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 (non-myeloid 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: Do not take GRANIX if you have had a serious allergic reaction to filgrastim or pegfilgrastim products. Before you receive GRANIX, tell your healthcare provider about all of your medical conditions, including if you have a sickle cell disorder, have kidney problems, plan to have bone scans or tests, are pregnant or plan to become pregnant (it is not known if GRANIX will harm your unborn baby; you should not become pregnant during treatment with GRANIX), are breastfeeding or plan to breastfeed (it is not known if GRANIX passes into your breast milk).

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Resources for patients and caregivers

As a patient with cancer, you and your loved ones have a wide range of resources and support organizations that are ready to assist you.

Teva Oncology CORE (Comprehensive Oncology Reimbursement Expertise) Program

A convenient reimbursement resource that provides a support program along with online tools to help make it easier to understand the reimbursement process. 1-888-587-3263, Monday–Friday, 9 AM–8 PM ET

American Cancer Society® (ACS)

Education, news, and networks. 1-800-227-2345

CancerCare®

A national organization offering free information and support services to cancer patients, their loved ones, caregivers, and the bereaved. CancerCare provides access to educational publications and workshops, financial assistance programs, support groups, and individual counseling with oncology social workers.

1-800-813-HOPE (4673)

Cancer Hope Network

Free and confidential one-on-one support for cancer patients and their families.

1-877-HOPENET (467-3638)

Cancer Support Community

Provides support, education, and hope to people affected by cancer.

1-888-793-9355

Cancer Wellness Center

Free services and resources for cancer patients in most states across the country.

National Coalition for Cancer Survivorship (NCCS)

A nationwide network of independent organizations and individuals working in the area of cancer support and information.

1-877-622-7937

This is a list of sources that you may find helpful. Please note that this information was accurate at the time of publication, but is subject to change without notice. Ask your healthcare team to recommend additional resources.

Approved use of GRANIX

GRANIX is a prescription medication given to people with certain types of cancer (non-myeloid 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.

Important Safety Information

Do not take GRANIX if you have had a serious allergic reaction to filgrastim or pegfligrastim products.

Before you receive GRANIX, tell your healthcare provider about all of your medical conditions, including if you:

  • have a sickle cell disorder
  • have kidney problems
  • plan to have bone scans or tests
  • are pregnant or plan to become pregnant. It is not known if GRANIX will harm your unborn baby. You should not become pregnant during treatment with GRANIX
  • are breastfeeding or plan to breastfeed. It is not known if GRANIX passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of GRANIX?

Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in your left upper stomach (abdomen)-area or your left shoulder during treatment with GRANIX.

A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without fever, trouble breathing, or a fast rate of breathing.

Serious Allergic Reactions. GRANIX can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using GRANIX and call your healthcare provider or get emergency help right away.

Sickle cell crisis. You may have a serious sickle cell crisis if you have a sickle cell disorder and use GRANIX. Serious sickle cell crisis has happened in people with sickle cell disorder receiving filgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). GRANIX can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:

  • swelling of your face or ankles
  • blood in your urine or dark colored urine
  • you urinate less than usual

Capillary Leak Syndrome. GRANIX can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:

  • swelling or puffiness and are urinating less than usual
  • trouble breathing
  • swelling of your stomach-area (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness

Your healthcare provider may decrease your dose, temporarily stop, or permanently stop treatment with GRANIX if you have certain side effects. The most common side effect of GRANIX is bone pain.

Tell your healthcare provider right way if you have any signs of infection during treatment with GRANIX such as fever, redness, or swelling.

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