If you need to take iron or calcium supplements by mouth during treatment with TIVICAY: If you take TIVICAY with food, you may take these supplements at the same time that you take TIVICAY. Reasons for updating. currently on TIVICAY who are actively trying to become pregnant, or if help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. have ever had an allergic reaction to a medicine that contains dolutegravir. with severe renal impairment, as the decrease in dolutegravir concentrations There were 808 subjects included in the efficacy and safety analyses. Response rates by baseline phenotype were analyzed in an as-treated analysis using all subjects with available baseline phenotypes through Week 48 (n = 163) (see Table 12). A total of 1,024 adult HIV-1–infected subjects who were on a stable suppressive antiretroviral regimen (containing 2 NRTIs plus either an INSTI, an NNRTI, or a PI) for at least 6 months (HIV-1 RNA less than 50 copies per mL), with no history of treatment failure and no known substitutions associated with resistance to dolutegravir or rilpivirine received treatment in the trials. The rate of adverse events leading to discontinuation was 4% of subjects at Week 48. Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. Other frequently emergent INSTI-resistance substitutions included L74M, I or V, E138K or A, G140S, Q148H, R or K, M154I, or N155H. Table 4. Patients. it may show up when you take Tivicay (dolutegravir 25 mg and 50 mg). At baseline, the median age of subjects was 36 years, 13% female, 15% non-white, 11% had hepatitis B and/or C virus co-infection, 2% were CDC Class C (AIDS), 28% had HIV-1 RNA greater than 100,000 copies per mL, 48% had CD4+ cell count less than 350 cells per mm3, and 39% received EPZICOM; these characteristics were similar between treatment groups. Coadministration is contraindicated with TIVICAY [see. Dolutegravir exhibited antiviral activity against laboratory strains of wild-type HIV-1 with mean EC50 values of 0.5 nM (0.21 ng per mL) to 2.1 nM (0.85 ng per mL) in peripheral blood mononuclear cells (PBMCs) and MT-4 cells. Bottle of 30 tablets with child-resistant closure. Use In Specific Populations]. In HIV-2 mutants, combinations of substitutions A153G/N155H/S163G and E92Q/T97A/N155H/S163D conferred 4-fold decreases in dolutegravir susceptibility, and E92Q/N155H and G140S/Q148R showed 8.5-fold and 17-fold decreases in dolutegravir susceptibility, respectively. If you have an infection that you did not know you had, The proportion of subjects with HIV- 1 RNA greater than or equal to 50 copies per mL (virologic failure) at Week 48 was 0.6% and 1.2% for the dolutegravir plus rilpivirine treatment group and the current antiretroviral regimen treatment groups, respectively; treatment difference and 95% CI was -0.6% (-1.7%, 0.6%). Table 11. At failure, the median dolutegravir foldchange from reference was 61-fold (range: 0.75 to 209) for isolates with emergent INSTIresistance substitutions (n = 33). Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs. Instruct patients to immediately stop taking the exposure in humans at the MRHD. No treatment-emergent genotypic resistance to the background regimen was observed in the dolutegravir arm in either the SPRING-2 or SINGLE trials. elevations with use of TIVICAY [see ADVERSE REACTIONS]. Drug-induced C. Advise adolescents and adults of childbearing potential When taken in combination with other HIV-1 medicines, TIVICAY can help provide effective HIV-1 treatment in adults and children who weigh at least 66 pounds. Instruct patients to store the TIVICAY 10-mg tablets in Subjects were stratified by age, enrolling adolescents first (Cohort 1: aged 12 to less than 18 years) and then younger children (Cohort 2A: aged 6 to less than 12 years). polymyositis, and Guillain-Barré syndrome) have also been reported to occur in In a birth outcome surveillance study in Botswana, there At Week 24, the proportion of subjects with HIV-1 RNA less than 50 copies per mL in Cohort 1 and Cohort 2A was 70% (16/23) and 61% (14/23), respectively. Contact Seller Ask for best deal. kg, and rats were administered doses of up to 50 mg per kg. Virologically Suppressed Subjects: The ARs observed for TIVICAY plus rilpivirine in the Week 48 analysis of pooled data from 2 identical, international, multicenter, open-label trials (SWORD-1 and SWORD-2) of 513 HIV-1–infected, virologically suppressed subjects switching from their current antiretroviral