Tivicay PD

TIVICAY PD- dolutegravir sodium tablet, for suspension
TIVICAY- dolutegravir sodium tablet, film coated
ViiV Healthcare Company

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.

2 DOSAGE AND ADMINISTRATION

2.1 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 )] .

2.2 Recommended Dosage in Adults

TIVICAY tablets may be taken with or without food.

Table 1. Dosing Recommendations for TIVICAY Tablets 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 (7.3)].

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

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).

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

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

2.5 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

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

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

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