dolutegravir drug interactions

The metabolism of Dolutegravir can be decreased when combined with Diflunisal. The serum concentration of Digitoxin can be increased when it is combined with Dolutegravir. The serum concentration of Digoxin can be increased when it is combined with Dolutegravir. Dolutegravir is neither an inducer nor an inhibitor of metabolising enzymes, and it therefore has a low propensity to act as a perpetrator of drug-drug interactions. Clinically important drug interactions in epilepsy: general features and interactions between antiepileptic drugs. In drug interaction studies, dolutegravir increased both the Cmax and AUC of metformin when metformin 500 mg PO twice daily was coadministered. Safety and efficacy have not been established. Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. There is no drug interaction reported. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat. Dolutegravir Interactions. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. This includes prescription and over-the-counter medicines, vitamins, and herbal products. No clinically significant drug interactions are expected between dolutegravir, abacavir, and lamivudine. Read important information about dosing and administration and potential drug interactions for the HIV-1 medication JULUCA (dolutegravir 50 mg/rilpivirine 25 mg). Dolutegravir has some drug-drug interactions that healthcare workers should be aware of, says Venter. dolutegravir + lumacaftor/ ivacaftor. carbamazepine oral will decrease the level or effect of dolutegravir oral by increasing metabolism. Established And Other Potentially Significant Drug Interactions. The purpose of this study is to evaluate the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals. It has few interactions with other medicines: dolutegravirhas fewer drug interactions compared to EFV. 353-361. View dosing and drug interactions for DOVATO (dolutegravir 50 mg, lamivudine 300 mg), an HIV-1 treatment for treatment-nave and virologically suppressed adult patients. Dolutegravir is neither an inducer nor an inhibitor of metabolising enzymes, and it therefore has a low propensity to act as a perpetrator of drug-drug interactions. Not all possible interactions are listed here. These events were reported in less than 1% of subjects receiving dolutegravir in Phase 3 clinical trials. Clinically significant decreases in dolutegravir exposure occur when it is co-administered with strong inducers (e.g. These include cation-containing medicines [ 12 , 13 ], metformin [ 14 ], rifampicin [ 15 , 16 ] and some anti-epileptic drugs [ 17 - 19 ]. The phase IV clinical study analyzes what interactions people who take Dolutegravir and Forane have. avoid combo: combo may decr. vitamin or mineral supplements that contain calcium or iron (but if you take dolutegravir with food, you can take these supplements at the same time). 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 Drug Interactions (7.3), Clinical Pharmacology (12.3)]. View dosing and drug interactions for JULUCA. This medicine is not a cure for HIV or AIDS.. Triumeq is for use in adults and children who weigh at least 88 pounds (40 kilograms). Dolutegravir has some drug-drug interactions that healthcare workers should be aware of, says Venter. These include severe skin rash and allergic reactions, liver problems, and drug interactions. List Abstract. Rivaroxaban, dabigatran, apixaban: Avoid use of boosted PIs if possible. Dolutegravir concentrations were measured on days 4, 14, and 19. Drugs interactions Co-administration with potent CYP3A4 inducers such as rifampin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital and St. Johns Wort may decrease the concentration of dolutegravir and compromise efficacy. Triumeq may also be used for purposes not listed However, little is known regarding the interactions of DTG with preparations containing other multivalent metal cations or with polycation polymer preparations. These include cation-containing medicines [12,13], metformin [14], rifampicin [15,16]and some anti-epileptic drugs [1719]. Dolutegravir and Enjuvia drug interactions - a phase IV clinical study of FDA data Summary: We study 4,503 people who take Dolutegravir or Enjuvia. This site is intended for US healthcare professionals only. Refer to the full prescribing information for important drug interactions with dolutegravir tablets. The phase IV clinical study analyzes what interactions people who take Dolutegravir and Enjuvia have. Tell your doctor about all your current medicines and any medicine you start or stop using. Tivicay (dolutegravir) Uses, Dosages, Side effects, Drug Interactions. 