dovato
Dovato is a combination medicine containing Dolutegravir Sodium and Lamivudine.
Dolutegravir Sodium and Lamivudine · by Viiv Hlthcare
Key facts
- Active ingredient
- Dolutegravir Sodium and Lamivudine
- Form
- Tablet
- Strength
- Dolutegravir Sodium EQ 50MG Base; Lamivudine 300MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Viiv Hlthcare
- Half-life
- about 14 hours (how long it stays in your system)
- FDA application
- NDA211994
- FDA boxed warning
- Yes — see the boxed warning
What is Dovato?
From the FDA label:DOVATO is a fixed-dose combination tablet containing dolutegravir (as dolutegravir sodium), an integrase strand transfer inhibitor (INSTI), and lamivudine (also known as 3TC), a nucleoside analogue reverse transcriptase inhibitor (NRTI). DOVATO tablets are for oral administration. Each film-coated tablet contains the active ingredients 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 300 mg of lamivudine and the inactive ingredients magnesium stearate, mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients hypromellose, polyethylene glycol, titanium dioxide. Dolutegravir The chemical name of dolutegravir sodium is sodium (4 R ,12a S )-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H -pyrido[1',2':4,5]pyrazino[2,1- b ][1,3]oxazin-7-olate. The empirical formula is C 20 H 18 F 2 N 3 NaO 5 , and the molecular weight is 441.36 g/mol. It has the following structural formula: Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (‑)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (‑)2′,3′-dideoxy,…
How to use
Prior to or when initiating DOVATO, test patients for hepatitis B virus (HBV) infection. ( 2.1 ) • One tablet taken orally once daily with or without food. ( 2.2 ) • The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with carbamazepine or rifampin. If DOVATO is coadministered with carbamazepine or rifampin, take one tablet of DOVATO once daily, followed by an additional dolutegravir 50-mg tablet, approximately 12 hours from the dose of DOVATO. ( 2.3 ) 2.1 Testing Prior to or When Initiating Treatment with DOVATO Prior to or when initiating DOVATO, test patients for HBV infection [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage DOVATO is a fixed-dose combination product containing 50 mg of dolutegravir and 300 mg of lamivudine. The recommended dosage regimen of DOVATO in adults and adolescents 12 years of age and older and weighing at least 25 kg is one tablet taken orally once daily with or without food [see Clinical Pharmacology ( 12.3 )] . 2.3 Recommended Dosage with Certain Coadministered Drugs The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with drugs listed in Table 1 that may decrease dolutegravir concentrations; the following dolutegravir dosage regimen is recommended. Table 1. Dosing Recommendations for DOVATO with Coadministered Drugs Coadministered Drug Dosing Recommendation Carbamazepine, rifampin An…
Side effects
The following adverse reactions are discussed in other sections of the labeling: • Patients co-infected with HIV-1 and HBV [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.4 )] • Immune reconstitution syndrome [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (all grades) observed in ≥2% (in those receiving DOVATO) were headache, nausea, diarrhea, insomnia, fatigue, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials in Adults with No Antiretroviral Treatment History The safety assessment of DOVATO in HIV-1–infected adults with no antiretroviral treatment history and with a plasma viral load ≤500,000 HIV-1 RNA copies/mL at the screening visit, is based on the pooled Week 144 analyses of data from 2 identical, multicenter, double-blind,…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment [see Warnings and Precautions ( 5.1 )] . WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV See full prescribing information for complete boxed warning. • All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. • Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment. ( 5.1 )
Warnings
Important safety information
Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with dolutegravir. Discontinue DOVATO immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. ( 5.2 ) • Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with DOVATO. Monitoring for hepatotoxicity is recommended. ( 5.3 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.4 ) • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. ( 5.6 ) 5.1 Patients Co-infected with HIV-1 and HBV: Emergence of Lamivudine-Resistant HBV and the Risk of Posttreatment Exacerbations of HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of Lamivudine-Resistant HBV Safety and efficacy of lamivudine have not been established for treatment of chronic HBV in subjects dually infected with HIV-1 and HBV. Emergence of HBV variants associated with resistance to lamivudine has been reported in HIV‑1–infected subjects who have received lamivudine‑containing antiretroviral regimens in the presence of concurrent infection with HBV. If a decision is made to administer DOVATO to patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe Acute Exacerbations of HBV in Patients Co-infected with HIV-1 and HBV Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued products containing lamivudine, and may occur with discontinuation of DOVATO. Patients who are co-infected with HIV-1 and HBV who discontinue DOVATO should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with DOVATO. If appropriate, initiation of anti-HBV therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. 