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Understanding TIVICAY and TIVICAY PD 
(dolutegravir)

FAQs About TIVICAY and TIVICAY PD

Learning as much as you can about treatment choices can help make conversations with you or your child's healthcare provider even more productive. Below you will find some of the most common questions about HIV-1 treatment and TIVICAY or TIVICAY PD.

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 I TAKE TIVICAY OR TIVICAY PD?

  • Take TIVICAY or TIVICAY PD exactly as your healthcare provider tells you to take it.
  • Take TIVICAY or TIVICAY PD with or without food.
  • For children who cannot swallow tablets, read the Instructions for Use at the end of the 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.
  • Do not change your dose, switch medicines or stop taking TIVICAY or TIVICAY PD without talking with your healthcare provider first.
  • If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, TIVICAY or TIVICAY PD 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 or TIVICAY PD:
    • 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 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?

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 10-mg tablets 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.
  • Store TIVICAY PD 5-mg tablets for oral suspension at room temperature below 86°F (30°C) 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 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 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.