1 The effect of this drug has no homology in human host cells which gives it an excellent tolerability and minimal toxicity. Editorial Information. Clinical Drug Interactions Source: Dolutegravir (DTG) is an integrase inhibitor, whose gastrointestinal absorption is impaired by the formation of chelates with multivalent metal cation preparations. Dolutegravir is not a fully cure for HIV/AIDS. Dolutegravir is metabolized by UGT1A1 with some contribution from CYP3A. Condition or disease Interaction with dolutegravir oral ; dolutegravir oral Common Brand(s): Tivicay PD Generic Name(s): dolutegravir . Otchere-Darko explains that two of these drug-drug interactions are with rifampicin (used to treat drug-sensitive tuberculosis) and metformin (used to treat diabetes). The GEMINI trials have recently shown that a two-drug regimen of dolutegravir plus lamivudine was non-inferior to a three-drug regimen in HIV-infected nave patients. It also means the pills can be much smaller. What is Tivicay and how does it work. This is driven by effective virologic suppression, good tolerability, infrequent drugdrug interactions, and Name Dolutegravir sodium Drug Entry Dolutegravir. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. The antacid Maalox cut dolutegravir exposure more than 70% when the drugs were taken together, not because of a pH effect but because of metal cation chelation. Because of concerns regarding drug interactions, investigators conducted a pharmacokinetic study to assess whether 3HP can be safely administered with dolutegravir. 9 As such, the mechanisms of the dolutegravirmetformin drugdrug Participants received once-daily dolutegravir 50 mg alone (days 1 to 4) and with once-weekly isoniazid 900 mg, rifapentine 900 mg, and pyridoxine 50 mg (days 5 to 19). The dosage of dolutegravir should be adjusted to 50 mg twice a day. It is created by eHealthMe based on reports the from the FDA, and is updated regularly. Drug interactions between dolutegravir and metformin require further evaluation, as coadministration of these drugs is likely to increase with a growing obesity epidemic. While one of the touted advantages of dolutegravir is its lower potential for drugdrug interactions (DDIs) , pharmacokinetic studies have shown interactions with some commonly used drugs. Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore medicinal products that induce those The phase IV clinical study analyzes what interactions people who take Dolutegravir and Eplerenone have. Find more detailed information on DOVATO. While one of the touted advantages of dolutegravir is its lower potential for drugdrug interactions (DDIs) [11], pharmacokinetic studies have shown interactions with some commonly used drugs. This also includes antacids that include magnesium or aluminium. The drug interactions described are based on studies conducted with dolutegravir or lamivudine when administered alone. dolutegravir levels, efficacy (hepatic metab. It is taken by mouth. Drug interactions: There is a caution for interactions with some supplements (containing calcium, magnesium or aluminium), antacids and multivitamins. Four HIV-uninfected healthy volunteers received dolutegravir daily for 19 days; on day 5, once-weekly isoniazid and rifapentine was added. To the Editors: Song et al 1 have reported recently the results of a phase I parallel-group study aimed to evaluate the effect of dolutegravir on the steady-state pharmacokinetics (PK) of metformin in healthy volunteers. View dolutegravir drug monograph. Dolutegravir belongs to a class of drugs known as integrase inhibitors. Dolutegravir inhibits common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE1 and MATE2k View dosing and drug interactions for DOVATO (dolutegravir 50 mg, lamivudine 300 mg), an HIV-1 treatment for treatment-nave and virologically suppressed adult patients. Earlier scientific studies indicated a possible drug-drug interaction between dolutegravir and rifampicin, resulting in decreased concentrations of dolutegravir. These products need to be taken a minimum of DTG is a substrate for the efflux transporters P rifampin will decrease the level or effect of dolutegravir by increasing metabolism. Read important information about dosing and administration and potential drug interactions for the HIV-1 medication JULUCA (dolutegravir 50 mg/rilpivirine 25 mg). Dolutegravir AUC 33%, 41% and 66% when administered with low-fat (300 kcal, 7% fat), moderate fat (600 kcal, 30% fat) and high fat food (870 kcal, 53% fat), respectively. Separating administration of Maalox and dolutegravir by 2 hours attenuated this interaction. This also includes antacids that include magnesium or aluminium. Abstract. Learn more about Dolutegravir at EverydayHealth.com. The few drug interactions include: Not taking at the same time as multivitamin supplements that include calcium, magnesium or aluminium. Accordingly, it is important that physicians be aware and confident about the drug-drug interactions (DDIs) involving dolutegravir, lamivudine, and other medications. