What is Dovato? Uses, warnings & side effects
Dovato includes two antiretrovirals in one tablet, combining the integrase inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitor lamivudine. It was the first Food and Drug Administration (FDA)-approved two-drug, fixed-dose, complete regimen for adults who have never before received treatment for Human Immunodeficiency Virus type 1 (HIV-1). Dovato is available as a single tablet and is taken once daily. Dovato labeling includes a Boxed Warning cautioning individuals infected with both HIV and Hepatitis B should receive additional therapeutics for their Hepatitis B, or consider a different regimen. Otherwise, the side effects associated with Dovato are relatively benign, including headache, diarrhea, nausea, insomnia, and fatigue.
Dovato overview
BRAND NAMES:
Dovato
Generic Names:
Dolutegravir/lamivudine
Uses:
Treats HIV infection. This medicine does not cure HIV or AIDS, but it may slow the progress of the disease.
Therapeutic Classes:
Antiretroviral agent
Forms:
Tablet
How it’s taken:
By mouth
What is Dovato used for?
Dovato is a complete regimen for treatment-naïve patients diagnosed with HIV-1.
Key takeaways
Dovato should only be started in patients that have not received prior treatment for HIV-1.
Dovato can be taken once daily with or without food.
Antacids or other aluminum or magnesium-containing products may reduce circulating levels of the dolutegravir component of Dovato. Dovato should therefore be taken 2 hours before or 6 hours after such products.
Any signs of a hypersensitivity reaction, such as severe rash with corresponding fever or aches, should be immediately reported to a medical professional.
Dovato may cause liver damage. Signs of such damage, including pale stools or abdominal pain, should be reported to the prescriber of Dovato immediately.
What form(s) does Dovato come in?
Tablet, Oral
Dovato: Dolutegravir 50 mg-lamivudine 300 mg
What are common Dovato dosages?
Tablet 50-300 mg
Dovato images - What does Dovato look like?
Dovato
30 tablets boxDovato
50-300mg tablet
How to take Dovato
Your doctor will tell you how much medicine to use. Do not use more than directed.
Do not stop using this medicine without checking first with your doctor. If you stop the medicine briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is low so you do not run out.
Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
What to do if you miss a dose of Dovato
If you miss a dose of Dovato, take it is as soon as you remember. However, if it’s close to the time of your next dose, do not double-up doses to make up for the missed dose. Take the next scheduled dose, and resume daily doses.
Dovato contraindications - Who shouldn't take Dovato?
This medicine is not right for everyone. Do not use it if you have an allergic reaction to dolutegravir or lamivudine.
Dovato warnings
Do not use this medicine during the first three months of your pregnancy. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.
Guidelines recommend speaking with a health care provider to discuss options for breastfeeding.
Tell your doctor if you have kidney disease or liver disease (including hepatitis B or C).
This medicine may cause the following problems: Liver problems, lactic acidosis (too much acid in the blood)
Your immune system may get stronger when you start using HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
Keep all medicine out of the reach of children. Never share your medicine with anyone.
Dovato interactions & what to avoid when taking Dovato
Do not use this medicine together with dofetilide.
Some medicines can affect how dolutegravir/lamivudine works. Tell your doctor if you are using any of the following: Dalfampridine, metformin, rifampin, sorbitol, St John's wort, or medicine to treat seizures (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
Take this medicine at least 2 hours before or 6 hours after you take sucralfate or an antacid, laxative, or other medicine that contains aluminum, calcium, magnesium, or iron.
Supplements that contain calcium or iron (including multivitamins) may be taken with this medicine if you take them with food.
Dovato side effects - How does Dovato make you feel?
Dovato should be discontinued immediately if signs of a hypersensitivity reaction develop, which may include a rash, rash with fever, blistering or peeling of skin, or difficulty breathing. In the setting of a hypersensitivity reaction, contact emergency medical services. Dovato should not be reinitiated.
Serious side effects
Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Blistering, peeling, red skin rash
Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
Fast or troubled breathing, lightheadedness, fainting, severe weakness, tiredness, or confusion
Fever, chills, cough, sore throat, joint or muscle aches, severe tiredness, pain or swelling around your eye
Sources:
FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment, FDA News Release (2019)
Clinical Review Report: Dolutegravir/Lamivudine (Dovato), Canadian Agency for Drugs and Technologies in Health (2019)
Recommendations for the use of the antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States, Clinical Info (2023)
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