Dovato is a combination antiviral medicine that prevents the human immunodeficiency virus (HIV) from multiplying in your body.

Dovato is used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Dovato 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.

You should not use Dovato if you are also taking dofetilide (Tikosyn).

Taking Dovato during the first trimester of pregnancy may cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

If you've ever had hepatitis B, it may become active and resistant to medication while you are taking Dovato. Hepatitis B may also get worse after you stop using this medicine. You may need frequent liver function tests for several months.

Before you start treatment with Dovato, your doctor may perform tests to make sure you do not have hepatitis B.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Dovato with or without food.

You will need frequent medical tests.

If you've ever had hepatitis B, this virus may become active or get worse during treatment with Dovato, or in the months after you stop using this medicine. You may need frequent liver function tests while using Dovato and for several months after your last dose.

Do not change your dose or stop using Dovato without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Use: As a complete regimen, for the treatment of HIV-1 infection in patients with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components, or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components.

Renal Dose Adjustments:

CrCl less than 50 mL/min: Not recommended.

Liver Dose Adjustments:

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Dose Adjustments:

Coadministration with carbamazepine or rifampin: An additional 50 mg/day of dolutegravir is recommended, separated from this combination product by 12 hours.

Precautions:

US BOXED WARNINGS:
PATIENTS COINFECTED WITH HBV AND HIV-1:
-EMERGENCE OF LAMIVUDINE-RESISTANT HBV: All patients with HIV-1 should be tested for HBV before/when starting this drug. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens reported. If this drug is used in HBV/HIV-1-coinfected patients, additional treatment should be considered to appropriately treat chronic HBV; otherwise, an alternative regimen should be considered.
-EXACERBATIONS OF HBV: Severe acute exacerbations of HBV reported in HBV/HIV-1-coinfected patients who have stopped lamivudine, a component of this drug. Hepatic function of HBV/HIV-1-coinfected patients should be monitored closely; if appropriate, anti-HBV therapy should be started.

CONTRAINDICATIONS:
Prior hypersensitivity reaction to either active component; coadministration with dofetilide

Safety and efficacy have not been established in patients younger than 18 years.

You should not use Dovato if you are allergic to dolutegravir or lamivudine, or if you are also taking dofetilide (Tikosyn).

To make sure Dovato is safe for you, tell your doctor if you have ever had:

• kidney problems; or

• liver disease, especially hepatitis B or C.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

You may need to have a negative pregnancy test before starting treatment with Dovato.

Dolutegravir and lamivudine may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Dovato on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

While Dovato can substantially reduce the risk of HIV transmission, there is still a chance the disease can spread. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Avoid taking an herbal supplement containing St. John's wort.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Dovato: fever, general ill feeling, trouble breathing, tiredness; joint or muscle pain, blisters or mouth sores, redness or swelling in your eyes; blistering or peeling skin; swelling of your face, lips, tongue, or throat.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast or irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild; or

• liver problems - nausea, vomiting, loss of appetite, upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Dolutegravir and lamivudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Dovato side effects may include:

• headache;

• tiredness;

• nausea, diarrhea; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make Dovato much less effective when taken at the same time. If you take any of the following medicines, take your Dovato dose 2 hours before or 6 hours after you take the other medicine.

• antacids or laxatives that contain calcium, magnesium, or aluminum (such as Amphojel, Di-Gel Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), or the ulcer medicine sucralfate (Carafate);

• buffered medicine; or

• vitamin or mineral supplements that contain calcium or iron (but if you take dolutegravir with food, you can take these supplements at the same time).

Many drugs interact with dolutegravir and lamivudine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.