Dolutegravir/Lamivudine — Membership Pricing

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What Dolutegravir/Lamivudine is approved for (FDA label)

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. DOVATO, a two-drug combination of dolutegravir (integrase strand transfer inhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptase inhibitor [NRTI]) 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. ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: October 29, 2025.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Dolutegravir/Lamivudine (FDA label)

WARNING: 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.

Source: FDA prescribing information (DailyMed). Set ID: 68e45422-43ed-4cfb-9356-fae88d14a53a. SPL document ID: 9b88da25-ebce-49ae-8c8a-dcee6f465957. Label effective date: October 29, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Dolutegravir/Lamivudine (FDA label)

DOVATO tablets are oval, biconvex, white, film-coated tablets, debossed with “SV 137” on one face. Each tablet contains 50 mg of dolutegravir and 300 mg of lamivudine. Tablets: 50 mg of dolutegravir and 300 mg of lamivudine. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 68e45422-43ed-4cfb-9356-fae88d14a53a. SPL document ID: 9b88da25-ebce-49ae-8c8a-dcee6f465957. Label effective date: October 29, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Dolutegravir/Lamivudine (FDA 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 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.

Source: FDA prescribing information (DailyMed). Set ID: 68e45422-43ed-4cfb-9356-fae88d14a53a. SPL document ID: 9b88da25-ebce-49ae-8c8a-dcee6f465957. Label effective date: October 29, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Dolutegravir/Lamivudine (FDA label)

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 )

Source: FDA prescribing information (DailyMed). Set ID: 68e45422-43ed-4cfb-9356-fae88d14a53a. SPL document ID: 9b88da25-ebce-49ae-8c8a-dcee6f465957. Label effective date: October 29, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Dolutegravir/Lamivudine (FDA label)

• 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.

Source: FDA prescribing information (DailyMed). Set ID: 68e45422-43ed-4cfb-9356-fae88d14a53a. SPL document ID: 9b88da25-ebce-49ae-8c8a-dcee6f465957. Label effective date: October 29, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Dolutegravir/Lamivudine (FDA label)

• 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

Source: FDA prescribing information (DailyMed). Set ID: 68e45422-43ed-4cfb-9356-fae88d14a53a. SPL document ID: 9b88da25-ebce-49ae-8c8a-dcee6f465957. Label effective date: October 29, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.