"The US Food and Drug Administration (FDA) has approved Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF; 25 mg), the company announced.
TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Limitations of Use
- Limited data exist on the use of TRIZIVIR alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Screening For HLA-B*5701 Allele Prior To Starting TRIZIVIR
Recommended Dosage For Adults And Pediatric Patients Weighing At Least 40 kg
The recommended dosage of TRIZIVIR is one tablet taken orally twice daily with or without food.
Not Recommended Due To Lack Of Dosage Adjustment
Because TRIZIVIR is a fixed-dose tablet and cannot be dose adjusted, TRIZIVIR is not recommended in:
- pediatric patients who weigh less than 40 kg [see Use in Specific Populations]
- patients with creatinine clearance less than 50 mL per minute [see Use In Specific Populations]
- patients with mild hepatic impairment. TRIZIVIR is contraindicated in patients with moderate or severe hepatic impairment [see CONTRAINDICATIONS, Use In Specific Populations].
Dosage Forms And Strengths
TRIZIVIR tablets contain 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green, capsule-shaped, film-coated, and imprinted with “GX LL1” on one side with no markings on the reverse side.
Storage And Handling
TRIZIVIR is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green capsule-shaped, film-coated, and imprinted with GX LL1 on one side with no markings on the reverse side. They are packaged as follows:
Bottles of 60 tablets (NDC 49702-217-18).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline Research Triangle Park, NC 27709. Revised: September 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/23/2015
Additional Trizivir Information
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