Patient information: uses, side effects, how to take - Tivicay Tablet 5 mg

What are 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 and children weighing at least 4.4 pounds (2 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 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 premature newborn babies, children who weigh less than 4.4 pounds (2 kg), or in children who have received certain types of HIV-1 medicine.

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.

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

have or have had liver problems, including hepatitis B or hepatitis C.
are pregnant or plan to become pregnant.
- Talk to your healthcare provider about the benefits and risks of treatment with TIVICAY or TIVICAY PD during pregnancy.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for those who take TIVICAY or TIVICAY PD 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. TIVICAY and TIVICAY PD pass to your baby in your breast milk. Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with TIVICAY and TIVICAY PD:
- the HIV-1 virus may pass to your baby if your baby does not have HIV-1.
- the HIV-1 virus may become harder to treat if your baby has HIV-1.
- your baby may get side effects from TIVICAY or TIVICAY PD.

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 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.

How should I take TIVICAY or TIVICAY PD?

Take TIVICAY or TIVICAY PD exactly as your healthcare provider tells you to take it.
Do not change your dose, switch medicines or stop taking TIVICAY or TIVICAY PD without talking to your healthcare provider first.
Take TIVICAY or TIVICAY PD with or without food.
Children should keep scheduled healthcare provider’s visits because their dosage may be adjusted as they get older or gain weight.
For children who cannot swallow tablets, read the Instructions for Use at the end of this Patient Information for detailed instructions on how to prepare a dose of TIVICAY PD tablets for oral suspension.
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.
If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, take TIVICAY or TIVICAY PD at least 2 hours before or 6 hours after you take these medicines.
If you take iron or calcium supplements by mouth during treatment with TIVICAY or TIVICAY PD:
- If you take TIVICAY or TIVICAY PD with food, you may take these supplements at the same time that you take TIVICAY or TIVICAY PD.
- If you do not take TIVICAY or TIVICAY PD with food, take TIVICAY or TIVICAY PD at least 2 hours before or 6 hours after you take these supplements.
Do not miss a dose of TIVICAY or TIVICAY PD. If you miss a dose of TIVICAY or TIVICAY PD, 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 or TIVICAY PD.
Do not run out of TIVICAY or TIVICAY PD. 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 or TIVICAY PD, call your healthcare provider or go to the nearest hospital emergency room right away.

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

TIVICAY or TIVICAY PD can cause serious side effects including:

Allergic reactions. Tell 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
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

Liver problems. People with a history of hepatitis B or hepatitis 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. Tell 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 in the upper 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 develop new symptoms of infection after you start treatment with TIVICAY or TIVICAY PD.
The most common side effects of TIVICAY or TIVICAY PD 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.

How should I store TIVICAY or TIVICAY PD?

Store TIVICAY 10 mg, 25 mg, and 50 mg tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Store TIVICAY PD 5 mg tablets for oral suspension at room temperature below 86°F (30°C).
Store TIVICAY 10 mg tablets and TIVICAY PD 5 mg tablets for oral suspension in the original bottle. Keep the bottle tightly closed and protected from moisture. The bottle 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, TIVICAY PD, and all medicines out of the reach of children.

General information about the safe and effective use of TIVICAY or TIVICAY PD.

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

What are the ingredients in TIVICAY and TIVICAY PD?

Active ingredient: dolutegravir.

Inactive ingredients:

TIVICAY tablets: 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.

TIVICAY PD tablets for oral suspension: calcium sulfate dihydrate, crospovidone, mannitol, microcrystalline cellulose, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, strawberry cream flavor, sucralose, and sodium stearyl fumarate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide.

Manufactured for:

ViiV Healthcare

Durham, NC 27701

TIVICAY and TIVICAY PD are trademarks owned by or licensed to the ViiV Healthcare group of companies.

