Dovato Dolutegravir/Lamivudine 50 mg/300 mg - 30 Film-Coated Tablets

Product Overview:

• Dovato (dolutegravir/lamivudine) is a complete, once-daily HIV-1 treatment combining two antiretroviral medications in a single tablet. Dovato is FDA-approved to treat HIV-1 infection in adults and adolescents 12 years and older weighing at least 55 pounds (25 kg). Unlike traditional three-drug HIV regimens, Dovato uses only two medications to effectively suppress HIV viral loads, offering a simplified treatment approach for eligible patients.


• Dovato contains 50 mg of dolutegravir (an integrase strand transfer inhibitor) and 300 mg of lamivudine (a nucleoside reverse transcriptase inhibitor). This 2-drug combination provides complete HIV treatment without requiring additional antiretroviral medications.This product contain 30 Film-Coated Tablets.

Key Features:

• Effective HIV-1 treatment


• Single-tablet regimen


• Contains dolutegravir and lamivudine


• Convenient once-daily dosing

How it Works:

• Dovato works through two distinct mechanisms to prevent HIV from replicating in your body.


• Dolutegravir (50 mg) - Integrase Strand Transfer Inhibitor (INSTI)


• Blocks the HIV integrase enzyme, essential for viral replication


• Prevents viral DNA from integrating into host cell chromosomes


• Provides a high barrier to resistance with proven efficacy


• Achieves rapid viral suppression, typically within 12-24 weeks.

Lamivudine (300mg) - Nucleoside Reverse Transcriptase Inhibitor (NRTI):

• Inhibits the reverse transcriptase enzyme, crucial for viral replication


• Acts as a faulty building block for viral DNA synthesis


• Well-established safety profile with decades of clinical use


• Synergistic effect when combined with integrase inhibitors.


• This dual-mechanism approach provides robust viral suppression while minimizing the risk of drug resistance development. By targeting two different steps in the HIV lifecycle, Dovato effectively prevents the virus from multiplying in the body.

Benefits:

• DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.

Directions for Use:

• Before you start Dovato, your doctor may perform tests to make sure you do not have hepatitis B. Follow all directions in the Dovato Package Insert. Use the medicine exactly as directed.


• Dovato Administration Instructions


• With or without food: Dovato can be taken with or without meals - there are no dietary restrictions


• Same time daily: Take Dovato at approximately the same time each day for optimal effectiveness


• Swallow whole: Do not crush, chew, or split Dovato tablets


• Long-term use: Continue taking Dovato long-term as directed by your healthcare provider


• Never stop abruptly: Do not discontinue Dovato without medical supervision

Standard Dovato Dosage for All Eligible Patients:

• Recommended Dose: 1 tablet (50 mg dolutegravir + 300 mg lamivudine) once daily.


• Special Dosing Considerations for Dovato

Drug Interactions Requiring Dose Adjustments:

• Your healthcare provider may prescribe an additional 50 mg dolutegravir tablet if you take certain medications such as carbamazepine, rifampin, or other enzyme-inducing drugs

Active Ingredient:

• DOLUTEGRAVIR SODIUM 50 mg, LAMIVUDINE 300 mg

Side Effects:

• Most Common Side Effects


• Headache, usually mild to moderate


• Fatigue/tiredness may improve over time


• Nausea often decreases with continued use


• Diarrhea, typically temporary


• Anxiety, monitor for mood changes


• Insomnia/sleep problems, discuss with a healthcare provider if persistent.


• Serious Side Effects Requiring Immediate Medical Attention

Severe Allergic Reactions:

Dovato may cause an allergic reaction. Call your healthcare provider right away if you develop:

• A skin rash with fever or systemic symptoms


• Breathing difficulties or shortness of breath


• Swelling of the face, lips, tongue, or throat


• Severe skin reactions with blistering or peeling.

Caution & Warnings:

• 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.


• Pregnancy Safety Warnings


• One of the medicines in Dovato, dolutegravir, may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Your healthcare provider may prescribe a different medicine if you are planning to become pregnant or if a pregnancy is confirmed during the first 12 weeks of treatment.


• If you can become pregnant, you may need to have a negative pregnancy test before starting treatment with Dovato. You and your healthcare provider should talk about the use of effective birth control (contraception) while taking Dovato.


• Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with Dovato. There is a pregnancy registry for those who take Dovato during pregnancy that collects information about your health and that of your baby. Talk with your healthcare provider about how you can take part in this registry.


• Breastfeeding Information

Dovato can pass to your baby through your breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment, such as:

• HIV-1 transmission risk through breast milk.


• HIV-1 may become harder to treat if your baby already has an HIV-1 infection


• Your baby may get side effects from Dovato.


• Avoid breastfeeding is recommended for all HIV-positive individuals.

Storage:

• Store at room temperature away from moisture and heat.

FAQs:

• Q:How effective is Dovato for HIV treatment?


• A:Clinical trials demonstrate that Dovato achieves viral suppression (HIV RNA <50 copies/mL) in >90% of patients when used as prescribed, comparable to traditional 3-drug regimens.

• Q:Can I switch to Dovato from my current HIV medications?


• A:Yes, if you're virologically suppressed on your current regimen with no history of treatment failure or resistance to dolutegravir or lamivudine, switching to Dovato may be appropriate.

• Q:Is Dovato safe for long-term use?


• A:Yes, both dolutegravir and lamivudine have extensive long-term safety data. Regular monitoring ensures early detection of any potential issues.

• Q:Does Dovato interact with birth control pills?


• A:Dovato doesn't significantly affect hormonal contraceptive effectiveness, but discuss all contraceptive methods with your healthcare provider.

• Q:Can I drink alcohol while taking Dovato?


• A:Moderate alcohol consumption is generally acceptable, but excessive alcohol use can worsen liver problems. Discuss alcohol use with your healthcare provider.