US healthcare professionals Patient Information Important Safety Information Instructions for Use

For US consumers

GRANIX® is a prescription medication given to people with certain types of cancer (nonmyeloid malignancies) who are receiving chemotherapy that affects the bone marrow to decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

Important Safety Information: Before you take GRANIX, tell your doctor if you have sickle cell anemia or other blood problems, plan to have bone scans or tests, are allergic to filgrastim (NEUPOGEN®) or pegfilgrastim (Neulasta®), or have any other medical conditions. It is not known if GRANIX will harm an unborn baby or passes into breast milk; tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.

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What is GRANIX?

GRANIX is a prescription medication given to people with certain types of cancer (nonmyeloid malignancies) who are receiving chemotherapy that affects the bone marrow to decrease the length of time that certain white blood cell White blood cell
Cell that fights infection in the body
levels (neutrophils) are very low (severe neutropeniaNeutropenia
An abnormally low number of neutrophils in the blood
)

How does GRANIX work?

GRANIX works by increasing the white blood cell White blood cell
Cell that fights infection in the body
levels in your body. To make sure GRANIX is working, your doctor will ask that you have regular blood tests to count the number of Neutrophils
White blood cells that help fight infection
neutrophils
you have. It is important that you follow your doctor's instructions about getting these tests.

How will I receive GRANIX?

GRANIX is given by an injection under your skin (subcutaneous).
Your first dose of GRANIX is given at least 24 hours after you receive your chemotherapy.
GRANIX injections are usually given 1 time each day until your white blood cell count returns to normal.
Your doctor will test your blood before your chemotherapy and during your GRANIX treatment until your white blood cell count returns to normal.
Keep all of your appointments for your GRANIX injections and blood tests.

How should I use GRANIX?

GRANIX injections can be given by a doctor or nurse, or your doctor may decide that your injections can be given at home by you or your caregiver. If GRANIX is taken at home, follow the detailed Instructions for Use included with your GRANIX package for information about the right way to:

  • Store GRANIX
  • Read the syringe markings and adjust the amount of medicine
  • Prepare and administer an injection

Your doctor will tell you how much GRANIX to inject and the timing of when to inject it. Inject GRANIX exactly as instructed.
Do not change your dose unless your doctor tells you to.
You or your caregiver will be shown how to prepare for an injection and how to inject GRANIX before you use it for the first time.
Take your first dose of GRANIX at least 24 hours after you receive your chemotherapy.
If you miss a dose or forget to take your dose of GRANIX, speak to your doctor about when to take your next dose.
If you use too much GRANIX, call your doctor right away.
If you or your caregiver get GRANIX on your skin, wash the area with soap and water.
If you or your caregiver get GRANIX in your eyes, flush your eyes with water and call your doctor right away.
Do not stop taking GRANIX without talking to your doctor.

What are the possible side effects of GRANIX?

GRANIX can cause serious side effects, including:

Spleen rupture, which can cause death. Call your doctor right away if you have pain in your left upper stomach area or left shoulder area while taking GRANIX. This pain could mean your spleen is enlarged or ruptured.

A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Get medical help right away if you have any of these symptoms of ARDS:

  • Fever
  • Shortness of breath
  • Trouble breathing

Serious Allergic Reactions. If you have a serious allergic reaction during a GRANIX injection, stop giving yourself the injections and call your doctor right away. Symptoms of serious allergic reaction can occur during or after your injection:

  • A rash over the whole body
  • Shortness of breath
  • Trouble breathing (wheezing)
  • Dizziness
  • Swelling around the mouth or eyes
  • Fast heart rate
  • Sweating

Severe Sickle Cell Crisis in people with sickle cell disease. If you have sickle cell disease, talk to your doctor about the risks of taking GRANIX.

The most common side effect of GRANIX is bone pain. If this happens, it can usually be relieved with a non-aspirin pain reliever such as acetaminophen; or an NSAID such as ibuprofen.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of GRANIX. For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report any side effects to FDA at 1-800-FDA-1088.

Approved use of GRANIX

GRANIX is a prescription medication given to people with certain types of cancer (nonmyeloid malignancies) who are receiving chemotherapy that affects the bone marrow to decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

It is not known if GRANIX is safe and effective in children under 18 years of age.

Important Safety Information

What should I tell my doctor before I receive GRANIX?

Before you take GRANIX, tell your doctor if you have sickle cell anemia or other blood problems, plan to have bone scans or tests, are allergic to filgrastim (NEUPOGEN®) or pegfilgrastim (Neulasta®), or have any other medical conditions. It is not known if GRANIX will harm an unborn baby or passes into breast milk; tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.

What are the possible side effects of GRANIX?

  • Spleen rupture, which can cause death. Call your doctor right away if you have pain in your left upper stomach area or left shoulder area while taking GRANIX. This pain could mean your spleen is enlarged or ruptured.
  • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Get medical help right away if you have any of these symptoms of Acute Respiratory Distress Syndrome (ARDS): fever, shortness of breath, trouble breathing.
  • Serious Allergic Reactions. If you have a serious allergic reaction during a GRANIX injection, stop giving yourself the injection and call your doctor right away. Symptoms of serious allergic reaction can occur during or after your injection and include: a rash over the whole body, shortness of breath, trouble breathing (wheezing), dizziness, swelling around the mouth or eyes, fast heart rate, sweating.
  • Severe Sickle Cell Crisis in people with sickle cell disease. If you have sickle cell disease, talk to your doctor about the risks of taking GRANIX.

The most common side effect of GRANIX is bone pain.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of GRANIX. For a complete list, ask your doctor or pharmacist.

Click here to access the Full Prescribing Information for GRANIX.

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