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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 (TIVICAY, TRIUMEQ®).
  • take dofetilide (Tikosyn®). Taking TIVICAY and dofetilide (Tikosyn) can cause side effects that may be serious or life-threatening.

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
      • extreme 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
    • 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
      • loss of appetite for several days or longer
      • pain, aching, or tenderness on the right side of your stomach area
  • Changes in liver tests. 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. Your healthcare provider may do tests to check your liver function before and during treatment with TIVICAY.
  • Changes in body fat can happen in people who
    take HIV-1 medicines.
    These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.
  • 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

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of TIVICAY.

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

Before you take TIVICAY, tell your healthcare provider if you:

  • have ever had an allergic reaction to TIVICAY.
  • have had liver problems, including hepatitis B or C infection.
  • have any other medical condition.
  • are pregnant or plan to become pregnant. It is not known if TIVICAY will harmyour unborn baby. Tell your healthcare provider if you become pregnant while taking TIVICAY.
    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines 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.

    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.

Over-the-counter medicines that interact with TIVICAY include:
  • St. John's wort (Hypericum perforatum). Avoid use of St. John’s wort with TIVICAY.
  • antacids, laxatives, or other medicines that contain aluminum, magnesium, sucralfate (Carafate®), or buffered medicines. TIVICAY should be taken at least 2 hours before or 6 hours after you take antacids, laxatives, or other medicines that contain aluminum, magnesium, sucralfate (Carafate), or buffered medicines.
  • iron or calcium supplements taken by mouth. Supplements containing calcium or iron may be taken at the same time with TIVICAY if taken with food. Otherwise, TIVICAY should be taken at least 2 hours before or 6 hours after you take these medicines.
  • 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 together with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV‑1) infection in adults and children who weigh at least 66 pounds. 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.

TIVICAY does not cure HIV‑1 infection or AIDS.
You must stay on continuous HIV‑1therapy to
control the HIV‑1 infection and decrease HIV-related
illnesses.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about 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
      • extreme tiredness
      • muscle or joint aches
      • blisters or sores in mouth
      • blisters or peeling of the skin
      • redness or swelling in the eyes
      • swelling of the mouth, face, lips or tongue
      • problems breathing
    • 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
      • loss of appetite for several days or longer
      • pain, aching, or tenderness on the right side of your stomach area

Who should not take TIVICAY?

  • Do not take TIVICAY if you:
    • have ever had an allergic reaction to a
      medicine that contains dolutegravir (TIVICAY, TRIUMEQ®).
    • take dofetilide (Tikosyn®).

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

  • Changes in liver tests. People with a history of hepatitis B or C virus may havean increased risk of developing new or worsening changes in certain liver tests
    during treatment with TIVICAY. Your healthcare provider may do tests to check
    your liver function before and during treatment with TIVICAY.
  • Changes in body fat can happen in people who take HIV‑1 medicines.
  • Changes in your immune system. 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.

Tell your healthcare provider about any side effect that bothers you or that does not goaway. These are not all the possible side effects of TIVICAY.

What should I tell my healthcare provider before taking TIVICAY?

Before you take TIVICAY, tell your healthcare provider if you:

  • have ever had an allergic reaction to TIVICAY.
  • have had liver problems, including hepatitis B or C.
  • have any other medical condition.
  • are pregnant or plan to become pregnant. It is not known if TIVICAY will harmyour unborn baby.
  • are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV‑1 can be passed to the baby in breast milk. It is not known if TIVICAY passes into your breast milk.

Tell your healthcare provider about the medicines you take

  • Keep a list that includes all prescription and over-the-counter medicines, vitamins, and herbal supplements and share it with your healthcare provider and pharmacist.
  • Ask your healthcare provider or pharmacist about medicines that should not be taken with TIVICAY. Some medicines interact with TIVICAY. Do not start taking a new medicine without telling your healthcare provider.
  • Over-the-counter medicines that interact with TIVICAY include:
    • St. John's wort (Hypericum perforatum). Avoid the use of St. John’s wort with TIVICAY.
    • antacids, laxatives, or other medicines that contain aluminum, magnesium, sucralfate (Carafate®), or buffered medicines. TIVICAY should be taken at least 2 hours before or 6 hours after you take these medicines.
    • iron or calcium supplements taken by mouth. Supplements (including multivitamins) containing calcium or iron may be taken at the same time with TIVICAY if taken with food. Otherwise, TIVICAY should be taken at least 2 hours before or 6 hours after you take these 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.

TIVICAY and TRIUMEQ are registered trademarks of ViiV Healthcare.

Other brands listed are trademarks of their respective owners and are not trademarks of ViiV Healthcare. The makers of these brands are not affiliated with and do not endorse ViiV Healthcare or its products.

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