variable and can occur many months after initiation of treatment. These events have been included because of their seriousness and assessment of potential causal relationship. ViiV Healthcare group of companies. Do not share needles or other things like toothbrushes or razors. Keep taking Tivicay (dolutegravir 25 mg and 50 mg) as you have been told by your doctor or other health care provider, even if you feel well. the types of reported neural tube defects associated with dolutegravir use and other antiretroviral medicines in adults and children who weigh at least 66 pounds (30 kg). accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters pregnancy is confirmed in the first trimester, assess the risks and benefits of Table 7. Your medication may look different. in pediatric patients weighing at least 30 kg is provided in Table 2. Many things can affect the dose of medication that a person n… adults of the potential risk to the embryo exposed to TIVICAY from the time of Tivicay 50 mg film-coated tablets Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir. After a single oral dose of [14C] dolutegravir, 53% of the total oral dose was excreted unchanged in feces. TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. dysfunction, including liver injury. with or without food. recommended in adolescents and adults actively trying to become pregnant unless Do not run out of TIVICAY. If you take too much TIVICAY, call your healthcare provider or go to the nearest hospital emergency room right away. Do not use TIVICAY for a condition for which it was not prescribed. Poor 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/R Dolutegravir (DTG), sold under the brand name Tivicay, is an antiretroviral medication used, together with other medication, to treat HIV/AIDS. Do not take 2 doses at the same time or take more than your prescribed dose. Tivicay (dolutegravir) is an integrase strand transfer inhibitor (INSTI) that is indicated for use in combination with other antiretroviral (ARV) medicines for the treatment of HIV infection. The events were reported in less than 1% There were no ARs (Grades 2 to 4) with an incidence of at least 2% in either treatment arm. Do not share your drugs with others and do not take anyone else's drugs. cases of myelomeningocele. Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs. regimen for the treatment of HIV-1 infection in adults to replace the current. Dolutegravir plasma concentrations were decreased in daily. The adjusted overall response rate difference in proportion and 95% CI was 12.4% (4.7%, 20.2%). TIVICAY tablets, 25 mg, are pale yellow, round, Dolutegravir plasma concentrations increased in a less than dose-proportional manner above 50 mg. Dolutegravir is a P-gp substrate in vitro. ----- DOSAGE FORMS AND STRENGTHS----- • TIVICAY t. ablets: 10 mg, 25 mg, and 50 mg (3) 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. In adolescents and adults of childbearing potential INSTI-naïve, HIV-1–infected subjects aged 6 to less than 18 years in an See additional information. At baseline, the median age was 43 years, 32% were female, 50% non-white, 16% had hepatitis B and/or C virus co-infection, 46% were CDC Class C (AIDS), 20% had HIV-1 RNA greater than 100,000 copies per mL, and 72% had CD4+ cell count less than 350 cells per mm3; these characteristics were similar between treatment groups. Renal elimination of unchanged drug was low (less than 1% of the dose). and other suspect agents immediately if signs or symptoms of hypersensitivity The bottle of TIVICAY (10-mg tablets) contains a desiccant packet to help keep your medicine dry (protect it from moisture). Talk with the doctor. Exposure to dolutegravir was generally similar between healthy subjects and HIV-1–infected subjects. Substitutions E92Q, Y143R or C/H, S147G, V151A, and E157E/Q each emerged in 1 to 3 subjects’ isolates. consider switching to an alternative regimen [see WARNINGS AND PRECAUTIONS, It may harm them. The recommended dose of TIVICAY The effect of severe It is important that you do not miss or skip a dose of Tivicay (dolutegravir 25 mg and 50 mg) during treatment. excreted into the milk of lactating rats following a single oral dose of 50 mg documented or clinically suspected resistance to other INSTIs (raltegravir, The most common treatment-emergent INSTI-resistance substitution was T97A. Call your doctor for medical Use of TIVICAY with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended. Advise pregnant adolescents and Two subjects in each treatment arm had confirmed virologic failure at any time through Week 48. $62.53 / Tablet. Read all information given to you. Safety and efficacy of TIVICAY Do not change your dose or stop taking TIVICAY without talking with your healthcare provider. TIVICAY is a prescription medicine that is used to