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Fulphila FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 5, 2019.

FDA Approved: Yes (First approved June 4, 2018)
Brand name: Fulphila
Generic name: pegfilgrastim-jmdb
Dosage form: Injection
Company: Mylan N.V.
Treatment for: Neutropenia Associated with Chemotherapy

Fulphila (pegfilgrastim-jmbd) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.

What is Fulphila?

Fulphila is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

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

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

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

How will I receive Fulphila?

Fulphila side effects

Fulphila may cause serious side effects, including:

The most common side effects of Fulphila are pain in the bones, arms, and legs.

These are not all the possible side effects of Fulphila.

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

How should I store Fulphila?

Keep the Fulphila prefilled syringe out of the reach of children.

General information about the safe and effective use of Fulphila.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fulphila for a condition for which it was not prescribed. Do not give Fulphila to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Fulphila that is written for health professionals.

What are the ingredients in Fulphila?

Active ingredient: pegfilgrastim-jmdb

Inactive ingredients: acetate, D-sorbitol, polysorbate 20, and sodium in Water for Injection.

Development timeline for Fulphila

Jun  4, 2018Approval FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta

Further information

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