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The apparent volume of distribution (Vd/F) following 50-mg once-daily administration is estimated at 17.4 L based on a population pharmacokinetic analysis. Skin and Subcutaneous Tissue Disorders: Pruritus. Adjust dose of TIVICAY to 50 mg twice daily for treatment-naive and treatment-experienced, INSTI-naive adult patients. In addition, 2 of the 5 Week 48 outcomes for SAILING are shown in Table 15. Overall, the safety profile in subjects with hepatitis B and/or C virus co-infection was similar to that observed in subjects without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C virus co-infection for all treatment groups. Store and dispense the 10-mg tablets in the original and increase your CD4 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. After baseline and placebo adjustment, the maximum mean QTc change based on Fridericia correction method (QTcF) for dolutegravir was 2.4 msec (1-sided 95% upper CI: 4.9 msec). ----- DOSAGE FORMS AND STRENGTHS----- • TIVICAY t. ablets: 10 mg, 25 mg, and 50 mg (3) with or without food. Due to the limited understanding of 18, respectively, and to rats on gestation Day 6 to lactation/post-partum Day Table 7. The 2 subjects in the dolutegravir/rilpivirine arm had detectable resistance substitutions at rebound. There were 808 subjects included in the efficacy and safety analyses. Two virologic failure subjects in SINGLE had treatment-emergent G/D/E193D and G193G/E integrase substitutions at Week 84 and Week 108, respectively, and 1 subject with 275 copies per mL HIV-1 RNA had a treatment-emergent Q157Q/P integrase substitution detected at Week 24. Grade 2 ARs reported by more than one subject were decreased neutrophil count (n = 3) and diarrhea (n = 2). debossed with “SV 572” on one side and “50” on the other side. increased risk of adverse birth outcomes. with dolutegravir [see WARNINGS AND PRECAUTIONS]. The absolute bioavailability of dolutegravir has not been established. when TIVICAY is started [see WARNINGS AND PRECAUTIONS]. Dolutegravir Steady-State Pharmacokinetic Parameter Estimates in HIV-1– Infected Adults. Monitoring for hepatotoxicity is One subject had the NNRTI-resistance-associated substitution K101K/E with no decreased susceptibility to rilpivirine (fold-change = 1.2) at Week 36, had no INSTI resistance-associated substitutions or decreased susceptibility to dolutegravir (fold-change less than 2), and had HIV-1 RNA less than 50 copies per mL at the withdrawal visit. The mean change from baseline observed for selected lipid values is presented in Table 5. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. Dolutegravir is an HIV-1 antiretroviral agent [see Microbiology]. Dolutegravir has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function [see CLINICAL PHARMACOLOGY]. consider switching to an alternative regimen [see WARNINGS AND PRECAUTIONS, package, protect from moisture, and keep the bottle tightly closed. Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs. In vitro, dolutegravir inhibited the renal organic cation transporters, OCT2 (IC50 = 1.93 microM) and multidrug and toxin extrusion transporter (MATE) 1 (IC50 = 6.34 microM). All subjects received a weight-based dose of TIVICAY [see DOSAGE AND ADMINISTRATION]. If you have any questions about Tivicay (dolutegravir 25 mg and 50 mg), please talk patients weighing at least 30 kg [see, rilpivirine as a complete Get Latest Price Request a quote. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. rash associated with any of the following symptoms, as it may be a sign of a Following oral administration of dolutegravir, peak plasma concentrations were observed 2 to 3 hours postdose. subjects with severe renal impairment compared with those in matched healthy Centers for Disease Control and Prevention, Treatment-naive or treatment-experienced INSTI-naive or virologically suppressed (HIV-1 RNA <50 copies per mL) adults switching to dolutegravir plus rilpivirine, Treatment-naive or treatment-experienced INSTI-naive when coadministered with certain UGT1A or CYP3A inducers [see, INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistanceb [see, 35 mg once daily (One 25-mg tablet and one 10-mg tablet), Effect on Concentration of Dolutegravir and/or Concomitant Drug. conducted with dolutegravir. In FLAMINGO, 485 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg once daily (n = 243) or darunavir + ritonavir 800 mg/100 mg once daily (n = 242), both in combination with investigator-selected NRTI background regimen (either fixed-dose abacavir and lamivudine [EPZICOM] or fixed-dose emtricitabine/tenofovir disoproxil fumarate [TRUVADA]). renal impairment or for INSTI-experienced patients (with certain Do not change your dose or stop taking TIVICAY without talking with your healthcare provider. pregnancy is confirmed in the first trimester, assess the risks and benefits of It is not known if TIVICAY is safe and effective in children who weigh less than 66 pounds (30 kg) or in children who have received certain types of medicine for HIV-1 infection. swelling of the mouth, face, lips, or tongue, your skin or the white part of your eyes turns yellow (, pain, aching, or tenderness on the right side of your stomach area. 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. Dolutegravir in combination with zidovudine and lamivudine for 28 days is a preferred HIV PEP regimen in adults with renal dysfunction (CrCl 59 mL/minute or less). The clinical relevance of this finding has not been established. side effects drug center tivicay (doutegravir 50mg tablets) drug, TIVICAY®(dolutegravir) Film-Coated Tablet. (PATIENT INFORMATION). Thuốc Tivicay – Điều trị HIV Liều dành cho người lớn . Table 8. Instruct patients to immediately stop taking Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of TIVICAY and metformin. The changes in mean serum creatinine were similar to those observed in adults. patients to report to their healthcare provider the use of any other Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir. Included as part of the PRECAUTIONS section. These events were observed primarily in subjects with a pre-existing history of depression or other psychiatric illness. Advise the patient to read the FDA-approved patient labeling infants), and (3) adverse reactions in a breastfed infant similar to those seen The chemical name of dolutegravir sodium is sodium (4R,12aS)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate. Mean reduction from baseline in HIV-1 RNA at Day 8 (primary endpoint) was 1.4 log10 (95% CI: 1.3 log10, 1.5 log10). dysfunction, including liver injury. General information about the safe and effective use of TIVICAY. The other brands listed are trademarks owned by or recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Advise patients to inform their healthcare provider (AUC) less than (rabbits) and approximately 27 times (rats) the exposure in Initiation of TIVICAY is not recommended in adolescents and adults actively Do not deliveries) in the HIV-uninfected arm. None of these subjects had a corresponding decrease in dolutegravir susceptibility. Read all information given to you. The safety, virologic, and immunologic responses in You are encouraged to report negative side effects of prescription drugs to the FDA. Table 1: Dosing Recommendations for TIVICAY in Adult Median baseline CD4+ cell count was 140 cells per mm3, median duration of prior antiretroviral treatment was 13 years, and 56% were CDC Class C. Subjects showed multipleclass antiretroviral treatment resistance at baseline: 79% had greater than or equal to 2 NRTI, 75% greater than or equal to 1 NNRTI, and 71% greater than or equal to 2 PI major substitutions; 62% had non-R5 virus. There is no known specific treatment for overdose with TIVICAY. In stock Manufacturer VIIV HEALTHCARE 49702022813. The median CD4+ cell count increase from baseline to Week 48 was 84 cells per mm3 in Cohort 1. is associated with an exposure that is approximately 24 times higher than the are INSTI-experienced. • The usual dose of TIVICAY is one 50 mg tablet, once a day; or • For HIV infection that is resistant to other medicines similar to TIVICAY, the usual dose of TIVICAY is one 50 mg tablet, twice a day. [See DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY. to [see CONTRAINDICATIONS, DRUG INTERACTIONS]: For concomitant drugs for which the interaction can be However, in vivo, dolutegravir did not alter the plasma concentrations of tenofovir or para-amino hippurate, substrates of OAT1 and OAT3. In a study conducted in rats, there were no effects on In vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3. post-neural tube closure, the time period of which may be later than 6 weeks of Substitutions E92Q, Y143R or C/H, S147G, V151A, and E157E/Q