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Date of Approval: August 29, 2012
Company: Teva Pharmaceuticals USA
Treatment for: Chemotherapy-Induced Neutropenia

FDA Approves tbo-filgrastim

The U.S. Food and Drug Administration (FDA) has approved tbo-filgrastim (XM02 filgrastim) to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow.

Tbo-filgrastim is a short-acting recombinant form of G-CSF designed to stimulate the bone marrow to produce white bloods cells to reduce the duration of severe neutropenia in patients receiving chemotherapy associated with a clinically significant incidence of febrile neutropenia (neutropenia with fever).

Tbo-filgrastim is a solution for subcutaneous injection and is supplied as a single use, preservative-free, prefilled syringe in doses of 300mcg/0.5mL and 480 mcg/0.8mL.

Patient Information for tbo-filgrastim

Read this Patient Information before you start receiving tbo-filgrastim and before each treatment course. There may be new information. This information does not take the place of you talking with your doctor about your medical condition or treatment.

What is tbo-filgrastim?

Tbo-filgrastim 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 infections

It is not known if tbo-filgrastim is safe and effective in children under 18 years of age.

What should I tell my doctor before I receive tbo-filgrastim?

Before you take tbo-filgrastim, tell your doctor if you:

  • have sickle cell anemia or other blood problem
  • plan to have bone scans or tests
  • are allergic to filgrastim (Neupogen) or pegfilgrastim (Neulasta)
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if tbo- filgrastim will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if tbo- filgrastim passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How will I receive tbo-filgrastim?

  • Tbo-filgrastim is given by an injection under your skin (subcutaneous) by a doctor or nurse.
  • Your first dose of tbo-filgrastim is given at least 24 hours after you receive your chemotherapy.
  • Tbo-filgrastim injections are usually given one time each day until your white blood cell count returns to normal.
  • Your doctor will test your blood before your chemotherapy and during your tbo-filgrastim treatment until your white blood cell count returns to normal.
  • Keep all of your appointments for your tbo-filgrastim injections and blood tests.

Tbo-filgrastim side effects

Tbo-filgrastim can cause serious side effects, including:

  • 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 tbo-filgrastim. 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 tbo-filgrastim injection, your doctor will treat your allergic reaction and stop giving you the injections. Tell your doctor right away if you have any of these symptoms during or after your injection:
    • 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 a sickle cell disease. If you have sickle cell disease, talk to your doctor about the risks of taking tbo-filgrastim.

The most common side effect of tbo-filgrastim is bone pain.

Tell your doctor about any side effect that bother you or that do not go away.

These are not all the possible side effects of tbo-filgrastim. For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1988.

See also: Side effects (in more detail)

General Information about tbo-filgrastim

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. This Patient Information leaflet summarizes the most important information about tbo-filgrastim. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about tbo-filgrastim that is written for health professionals. For more information, call 1-800-896-5855.

What are the ingredients in tbo-filgrastim?

Active ingredient: tbo-filgrastim

Inactive ingredient: glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection.

Further information

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