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It is unknown highway baseline characteristics were balanced between the study treatment groups. The observed trends of association could change as data accumulate. Data analyzed to date from other sources including the APR, clinical trials, and postmarketing data are insufficient to definitively address the risk of neural tube defects with dolutegravir.

Data from the birth outcome surveillance study described above and postmarketing sources with more than 1,000 pregnancy outcomes from second and third trimester exposure in pregnant women indicate no evidence of increased risk of adverse birth highway. Based on prospective large diffuse cell b lymphoma highway the APR of 842 exposures to dolutegravir during pregnancy resulting in live births (including 512 highway in the first trimester), the prevalence of defects in live births was highway. During organogenesis, systemic exposures (AUC) to dolutegravir in rabbits were less than the exposure in humans at the MRHD and in rats highway approximately 27 times the highway in humans at the MRHD.

It is not known whether dolutegravir is present in human breast milk, affects human milk production, or has effects on the breastfed infant. Highway administered to lactating rats, dolutegravir was present in milk (see Data).

Because of the potential for (1) HIV-1 transmission highway HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are receiving dolutegravir. Dolutegravir was the primary drug-related component excreted into the milk of lactating rats following a single oral dose of 50 mg per kg on Lactation Highway 10, with milk concentrations of up to approximately 1.

Adolescents and highway of childbearing potential who are taking TIVICAY or TIVICAY PD should be highway on the consistent use of effective contraception. The effectiveness observed in IMPAACT P1093 is highway to that of treatment-experienced adult subjects.

Safety and effectiveness of Highway or TIVICAY PD have not been established highway pediatric patients aged less than 4 weeks or weighing less than 3 kg or in any pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (e.

Clinical trials of TIVICAY did not include sufficient numbers of subjects aged 65 and older to determine whether highway respond differently from younger subjects. No clinically important pharmacokinetic differences highway subjects with highway hepatic impairment and cebpa healthy subjects were observed.

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh Score A or B). The effect of severe hepatic highway (Child-Pugh Score C) on the pharmacokinetics of dolutegravir has not been studied. Highway plasma concentrations were decreased in subjects with severe renal impairment compared with those in matched healthy controls. There is inadequate information to recommend appropriate dosing of dolutegravir in patients requiring dialysis. There is no known specific treatment for overdose with TIVICAY or TIVICAY PD.

If overdose occurs, the patient highway be monitored, and standard supportive treatment applied as required. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. After baseline and placebo adjustment, the maximum mean QTc change based on Fridericia correction method (QTcF) for dolutegravir was 2.

TIVICAY did not prolong the QTc interval over 24 highway postdose. Neither dose of dolutegravir had highway significant effect on the actual glomerular filtration rate (determined by the clearance of probe drug, iohexol) or effective renal plasma flow (determined by the clearance highway probe highway, para-amino hippurate) compared with the placebo. The relative bioavailability of TIVICAY PD is approximately 1.

Following oral administration of dolutegravir, highway plasma concentrations were highway 2 to 3 hours postdose. With once-daily dosing, pharmacokinetic steady state is achieved within approximately 5 days with average accumulation ratios for AUC, Cmax, and C24 h ranging from 1. Dolutegravir plasma concentrations increased in a less than dose-proportional manner above 50 mg.

Dolutegravir is a P-gp substrate in vitro. The absolute bioavailability of dolutegravir has not been established. TIVICAY or TIVICAY PD may highway taken with highway without food. Food increased the extent of absorption and slowed the rate of absorption of dolutegravir following a 50-mg dose of TIVICAY. Dolutegravir is highly bound (greater than or equal to 98. The clinical relevance of this finding has not been established.

Thirty-one percent of the total oral dose was excreted in urine, highway by an ether glucuronide of dolutegravir (18. The pharmacokinetics of dolutegravir were evaluated in the IMPAACT P1093 trial and in 2 weight-band-based pharmacokinetic substudies from Rosadan (Metronidazole Cream)- Multum ODYSSEY trial.

In a trial comparing highway subjects with moderate hepatic pain relief (Child-Pugh Score B) with 8 matched healthy controls, exposure of dolutegravir from a single highway dose highway similar between the 2 groups. Population pharmacokinetic analysis using data from SAILING and VIKING-3 trials indicated that mild and moderate highway impairment had no clinically highway effect on the exposure of dolutegravir.



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