TVC:16PIL

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

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 8/2026

INSTRUCTIONS FOR USE
TIVICAY PD (TIV-eh-kay Pe De) (dolutegravir) tablets for oral suspension
This Instructions for Use contains information on how to prepare and give TIVICAY PD as a liquid (oral suspension). Read this Instructions for Use before giving TIVICAY PD. Follow the steps below, using clean drinking water to prepare and give a dose to an infant or a child who cannot swallow the tablets. Important Information You Need to Know Before Preparing and Giving TIVICAY PD. Always give this medicine exactly as your healthcare provider tells you. Talk to your healthcare provider if you are not sure. TIVICAY PD is for oral use only (taken by mouth). Take TIVICAY PD with or without food. TIVICAY PD may be swallowed whole or prepared as an oral suspension. Do not chew, cut, or crush the tablets. If you forget to give a dose of medicine, give it as soon as you remember. Do not give 2 doses at the same time or give more than your healthcare provider has prescribed. If your child does not or cannot take the full dose, tell your healthcare provider. If you give too much medicine, get emergency medical help right away. If your child is able and prefers to swallow the tablets, then you may skip the following steps.
Your pack contains:
	A bottle containing 60 TIVICAY PD tablets for oral suspension. Dosing kit: Cup: Use this to prepare and give the medicine to children. Syringe: Use this to give the medicine to infants.
You will also need clean drinking water.
Getting Ready Step 1. Pour water
Figure A	Pour clean drinking water into the cup. The Water Volume Guide in Figure A shows the amount of water needed for the prescribed dose. See Figure A. Use drinking water only. Do not use any other drink or food to prepare the dose.
Step 2. Prepare the medicine
Figure B Figure C	Add the prescribed number of tablets to the water. See Figure B. Swirl the cup gently for 1 to 2 minutes to disperse the tablets. The medicine will be cloudy. Take care not to spill any of the medicine. See Figure C. Check that the medicine is ready. If there are any lumps of tablets, swirl the cup until they are gone.
If you spill any medicine, clean up the spill. Throw away the rest of the prepared medicine and make a new dose. You must give the dose of medicine within 30 minutes of preparing the dose. If it has been more than 30 minutes, wash away all the dose in the cup using water and prepare a new dose of medicine.
Giving the medicine Step 3. Give the medicine
Figure D	Make sure that the child is upright. Give all the prepared medicine to the child. See Figure D. Add another 5 mL of drinking water to the cup, swirl, and give it all to the child. Repeat if any medicine remains in the cup to make sure the child gets the full dose.
Figure E Figure F	Place the tip of the syringe into the prepared medicine and draw up all the medicine into the syringe by pulling up on the plunger. See Figure E. Place the tip of the syringe against the inside of the infant’s cheek. Gently push down the plunger to give the dose slowly. See Figure F. Add another 5 mL of drinking water to the cup and swirl. Draw up the remaining medicine into the syringe and give it all to the infant. Repeat if any medicine remains in the syringe to make sure the infant gets the full dose. Allow time for the medicine to be swallowed.
Cleaning Up Step 4. Clean the dosing items
Figure G Figure H	Wash the cup with water. See Figure G. Pull the plunger out of the syringe and wash the syringe parts separately with water. Allow parts to dry completely before reassembling and storing. See Figure H. All parts will need to be clean before preparing the next dose.
Storing TIVICAY PD Store TIVICAY PD tablets for oral suspension at room temperature below 86°F (30°C). Store TIVICAY PD tablets for oral suspension in the original bottle. Keep the bottle tightly closed and protect from moisture. The bottle 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 PD and all medicines out of the reach of children.
Disposing of TIVICAY PD When all the tablets in the bottle have been taken or are no longer needed, throw away the bottle, cup, and syringe based on your local household waste guidelines. You will get a new cup and syringe in your next pack.
Manufactured for: ViiV Healthcare Durham, NC 27701
Trademarks are owned by or licensed to the ViiV Healthcare group of companies. ©2026 ViiV Healthcare group of companies or its licensor. TVC: 4IFU
This Instructions for Use has been approved by the U.S. Food and Drug Administration.	Revised: 8/2026