Tivicay

(dolutegravir)
dolutegravir 10 MG Oral Tablet [Tivicay]dolutegravir 25 MG Oral Tablet [Tivicay]
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NO BLACK BOX WARNING

Dosage & administration

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.

Adult 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

50 mg twice daily

INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistanceb

50 mg twice daily

Pediatric Patients: Treatment-naïve or treatment-experienced INSTI-naïve patients aged at least 4 weeks and weighing at least 3 kg. See Tables 2, 3, and 4 for complete pediatric dosing recommendations. . TIVICAY and TIVICAY PD are not bioequivalent and are not interchangeable on a milligram-per-milligram basis.

a  If certain UGT1A or CYP3A inducers are coadministered, then adjust the weight-based dose of TIVICAY to twice daily.

Pediatric Population

Body Weight

Recommended Dosea

TIVICAY PD
Tablets for Oral Suspension

  3 kg to less than 6 kg

5 mg once daily

  6 kg to less than 10 kg

15 mg once daily

  10 kg to less than 14 kg

20 mg once daily

  14 kg to less than 20 kg

25 mg once daily

  20 kg and greater

30 mg once daily

Alternative dosing recommendations for TIVICAY tablets for patients weighing at least 14 kg :


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Instructions For Use [Tablets For Oral Suspension]: HIV
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