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. carbamazepine oral and dolutegravir oral. This study will evaluate the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals. 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. Amalgamating the adverse event profiles accrued from the randomized controlled trials of dolutegravir provides a robust evidence base. The total incidence of adverse effects approaches 90%, but this liberal estimate consists of predominantly mild reactions that largely remit with time and may not entirely be drug related. The study was a single-centre, open-label, fixed-sequence, drug-drug interaction study. HIV-1 infection The most comprehensive database on adverse drug reactions for our profession. Severe Interactions. Administer dolutegravir 2 hr before or 6 hr after taking medications containing polyvalent cations. Tivicay | dolutegravir. The main objectives of the drug information portion of the website/app are to provide a comprehensive and centralized repository of current data on HIV/HCV drug therapy for health care professionals with a main focus on drug interactions, and to promote safe and rational prescribing of Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Although the latter 2 agents may not have as fast an onset of action, there are no associated drug interactions with dolutegravir as seen with polyvalentcontaining antacids. This site is intended for US healthcare professionals only. Increase dose slowly if INR decreases. One interaction we know about is with the tuberculosis medicine rifampicin. Severe interactions are highlighted with a red marker. This site is intended for US healthcare professionals only. Dolutegravir, the newest INSTI, is an effective antiretroviral agent for both treatment-nave and treatment-experienced patients infected with HIV. Switching to an H2 receptor antagonist or proton pump inhibitor from an antacid may also benefit patients who are unable to comply with the recommended dosing schedule as outlined by the dolutegravir receiving dofetilide, due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events with concomitant use of dolutegravir [see Drug Interactions (7)]. These medications are not usually taken together. Dolutegravir is a HIV-1 intergrase inhibitor that blocks the strand transfer step of the integration of the viral genome into the host cell (INSTI). Dolutegravir (DTG; S/GSK1349572) is a potent HIV-1 integrase inhibitor with a distinct resistance profile and a once-daily dose regimen that does not require pharmacokinetic boosting. The in vitro, protein-adjusted 90 % inhibitory concentration (IC90) of dolutegravir for wild-type virus is 0.064 g/ml, and it retains in vitro anti-HIV 1 activity across a broad range of viral phenotypes that are Avoid coadministration; insufficient data to recommend dosage adjustment. A series of mini-lectures on topics including pharmacology, hepatitis and drug-drug interactions Prescribing Resources. Dolutegravir inhibits common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE1 and MATE2k Contact your health care provider right away if you develop a rash while taking dolutegravir. with prior hypersensitivity reaction to abacavir, dolutegravir [see Warnings and Precautions (5.1)], or lamivudine. Effect of other agents on the pharmacokinetics of dolutegravir: All factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance. Dolutegravir has the following interaction information: Drug interaction information. Refer to the full prescribing information for important drug interactions with TIVICAYor TIVICAY PD. Dolutegravir is metabolized by UGT1A1 with only 1015% metabolized by CYP3A4, therefore few drug interactions are expected. Find out more about BNF interactions information. Dolutegravir(Tivicay) generic is an integrase inhibitor prescribed for the treatment of HIV-1 infection in adults and pediatric patients aged 12 years and older and weighing at least 40 kg. Interaction tables, treatment selectors, clinical prescribing resources, and pharmacokinetic fact sheets Twitter @hepinteractions. (7.2, 7.3) Dolutegravir tablets should be taken 2 hours before or 6 hours after taking cation- rifampin. Dolutegravir was approved for medical purpose in the United States in 2013. These events were reported in less than 1% of subjects receiving dolutegravir in Phase 3 Not all possible interactions are listed here. With medical big data and AI