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Understanding TIVICAY® (dolutegravir)

FAQs About TIVICAY

Learning as much as you can about treatment
choices can help makeconversations with your
healthcare provider even more productive.
Below
you will find some of the most common
questions about HIV-1 treatmentand 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.

  • Take TIVICAY exactly as your healthcare provider tells you to take it.
  • If you miss a dose of TIVICAY, take it as soon as you remember. Do not take 2 doses at the same time or take more than what your healthcare provider tells you to take.
  • Stay under the care of a healthcare provider during treatment with TIVICAY.
  • TIVICAY may be taken with or without food.
  • Do not run out of TIVICAY. 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 TIVICAY, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Store TIVICAY at room temperature between 68°F
    to 77°F (20°C to 25°C).
  • The bottle of TIVICAY (10‑mg tablets) contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not remove the desiccant packet. Store TIVICAY 10-mg tablets in the original bottle. Keep the bottle tightly closed and protected from moisture.

Keep TIVICAY and all medicines out of the reach
of children.

Medicines are sometimes prescribed for purposes
other than those listed in a PatientInformation
leaflet. Do not use TIVICAY for a condition for which
it was not prescribed. Do notgive TIVICAY to other
people, even if they have the same symptoms you
have. It may harmthem.

You can ask your healthcare provider or pharmacist
for information about TIVICAY that iswritten for
health professionals.

For more information, go to www.TIVICAY.com or
call 1-877-844-8872.

Active ingredient: dolutegravir sodium.

Inactive ingredients: d‑mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film‑coating contains the inactive ingredients iron oxide yellow (for the 25‑mg and 50‑mg tablets), macrogol/PEG, polyvinyl alcohol‑part hydrolyzed, talc, and titanium dioxide.

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.