Tivicay Dosage

Generic name: DOLUTEGRAVIR SODIUM 5mg
Dosage form: tablet, film coated
Drug class: Integrase strand transfer inhibitor

Medically reviewed by Drugs.com. Last updated on Oct 7, 2022.

Pregnancy Testing before Initiation

Pregnancy testing is recommended before initiation of TIVICAY or TIVICAY PD in adolescents and adults of childbearing potential [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Recommended Dosage in Adults

TIVICAY tablets may be taken with or without food.

Table 1. Dosing Recommendations for TIVICAY Tablets in Adult Patients
INSTI = integrase strand transfer inhibitor.
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 (7.3)].
Population	Recommended Dosage
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 uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A) or cytochrome P450 (CYP)3A inducers [see Drug Interactions (7.2, 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

General Dosing and Administration Instructions for Pediatric Patients

Do not interchange TIVICAY tablets and TIVICAY PD tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles [see Warnings and Precautions (5.6), Clinical Pharmacology (12.3)]. If switching from the tablets to the tablets for oral suspension, follow the recommended dosage in Table 3. If switching from the tablets for oral suspension to the tablets, follow the recommended dosage in Table 4. See administration instructions in Dosage and Administration (2.6).

Recommended Dosage in Pediatric Patients Weighing 3 to 14 kg

The recommended weight-based dosage of TIVICAY PD tablets for oral suspension in pediatric patients weighing 3 to 14 kg (4 weeks and older, treatment-naïve, or treatment-experienced but naïve to INSTI treatment) is described in Table 2.

Do not use TIVICAY tablets in patients weighing 3 to 14 kg. See administration instructions in Dosage and Administration (2.6).

Table 2. Recommended Dosage of TIVICAY PD in Pediatric Patients 4 Weeks and Older Weighing 3 to 14 kg
a If certain UGT1A or CYP3A inducers are coadministered, then administer TIVICAY PD twice daily [see Drug Interactions (7.2, 7.3)].
Body Weight	TIVICAY PD Tablets for Oral Suspension
Body Weight	Daily Dosea	Number of 5-mg Tablets
3 kg to less than 6 kg	5 mg once daily	1
6 kg to less than 10 kg	15 mg once daily	3
10 kg to less than 14 kg	20 mg once daily	4

Recommended Dosage in Pediatric Patients Weighing 14 kg or Greater

For pediatric patients weighing 14 kg or greater (4 weeks and older, treatment-naïve, or treatment-experienced but naïve to INSTI treatment) administer either:

•: TIVICAY PD tablets for oral suspension (preferred in pediatric patients weighing less than 20 kg) (Table 3), or
•: TIVICAY tablets for oral use (Table 4)

Table 3. Recommended Dosage of TIVICAY PD Tablets for Oral Suspension in Pediatric Patients Weighing 14 kg or Greater
a If certain UGT1A or CYP3A inducers are coadministered, then administer TIVICAY PD twice daily [see Drug Interactions (7.2, 7.3)].
Body Weight	TIVICAY PD Tablets for Oral Suspension
Body Weight	Daily Dosea	Number of 5-mg Tablets
14 kg to less than 20 kg	25 mg once daily	5
20 kg and greater	30 mg once daily	6

Table 4. Recommended Dosage of TIVICAY Tablets in Pediatric Patients Weighing 14 kg or Greater
a If certain UGT1A or CYP3A inducers are coadministered, then administer TIVICAY twice daily [see Drug Interactions (7.2, 7.3)].
Body Weight	TIVICAY Tablets
Body Weight	Daily Dosea	Number of Tablets
14 kg to less than 20 kg	40 mg once daily	4 x 10-mg
20 kg and greater	50 mg once daily	1 x 50-mg

Additional Administration Instructions

Administer TIVICAY tablets and TIVICAY PD tablets for oral suspension with or without food.

Administration Instructions for TIVICAY PD

Do not chew, cut, or crush TIVICAY PD [see Instructions for Use]. Instruct patients (or instruct caregivers) to either:

•: Swallow the tablets for oral suspension whole (if more than one tablet is required, swallow one tablet at a time to reduce the risk of choking), or
•: Fully disperse the tablets for oral suspension in 5 mL of drinking water (if using 1 or 3 tablets for oral suspension) or 10 mL (if using 4, 5, or 6 tablets for oral suspension) in the supplied cup; swirl the suspension so that no lumps remain. After full dispersion, administer the oral suspension within 30 minutes of mixing [see Instructions for Use].