algorithms, eHealthMe enables everyone to run phase IV clinical trial to detect adverse drug outcomes and monitor effectiveness. The clinical significance Drug Interactions . Avoid/Use Alternative. Section 7: DRUG INTERACTIONS Riociguat Abacavir: Coadministration with TRIUMEQ resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions. The drug can also increase metformin concentrations and consequently monitoring is recommended in case dose adjustment is required. We would like to show you a description here but the site wont allow us. That is why WHO guidelines recommend the twice-daily dose (instead of single daily dose) of dolutegravir to people with TB/HIV co-infection who are on rifampicin-based anti-TB therapy. Dolutegravir can reduce renal tubule secretion of substances excreted via OCT2, with a slight initial increase in creatinine, with no risk of renal toxicity. Tivicay is approved for children of age at least 12 years and older weighing at least 40 kilograms. lumacaftor/ ivacaftor. Clinically significant decreases in dolutegravir exposure occur when it is co-administered with strong inducers (e.g. Abstract. This is important given high rates of TB and HIV co-infection. Severe interactions of dolutegravir include: dofetilide; Serious interactions of dolutegravir include: aluminum hydroxide/magnesium carbonate; carbamazepine; efavirenz; etravirine; fosamprenavir; fosphenytoin; magnesium citrate; magnesium gluconate; magnesium oxide; nevirapine; oxcarbazepine; phenobarbital; phenytoin; Prussian blue; rifampin; St John's It is created by eHealthMe based on reports the from the FDA, and is updated regularly. They found that co-administration of dolutegravir dose-dependently (dolutegravir was in fact given at 50 mg q24h or 50 mg q12h) increased metformin Medication Class: Antiretroviral Agent, Integrase Inhibitor Manufacturer: ViiV Healthcare Approval Date: August 2013. It is created by eHealthMe based on reports of 1 person who takes the same drugs from the FDA, and is updated regularly. Drug interactions are reported only by a few people who take Xarelto and Dolutegravir together. The phase IV clinical study analyzes what interactions people who take Xarelto and Dolutegravir have. Managing drug-drug interactions in HIV/TB coinfection can be complex. Study Design Go to Resource links provided by the National Library of Medicine The Toronto General Hospital website has been in operation since 2000. Click on the DRUG REVIEW ARTICLE tab (above) to see a review of dolutegravir in the Taylor & Francis journal Expert Opinion on Drug Safety. When coadministration of these doses was compared to once daily dolutegravir (50 mg once daily, n=11), dolutegravir Cmax, AUC and Ctrough increased by 18%, 33% and 22%, respectively. Avoid or Use Alternate Drug. Many drugs can affect dolutegravir and lamivudine. Many drugs can affect dolutegravir. There were no drug-drug interaction trials conducted with the abacavir, dolutegravir, and lamivudine fixed-dose combination tablets. Dolutegravir (DTG) is an antiretroviral medication used together with other medication to treat HIV/AIDS. In drug interaction studies, dolutegravir increased both the Cmax and AUC of metformin when metformin 500 mg PO twice daily was coadministered. Find more detailed information on DOVATO. It is easy to take: People only require a small dosage of dolutegravir. The phase IV clinical study analyzes what interactions people who take Dolutegravir and Forane have. 7.2 Effect of Other Agents on the Pharmacokinetics of Dolutegravir. Dolutegravir is neither an inducer nor an inhibitor of metabolising enzymes, and it therefore has a low propensity to act as a perpetrator of drug-drug interactions. There is no drug interaction reported. Dolutegravir may be administered with or without food and without regard to fat This requires separating the dolutegravir dose. 11,12 Melissa Badowski, PharmD, MPh, FCCP, FIDSA, Consistent with the unchanged metformin tmax during period 2 of the present study, dolutegravir did not enhance metformin absorption through the paracellular pathway, and it did not affect metformin intestinal cell uptake, a process in which all the transport systems have not been reported in the literature. Bictegravir, dolutegravir, and raltegravir are not extensively metabolized via CYP450 and thus are unlikely to cause significant drug interactions with warfarin. Dabigatran: 1) Separate doses of dabigatran and boosted PIs by at least 2 hours. A regimen with dolutegravir may be useful when drug interactions or the potential for preterm delivery with protease inhibitors are a concern. Information regarding potential drug interactions with the individual components of Triumeq are provided