Skip to main content

Nivestym FDA Approval History

Last updated by Judith Stewart, BPharm on July 21, 2018.

FDA Approved: Yes (First approved July 20, 2018)
Brand name: Nivestym
Generic name: filgrastim-aafi
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Febrile Neutropenia

Nivestym (filgrastim-aafi) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.

Nivestym is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

  • patients with cancer receiving myelosuppressive chemotherapy;
  • patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
  • patients with cancer undergoing bone marrow transplantation;
  • patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
  • patients with severe chronic neutropenia.

Nivestym Important Safety Information

Do not take Nivestym if you have had a serious allergic reaction to human G-CSFs such as filgrastim or pegfilgrastim products.

Before you take Nivestym, tell your healthcare provider all about your medical conditions, including if you:

  • have a sickle cell disorder
  • have kidney problems
  • are receiving radiation therapy
  • are pregnant or plan to become pregnant. It is not known if Nivestym will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if Nivestym 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.

How will I receive Nivestym?

Nivestym injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide that subcutaneous injections can be given at home by you or your caregiver. If Nivestym is given at home, see the detailed "Instructions for Use" that comes with your Nivestym prescription for information on how to prepare and inject a dose of Nivestym.

You and your caregiver should be shown how to prepare and inject Nivestym, before you use it, by your healthcare provider.

Your healthcare provider will tell you how much Nivestym to inject and when to inject it. Do not change your dose or stop Nivestym unless your healthcare provider tells you to.

If you are receiving Nivestym because you are also receiving chemotherapy, your dose of Nivestym should be injected at least 24 hours before or 24 hours after your dose of chemotherapy.

If you miss a dose of Nivestym, talk to your healthcare provider about when you should give your next dose.

Nivestym side effects

Nivestym may cause serious side effects including:

  • Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death.
  • Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious lung problem.
  • Serious allergic reactions. These can occur anywhere in your body. If you have an allergic reaction, stop using Nivestym.
  • Sickle cell crises. Serious sickle cell crises have happened in people with sickle cell disorders receiving Nivestym that have sometimes led to death.
  • Kidney injury (glomerulonephritis). Nivestym can cause kidney injury.
  • Capillary Leak Syndrome. Nivestym 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.
  • Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Nivestym. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Nivestym. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
  • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Nivestym.
  • Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider if you develop purple spots or redness of your skin.

Call your healthcare provider or seek emergency medical help right away if you have:

  • pain in the left upper stomach area or left shoulder
  • symptoms of sickle cell crisis such as pain or trouble breathing
  • shortness of breath, with or without a fever, any trouble breathing, wheezing or a fast rate of breathing
  • a rash over your whole body, swelling around your mouth or eyes, fast heart rate and sweating
  • swelling or puffiness, especially swelling of your stomach-area and feeling of fullness
  • swelling of your face and ankles
  • blood in your urine or dark colored urine
  • less than usual urination
  • dizziness or are feeling faint
  • a general feeling of tiredness

The most common side effects of Nivestym include aching in the bones and muscles.

These are not all the possible side effects of Nivestym. Call your healthcare provider for medical advice about side effects.

Development timeline for Nivestym

Jul 20, 2018Approval FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.