Tivicay
TIVICAY- dolutegravir sodium tablet, film coated
RedPharm Drug, Inc.
1 INDICATIONS AND USAGE
‑ TIVICAY and TIVICAY PD are indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑ 1) infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve)aged at least 4 weeks and weighing at least 3 kg [ see Microbiology ( 12.4)].
TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
2 DOSAGE AND ADMINISTRATION
2.1 Pregnancy Testing before Initiation
Perform pregnancy testing before initiation of dolutegravir in adolescents and adults of childbearing potential [see Warnings and Precautions ( 5.3), Use in Specific Populations ( 8.1, 8.3)].
2.2 Recommended Dosage in Adults
TIVICAY tablets may be taken with or without food.
| 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 rilpivirine a | 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 resistance b [see Microbiology ( 12.4)] | 50 mg twice daily |
2.3 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) .
2.4 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)] . | ||
| Body Weight | TIVICAY PD Tablets for Oral Suspension | |
| Daily Dose a | 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 |
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