Medication info
Dovato Tablet

Dovato Tablet

Prescription medicationTabletOral · Ear drops
Ingredient · strength
Lamivudine›300mg / 1 tabletDolutegravir Sodium Micronized›52.6mg / 1 tablet
Manufacturer / importer
GSK Korea
Appearance
White, oval film-coated tablet with a biconvex shape
Packaging
30 tablets per bottle
Approval status
Active

MFDS item code 202001791 · Approved 2020.03.16 · Insurance code 650003200

Summary

Main use
Treatment of human immunodeficiency virus (HIV-1) infection
Who uses it
Adults · Children
Adult dosage
This medicine should be prescribed by a physician experienced in treating HIV-1 infection and is administered orally. It may be taken with or without food. Adults and adolescents aged 12 years and older (body weight 40 kg or more) The recommended dose is 1 tablet once daily. This medicine is not recommended in cases of resistance to any of its components. If the dose of one of the individual components of this medicine needs to be adjusted, dolutegravir or lamivudine may be prescribed separately; in such cases, the physician should refer to the product information for the individual products. If a patient misses a dose of this medicine and there are more than 4 hours until the next scheduled dose, take it as soon as possible. If the next scheduled dose is within 4 hours, skip the missed tablet and resume the usual dosing schedule. This medicine is not recommended for patients with creatinine clearance less than 30mL/min. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). Since no data are available for patients with severe hepatic impairment (Child-Pugh score C), administer this medicine with caution to these patients.
Children's dosage
Do not administer to adolescents and adults weighing less than 40 kg.

Ingredients

Importer
GSK Korea

Efficacy & effects

Treatment of human immunodeficiency virus (HIV-1) infection

View approved original text

This medication is used for patients who are starting antiretroviral therapy for the first time or those who are consistently suppressing viral load without treatment failure on existing therapy. It is especially effective for the treatment of HIV-1 infection in adults and adolescents 12 years of age or older (weighing more than 40 kg) without known or suspected resistance mutations to this drug's components. Therefore, it is recommended as a therapeutic agent that helps suppress the virus and contributes to the improvement of immune function for patients suffering from HIV-1 infection.

Dosage and Administration

Adult dosage

This medicine should be prescribed by a physician experienced in treating HIV-1 infection and is administered orally. It may be taken with or without food. Adults and adolescents aged 12 years and older (body weight 40 kg or more) The recommended dose is 1 tablet once daily. This medicine is not recommended in cases of resistance to any of its components. If the dose of one of the individual components of this medicine needs to be adjusted, dolutegravir or lamivudine may be prescribed separately; in such cases, the physician should refer to the product information for the individual products. If a patient misses a dose of this medicine and there are more than 4 hours until the next scheduled dose, take it as soon as possible. If the next scheduled dose is within 4 hours, skip the missed tablet and resume the usual dosing schedule. This medicine is not recommended for patients with creatinine clearance less than 30mL/min. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). Since no data are available for patients with severe hepatic impairment (Child-Pugh score C), administer this medicine with caution to these patients.

Children's dosage

Do not administer to adolescents and adults weighing less than 40 kg.

Precautions

This medication can cause hypersensitivity reactions, so if symptoms such as rash, fever, fatigue, or muscle aches occur, use should be stopped immediately and a doctor should be consulted. Patients co-infected with hepatitis B may face a risk of hepatitis recurrence if this drug is used alone, necessitating additional treatment. Patients with compromised liver function may experience worsening of liver function while taking this medication; regular liver function tests are required. Serious side effects such as lactic acidosis may occur, so particularly overweight women or patients at risk for liver disease should stop medication immediately if symptoms arise. Patients allergic to dolutegravir or lamivudine or using certain heart medications together pose risks and should not use this drug. This medication may cause side effects, including headache, nausea, diarrhea, insomnia, dizziness, and should be discussed with healthcare providers if symptoms are severe. There are many potential interactions with other medications; it is essential to inform healthcare professionals about all medications currently being taken before use to avoid changes in drug concentration or the risk of side effects. The impact on the fetus during pregnancy appears to be low; however, if pregnancy is planned or if in early pregnancy, the decision to use should be made after consulting a physician. During breastfeeding, a small amount of the drug may be transmitted through breast milk, so the decision to breastfeed should also be discussed with healthcare providers. Safety and efficacy in children and elderly patients have not been established, so should be used with caution, and if overdose occurs, seek appropriate medical treatment immediately. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects

rash, systemic findings, severe liver reactions, elevated liver enzymes, fever, systemic malaise, fatigue, myalgia, arthralgia, vesicles, oral lesions, conjunctivitis, facial edema, eosinophilia, angioedema, neutropenia, anemia, thrombocytopenia, pure red cell aplasia, iron deficiency anemia, hypersensitivity, immune reconstitution syndrome, lactic acidosis, depression, anxiety, insomnia, vivid dreams, suicidal thoughts, suicide attempts, suicide, headache, dizziness, drowsiness, peripheral neuropathy, paresthesia, nausea, diarrhea, vomiting, bloating, abdominal pain, abdominal discomfort, pancreatitis, hepatitis, acute liver failure, pruritus, hair loss, angioedema, rhabdomyolysis, fatigue, elevated CPK, elevated ALT, elevated AST, weight gain, elevated amylase, increased serum creatinine, slight increase in serum bilirubin, asymptomatic increase in creatine phosphokinase, gastroenteritis, edema, drowsiness

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness.

Appearance and packaging

Appearance

White, oval film-coated tablet with a biconvex shape

Package unit

30 tablets per bottle

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.