history of seizures or other neurologic disorders
  • have, or have had, reduced bone marrow function.

Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3-month intervals on ACTIMMUNE therapy

What are the side effects of ACTIMMUNE?

The most common side effects with ACTIMMUNE are "flu-like" symptoms such as fever, headache, chills, muscle pain, or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may help reduce some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.

    What other medications might interact with ACTIMMUNE?

    Some drugs may interact with ACTIMMUNE to potentially increase the risk of damage to your heart or nervous system, such as certain chemotherapy drugs. Tell your doctor about all other medications you are taking.

    Avoid taking ACTIMMUNE at the same time as a vaccination.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    The risk information provided here is not comprehensive. To learn more, talk about ACTIMMUNE with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at http://www.ACTIMMUNE.com or 1-866-479-6742.

    Important Safety Information

    What is ACTIMMUNE® (Interferon gamma-1b) used for?

    ACTIMMUNE® is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body's ability to fight infections effectively. CGD is often treated (though not cured) with antibiotics, antifungals, and ACTIMMUNE.

    ACTIMMUNE is also used to slow the worsening of severe, malignant osteopetrosis (SMO). SMO is a genetic disorder that affects normal bone formation and is usually diagnosed in the first few months after birth.

    When should I not take ACTIMMUNE?

    Don't use ACTIMMUNE if you are allergic to interferon-gamma, E coli derived products, or any ingredients contained in the product.

    What warnings should I know about ACTIMMUNE?

    At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions.

    ACTIMMUNE may cause decreased mental status, walking disturbances, and dizziness, particularly at very high doses. These symptoms are usually reversible within a few days upon dose reduction or discontinuation of therapy.

    Bone marrow function may be suppressed with ACTIMMUNE, and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced.

    Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than 1 year old. Your doctor should monitor your liver function every 3 months, and monthly in children under 1 year.

    In rare cases, ACTIMMUNE can cause severe allergic reactions and/or rash. If you experience a serious reaction to ACTIMMUNE, discontinue it immediately and contact your doctor or seek medical help.

    What should I tell my healthcare provider?

    Be sure to tell your doctor about all the medications you are taking.

    Tell your doctor if you:

    • are pregnant or plan to become pregnant or plan to nurse
    • have a cardiac condition such as irregular heartbeat, heart failure, or decreased blood flow to your heart
    • have a history of seizures or other neurologic disorders
    • have, or have had, reduced bone marrow function.

    Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3-month intervals on ACTIMMUNE therapy

    What are the side effects of ACTIMMUNE?

    The most common side effects with ACTIMMUNE are "flu-like" symptoms such as fever, headache, chills, muscle pain, or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may help reduce some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.

      What other medications might interact with ACTIMMUNE?

      Some drugs may interact with ACTIMMUNE to potentially increase the risk of damage to your heart or nervous system, such as certain chemotherapy drugs. Tell your doctor about all other medications you are taking.

      Avoid taking ACTIMMUNE at the same time as a vaccination.

      You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

      The risk information provided here is not comprehensive. To learn more, talk about ACTIMMUNE with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at http://www.ACTIMMUNE.com or 1-866-479-6742.