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Risks & Side Effects of TIVICAY® (dolutegravir)

It’s important to learn about any other medications
you’re currently taking or areconsidering
taking. You should always talk with your
healthcare provider ifyou have any concerns.

These are not all of the risks and side effects of
TIVICAY, and this information does notreplace talking with your healthcare provider about your
medical condition or treatment.For more
information, talk to your healthcare provider and
refer to thePatient Information for TIVICAY.

Do not take TIVICAY if you:

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

TIVICAY can cause serious side effects
including:

  • Allergic reactions. Call your healthcare provider right away if you develop a rash with TIVICAY. Stop taking TIVICAY 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 TIVICAY. 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. Call your healthcare provider right away if you develop 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
  • 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 TIVICAY.
  • The most common side effects of TIVICAY include:
      • trouble sleeping
      • tiredness
      • headache

These are not all the possible side effects of TIVICAY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

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

  • have ever had an allergic reaction to dolutegravir.
  • have had liver problems, including hepatitis B or C infection.
  • are pregnant or plan to become pregnant. It is not known if TIVICAY will harmyour unborn baby.
    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medications, including TIVICAY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take TIVICAY.
      • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
      • It is not known if TIVICAY can pass to your baby in your breast milk.
        Talk with your healthcare provider about the best way to feed your baby.

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

Some medicines interact with TIVICAY. 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 TIVICAY.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TIVICAY with other medicines.

What is TIVICAY?

TIVICAY is a prescription medicine that is used to treat Human Immunodeficiency Virus‑1 (HIV‑1) infection together with:

  • other antiretroviral medicines in adults and children who weigh at least 66 pounds.
  • rilpivirine in adults to replace their current anti-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 TIVICAY is safe and effective in children who weigh less than 66 pounds or in children who have received certain types of medicine for HIV-1 infection.

IMPORTANT SAFETY INFORMATION

Who should not take TIVICAY?

  • Do not take TIVICAY if you:
    • have ever had an allergic reaction to a medicine that contains dolutegravir.
    • take dofetilide.

What are the possible side effects of TIVICAY?
TIVICAY can cause serious side effects including:

  • Allergic reactions. Call your healthcare provider right away if you develop a rash with TIVICAY. Stop taking TIVICAY and get medical help right away if you develop a rash with any of the following signs or symptoms:
    • fever
    • general 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 TIVICAY. 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. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:
    • your skin or the white part of your eyes turn yellow
    • 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
  • 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. Tell your healthcare provider right away if you start having new symptoms after you start taking TIVICAY.
  • The most common side effects of TIVICAY include: trouble sleeping, tiredness, and headache.

These are not all the possible side effects of TIVICAY. Call your doctor for medical advice about side effects.

What should I tell my healthcare provider before taking TIVICAY?

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

  • have ever had an allergic reaction to dolutegravir.
  • have had liver problems, including hepatitis B or C.
  • are pregnant or plan to become pregnant. It is not known if TIVICAY will harmyour unborn baby.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take TIVICAY. It is not known if TIVICAY can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby.

  • Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with TIVICAY. 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 TIVICAY. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TIVICAY 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.

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

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

To learn about another prescription product for HIV‑1, CLICK HERE.