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 (30 kg).
- 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 (30 kg) 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.
- take dofetilide.
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 or have had liver problems, including hepatitis B or C infection.
- are pregnant or plan to become pregnant. Tivicay may harm your unborn baby.
- Your healthcare provider may prescribe a different medicine than Tivicay 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 Tivicay.
- If you can become pregnant, you should consistently use effective birth control (contraception) during treatment with Tivicay.
- 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 Tivicay.
Pregnancy Registry. There is a pregnancy registry for individuals who take antiretroviral medicines, including Tivicay, during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with 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 all 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.
How should I take Tivicay?
- Take Tivicay exactly as your healthcare provider tells you to take it.
- Take Tivicay with or without food.
- Do not change your dose or stop taking Tivicay without talking with your healthcare provider.
- If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, Tivicay should be taken at least 2 hours before or 6 hours after you take these medicines.
- If you need to take iron or calcium supplements by mouth during treatment with Tivicay:
- If you take Tivicay with food, you may take these supplements at the same time that you take Tivicay.
- If you do not take Tivicay with food, take Tivicay at least 2 hours before or 6 hours after you take these supplements.
- Do not miss a dose of Tivicay.
- 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 your prescribed dose.
- Stay under the care of a healthcare provider during treatment with Tivicay.
- 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:
- 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:
- generally ill feeling
- 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
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.
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.
How should I store Tivicay?
- Store Tivicay at room temperature between 68°F to 77°F (20°C to 25°C).
- Store Tivicay 10-mg tablets in the original bottle. Keep the bottle tightly closed and protected from moisture.
- The bottle of Tivicay (10-mg tablets) contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.
Keep Tivicay and all medicines out of the reach of children.
What are the ingredients in Tivicay?
Active ingredient: dolutegravir.
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 only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.