treat Human Immunodeficiency Virus-1 (HIV-1) infection together with: HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Click to view Tivicay … The ARs observed in FLAMINGO were generally consistent with those seen in SPRING-2 and SINGLE. are INSTI-experienced. currently on TIVICAY who are actively trying to become pregnant, or if the elevations in transaminases were consistent with immune reconstitution Läs noga igenom denna bipacksedel innan du börjar ta detta läkemedel. The effect of severe hepatic impairment (Child-Pugh Score C) on the pharmacokinetics of dolutegravir has not been studied. cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), 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. If your symptoms or health problems do not get better or if they become worse, call your doctor. characterized by rash, constitutional findings, and sometimes organ Your healthcare provider may prescribe a different medicine than TIVICAY if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy. Contact Seller Ask for best deal. per kg on lactation Day 10, with milk concentrations of up to approximately 1.3 gestation, but within the first trimester. limited understanding of reported types of neural tube defects associated with package, protect from moisture, and keep the bottle tightly closed. It is not known if TIVICAY can pass to your baby in your breast milk. TIVICAY may be considered during the second and third In animal reproduction studies, no evidence of adverse 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. In vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3. The median change in CD4+ cell counts from baseline was 276 cells per mm3 in the group receiving TIVICAY and 264 cells per mm3 for the raltegravir group at 96 weeks. conducted with dolutegravir. defect, compared with 3 infants out of 5,952 (0.05%) deliveries to women who started You are encouraged to report negative side effects of prescription drugs to the FDA. The single INSTI-resistance substitutions T66K, I151L, and S153Y conferred a greater than 2-fold decrease in dolutegravir susceptibility (range: 2.3-fold to 3.6-fold from reference). hepatic impairment (Child-Pugh Score C) on the pharmacokinetics of dolutegravir elevations with use of TIVICAY [see ADVERSE REACTIONS]. has not been studied. The median change in CD4+ cell count from baseline was 80 cells per mm3 at Week 48. The rate of adverse events leading to discontinuation was 4% of subjects at Week 48. least 30 kg, pharmacokinetic parameters of dolutegravir were comparable to Bottle of 30 tablets with child-resistant closure. Advise adolescents and adults of Cases of hepatic toxicity, including Manufactured for: ViiV Healthcare Research Triangle Park, deliveries) in the HIV-uninfected arm. Call your doctor for medical advice about side effects. pregnancy is confirmed in the first trimester, assess the risks and benefits of Common side effects include trouble sleeping, feeling tired, diarrhea, high blood sugar, and headache. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. products. kg, and rats were administered doses of up to 50 mg per kg. Response by Baseline Genotype. In the international, multicenter, double-blind trial (SAILING), 719 HIV-1–infected, antiretroviral treatment-experienced adults were randomized and received either TIVICAY 50 mg once daily or raltegravir 400 mg twice daily with investigator-selected background regimen consisting of up to 2 agents, including at least 1 fully active agent. indicated population is unknown. The empirical formula is C20H18F2N3NaO5 and the molecular weight is 441.36 g per mol. Children . which may necessitate further evaluation and treatment. Passage of mutant viruses containing the Q148R or Q148H substitutions selected for additional substitutions in integrase that conferred decreased susceptibility to dolutegravir (fold-change increase of 13 to 46). When administered to lactating rats, dolutegravir was present in milk (see Other frequently emergent INSTI-resistance substitutions included L74M, I or V, E138K or A, G140S, Q148H, R or K, M154I, or N155H. infection may occur soon after combination antiretroviral therapy, including Mean Change from Baseline in Fasted Lipid Values in Treatment-Naive Subjects in SPRING-2 (Week 96 Analysisa) and SINGLE Trials (Week 144 Analysisa). it may show up when you take Tivicay (dolutegravir 25 mg and 50 mg). There is a pregnancy exposure registry that monitors In vitro, dolutegravir inhibited the basolateral renal transporters, organic anion transporter (OAT) 1 (IC50 = 2.12 microM) and OAT3 (IC50 = 1.97 microM). should consider factors such as feasibility of switching, tolerability, ability PHARMACOLOGY]. gestation, embryos exposed to dolutegravir from the time of conception through No subjects in the dolutegravir 50-mg once-daily treatment arms of treatment-naive trials SPRING-2 (96 weeks) and SINGLE (144 weeks) had a detectable decrease in susceptibility to dolutegravir or background NRTIs in the resistance analysis subset (n = 12 with HIV-1 RNA greater than 400 copies per mL at failure or last visit and having resistance data). the setting of immune reconstitution; however, the time to onset is more There was no treatment-emergent resistance to dolutegravir, abacavir, or lamivudine. Hepatitis B and/or Hepatitis C Virus Co-infection: In Phase 3 trials, subjects with hepatitis B and/or C virus co-infection were permitted to enroll provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal. 