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FDA Labeling Changes
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Uses
VITEKTA in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults.
Limitations of Use:
- There are no comparative pharmacokinetic or clinical data evaluating VITEKTA with cobicistat as single entities compared to STRIBILD®.
- VITEKTA coadministered with protease inhibitors and cobicistat is not recommended [see Warnings and Precautions (5.2)].
- Coadministration of VITEKTA with dosage regimens or HIV-1 protease inhibitors other than those presented in Table 1 is not recommended.
History
There is currently no drug history available for this drug.
Other Information
VITEKTA (elvitegravir) is a human immunodeficiency virus-1 (HIV-1) integrase strand transfer inhibitor.
The chemical name of elvitegravir is 6-(3-Chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. It has a molecular formula of C23H23ClFNO5 and a molecular weight of 447.9. It has the following structural formula:
Elvitegravir is a white-to-pale yellow solid with a solubility of less than 0.3 mcg/mL in water at 20 °C.
VITEKTA tablets are for oral administration and contain 85 mg or 150 mg of elvitegravir. The 85 mg and the 150 mg tablets each include the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate. The tablets are film-coated with a coating material containing polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, indigo carmine, FD&C Blue #2 aluminum lake, and iron oxide yellow.
Sources
Vitekta Manufacturers
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Gilead Sciences, Inc.
Vitekta | Gilead Sciences, Inc.
VITEKTA must be administered once daily with food in combination with a protease inhibitor coadministered with ritonavir and another antiretroviral drug. The protease inhibitor and ritonavir dosing regimens presented in Table 1 are the recommended regimens for use with VITEKTA. For additional dosing instructions for these protease inhibitors and other concomitant antiretroviral drugs, refer to their respective prescribing information.
Table 1 Recommended Regimens* Dosage of VITEKTA Dosage of Concomitant Protease Inhibitor Dosage of Concomitant Ritonavir * VITEKTA in combination with a protease inhibitor and ritonavir must be coadministered with another antiretroviral drug. 85 mg orally once daily Atazanavir 300 mg orally once daily 100 mg orally once daily Lopinavir 400 mg orally twice daily 100 mg orally twice daily 150 mg orally once daily Darunavir 600 mg orally twice daily 100 mg orally twice daily Fosamprenavir 700 mg mg orally twice daily 100 mg orally twice daily Tipranavir 500 mg orally twice daily 200 mg orally twice dailyTreatment history and, when available, resistance testing should guide the use of VITEKTA-containing regimens.
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