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IMPORTANT SAFETY INFORMATION

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

If you have both 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?”

 

Who should not take DOVATO?

• Do not take DOVATO if you:
  
  • have ever had an allergic reaction to a medicine that contains dolutegravir or lamivudine. Please see 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.

 

What are other 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.

 

What should I tell my healthcare provider before taking DOVATO?

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. One of the medicines in DOVATO (dolutegravir) may harm your unborn baby.
  • Your healthcare provider may prescribe a different medicine than DOVATO if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy.
  • If you can become pregnant, your healthcare provider may perform a pregnancy test before you start treatment with DOVATO.
  • If you can become pregnant, you and your healthcare provider should talk about the use of 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.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

Indication

DOVATO is a complete prescription regimen to treat HIV-1 in adults who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines when their doctor determines they meet certain requirements.

 

Please read the Patient Information for DOVATO and discuss it with your healthcare provider.

 

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