August 29, 2016
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Tivicay

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Tivicay

PATIENT INFORMATION

TIVICAY®
(TIV-eh-kay)
(dolutegravir) Tablets

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
      • 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

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.

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®). Taking TIVICAY and dofetilide (TIKOSYN) can cause side effects that may be serious or life-threatening.

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 infection.
  • have any other medical condition.
  • are pregnant or plan to become pregnant. It is not known if TIVICAY will harm your 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.

How should I take TIVICAY?

  • 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.

What are the possible side effects of TIVICAY?

  • TIVICAY can cause serious side effects including:
  • See “What is the most important information I should know about TIVICAY?”
  • 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 effects to FDA at 1-800-FDA-1088.

How should I store TIVICAY?

  • 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.

General information about the safe and effective use of TIVICAY.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TIVICAY for a condition for which it was not prescribed. Do not give TIVICAY to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TIVICAY that is written for health professionals. For more information, go to www.TIVICAY.com or call 1-877-844-8872.

What are the ingredients in TIVICAY?

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.

Last reviewed on RxList: 6/17/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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