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Tivicay Dosage

Generic name: DOLUTEGRAVIR SODIUM 10mg
Dosage form: tablet, film coated

Medically reviewed on September 6, 2018.

Pregnancy Testing before Initiation of TIVICAY

Perform pregnancy testing before initiation of TIVICAY in adolescents and adults of childbearing potential [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Adults

TIVICAY tablets may be taken with or without food.

Table 1. Dosing Recommendations for TIVICAY in Adult Patients
a Rilpivirine dose is 25 mg once daily for those switching to dolutegravir plus rilpivirine.
b Alternative combinations that do not include metabolic inducers should be considered where possible [see Drug Interactions (7)].

Population

Recommended Dose

Treatment-naïve or treatment-experienced INSTI-naïve or virologically suppressed (HIV-1 RNA <50 copies per mL) adults switching to dolutegravir plus rilpivirinea

50 mg once daily

Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with certain UGT1A or CYP3A inducers [see Drug Interactions (7.3)]

50 mg twice daily

INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistanceb [see Microbiology (12.4)]

50 mg twice daily

Pediatric Patients

TIVICAY tablets may be taken with or without food.

Treatment-Naïve or Treatment-Experienced INSTI-Naïve

The recommended dose of TIVICAY in pediatric patients weighing at least 30 kg is provided in Table 2.

Table 2. Dosing Recommendations for TIVICAY in Pediatric Patients Weighing at Least 30 kg
a If certain UGT1A or CYP3A inducers are coadministered, then increase the weight-based dose of TIVICAY to twice daily [see Drug Interactions (7.3) for relevant inducers].

Body Weight (kg)

Daily Dosea

(Number of Tablets per Dose when Different Strength(s) are Required)

30 to less than 40

35 mg once daily
(One 25-mg tablet and one 10-mg tablet)

40 or greater

50 mg once daily

Safety and efficacy of TIVICAY have not been established in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

Further information

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

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