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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How GRANIX works

GRANIX works to help shorten the time patients have severe neutropenia Neutropenia
An abnormally low number of neutrophils in the blood
during chemotherapy.

  • In a clinical study, GRANIX reduced the time patients had severe neutropenia Neutropenia
    An abnormally low number of neutrophils in the blood
    to a little more than a day
  • As part of the clinical study, a group of patients not treated with GRANIX had severe neutropenia Neutropenia
    An abnormally low number of neutrophils in the blood
    for almost 4 days

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.