Tivicay

2 DOSAGE AND ADMINISTRATION May be taken without regard to food. ( 2.2 , 2.6) UGT = uridine diphosphate glucuronosyltransferase; CYP = cytochrome P450. 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 rilpivirine a ( 2.1 ) 50 mg once daily Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with certain UGT1A or CYP3A inducers ( 2.1 , 7.2 , 7.3 ) 50 mg twice daily INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance b ( 2.1 , 12.4 ) 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. ( 2.3 , 2.4 , 2.5 ). TIVICAY and TIVICAY PD are not bioequivalent and are not substitutable 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. ( 2.3 , 2.4 , 7.2 , 7.3 ) Pediatric Population Body Weight Recommended Dose a 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 ( Table 4 ): 14 kg to less than 20 kg: 40 mg once daily. 20 kg and greater: 50 mg once daily. 2.1 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/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 2.2 General Dosing and Administration Instructions for Pediatric Patients Do not substitute TIVICAY tablets and TIVICAY PD tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles [see Warnings and Precautions ( 5.5 ), 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 ( 2.5 )] . 2.3 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 ( 2.5 )] . Table 2. Recommended Dosage of TIVICAY PD in Pediatric Patients 4 Weeks and Older Weighing 3 to 14 kg a If certain uridine diphosphate glucuronosyltransferase (UGT)1A or cytochrome P450 (CYP)3A 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 2.4 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 Daily Dose a 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 Dose a 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 2.5 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] .

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1 INDICATIONS AND USAGE TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of 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 )].