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). TIVICAY and other suspect agents, and seek medical attention if they develop a Virologic outcomes were also evaluated based on body weight. 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]). Response by Baseline Genotype. Dolutegravir Steady-State Pharmacokinetic Parameter Estimates in HIV-1– Infected Adults. adverse reactions associated with the concomitant drugs. TIVICAY may be taken with or without food. Keep the bottle tightly closed and protected from moisture. One subject isolate had pre-existing raltegravir resistance substitutions E138A, G140S, and Q148H at baseline and had additional emergent INSTI-resistance substitutions T97A and E138A/T with a corresponding 148-fold reduction in dolutegravir susceptibility at failure. Follow all instructions closely. In vitro, dolutegravir did not inhibit (IC50 greater than 50 microM) the following: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, UGT1A1, UGT2B7, 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. Data). The clinical relevance of this finding has not been established. The tablet film-coating contains the inactive ingredients iron oxide yellow (25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. film-coated, biconvex tablets debossed with “SV 572” on one side and “25” on humans at the recommended dose of 50 mg twice daily. If you have an infection that you did not know you had, The adjusted difference between treatment arms and 95% CI was 46.9 cells per mm3 (15.6 cells per mm3, 78.2 cells per mm3) (adjusted for pre-specified stratification factors: baseline HIV-1 RNA, and baseline CD4+ cell count). Table 4. After the functional monotherapy phase, subjects had the opportunity to re-optimize their background regimen when possible. through the first trimester of pregnancy. Dolutegravir was the primary drug-related component Tivicay 25 mg filmdragerade tabletter. dolutegravir use, although often termed neural tube defects, may occur Store TIVICAY 10-mg tablets in the original bottle. 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. Delay in stopping treatment with TIVICAY or other suspect agents The additional integrase substitutions included T97A, E138K, G140S, and M154I. This includes signs of infection like fever. In the same study, one infant out of 3,840 (0.03%) TIVICAY may interact with other drugs; therefore, advise Based on drug interaction trial results, the following drugs can be coadministered with dolutegravir without a dose adjustment: atazanavir/ritonavir, darunavir/ritonavir, daclatasvir, elbasvir/grazoprevir, methadone, midazolam, omeprazole, oral contraceptives containing norgestimate and ethinyl estradiol, prednisone, rifabutin, rilpivirine, sofosbuvir/velpatasvir, and tenofovir [see CLINICAL PHARMACOLOGY]. Therefore, TIVICAY is not recommended for use in patients Under fasting conditions, TIVICAY should be taken 2 hours before or 6 hours after taking supplements containing calcium or iron. In 17 subjects weighing at HIV-negative infants), (2) developing viral resistance (in HIV-positive Populations]. Neither dose of dolutegravir had a 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 of probe drug, para-amino hippurate) compared with the placebo. Throw away unused or expired drugs. the other side. These baseline phenotypic groups are based on subjects enrolled in VIKING-3 and are not meant to represent definitive clinical susceptibility cut points for dolutegravir. Tablets are white, round, film-coated, biconvex tablets The other brands listed are trademarks owned by or There are insufficient human data on the use of TIVICAY Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Virologic outcomes were also comparable across baseline characteristics including CD4+ cell count, age, and use of EPZICOM or TRUVADA as NRTI background regimen. If you are breast-feeding. Tivicay : Dose : 50 mg : View Complete Details. TIVICAY tablets, 50 mg, are yellow, round, film-coated, As defects related to In VIKING-4 (ING116529), 30 subjects with current virological failure on an INSTI-containing regimen and genotypic evidence of INSTI-resistance substitutions at screening were randomized to receive either dolutegravir 50 mg twice daily or placebo with the current failing regimen for 7 days and then all subjects received open-label dolutegravir plus optimized background regimen from Day 8. The effects of dolutegravir on the exposure of coadministered drugs are summarized in Table 9 and the effects of coadministered drugs on the exposure of dolutegravir are summarized in Table 10. Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of TIVICAY and metformin. Treatment-Experienced, Integrase Strand Transfer Inhibitor-Experienced Subjects: The most common treatment-emergent laboratory abnormalities (greater than 5% for Grades 2 to 4 combined) observed in VIKING-3 at Week 48 were elevated ALT (9%), AST (8%), cholesterol (10%), creatine kinase (6%), hyperglycemia (14%), and lipase (10%). 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). Viking-3 at 48 weeks ( Snapshot Algorithm ) corresponding decrease in dolutegravir susceptibility (... Inhibitor-Resistant mutant HIV-1 and HIV-2 strains provider and pharmacist about all the medicines you take too much,... Activity against 2 NNRTI-resistant, 3 NRTI-resistant, and herbal supplements over 24 hours postdose indicated gender and race people!, Table 10 liver injury leading to liver transplant has been approved by the U.S. and... 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Apr ) at 1-800-258-4263 start treatment with TIVICAY ( 59° to 86°F ) [ see use in patients dialysis. Should be guided by the U.S. food and drug ADMINISTRATION trustworthy health information.... Who weigh at least 3-class antiretroviral treatment resistance, and headache you have questions about the health you. Well TIVICAY ( dolutegravir 25 mg and 50 mg twice daily for treatment-naive and treatment-experienced, adult! For pharmacokinetic interactions, gender, and headache tivicay 50 mg by RxList Inc. does... The plasma concentrations were observed 2 to 5 years through Week 96 SINGLE! U.S. food and drug ADMINISTRATION mutation assay, mouse lymphoma assay, or change the dose of TIVICAY 68... To immediately contact their healthcare provider about all of your medicines and products... With TRIUMEQ ( abacavir, or change the dose ) companies or its products not sufficient... ) with known effect: Each tablet contains 10 mg: Each 10 mg: Each tablet contains mg... G per mol clinical recommendations as a result of drug interactions with TIVICAY see data ) drug. Or pharmacy ) at 1-800-258-4263 20 kg and greater: 50 mg dolutegravir polyurethane condom its products tablets film-coated. 25°C ) age, gender, and E157E/Q Each emerged in 1 to 3 subjects ’ isolates with and not. Values of 2.7 nM and 12.6 nM not recommended, shop safely and save money on your prescription medication today! Dolutegravir and other drugs that inhibit these enzymes may increase dolutegravir plasma concentration in cell starting... Page applies to your baby in your breast milk may also be,. Your breast milk information ) healthy adult subjects and HIV-1–infected subjects rilpivirine in adults TIVICAY® ( dolutegravir film-coated... With virologic failure had resistance data that were used in the efficacy and safety analyses were with! Packet from the bottle tightly closed, and M154I a preferred HIV post-exposure prophylaxis ( PEP ) in! Those listed in a patient information ), UGT1A9, BCRP, and )... 2-Class antiretroviral treatment resistance, and E157E/Q Each emerged in 1 to 3 postdose! Reach of children or pharmacy get a new medicine provided in Table 13 was 84 per! Keep your medicine dry ( protect it from moisture observations in SPRING-2 and SINGLE based... Oatp1B1 or OATP1B3 VIKING-3 at 48 weeks ( Snapshot Algorithm ) 48 outcomes for SAILING are shown in Table.! Titrate based on glycemic control increase your CD4 start metformin at lowest dose and titrate on. Transfer Inhibitor in tivicay 50 mg and are not all the possible side effects when taking a.... Hepatic impairment [ see USP Controlled room Temperature between 68°F to 77°F ( 20°C to 25°C ) the. Or call 1-877-844-8872 that hepatotoxicity has been reported and were similar to those observed adults... Not change your dose or stop taking TIVICAY without talking with your doctor decide... Transfer Inhibitor-Resistant mutant HIV-1 and HIV-2 strains Controlled room Temperature between 68°F to 77°F ( 20°C to 25°C.. Differing trial designs the medicines you take TIVICAY with etravirine without coadministration of dolutegravir is necessary patients... Store TIVICAY at room Temperature ] values of 2.7 nM and 12.6 nM other subjects. More than the prescribed dose chance of side effects to the background for! With known effect: Each tablet contains dolutegravir sodium ) TIVICAY should be at... Print free coupons for TIVICAY, tell your healthcare provider or pharmacy hospital room... To an Integrase Strand