Dovato

Dovato is a prescription medication used to treat HIV (human immunodeficiency virus). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Dovato is a single product containing 2 medications: dolutegravir and lamivudine. Dolutegravir belongs to a group of drugs called integrase strand transfer inhibitors [INSTIs]. Lamivudine belongs to a group of drugs called nucleoside analogue reverse transcriptase inhibitors [NRTIs]. These two drugs inhibit the viral cycle at two different sites, which stops the virus from multiplying. 

Dovato comes in tablet form and is taken by mouth, once daily, at the same time every day. It can be taken with our without food.

Common side effects include headache, diarrhea, nausea, trouble sleeping, and tiredness.

Dovato is a prescription medicine that is used without other antiretroviral medicines to treat HIV-1 infection in adults:

• who have not received antiretroviral medicines in the past, and 
• without known resistance to the medicines dolutegravir or lamivudine.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Dovato. See the "Dovato Precautions" section.

Common side effects of Dovato include the following:

• headache
• diarrhea
• nausea
• insomnia
• fatigue

This is not a complete list of Dovato side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. 

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

Tell you doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other HIV medications such as abacavir, ritonavir and efavirenz
• drugs eliminated by OCT2 or MATE1 such as dofetilide and metformin
• polyvalent cation-containing products such as calcium, iron and magnesium
• metabolism inducers such as carbamazepine and rifampin 

This is not a complete list of Dovato drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Dovato inclluding the following:

• Resistant HBV infection. Your healthcare provider will test you for HBV infection before you start treatment with Dovato. If you have HIV-1 and hepatitis B, the hepatitis B virus 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 HIV-1 and HBV infection, 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. Worsening liver disease can be serious and may lead to death.
  • 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.
• 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). Lactic acidosis 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.

Do not take Dovato if you:

• have ever had an allergic reaction to a medicine that contains dolutegravir or lamivudine.
• take dofetilide

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Dovato, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Dovato, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or have had liver problems, including hepatitis B or C infection.
• have kidney problems.
• are pregnant or plan to become pregnant. One of the medicines in Dovato (dolutegravir) may harm your unborn baby. 
  • You should not take Dovato if you are planning to become pregnant or during the first 12 weeks of pregnancy. Your healthcare provider may prescribe a different medicine if you are planning to become pregnant or become pregnant during treatment with Dovato.
  • If you can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with Dovato.
  • If you can become pregnant, you should consistently use 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.

• are breastfeeding or plan to breastfeed. Do not breastfeed if you take Dovato.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • One of the medicines in Dovato (lamivudine) passes into your breast milk.
  • Talk with your healthcare provider about the best way to feed your baby.

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.

Tell your doctor if you are pregnant or plan to become pregnant. 

• You should not take Dovato if you are planning to become pregnant or during the first 12 weeks of pregnancy. Your healthcare provider may prescribe a different medicine if you are planning to become pregnant or become pregnant during treatment with Dovato.
• If you can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with Dovato.
• If you can become pregnant, you should consistently use 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.

Pregnancy Registry. There is a pregnancy registry for people who take antiretroviral medicines, including 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.

The Centers for Disease Control and Prevention recommends that HIV-1–infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.

• Do not breastfeed if you take Dovato.
• You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. 
• One of the medicines in Dovato (lamivudine) passes into your breast milk.
• Talk with your healthcare provider about the best way to feed your baby.

• 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Dovato is a fixed-dose combination product containing 50 mg of dolutegravir and 300 mg of lamivudine. Your dosage may differ if you are taking other medications.

If you take too much Dovato, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• 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.
• Store Dovato below 86°F (30°C).
• Keep this and all medicines out of the reach of children.

WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINERESISTANT HBV AND EXACERBATIONS OF HBV

All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.