5.2 Hypersensitivity Reactions Hypersensitivity reactions have been reported with the use of dolutegravir, a component of DOVATO, and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. These events were reported in <1% of subjects receiving dolutegravir in Phase 3 clinical trials. Discontinue DOVATO immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing). Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. Delay in stopping treatment with DOVATO or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction [see Contraindications ( 4 )] . 5.3 Hepatotoxicity Hepatic adverse events have been reported in patients receiving a dolutegravir-containing regimen [see Adverse Reactions ( 6.1 )] . Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of DOVATO [see Adverse Reactions ( 6.1 )] . In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or HBV reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Cases of hepatic toxicity, including elevated serum liver biochemistries, hepatitis, and acute liver failure, have also been reported in patients receiving a dolutegravir-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors. Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ (abacavir, dolutegravir, and lamivudine). Monitoring for hepatotoxicity is recommended. 5.4 Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine (a component of DOVATO). A majority of these cases have been in women. Female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues. Monitor closely when administering DOVATO to any patient with known risk factors for liver disease. Treatment with DOVATO should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations. 5.5 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions The coadministration of DOVATO and other drugs may result in known or potentially significant drug interactions, some of which may lead to [see Contraindications ( 4 ), Drug Interactions ( 7.4 )] : • Loss of therapeutic effect of DOVATO and possible development of resistance. • Possible clinically significant adverse reactions from greater exposures of coadministered drugs. See Table 5 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during therapy with DOVATO, review coadministered drugs during therapy with DOVATO, and monitor for the adverse reactions associated with the coadministered drugs. 5.6 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including DOVATO. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.
Who should not take Dovato
DOVATO is contraindicated in patients: • with prior hypersensitivity reaction to dolutegravir or lamivudine [see Warnings and Precautions ( 5.2 )] . • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7.2 )] . • Prior hypersensitivity reaction to dolutegravir or lamivudine. ( 4 ) • Coadministration with dofetilide. ( 4 )
Overdose — what happens if you take too much
There is no known specific treatment for overdose with DOVATO. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required. Dolutegravir As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. Lamivudine Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
DOVATO is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended. ( 7.1 ) • Refer to the full prescribing information for important drug interactions with DOVATO. ( 4 , 5.5 , 7 ) 7.1 Coadministration with Other Antiretroviral Drugs DOVATO is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended [see Indications and Usage ( 1 )] . Information regarding potential drug-drug interactions with other antiretroviral drugs is not provided [see Contraindications ( 4 ), Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.3 )]. 7.2 Potential for DOVATO to Affect Other Drugs Dolutegravir, a component of DOVATO, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1; thus, it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )]. 7.3 Potential for Other Drugs to Affect the Components of DOVATO Dolutegravir is metabolized by uridine diphosphate (UDP)-glucuronosyl transferase (UGT)1A1 with some contribution from cytochrome P450 (CYP)3A. Dolutegravir is also a substrate of UGT1A3, UGT1A9, breast cancer resistance protein (BCRP), and P-glycoprotein (P-gp) in vitro. Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentrations and reduce the therapeutic effect of DOVATO [see Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )] . Coadministration of DOVATO and other drugs that inhibit these enzymes may increase dolutegravir plasma concentrations. Coadministration of dolutegravir with polyvalent cation-containing products may lead to decreased absorption of dolutegravir [see Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )] . 