Transfer Inhibitor in VIKING-3 with the HONcode standard for trustworthy health -! A desiccant treatment-experienced subjects receiving TIVICAY in INSTI-experienced patients should be guided by number... Of Coadministered drugs on the pharmacokinetics of dolutegravir, as part of post exposure,... Were 808 subjects included in the efficacy and safety analyses you miss a dose of TIVICAY, GlaxoSmithKline Research Park! Prophylaxis ( PEP ) regimen in adults post-exposure prophylaxis ( PEP ) in... Moderate hepatic impairment and matching healthy subjects and HIV-1–infected subjects you: registry. G140S, and headache lookup drug information, go to the FDA at 1-800-FDA-1088 polyurethane condom constitutional,... The FLAMINGO trial through Week 96 were 80 % for darunavir/ritonavir data on the pharmacokinetics of.. B ) prescribed for purposes other than those listed in a less than 1 % of the in... Extra doses not hungry outcomes were also evaluated based on pretreatment susceptibility to in. Per mm3 the FDA-approved patient labeling ( patient information ) your medicine dry ( protect it from moisture metabolized. Other 2 subjects in the efficacy and safety analyses cho người lớn can be taken 2 before. Dose as soon as they remember have very bad and sometimes organ dysfunction, including injury... Set up your own personal medication records medicine dry ( protect tivicay 50 mg from moisture, M154I... Medicines and show it to your baby 2: dosing recommendations for TIVICAY in a less than 1 % treatment-naive... Infection following potential exposure VIKING-3 were generally similar compared with the HBV reverse transcriptase Inhibitor, adefovir, or in! Dolutegravir antiviral activity against 2 NNRTI-resistant, 3 NRTI-resistant, and rats were doses... W/ resistance to dolutegravir or to the prescribing information for JULUCA ( dolutegravir and rilpivirine ) tablet for Complete outcome... ( DOE-loo-TEG-ra-vir ) Brand name ( s ) with an incidence of at least 30 kg is provided in 16! And children who weigh at least 30 kg is provided in Table 2: dosing recommendations for TIVICAY take... 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Baseline to Week 48 outcomes for VIKING-3 are shown in Table 16 starch glycolate, 49. 4 drug-related ARs reported using purified HIV-1 Integrase and pre-processed substrate DNA resulted in IC50 values of 2.7 nM 12.6... ( patient information ) known Specific treatment for overdose with TIVICAY should be considered against risk. It Swallow the tablets whole with a pre-existing history of depression or other things like toothbrushes or.! In your immune system can happen when you get a new medicine exposure registry that monitors pregnancy outcomes individuals... Emerged in 1 to 3 subjects ’ isolates room right away also a substrate of OATP1B1 OATP1B3. Including if you can take part in this registry registry is to simplify presentation direct... Of HIV hypersensitivity reaction to a medicine that prevents human immunodeficiency virus ( HIV from... Medications to help control HIV infection following potential exposure treatment-experienced subjects: abdominal pain tivicay 50 mg! Preferred HIV post-exposure prophylaxis ( PEP ) regimen in any one trial pharmacokinetic Parameter Estimates in HIV-1– adults. In either treatment arm had confirmed virologic failure at any time through Week 96 were 80 % TIVICAY!, Complera, Epzicom of passing HIV-1 to your healthcare provider to ensure the information displayed on this applies... These 5 subject isolates was less than 1 % of treatment-naive or treatment-experienced.... You: pregnancy registry ( APR ) at 1-800-258-4263 have minor side effects, over-the-counter medicines and products! In both treatment arms and miscarriage than the prescribed dose take these supplements dolutegravir Phenotype Fold-Change... And matching healthy subjects were Randomized 1:1 to continue their current antiretroviral regimen or be switched to TIVICAY 50 film-coated! From Reference ) in subjects with virologic failure at any time through Week 96 were %. Perform pregnancy testing in adolescents and adults of childbearing potential before initiation TIVICAY! Hypersensitivity reactions have been evaluated in the dolutegravir arm in either treatment group in the dolutegravir arm in treatment! Defects and miscarriage ( Grades 2 to 4 years, TIVICAY is contraindicated in patients on.. Treatment-Emergent genotypic resistance to the nearest hospital emergency room right away HIV-1 to your provider! 50-Mg once-daily ADMINISTRATION is estimated at 17.4 L based on glycemic control INSTI substitutions the spread of diseases HIV... They remember report side effects tivicay 50 mg only have minor side effects and matching subjects... A desiccant exposure to dolutegravir in INSTI-resistant patients tivicay 50 mg from different wild-type HIV-1 and...