What is GRANIX?

GRANIX helps support your body’s efforts to increase white blood cell levels.

Doctors may prescribe GRANIX to shorten the time their patients may have severe neutropenia during chemotherapy.

  • GRANIX is a type of therapy called a growth factor or a colony-stimulating factor
  • Growth factors help your body increase blood cell counts,specifically white blood cells
White blood cells are produced in the bone marrow

How GRANIX works

GRANIX works to help shorten the time patients have severe neutropenia during chemotherapy.

  • In a clinical study, GRANIX reduced the time patients had severe neutropenia to a little more than a day
  • As part of the clinical study, a group of patients not treated with GRANIX had severe neutropenia for almost 4 days

GRANIX dosing

  • GRANIX is given by an injection under your skin (subcutaneous) by a healthcare provider. Your healthcare provider may decide injections can be given at home by you or your caregiver. If GRANIX is given at home, see the detailed “Instructions for Use” that comes with your GRANIX for information on how to prepare and inject a dose of GRANIX
  • Your healthcare provider will tell you how much GRANIX to inject and when to inject it. Do not stop using GRANIX or change your dose unless your healthcare provider tells you to
  • GRANIX injections are usually given 1 time each day until your white blood cell count returns to normal
  • Your first dose of GRANIX is given at least 24 hours after you receive your chemotherapy
  • Do not inject GRANIX within 24 hours before your next dose of chemotherapy
  • Your healthcare provider will test your blood before your chemotherapy and during treatment with GRANIX until your white blood cell count returns to normal

Taking GRANIX at home

If you and your healthcare provider decide you should take GRANIX in your home, you will receive instructions on proper injection techniques, dosing, and safety. Be sure to follow your healthcare provider’s instructions carefully.

Download Instructions for Use

If you need additional instructions, or have questions, contact your healthcare provider.

Approved Use

GRANIX is a prescription medicine:

  • used in people with certain types of cancer (non-myeloid malignancies), who are receiving chemotherapy that affects the bone marrow
  • given to help decrease the length of time that the number of certain white blood cells (neutrophils) are very low (severe neutropenia). Neutrophils are white blood cells that are important in fighting bacterial infection
    It is not known if GRANIX is safe and effective in children younger than 1 month of age.

Important Safety Information

Do not take GRANIX if you have had a serious allergic reaction to filgrastim products 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?

GRANIX can cause serious side effects, including:

  • 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, which could lead to death, if you have a sickle cell disorder and use GRANIX. 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
  • Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received another filgrastim product. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.
  • 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.
  • Other possible side effects of other filgrastim products that may also happen with GRANIX may include muscle aches (myalgia), headache, weakness, diarrhea, fatigue, vomiting, inflamed blood vessels in the skin (cutaneous vasculitis), low platelet count (thrombocytopenia), and Sweet’s syndrome (a rare skin condition that mainly includes fever and painful skin lesions that appear mostly on the arms, neck, head and trunk).

These are not all of the possible side effects of GRANIX.

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

Click here to access the full Prescribing Information for GRANIX.