Approved Uses and Important Safety Information

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

ACTIMMUNE is 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 risk of serious infection

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.

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image severe malignant osteopetrosis

WHAT IS SEVERE MALIGNANT OSTEOPETROSIS (SMO)?

Osteopetrosis is a disease of the bones. It is NOT the same as osteoporosis, when bones become fragile and less dense from loss of tissue. That is a different condition. There are different forms of osteopetrosis, but all forms of osteopetrosis have to do with an abnormal increase in the density (thickness) of the bones.

Severe malignant osteopetrosis (SMO) is a form of osteopetrosis that is sometimes called marble bone disease or malignant infantile osteopetrosis (MIOP). Severe malignant osteopetrosis is a very severe form of osteopetrosis. While exact numbers are not known, it is thought that about 1 in 250,000 children are born with SMO.
 

What happens in the body with SMO?

In normal bone development, bone material is replaced by new bone over and over again. Cells called osteoblasts help create new bone material. Other cells called osteoclasts remove the old bone material.

In people with osteopetrosis, the osteoclasts do not function the right way. As a result, abnormal bone development happens. This can cause many problems in the body, such as:

  • Blood disorders
  • Difficulty fighting infections
  • Bone fractures
  • Problems with vision and hearing
  • Abnormal look of the face and head


Common characteristics of SMO

In SMO, the buildup of bone materials can narrow the space inside the bone. This means there is less space to make bone marrow. Bone marrow is where new blood cells are formed. Less space to make bone marrow can cause:

  • Anemia due to low red blood cells. Symptoms of anemia include pale skin and lack of energy
  • Bleeding problems because of low platelets. Platelets are blood cells the body needs to help stop bleeding
  • Repeated infections because of low white blood cells. White blood cells are needed to fight infections

With SMO, there can also be a narrowing of the tunnels within the bones of the skull. The nerves for vision and hearing pass through these tunnels. These nerves can be squeezed by bones that overdevelop because of SMO. This causes patients to have problems with their vision and hearing.


Patients often suffer serious effects from SMO. These may include:

  • Failure to thrive and slow growth in childhood
  • Difficulty seeing or blindness
  • Hearing loss
  • Abnormal head shape
  • Bone marrow failure, causing anemia
  • Infections that happen often and over and over
  • Repeated bone fractures

SMO can also cause a lower life expectancy. Most children with SMO who are untreated pass away within the first 10 years of life.

Approved Uses and Important Safety Information

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

ACTIMMUNE is 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.

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?

Do not 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?

ACTIMMUNE can cause flu-like symptoms. At high doses, the resulting symptoms may worsen some pre-existing heart conditions.

ACTIMMUNE may cause decreased mental status, such as confusion, depression, and hallucinations. It may also cause difficulty walking and dizziness, particularly at high doses. These symptoms usually resolve a few days after reducing the amount of ACTIMMUNE you take, or if you are no longer taking it at all, as prescribed by your doctor.

Use of ACTIMMUNE may affect bone marrow function and may limit the production of cells important to your body. This can be severe and usually goes away after reducing the amount of ACTIMMUNE you take or if you stop taking it entirely as prescribed by your doctor.

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 of age.

In rare cases, ACTIMMUNE can cause severe allergic reactions and/or rash. If you experience a serious reaction to ACTIMMUNE, stop taking 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 heart 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 every 3 months while you are taking ACTIMMUNE

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 the longer you take ACTIMMUNE. Taking ACTIMMUNE at bedtime may help with these symptoms, and acetaminophen may help prevent fever and headache.

What other medications might interact with ACTIMMUNE?

Some drugs, like certain chemotherapy drugs, may interact with ACTIMMUNE and could make it more likely that your heart or nervous system could be damaged. Tell your doctor about all the medicines you take.

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/safety/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 www.ACTIMMUNE.com or 1-866-479-6742.

Approved Uses and Important Safety Information

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

ACTIMMUNE is 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.

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?

Do not 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?

ACTIMMUNE can cause flu-like symptoms. At high doses, the resulting symptoms may worsen some pre-existing heart conditions.

ACTIMMUNE may cause decreased mental status, such as confusion, depression, and hallucinations. It may also cause difficulty walking and dizziness, particularly at high doses. These symptoms usually resolve a few days after reducing the amount of ACTIMMUNE you take, or if you are no longer taking it at all, as prescribed by your doctor.

Use of ACTIMMUNE may affect bone marrow function and may limit the production of cells important to your body. This can be severe and usually goes away after reducing the amount of ACTIMMUNE you take or if you stop taking it entirely as prescribed by your doctor.

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 of age.

In rare cases, ACTIMMUNE can cause severe allergic reactions and/or rash. If you experience a serious reaction to ACTIMMUNE, stop taking 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 heart 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 every 3 months while you are taking ACTIMMUNE

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 the longer you take ACTIMMUNE. Taking ACTIMMUNE at bedtime may help with these symptoms, and acetaminophen may help prevent fever and headache.

What other medications might interact with ACTIMMUNE?

Some drugs, like certain chemotherapy drugs, may interact with ACTIMMUNE and could make it more likely that your heart or nervous system could be damaged. Tell your doctor about all the medicines you take.

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/safety/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 www.ACTIMMUNE.com or 1-866-479-6742.

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