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Neutroval (tbo-filgrastim)

Company: Teva Pharmaceutical
Approval Status: Approved August 2012
Treatment for: severe chemotherapy-induced neutropenia
Areas: Hematology; Cancer & Oncology

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Neutroval (tbo-filgrastim) is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.

tbo-filgrastim is specifically approved to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

tbo-filgrastim is supplied as a solution for subcutaneous injection. The recommended dose of tbo-filgrastim is 5 mcg/kg per day administered as a subcutaneous injection. Administer the first dose of tbo-filgrastim no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer tbo-filgrastim within 24 hours prior to chemotherapy.


Clinical Results

FDA Approval
The FDA approval of tbo-filgrastim was based on a multinational, multicenter, randomized and controlled study in 348 chemotherapy-naive subjects with high-risk stage II, stage III, or stage IV breast cancer receiving doxorubicin (60 mg/m2) and docetaxel (75 mg/m2). The trial compared tbo-filgrastim to placebo and a non-US-approved filgrastim product as controls. Tbo-filgrastim, placebo, and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of >10,000x106/L after nadir was reached. Tbo-filgrastim was superior to placebo in duration of severe neutropenia, with a statistically significant reduction in duration (1.1 days versus 3.8 days; p < 0.0001).


Side Effects

Adverse events associated with the use of tbo-filgrastim may include, but are not limited to, the following:

  • bone pain
  • leukocytosis


Mechanism of Action

Neutroval (tbo-filgrastim) is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.


Literature References

Gatzemeier U, Ciuleanu T, Dediu M, Ganea-Motan E, Lubenau H, Del Giglio A XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy. Journal of Thoracic Oncology : official publication of the International Association for the Study of Lung Cancer. 2009 Jun;4(6):736-40

del Giglio A, Eniu A, Ganea-Motan D, Topuzov E, Lubenau H XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy. BMC cancer 2008 Nov 12;8:332


Additional Information

For additional information regarding Neutroval (tbo-filgrastim) or severe chemotherapy-induced neutropenia, please visit the Teva Pharmaceuticals web page.




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Neutroval Drug Information

The Neutroval drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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