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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¿Qué es la EGC?

La EGC es una enfermedad genética poco común en la que el sistema inmunitario no funciona como debería. Las personas que viven con EGC no pueden combatir las infecciones causadas por ciertas bacterias y hongos, llamados patógenos. Cuando los glóbulos blancos acuden al lugar de la infección y no pueden destruirla, se acumulan. Estas acumulaciones de glóbulos blancos forman bultos llamados granulomas, que pueden desarrollarse en la vejiga, los intestinos, los pulmones, el estómago y la piel. De ahí proviene el nombre EGC.

In a study, ACTIMMUNE has been proven to result in a†,‡:

ACTIMMUNE has been shown to result in a†,‡:

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64%

decrease in serious* infections

20 serious* infections with ACTIMMUNE vs 56 serious infections with placebo

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67%

lower risk of serious* infections

ACTIMMUNE (n=63) compared to placebo (n=65) at 12 months

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67%

decrease in days in the hospital

497 days with ACTIMMUNE vs 1493 days with placebo

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, and tiredness. See the full Important Safety Information for ACTIMMUNE.

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TIP: Taking ACTIMMUNE at bedtime may also help with some of these symptoms. Acetaminophen (for example, Tylenol®) may help in preventing fever and headache. See more information about taking ACTIMMUNE.

Don’t use ACTIMMUNE if you are allergic to interferon gamma, E. coli-derived products, or any of the ingredients contained in ACTIMMUNE. See more ACTIMMUNE Safety Information.

Consejos para seguir el tratamiento

Ser constante en la toma de ACTIMMUNE ayuda a prevenir infecciones graves*.

Stay on schedule Stay on schedule

Stay on schedule

Take ACTIMMUNE 3 times a week at the same time each day to get the best results. For example, if you choose Monday, Wednesday, and Friday at 8 PM as your injection days and time, make sure this schedule stays the same over the next few months so that it becomes routine.

Take at bedtime Take at bedtime

Take at bedtime

Consider taking ACTIMMUNE just before going to bed. This can help with some of the flu-like side effects. Taking acetaminophen (for example, Tylenol®) may be helpful in preventing fever and headache.

Switch sites Switch sites

Switch sites

Change the injection site every time and use a different area on the body for each injection. Doing this helps the skin heal before the same site is used again. It also helps keep possible side effects to a minimum.

  • Take the ACTIMMUNE vial out of the fridge about 15 minutes prior to injection time so that it can reach room temperature before administration.
  • Look the vial over to make sure it’s not past the expiration date and its contents aren’t discolored.
  • Set the following items onto a clean, flat surface:
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Alcohol swabs

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Syringe, needle, and vial

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Sharps container for disposing of the syringe, needle, and vial

Wash your hands with soap Wash your hands with soap

Wash your hands with soap and water before measuring your dose of ACTIMMUNE.

1

Remove the plastic cap Remove the plastic cap

Remove the plastic cap from the vial, and then wipe the tip of the rubber stopper with an alcohol swab.

2

Take the syringe out Take the syringe out

Take the syringe out of its package. Remove the needle guard and set aside. Then, draw air into the syringe by pulling back on the plunger. Pull it back to the mark for the dose of ACTIMMUNE your doctor prescribed.

3

Stick the needle Stick the needle

Next, carefully stick the needle in through the rubber top, and push the plunger down all the way so the air goes into the vial.

4

Measure your dose Measure your dose

Hold the vial upside down with one hand, and with the other hand, slowly pull the plunger out to the mark for the dose of ACTIMMUNE prescribed by your doctor. Each vial is good for only one use.

5

Select a site that’s padded by some fat underneath the skin and be sure to rotate the site with every injection, so the skin has time to heal.

Below are common injection sites you may choose from:

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Right upper arm (back and sides), left upper arm (back and sides)

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Right thigh, left thigh

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Abdomen† (right upper and lower, left upper and lower)

†If you select the abdomen, make sure you inject at least 2 inches from the belly button.

Clean the injection site Clean the injection site

Clean the injection site with an alcohol swab.

1

Remove the needke guard Remove the needke guard

Remove the needle guard while holding the syringe like a pencil.

2

Inject the medication Inject the medication

With the other hand, gently pinch the skin to be injected in between your fingers. Insert the needle at a 45° angle with a quick, firm motion. This hurts less than pushing the needle in slowly.

3

Release the pinch and inject Release the pinch and inject

Release the pinch, and slowly inject the ACTIMMUNE by gently pushing the plunger until the syringe is empty. This should only take a few seconds.

4

Apply the pressure with cotton Apply the pressure with cotton

Then quickly pull the needle straight out of the skin. Apply pressure with a cotton ball or gauze.

5

Clean up Clean up

After you’re done with the injection process, place the used needle, syringe, and any unused ACTIMMUNE into the sharps container. If you need help disposing of your sharps container, visit sharpsdisposal.com.

*Una infección es grave si usted tiene que ir al hospital y/o recibir antibióticos por vía intravenosa (IV).
†Datos de hospitalización: Los pacientes que recibieron placebo requirieron tres veces más días de hospitalización para el tratamiento de eventos clínicos que los pacientes que recibieron interferón gamma-1b (1493 días frente a 497 días respectivamente); la estadía media fue de 32 días en el grupo de interferón gamma-1b y de 48 días en el grupo del placebo (P=0,02).
‡Diseño del estudio: Un estudio aleatorizado, doble ciego, controlado con placebo en 128 pacientes con enfermedad granulomatosa crónica.

CGD support and resources

Watch Luis’ story and download information about CGD.

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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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