Dosage forms (ie, Ticivay, Ticivay PD) are not bioequivalent or interchangeablePoor virologic response was observed in subjects treated with TIVICAY 50 mg BID with an 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/RIn patients with underlying hepatitis B or C, measure hepatic enzymes before initiating therapy and periodically thereafterPerform pregnancy testing before initiation in females of childbearing potentialIndicated in combination with other ARTs for treatment-naïve or treatment-experienced, but INSTI-naïve children aged ≥4 weeks who weigh ≥3 kgCoadministration with potent UGT1A or CYP3A inducers (eg, efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin): Increase weight-based dose to twice dailyDosage forms (ie, Ticivay, Ticivay PD) are not bioequivalent or interchangeablePerform pregnancy testing before initiation of dolutegravir in females of childbearing potentialIncreased cholesterol and triglycerides (up to 17%)Coadministration with dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening eventsHypersensitivity reactions reported; characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury (see Contraindications)Hepatic adverse events reported; patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations; in some cases, transaminase elevations were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where antihepatitis therapy was withdrawnHepatic toxicity, including elevated serum liver biochemistries, hepatitis, and acute liver failure reported without pre-existing hepatic disease or other identifiable risk factors; drug-induced liver injury leading to liver transplant reported; monitoring for hepatotoxicity recommendedImmune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy; may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia [PCP], or tuberculosis) or autoimmune disorders (eg, Graves disease, polymyositis, and Guillain-Barré syndrome)Dosage forms (ie, tablets and tablets for oral suspension) are not bioequivalent and are not interchangeable on a mg-per-mg basis; if a pediatric patient switches from one formulation to the other, the dose must be adjusted for the new dosage formulation; incorrect dosing of a given formulation may result in underdosing and loss of therapeutic effect and possible resistance or clinically significant adverse reactions from greater exposure of dolutegravirDosage forms are not interchangeable on a milligram per milligram basis; dose must be adjusted for new dosage formulation; incorrect dosing may lead to loss of therapeutic effect when underdosing and clinically significant adverse reactions when overdosingPotential risk of neural tube birth defects (see Pregnancy)A pregnancy exposure registry monitors pregnancy outcomes in women during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263There are insufficient human data on use during pregnancy to inform a drug-associated risk of birth defects and miscarriage; given the limited number of pregnancies exposed to dolutegravir-based regimens reported to APR, no definitive conclusions can be drawn on safety in pregnancy, and continued monitoring is ongoing through the APRInitiation of therapy is not recommended in individuals actively trying to become pregnant unless there is no suitable alternative; a benefit-risk assessment should consider factors such as feasibility of switching, tolerability, ability to maintain viral suppression, and risk of transmission to infant against risk of neural tube defectsIn adolescents and adults of childbearing potential currently receiving therapy who are actively trying to become pregnant, or if pregnancy is confirmed in the first trimester, assess risks and benefits of continuing therapy versus switching to another antiretroviral regimen and consider switching to an alternative regimenAdvise pregnant adolescents and adults of potential risk to embryo exposed to drug from time of conception through first trimester of pregnancy; a benefit-risk assessment should consider factors such as feasibility of switching, tolerability, ability to maintain viral suppression, and risk of transmission to infant against risk of neural tube defectsPerform pregnancy testing in adolescents and adults of childbearing potential before initiation of therapyIn animal reproduction studies, no evidence of adverse developmental outcomes was observed during organogenesisThe Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection; not known whether drug is present in human breast milk, affects human milk production, or has effects on breastfed infant; when administered to lactating rats, dolutegravir was present in milkIt is not known whether drug is present in human breast milk, affects human milk production, or has effects on breastfed infant; when administered to lactating rats, dolutegravir was present in milkBecause of potential for (1) HIV-1 transmission (in HIV-negative infants), and (2) developing viral resistance (in HIV-positive infants), instruct mothers not to breastfeed if they are receiving drug therapyA: Generally acceptable.
This drug does not have any food or water restrictions and it can be taken day or night. PEP initiation should not be delayed; the first dose of PEP medications should be administered to the exposed individual before HIV testing and exposure evaluation.
Medscape - HIV infection dosing for Tivicay, Tivicay PD (dolutegravir), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information.
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