Dolutegravir/lamivudine

What is Dolutegravir/lamivudine?

• Dolutegravir/lamivudine (Dovato), is a two-drug combination of dolutegravir (integrase strand transfer inhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptase inhibitor [NRTI]).

Dolutegravir

Dolutegravir ball-and-stick model

Lamivudine

Lamivudine ball-and-stick

What are the uses of this medicine?

Dolutegravir/lamivudine (Dovato), is a prescription medicine that is used without other HIV-1 medicines to treat HIV-1 infection in adults:

• who have not received HIV-1 medicines in the past, or
• to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.
• HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

How does this medicine work?

• Dolutegravir/lamivudine (Dovato), is a fixed-dose combination of the HIV‑1 antiretroviral agents, dolutegravir and lamivudine.

Dolutegravir:

• Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for the HIV replication cycle.
• Strand transfer biochemical assays using purified recombinant HIV‑1 integrase and pre-processed substrate DNA resulted in IC50 values of 2.7 nM and 12.6 nM.

Lamivudine:

• Lamivudine is a synthetic nucleoside analogue.
• Intracellularly lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC‑TP).
• The principal mode of action of 3TC‑TP is inhibition of reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have ever had an allergic reaction to a medicine that contains dolutegravir or lamivudine.
• take dofetilide. Taking Dovato and dofetilide can cause side effects that may be serious or life-threatening.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• carbamazepine (Carbatrol, Equetro, Tegretol, others), dalfampridine (Ampyra), metformin (Glumetza, Glucophage, Riomet, in Invokamet, in Janumet, others), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and sorbitol or medications that contain sorbitol.
• St. John's wort

Is this medicine FDA approved?

• It was approved for use in the United States in April 2019, and in the European Union in July 2019, and again with revisions in June 2022.

How should this medicine be used?

• Prior to or when initiating Dovato, test patients for HBV infection.
• Pregnancy testing is recommended before initiation of Dovato in individuals of childbearing potential.

Recommended dosage:

• The recommended dosage regimen of Dovato in adults is one tablet taken orally once daily with or without food.

Administration:

• Take Dovato 1 time a day exactly as your healthcare provider tells you.
• Take Dovato with or without food.
• Do not change your dose or stop taking Dovato without talking with your healthcare provider.
• If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, Dovato should be taken at least 2 hours before or 6 hours after you take these medicines.
• If you need to take iron or calcium supplements, including multivitamins that contain iron or calcium, by mouth during treatment with Dovato:
• You may take these supplements at the same time that you take Dovato with food.
• If you do not take these supplements with Dovato and food, take Dovato at least 2 hours before or 6 hours after you take these supplements.
• Do not miss a dose of Dovato. If you miss a dose of Dovato, take it as soon as you remember. Do not take 2 doses at the same time or take more than your prescribed dose.
• Stay under the care of a healthcare provider during treatment with Dovato.
• Do not run out of Dovato. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 50 mg of dolutegravir and 300 mg of lamivudine.

This medicine is available in fallowing brand namesː

• Dovato

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• diarrhea
• trouble sleeping
• tiredness
• anxiety

Less common, but serious side effects may include:

• Resistant HBV
• Worsening of HBV infection
• Allergic reactions
• Liver problems
• lactic acidosis
• Immune Reconstitution Syndrome

What special precautions should I follow?

• 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.
• 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.
• Embryo-fetal toxicity may occur when used at the time of conception and in early pregnancy. Assess the risks and benefits of Dovato and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester due to the risk of neural tube defects. Individuals of childbearing potential should be counseled on the consistent use of effective contraception.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.
• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
• Advise all patients with HIV-1 to be tested for the presence of HBV prior to or when initiating Dovato. Advise patients to discuss any changes in regimen with their healthcare provider.
• If you are taking antacids or laxatives that contain aluminum or magnesium; sucralfate (Carafate); or buffered medications such as buffered aspirin, take them at least 2 hours after or 6 hours before you take dolutegravir and lamivudine.
• If you are taking iron or calcium supplements, or multivitamins that contain iron or calcium, take them at the same time that you take dolutegravir and lamivudine along with food, or take them at least 2 hours after or 6 hours before you take dolutegravir and lamivudine.
• Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• One of the medicines in Dovato (dolutegravir) may harm your unborn baby.
• Your healthcare provider may prescribe a different medicine than Dovato if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy.
• If you can become pregnant, your healthcare provider may perform a pregnancy test before you start treatment with Dovato.
• If you can become pregnant, you and your healthcare provider should talk about the use of effective birth control (contraception) during treatment with 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.

Can this medicine be used in children?

• It is not known if Dovato is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredients: dolutegravir and lamivudine.
• Inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, sodium stearyl fumarate.
• The tablet film-coating contains: hypromellose, polyethylene glycol, titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured for:

• ViiV Healthcare
• Durham, NC

by:

• GlaxoSmithKline
• Durham, NC

What should I know about storage and disposal of this medication?

• Store Dovato below 86°F (30°C).
• Dovato comes in a child-resistant package.

• Dailymed label info on Dolutegravir/lamivudine
• FDA Dolutegravir/lamivudine

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