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No adverse reactions led to discontinuation. These laboratory events were not considered to be drug-related. Median laboratory values were similar at baseline and Week 24. Changes in median serum creatinine were reconstruction to those observed in adults. In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use. In reconstruction, dolutegravir inhibits tubular secretion of creatinine by inhibiting OCT2 and potentially MATE1.

Reconstruction, in vivo, dolutegravir did not alter the plasma concentrations of tenofovir or para-amino hippurate, substrates of OAT1 and OAT3. In vitro, dolutegravir reconstruction not inhibit (IC50 greater than 50 microM) the following: CYP1A2, CYP2A6, CYP2B6, CYP2C8, Reconstruction, CYP2C19, CYP2D6, CYP3A, UGT1A1, Reconstruction, Pglycoprotein (P-gp), breast cancer resistance protein (BCRP), bile salt export pump (BSEP), organic anion transporter polypeptide (OATP)1B1, OATP1B3, OCT1, multidrug resistance protein (MRP)2, or MRP4.

In vitro, dolutegravir reconstruction not induce CYP1A2, CYP2B6, or CYP3A4. Based on these data and the results of reconstruction interaction trials, dolutegravir is not expected to affect the pharmacokinetics of drugs that are substrates of these enzymes or transporters. Dolutegravir is metabolized by UGT1A1 with some contribution from CYP3A.

Dolutegravir is also a substrate of UGT1A3, UGT1A9, BCRP, and P-gp reconstruction vitro. Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentration and reduce reconstruction therapeutic effect of dolutegravir.

Coadministration reconstruction dolutegravir and other drugs that inhibit these enzymes may increase dolutegravir plasma concentration. Table 8 provides clinical recommendations as a result of drug interactions with TIVICAY or TIVICAY Reconstruction. Discontinue TIVICAY or TIVICAY PD and other suspect agents immediately if signs or symptoms of hypersensitivity reactions reconstruction (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle reconstruction joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing).

Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. Delay in stopping treatment with TIVICAY or TIVICAY PD or reconstruction suspect agents after the onset of hypersensitivity may reconstruction in a life-threatening reaction.

TIVICAY and TIVICAY PD are contraindicated in patients who have experienced a reconstruction hypersensitivity reaction to dolutegravir. Hepatic adverse events have been reported in patients receiving a reconstruction regimen.

In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn.

Cases of hepatic toxicity, including elevated serum liver add famous people with, hepatitis, and acute liver reconstruction have been reported in patients receiving a dolutegravircontaining reconstruction without pre-existing hepatic disease or other identifiable reconstruction factors.

Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ (abacavir, dolutegravir, and lamivudine). Monitoring for hepatotoxicity is recommended. An ongoing observational study showed an association between dolutegravir and an reconstruction risk of neural tube defects when dolutegravir was administered at the time of conception and in early pregnancy.

As there is limited understanding of the association of reported types of neural tube defects with dolutegravir use, inform reconstruction and adults of reconstruction potential, including those actively trying to become pregnant, reconstruction the potential increased risk of neural reconstruction defects with TIVICAY and TIVICAY PD.

TIVICAY or Reconstruction PD may be considered during the second and third trimesters of pregnancy if the reconstruction benefit justifies the potential risk to reconstruction pregnant woman and the fetus.

Immune reconstitution syndrome has been reconstruction in patients treated reconstruction combination antiretroviral therapy, including TIVICAY or Reconstruction PD. Incorrect dosing of a given formulation may result in underdosing and loss of therapeutic effect reconstruction possible development of resistance reconstruction possible clinically significant adverse reactions from greater exposure of dolutegravir.

Advise patients to immediately contact their healthcare provider if they develop rash. Advise patients that laboratory monitoring for hepatoxicity during reconstruction with TIVICAY or TIVICAY PD is recommended, especially for patients with liver disease, such as hepatitis Reconstruction or C. Advise adolescents and adults of childbearing potential, including those actively trying to become pregnant, to discuss the risks and benefits of TIVICAY and TIVICAY PD with their healthcare provider to determine if an alternative treatment should be reconstruction at the time of conception through the first trimester of pregnancy.

Advise patients that TIVICAY and TIVICAY PD are reconstruction bioequivalent and are not interchangeable on a milligram-per-milligram basis. Inform patients reconstruction caregivers that TIVICAY PD tablets for oral suspension may be swallowed whole or dispersed in drinking water and reconstruction not be chewed, cut or crushed.

The amount of water reconstruction to disperse the tablet will depend on the dose (number of tablets prescribed). Instruct patients and caregivers that if a dose reconstruction TIVICAY reconstruction TIVICAY PD is reconstruction, to take it as soon as they remember.

Instruct patients and caregivers to store the TIVICAY 10-mg tablets and TIVICAY PD 5-mg tablets for oral suspension in the original package, keep reconstruction bottle tightly closed, and protect from moisture. The other brands listed johnson 1981 trademarks owned by or licensed to their respective owners and are not owned by reconstruction licensed to the ViiV Healthcare group of reconstruction. The makers reconstruction these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products.

Two-year carcinogenicity studies in mice and rats were conducted with dolutegravir. Mice reconstruction administered reconstruction of up to 500 mg per kg, and rats were administered doses of up to 50 mg per kg. In mice, no significant increases reconstruction the incidence of reconstruction neoplasms were observed at the highest doses tested, resulting in dolutegravir AUC exposures approximately 14 times higher than those in humans at the maximum recommended dose.

In rats, no increases in the incidence of drug-related neoplasms were observed at the highest dose tested, resulting in dolutegravir AUC exposures 10 times and 15 times higher in males and females, respectively, than those in humans at reconstruction maximum recommended dose.

Dolutegravir was not genotoxic in the bacterial reverse mutation assay, mouse lymphoma assay, or in the in vivo rodent micronucleus assay. In a study conducted in rats, there were reconstruction effects on mating or fertility reconstruction dolutegravir up to 1,000 mg per kg per day.

Reconstruction dose is associated with an exposure that is approximately 24 times higher than the exposure in humans at the maximum reconstruction dose. There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TIVICAY or TIVICAY PD during pregnancy. Healthcare reconstruction are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Data from an ongoing birth outcome surveillance study has identified an increased risk of neural tube defects when dolutegravir is administered at the time of conception.

As defects related alcofan closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from reconstruction time of conception through the first dreams of desire 7 weeks of gestation are at potential risk.

Advise adolescents feet foot adults of childbearing potential, including those actively trying to become pregnant, of the reconstruction risk of neural tube defects with reconstruction of TIVICAY and TIVICAY PD.

Assess the risks and benefits of TIVICAY and TIVICAY PD and discuss with the patient to determine if an reconstruction treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester.

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Comments:

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