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IMPORTANT SAFETY INFORMATION

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

TRIUMEQ can cause serious side effects, including:

• Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with TRIUMEQ and other abacavir-containing products. Your risk of this allergic reaction to abacavir is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get symptoms from 2 or more of the following groups while taking TRIUMEQ, call your healthcare provider right away:

  Group 1: fever
  Group 2: rash 
  Group 3: nausea, vomiting, diarrhea, or stomach pain
  Group 4: generally ill feeling, extreme tiredness, or achiness
  Group 5: shortness of breath, cough, or sore throat

  Your pharmacist will give you a Warning Card with a list of these symptoms. Carry this Warning Card with you at all times. 
  If you stop taking TRIUMEQ because of an allergic reaction, never take TRIUMEQ or any other medicine that contains abacavir or dolutegravir again. If you have an allergic reaction, dispose of any unused TRIUMEQ. Ask your pharmacist how to properly dispose of medicines. If you take TRIUMEQ or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death. If you stop TRIUMEQ for any other reason, even for a few days, and you are not allergic to TRIUMEQ, talk with your healthcare provider before taking it again. Taking TRIUMEQ again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If your healthcare provider tells you that you can take TRIUMEQ again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.

• Worsening of hepatitis B virus in people who have HIV-1 infection. If you have HIV-1 and hepatitis B virus (HBV), your HBV may get worse (flare-up) if you stop taking TRIUMEQ. A “flare-up” is when your HBV suddenly returns in a worse way than before. Worsening liver disease can be serious and may lead to death. Do not stop taking TRIUMEQ without first talking to your healthcare provider, so he or she can monitor your health.

• Resistant hepatitis B virus. If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with TRIUMEQ and become harder to treat (resistant).

Who should not take TRIUMEQ?

• Do not take TRIUMEQ if you:
  • have the HLA-B*5701 gene variation
  • are allergic to abacavir, dolutegravir, lamivudine or any of the ingredients in TRIUMEQ
  • take dofetilide (Tikosyn^®). Taking TRIUMEQ and dofetilide can cause serious or life-threatening side effects
  • have certain liver problems

What are other possible side effects of TRIUMEQ?

• Serious 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 function tests during treatment with TRIUMEQ. Liver problems, including liver failure, have also happened with TRIUMEQ in people without a history of liver disease or other risk factors. Liver failure resulting in liver transplant has also been reported with TRIUMEQ. Your healthcare provider may do blood tests to check your liver function. Call your healthcare provider right away if you develop any of the signs or symptoms of liver problems listed below:
  • yellow skin, or the white part of the eyes turns yellow (jaundice)
  • dark urine
  • light-colored stools
  • loss of appetite
  • nausea or vomiting
  • pain, aching, or tenderness on the right side of your stomach area
• A build-up of acid in your blood (lactic acidosis), which is a serious medical emergency that can cause death. Call 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
  • have unusual muscle pain
  • have trouble breathing
  • have stomach pain with nausea and vomiting
  • feel cold, especially in your arms and legs
  • feel dizzy/light-headed
  • have a fast/irregular heartbeat
• Lactic acidosis can also lead to serious liver problems, which can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the signs or symptoms of liver problems which are listed above under "Serious liver problems." You may be more likely to get lactic acidosis or serious 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 TRIUMEQ.

• Heart attack. Some HIV-1 medicines, including TRIUMEQ, may increase your risk of heart attack.

The most common side effects of TRIUMEQ include:

• trouble sleeping
• tiredness
• headache

These are not all the possible side effects of TRIUMEQ. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

What should I tell my healthcare provider before taking TRIUMEQ?

• Before you take TRIUMEQ, tell your healthcare provider about all of your medical conditions, including if you:
  • have been tested and know whether or not you have a gene variation called HLA-B*5701
  • have or have had liver problems, including hepatitis B or C infection
  • have kidney problems
  • have heart problems, smoke, or have diseases that increase your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes
  • drink alcohol or take medicines that contain alcohol
  • are pregnant or plan to become pregnant. One of the medicines in TRIUMEQ, called dolutegravir, may harm your unborn baby
    • Your healthcare provider may prescribe a different medicine than TRIUMEQ 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 will perform a pregnancy test before you start treatment with TRIUMEQ, and you should consistently use effective birth control (contraception) during treatment with TRIUMEQ
    • 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 TRIUMEQ
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take TRIUMEQ. Two of the medicines in TRIUMEQ (abacavir and lamivudine) pass into your breastmilk

• 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 TRIUMEQ. Keep a list of your medicines to show 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 TRIUMEQ.
• Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TRIUMEQ with other medicines.

What is TRIUMEQ?

TRIUMEQ is a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used to treat HIV-1 infection in adults and in children who weigh at least 88 pounds. HIV-1 is the virus that causes AIDS. TRIUMEQ is not for use by itself in people who have or have had resistance to abacavir, dolutegravir, or lamivudine. It is not known if TRIUMEQ is safe and effective in children who weigh less than 88 pounds.

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.

Please read the Medication Guide for TRIUMEQ and discuss it with your healthcare provider.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies. 
The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks of the ViiV Healthcare group of companies. The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products.

Please click here for full Prescribing Information, including Boxed Warning and Medication Guide, for TRIUMEQ.