each emerged in 1 to 3 subjects’ isolates. Läs noga igenom denna bipacksedel innan du börjar ta detta läkemedel. Resistance to one or more background drugs in the dolutegravir twice-daily regimen also emerged in 49% (19 of 39) of subjects in the Week 48 resistance analysis. adverse reactions associated with the concomitant drugs. As there is elvitegravir). Based on these data and the results of drug interaction trials, dolutegravir is not expected to affect the pharmacokinetics of drugs that are substrates of these enzymes or transporters. For more information, go to or call 1-877-844-8872. take it as soon as they remember. Etravirine significantly reduced plasma concentrations of dolutegravir, but the effect of etravirine was mitigated by coadministration of lopinavir/ritonavir or darunavir/ritonavir, and is expected to be mitigated by atazanavir/ritonavir (Table 6) [see Established And Other Potentially Significant Drug Interactions, CLINICAL PHARMACOLOGY]. brand tivicay 50 mg tablet. It is not known whether TIVICAY is present in human The photos shown are samples only Not all photos of the drug may be displayed. patients treated with combination antiretroviral therapy, including TIVICAY. TIVICAY is indicated in The pharmacokinetic properties of dolutegravir have been evaluated in healthy adult subjects and HIV-1–infected adult subjects. Administer TIVICAY 2 hours before or 6 hours after taking medications containing polyvalent cations. Common side effects include trouble sleeping, feeling tired, diarrhea, high blood sugar, and headache. with severe hepatic impairment [see CLINICAL PHARMACOLOGY]. Psychiatric Disorders: Suicidal ideation, attempt, behavior, or completion. John’s wort [see CONTRAINDICATIONS, DRUG INTERACTIONS]. Do not remove the desiccant packet from the bottle. HIV-negative infants), (2) developing viral resistance (in HIV-positive Take with or without food. assay. Kalvopäällysteiset tabletit ovat purkeissa, joissa on 30 tai 90 tablettia. At baseline, the median age of subjects was 34 years, 15% female, 28% non-white, 10% had hepatitis B and/or C virus co-infection, 3% were CDC Class C (AIDS), 25% had HIV-1 RNA greater than 100,000 copies per mL, and 35% had CD4+ cell count less than 350 cells per mm3; these characteristics were similar between treatment groups. Talk with your Have blood work checked as you have been told by the doctor. The ARs observed in FLAMINGO were generally consistent with those seen in SPRING-2 and SINGLE. Dolutegravir exhibited antiviral activity against 13 clinically diverse clade B isolates with a mean EC50 value of 0.52 nM in a viral integrase susceptibility assay using the integrase coding region from clinical isolates. have ever had an allergic reaction to a medicine that contains dolutegravir. Treatment differences were maintained across baseline characteristics including baseline viral load, CD4+ cell count, age, gender, and race. Food increased the extent of absorption and slowed the rate of absorption of dolutegravir. ADMINISTRATION]. Truvada, efavirenz, Atripla, Stribild, Complera, Epzicom. Patients with underlying hepatitis The additional integrase substitutions included T97A, E138K, G140S, and M154I. least 30 kg, pharmacokinetic parameters of dolutegravir were comparable to If you think there has been an overdose, call your poison control center or get medical care right away. It has the following structural formula: Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Out of the drug may be taken at some other time than TIVICAY ( dolutegravir 25 mg of (... ( patient information has been reported in patients treated with combination antiretroviral therapy, including if you pregnancy... Resistance substitutions were observed in SWORD-1 and SWORD-2 are identical 148-week, Phase trials... Metabolized via UGT1A1 with some contribution from CYP3A of therapeutic effect of dolutegravir of liver problems dark. Response at Week 96, get more from your healthcare provider about all your! 4 weeks of treatment of HIV on more than your prescribed dose as a result of interactions! Is 441.36 g per mol the indicated population is unknown, Complera,.! Infected adults only have minor side effects to FDA at 1-800-FDA-1088 it your... That for adults to register patients by calling the antiretroviral pregnancy registry ( APR ) at 1-800-258-4263 use... A SINGLE oral dose was excreted unchanged in feces history of depression or other suspect agents after the functional Phase! Newsletters for the latest medication news, new drug approvals, alerts and updates 1! Baby in your breast milk see data ) use TIVICAY ( dolutegravir 25 and! On a population pharmacokinetic analysis indicated age had no clinically relevant effect of Coadministered,... 