Patient information: uses, side effects, how to take - Dovato

What is the most important information I should know about DOVATO?

If you have both human immunodeficiency virus-1 (HIV-1) infection and Hepatitis B virus (HBV) infection, DOVATO can cause serious side effects, including:

Resistant HBV. Your healthcare provider will test you for HBV infection before you start treatment with DOVATO. If you have HIV-1 and hepatitis B, the HBV can change (mutate) during your treatment with DOVATO and become harder to treat (resistant). It is not known if DOVATO is safe and effective in people who have HIV-1 and HBV infection.
Worsening of HBV infection. If you have HBV infection and take DOVATO, your HBV may get worse (flare-up) if you stop taking DOVATO. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
- Do not run out of DOVATO. Refill your prescription or talk to your healthcare provider before your DOVATO is all gone.
- Do not stop DOVATO without first talking to your healthcare provider.
- If you stop taking DOVATO, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver function and monitor your HBV infection. It may be necessary to give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking DOVATO.

For more information about side effects, see “What are the possible side effects of DOVATO?”

What is DOVATO?

DOVATO is a prescription medicine that is used without other HIV-1 medicines to treat HIV-1 infection in adults and adolescents 12 years of age and older who weigh at least 55 pounds (25 kg):

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).

It is not known if DOVATO is safe and effective in children less than 12 years of age or weighing less than 55 pounds (25 kg).

Do not take DOVATO if you:

have ever had an allergic reaction to a medicine that contains dolutegravir or lamivudine. See the end of this Patient Information for a complete list of ingredients in DOVATO.
take dofetilide. Taking DOVATO and dofetilide can cause side effects that may be serious or life-threatening.

Before you take DOVATO, tell your healthcare provider about all of your medical conditions, including if you:

have or have had liver problems, including hepatitis B or C infection.
have kidney problems.
are pregnant or plan to become pregnant. Talk to your healthcare provider about the benefits and risks of treatment with DOVATO during pregnancy.
Pregnancy Registry. There is a pregnancy registry for those who take DOVATO during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
are breastfeeding or plan to breastfeed. DOVATO passes to your baby in your breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with DOVATO:
- the HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection.
- the HIV-1 virus may become harder to treat if your baby has HIV-1 infection.
- your baby may get side effects from DOVATO.

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

Some medicines interact with DOVATO. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with DOVATO.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take DOVATO with other medicines.

How should I take DOVATO?

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.
If you take too much DOVATO, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of DOVATO?

DOVATO can cause serious side effects, including:

See “What is the most important information I should know about DOVATO?”
Allergic reactions. Call your healthcare provider right away if you develop a rash with DOVATO. Stop taking DOVATO and get medical help right away if you develop a rash with any of the following signs or symptoms:

fever
generally ill feeling
tiredness
muscle or joint aches
blisters or sores in mouth

blisters or peeling of the skin
redness or swelling of the eyes
swelling of the mouth, face, lips, or tongue
problems breathing

Liver problems. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver tests during treatment with DOVATO. Liver problems, including liver failure, have also happened in people without a history of liver disease or other risk factors. Your healthcare provider may do blood tests to check your liver.
Tell your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

your skin or the white part of your eyes turns yellow (jaundice)
dark or “tea-colored” urine
light-colored stools (bowel movements)

nausea or vomiting
loss of appetite
pain, aching, or tenderness on the right side of your stomach area

Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious medical emergency that can lead to death.
Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

feel very weak or tired
unusual (not normal) muscle pain
trouble breathing
stomach pain with nausea and vomiting

feel cold, especially in your arms and legs
feel dizzy or light-headed
have a fast or irregular heartbeat

Lactic acidosis can also lead to severe liver problems, which can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Tell your healthcare provider right away if you get any of the signs or symptoms of liver problems which are listed above under “Liver problems”. You may be more likely to get lactic acidosis or severe liver problems if you are female or very overweight (obese).
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking DOVATO.

The most common side effects of DOVATO include:

headache
nausea
diarrhea

trouble sleeping
tiredness
anxiety

These are not all the possible side effects of DOVATO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

How should I store DOVATO?

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

Keep DOVATO and all medicines out of the reach of children.

General information about the safe and effective use of DOVATO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DOVATO for a condition for which it was not prescribed. Do not give DOVATO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about DOVATO that is written for health professionals.

What are the ingredients in DOVATO?

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.

Manufactured for:

ViiV Healthcare

Durham, NC 27701

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

DVT:11PIL

For more information go to www.DOVATO.com or call 1-877-844-8872.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 4/2024

Dovato: Uses, Side Effects and Dosage