7.4 Established and Other Potentially Significant Drug Interactions No drug interaction studies were conducted with DOVATO. The drug interactions described are based on studies conducted with dolutegravir or lamivudine when administered alone [see Clinical Pharmacology ( 12.3 )] . Information regarding potential drug interactions with DOVATO are provided in Table 5 . These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy [see Contraindications ( 4 ), Clinical Pharmacology ( 12.3 )]. Table 5. Established and Other Potentially Significant Drug Interactions for DOVATO: Alterations in Dose May Be Recommended Based on Drug Interaction Trials or Predicted Interactions ↑ = Increase, ↓ = Decrease. a See Clinical Pharmacology ( 12.3 ) Table 8 or Table 9 for magnitude of interaction. Coadministered Drug Class: Drug Name Effect on Concentration Clinical Comment Antiarrhythmic: Dofetilide ↑Dofetilide Coadministration is contraindicated with DOVATO [see Contraindications ( 4 )] . Anticonvulsant: Carbamazepine a ↓Dolutegravir An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from DOVATO [see Dosage and Administration ( 2.3 )] . Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations. Antidiabetic: Metformin a ↑Metformin Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin. Antimycobacterial: Rifampin a ↓Dolutegravir An additional 50-mg dose of dolutegravir should be taken, separated by 12 hours from DOVATO [see Dosage and Administration ( 2.3 )] . Herbal product: St. John’s wort ( Hypericum perforatum ) ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations. Medications containing polyvalent cations (e.g., Mg or Al): Cation-containing antacids a or laxatives Sucralfate Buffered medications ↓Dolutegravir Administer DOVATO 2 hours before or 6 hours after taking medications containing polyvalent cations. Oral calcium and iron supplements , including multivitamins containing calcium or iron a ↓Dolutegravir When taken with food, DOVATO and supplements or multivitamins containing calcium or iron can be taken at the same time. Under fasting conditions, DOVATO should be taken 2 hours before or 6 hours after taking supplements containing calcium or iron. Potassium channel blocker: Dalfampridine ↑Dalfampridine Elevated levels of dalfampridine increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with DOVATO should be considered against the risk of seizures in these patients. Sorbitol a ↓Lamivudine When possible, avoid use of sorbitol-containing medicines with DOVATO.
How long does Dolutegravir Sodium and Lamivudine stay in your body?
The elimination half-life of dolutegravir sodium and lamivudine is about 14 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life, which the TIVICAY label gives as "approximately 14 hours," based on population pharmacokinetic analyses; the label reports no separate distribution-phase half-life. Dolutegravir is not a prodrug, and the label describes no active metabolite — it is metabolized mainly by UGT1A1 (with some CYP3A) to an ether glucuronide and oxidative metabolites that the label does not characterize as active, and just over half the dose leaves unchanged in the feces. On populations the label names: age had no clinically relevant effect on dolutegravir pharmacokinetics; mild and moderate kidney impairment had no clinically relevant effect on exposure, and in severe kidney impairment (CrCl under 30 mL/min) exposure was actually lower, not higher (AUC down 40%), with too little information to recommend dosing in people on dialysis; in moderate liver impairment (Child-Pugh B) exposure was similar to healthy controls, and severe liver impairment (Child-Pugh C) has not been studied. The label frames these as changes in exposure rather than stating a revised half-life for each group. People with UGT1A1 genotypes conferring poor metabolism had 32% lower clearance and 46% higher AUC. This figure describes how long the drug itself is cleared from plasma — it is not a drug-test detection window (metabolites can be detected far longer) and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — TIVICAY (dolutegravir sodium) tablet, film coated — Clinical Pharmacology (12.3).
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- Is there a coupon or discount for Dovato?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dovato. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Dovato?
- Dovato is marketed by Viiv Hlthcare. You can see Viiv Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Dovato a brand-name or generic drug?
- Dovato is a brand-name product with the active ingredient Dolutegravir Sodium and Lamivudine.
- Is Dovato available over the counter?
- No. Dovato is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Dovato come in?
- Dovato is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Dovato FDA-registered?
- Dovato is on record with the U.S. FDA under application number NDA211994. You can verify this on its official FDA label.
- Is Dovato safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Dovato. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Dovato?
- Dovato's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in other sections of the labeling: • Patients co-infected with HIV-1 and HBV [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Lactic acido… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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