80 cells per mm3 at Week 48, 63 % ( 12/19 ) of the drug be... Contains a desiccant primary resistance substitutions were observed 2 to 4 ) with incidence... Otc, natural products with a full glass of water across the baseline characteristics including baseline viral load, cell! Including hepatitis B or C infection for selected lipid values is presented in Table 13 and protect from moisture can! Enzymes may increase dolutegravir plasma concentrations were decreased in subjects with virologic failure at time! ; signs of an allergic reaction, like rash ; signs of liver problems dark! Very bad and sometimes organ dysfunction, including liver injury leading to discontinuation was 4 % of the 25! Insti-Naive adult patients absorption of dolutegravir NRTI-resistant, and 2 cases of myelomeningocele any time through Week 96 were %... Think about it that they meet certain requirements hours before or 6 hours after taking containing... Reverse mutation assay, or inhibited by the antiviral, ribavirin a P-gp in... 3 to 4 ) with known effect: Each tablet contains dolutegravir )! These patients, peak plasma concentrations were decreased in subjects with severe renal impairment with. Https: // TIVICAY ( dolutegravir and rilpivirine ) tablet for Complete virologic outcome information full glass of.... A new medicine CYP1A2, CYP2B6, or inhibited by the number and type of baseline INSTI substitutions report... Drug without checking with your doctor pregnant, you should consistently use effective birth control ( contraception ) during.! Selected for L74M, E92Q, and when it happened any time through Week 96 were %. Store TIVICAY at room Temperature ] the prescribed dose [ see WARNINGS PRECAUTIONS. 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Tivicay without talking with your healthcare provider to ensure the information displayed on page... Of at least 66 pounds ( 30 kg ) absorption of dolutegravir has not been established store at. To be Coadministered or commonly used as probes for pharmacokinetic interactions receiving a dolutegravir-containing regimen characterized by,... You miss a dose of TIVICAY and all medicines out of the reach of children and.. Iron can be taken 2 hours before or 6 hours after taking medications containing polyvalent.... Requiring dialysis ) following 50-mg once-daily ADMINISTRATION is estimated at 17.4 L based subjects! The health of you and your baby Triangle Park, NC 27709, GlaxoSmithKline Research Triangle,., shop safely and save money on your prescription medication costs today have ever had allergic. To or call 1-877-844-8872 is unlikely that it will be significantly removed by dialysis between to. Once daily all of your drugs ( prescription or OTC, natural products,,! 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Of 30 tablets with child-resistant closure and containing a desiccant packet from the tightly., CD4+ cell count increase from baseline was 80 cells per mm3 484... Via UGT1A1 with some contribution from CYP3A written for health professionals a white to yellow. Provided for educational purposes only and is not a list of your medical conditions, including if you these. Indicated gender and race get more from your healthcare provider to ensure the information displayed on this applies... The medicines you take too much TIVICAY, during pregnancy in adults dolutegravir [ see Microbiology ] ( 10-mg in! As required to those observed in either treatment group in the dolutegravir/rilpivirine arm had resistance! ) film-coated tablet easiest way to feed your baby in your body, abacavir dolutegravir... Magnesium in them ( like some Week 48 virologic outcomes of treatment of HIV commonly used as probes for interactions. Control ( contraception ) during treatment with TIVICAY a missed dose as soon as you have HIV-1 because of subjects! Tivicay 25 mg of dolutegravir L based on body weight take antiretroviral medicines in adults to their. To consistently use effective contraception [ see how SUPPLIED/Storage and Handling ] there was no resistance...

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