cts on Serum Liver Biochemistries in Patients With Hepatitis B or C Co‑infection
5.3 Fat Redistribution
5.4 Immune Reconstitution Syndrome
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience in Adult Subjects
6.2 Clinical Trials Experience in Pediatric Subjects
7 DRUG INTERACTIONS
7.1 Effect of Dolutegravir on the Pharmacokinetics of Other Agents
7.2 Effect of Other Agents on the Pharmacokinetics of Dolutegravir
7.3 Established and Other Potentially Significant Drug Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Adult Subjects
14.2 Pediatric Subjects
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
TIVICAY® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg.
The following should be considered prior to initiating treatment with TIVICAY:
•
Poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an integrase strand transfer inhibitor (INSTI)-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R [see Microbiology (12.4)].
2 DOSAGE AND ADMINISTRATION
TIVICAY tablets may be taken with or without food.
2.1 Adults
Table 1. Dosing Recommendations for TIVICAY in Adult Patients Population
Recommended Dose
Treatment-naïve or treatment-experienced INSTI-naïve
50 mg once daily
Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with the following potent UGT1A/CYP3A inducers: efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin
50 mg twice daily
INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistancea [see Microbiology (12.4)]
50 mg twice daily
a Alternative combinations that do not include metabolic inducers should be considered where possible [see Drug Interactions (7)].
The safety and efficacy of doses above 50 mg twice daily have not been eva luated.
2.2 Pediatric Patients
Treatment-Naïve or Treatment-Experienced INSTI-Naïve: The recommended dose of TIVICAY in pediatric patients aged 12 years and older and weighing at least 40 kg is 50 mg administered orally once daily.
If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, the recommended dose of TIVICAY is 50 mg twice daily.
Safety and efficacy of TIVICAY have not been established in pediatric patients younger than 12 years or weighing less than 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, |
