Naivex

The integrase inhibitor dolutegravir was approved by the FDA as a once-daily oral medication, an HIV integrase inhibitor, intended to be used in combination with other antiretroviral agents for previously treated or treatment-naïve HIV-1-infected adults and children 12 years and older weighing at least 40 kilograms. Dolutegravir Tablets, for oral use

Indications and Use

Dolutegravir is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) for use in combination with:

• Other antiretroviral drugs, indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

•rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults who have been virologically suppressed (HIV-1 RNA less than 50 copies/ mL) alternatives to current antiretroviral treatment regimens with no history of treatment failure or known alternatives associated with resistance to antiretroviral agents. Mechanism of Action Dolutegravir is an HIV-1 antiretroviral agent [see Microbiology].

Dosage Forms and Strengths

Tablets: 10 mg, 25 mg and 50 mg daily

Contraindications

• Previous allergic reaction to dolutegravir.

•Combined with dofetilide. Warnings

& Precautions

• Hypersensitivity reactions characterized by rash, structural and organ dysfunction (including liver damage) have been reported. If signs or symptoms of an allergic reaction occur, discontinue dolutegravir and other suspected medications immediately, as delay in discontinuing treatment may result in a life-threatening reaction.

Recommended dosage

Treatment for patients who are new to audio or have experienced INSTI treatment or virological suppression (HIV-1 RNA <50 copies/ mL) of adults, switch to dolutegravir plus rilpivirinea.

50 mg once daily

Naïve or treated INSTI-

naïve when coadministered with certain UGT1A or CYP3A inducers. 50 mg twice daily

INSTI experienced resistance substitution associated with certain INSTIs or clinically suspected INSTI

Resistant b. 50 mg twice daily

For those patients switching to dolutegravir plus rilpivirine, the rilpivirine dose is 25 mg.b

An alternative combination that does not include a metabolic inducer should be considered if possible.

Pediatric patients: (untreated or treated INSTI-naïve patients weighing at least 30 kg).

• If at least kg 50 mg once daily.

•Patients 30 kg to less than 40 kg: The recommended dose is dolutegravir 35 mg once daily.

• If certain UGT1A or CYP3A inducers are co-administered, adjust the weight-based dose of dolutegravir to twice daily

Packaging Supply/Storage and Handling

Dolutegravir tablets 10 mg are white, round, film-packaged biconvex tablets with "SV 572" on one side and "10" on the other. Bottle of 30 tablets with childproof seal and containing desiccant. NDC 49702-226-13.

Store and aliquot 10-mg tablets in original packaging, protect from moisture, and keep bottles tightly closed. Do not remove desiccant

. Dolutegravir tablets 25 mg are light yellow, round, film-coated, biconvex tablets, stamped with "SV 572" on one side and "SV 572" on the other side. Bottle of 30 pieces with child-safe seal. NDC 49702-227-13.

Dolutegravir tablets are 50 mg biconvex tablets wrapped in a yellow round film, with "SV 572" on one side and "50" on the other side. A bottle of 30 tablets. Childproof closure NDC 49702-228-13.

Store at 25°C (77°F); deviations of 15° to 30°C (59° to 86°F) allowed [see USP Controlled Room Temperature].