PATIENT INFO|PRESCRIBING INFO|FOR US HEALTHCARE PROVIDERS

IMPORTANT SAFETY INFORMATION

Who should not take TIVICAY or TIVICAY PD?

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

See full Important Safety Information below

TIVICAY PD can be used by infants and children

What is TIVICAY and TIVICAY PD?

TIVICAY and TIVICAY PD are prescription medicines used to treat Human Immunodeficiency Virus-1 (HIV-1) infection together with:

other HIV-1 medicines in adults who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines.
other HIV-1 medicines in children, aged at least 4 weeks and weighing at least 6.6 pounds (3 kg), who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

TIVICAY is used together with rilpivirine as a complete regimen to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults to replace their current 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 or TIVICAY PD is safe and effective in children who are less than 4 weeks of age and weigh less than 6.6 pounds (3 kg) or in children who have received certain types of medicine for HIV-1 infection.

HOW SHOULD TIVICAY PD BE TAKEN?

TIVICAY PD should be taken exactly as directed by you or your child's healthcare provider.

TIVICAY PD may be swallowed whole or dispersed in drinking water and should not be chewed, cut, or crushed.

TIVICAY tablets are not the same as TIVICAY PD tablets for oral suspension and cannot be substituted for each other. Check to make sure you receive the correct form of TIVICAY each time you or your child’s prescription is filled to avoid using the wrong medicine.

Please see the Patient Information and Instructions for Use for information on how to give TIVICAY PD.

If your child needs HIV-1 treatment, talk to their doctor about TIVICAY or TIVICAY PD.

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What is TIVICAY and TIVICAY PD?

TIVICAY and TIVICAY PD are prescription medicines used to treat Human Immunodeficiency Virus-1 (HIV-1) infection together with:

other HIV-1 medicines in adults who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines.
other HIV-1 medicines in children, aged at least 4 weeks and weighing at least 6.6 pounds (3 kg), who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

TIVICAY is used together with rilpivirine as a complete regimen to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults to replace their current 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 or TIVICAY PD is safe and effective in children who are less than 4 weeks of age and weigh less than 6.6 pounds (3 kg) or in children who have received certain types of medicine for HIV-1 infection.

IMPORTANT SAFETY INFORMATION

Who should not take TIVICAY or TIVICAY PD?

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

What are the possible side effects of TIVICAY or TIVICAY PD?

TIVICAY or TIVICAY PD can cause serious side effects, including:

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

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

What should I tell my healthcare provider before taking TIVICAY or TIVICAY PD?

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

have had liver problems, including hepatitis B or C infection.
are pregnant or plan to become pregnant. TIVICAY or TIVICAY PD may harm your unborn baby.
- Your healthcare provider may prescribe a different medicine than TIVICAY or TIVICAY PD 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 may perform a pregnancy test before you start treatment with TIVICAY or TIVICAY PD.
- If you can become pregnant, you and your healthcare provider should talk about the use of effective birth control (contraception) during treatment with TIVICAY or TIVICAY PD.
- 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 or TIVICAY PD.
are breastfeeding or plan to breastfeed. Do not breastfeed if you take TIVICAY or TIVICAY PD.
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
- TIVICAY and TIVICAY PD 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 or TIVICAY PD. 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 or TIVICAY PD.
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 or TIVICAY PD 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 TIVICAY PD and discuss it with your healthcare provider.

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