below. In drug interaction trials, dolutegravir did not have a clinically relevant effect on the pharmacokinetics of daclatasvir. It blocks the virus from growing and infecting more cells.Dolutegravir is not a cure for HIV infection. Clinically significant decreases in dolutegravir exposure occur when it is co-administered with strong inducers (e.g. induced, P-gp-mediated transport possibly induced) mavacamten. As new studies are published and recommendations may change, best practices call for referring to resources such as the US Department of Health & Human Services HIV guidelines or the University of Liverpool HIV drug interaction checker. The small dose makes it ideal to combine in a single tablet with other antiretrovirals. Increase dolutegravir dose to 50 mg BID when coadministered with strong UGT1A/CYP3A inducers Coadministration of rifampin (600 mg once daily) and dolutegravir (50 mg twice daily) to 11 subjects decreased dolutegravir Cmax, AUC and Ctrough by 43%, 54% and 72%, respectively. drug interactions or adverse effects, nor should it Dolutegravir is eliminated mainly through metabolism by UGT1A1. In 2019, the Department of Health started providing the antiretroviral drug dolutegravir as part of HIV treatment in the public sector. In vitro investigations into the roles of drug transporters and metabolizing enzymes in the disposition and drug interactions of dolutegravir, a hiv integrase inhibitor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. This requires separating the dolutegravir dose. Alternatively, dolutegravir and supplements containing calcium or iron can be taken together with food. Take 2 hours before or 6 hours after cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Based on accumulated non-clinical and clinical drug metabolism and pharmacokinetic data, there is a low likelihood of drug interaction between DTG and most widely used OC drugs. 1 interaction. Drug interactions and 46 reactions for Dolutegravir. View dosing and drug interactions for JULUCA. Triumeq (abacavir/ dolutegravir/ lamivudine) +. Avoid or Use Alternate Drug. (4, 7) Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir. Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of dolutegravir and other drugs may occur (see Contraindications and Drug Interactions) Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of dolutegravir The drug interaction trials described were conducted with dolutegravir, abacavir, and/or lamivudine as single entities; no drug interaction trials have been conducted using the combination of abacavir, dolutegravir, and lamivudine. Information regarding potential drug interactions with dolutegravir and rilpivirine are provided in Table 4. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) currently under review by the US Food and Drug Administration for marketing approval. This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin. The rollout of dolutegravir hasnt all been smooth sailing. View Free Coupon . Food Dolutegravir absorption is modestly increased with food according to fat content. Stop taking dolutegravir and get medical help right away if you develop a rash with any of the following symptoms: General ill feeling; Extreme tiredness This work investigated the in vitro drug transport and metabolism of DTG and assessed the potential for clinical drug-drug interactions. ViiV is proposing administering dolutegravir 2 hours before or 6 hours after an antacid. Drug Metab Dispos, 41 (2013), pp. Severe Interactions These medications are not usually taken together. Apixaban: Reduce dose to 2.5 mg twice per day, and if patient is already taking 2.5 mg twice per day, avoid concomitant use. Abacavir, dolutegravir, and lamivudine (Triumeq) is a combination medicine used to treat human immunodeficiency virus (), the virus that can cause acquired immunodeficiency syndrome (). Information regarding potential drug interactions with Dovato are provided in Table 5. Find everything you need to know about Dolutegravir, including what it is used for, warnings, reviews, side effects, and interactions. Common interactions include acute hepatic failure among males. Although dose and dosing regimens for different rifamycins continues to be evaluated (e.g. This site is intended for US healthcare professionals only. Drug interactions are reported among people who take Dolutegravir and Eplerenone. Appropriate studies have not been performed on the relationship of age to the effects of dolutegravir in children younger than 4 weeks of age or weighing less than 3 kilograms (kg). It has few interactions with other medicines: dolutegravir has fewer drug interactions compared to EFV.

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