Drug Detail:Tivicay (Dolutegravir [ doe-loo-teg-ra-vir ])
Generic Name: DOLUTEGRAVIR SODIUM 5mg
Dosage Form: tablet, film coated
Drug Class: Integrase strand transfer inhibitor
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.
| 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)]. |
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|
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).
| a If certain UGT1A or CYP3A inducers are coadministered, then administer TIVICAY PD twice daily [see Drug Interactions (7.2, 7.3)]. | ||
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Body Weight |
TIVICAY PD Tablets for Oral Suspension |
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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)
| a If certain UGT1A or CYP3A inducers are coadministered, then administer TIVICAY PD twice daily [see Drug Interactions (7.2, 7.3)]. | ||
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Body Weight |
TIVICAY PD |
|
|
Daily Dosea |
Number of 5-mg Tablets |
|
|
14 kg to less than 20 kg |
25 mg once daily |
5 |
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20 kg and greater |
30 mg once daily |
6 |
| a If certain UGT1A or CYP3A inducers are coadministered, then administer TIVICAY twice daily [see Drug Interactions (7.2, 7.3)]. | |||||
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Body Weight |
TIVICAY Tablets |
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Daily Dosea |
Number of Tablets |
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14 kg to less than 20 kg |
40 mg once daily |
4 x 10-mg |
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20 kg and greater |
50 mg once daily |
1 x 50-mg |
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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].