regimen to dolutegravir plus rilpivirine, were consistent with the AR profiles and severities for the individual components when administered with other antiretroviral agents. trimesters of pregnancy if the expected benefit justifies the potential risk to The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R. A decrease in creatinine clearance, as determined by 24-hour urine collection, was observed with both doses of dolutegravir after 14 days of treatment in subjects who received 50 mg once daily (9% decrease) and 50 mg twice daily (13% decrease). Tivicay is not a cure for HIV or AIDS. Dolutegravir demonstrated antiviral activity in cell culture against a panel of HIV-1 clinical isolates (3 in each group of M clades A, B, C, D, E, F, and G, and 3 in group O) with EC50 values ranging from 0.02 nM to 2.14 nM for HIV-1. the MRHD). HIV-negative infants), (2) developing viral resistance (in HIV-positive administered at the time of conception compared with breast milk, affects human milk production, or has effects on the breastfed because the date of conception may not be determined with precision, an Sold under the brand name Tivicay, Instgra 50 mg is not only used in the treatment of HIV. The only treatment-emergent AR of moderate to severe intensity with at least 2% frequency in either treatment group was diarrhea, 2% (6 of 354) in subjects receiving TIVICAY 50 mg once daily + background regimen and 1% (5 of 361) in subjects receiving raltegravir 400 mg twice daily + background regimen. Mean Change from Baseline in Fasted Lipid Values in Treatment-Naive Subjects in SPRING-2 (Week 96 Analysisa) and SINGLE Trials (Week 144 Analysisa). You may report side effects to the FDA at 1-800-332-1088. Site-Directed Integrase Strand Transfer Inhibitor-Resistant Mutant HIV-1 and HIV-2 Strains. The Grade 3 or 4 laboratory abnormalities reported in more than one subject were elevated total bilirubin (n = 3) and decreased neutrophil count (n = 2). NDC 49702-226-13. However, many people have no side effects or only have minor side effects. Use Tivicay (dolutegravir 25 mg and 50 mg) as ordered by your doctor. Dolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin, Table 6) [see CONTRAINDICATIONS, Established And Other Potentially Significant Drug Interactions]. dark or tea-colored urine, pale-colored stools or bowel movements, nausea, childbearing potential before initiation of TIVICAY [see DOSAGE AND may result in loss of therapeutic effect and development of resistance to have ever had an allergic reaction to dolutegravir. provider if they develop rash. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Monitor for metformin adverse effects. recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 50 mg PO once daily with tenofovir and emtricitabine for 28 days is a preferred HIV post-exposure prophylaxis (PEP) regimen in adults. In vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3. Drug interaction trials were performed with TIVICAY and other drugs likely to be coadministered or commonly used as probes for pharmacokinetic interactions. alternative treatment to TIVICAY should be considered at the time of conception Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir. However, no dosage adjustment is necessary for treatment-naïve or Grades 2 to 4 ALT abnormalities in hepatitis B and/or C co-infected compared with HIV monoinfected subjects receiving TIVICAY were observed in 18% vs. 3% with the 50-mg once-daily dose and 13% vs. 8% with the 50-mg twice-daily dose. Läs noga igenom denna bipacksedel innan du börjar ta detta läkemedel. This medicine may cause harm to an unborn baby. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. … The bottle of TIVICAY (10-mg tablets) contains a desiccant packet to help keep your medicine dry (protect it from moisture). The lowest GoodRx price for the most common version of Tivicay is around $1,810.03, 20% off the average retail price of $2,277.25. immediately of any signs or symptoms of infection as inflammation from previous PHARMACOLOGY]. The potential benefits of taking dalfampridine concurrently with TIVICAY should be considered against the risk of seizures in these patients. deliveries to women who started dolutegravir during pregnancy had a neural tube Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. See additional information. Do not flush down a toilet or pour down a drain unless you are told to do so. 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