Tivicay PD (Page 9 of 9)

ViiV Healthcare Company 4 May 2022

14.3 Pediatric Subjects

IMPAACT P1093 is an ongoing Phase 1/2, multicenter, open-label trial to evaluate the pharmacokinetic parameters, safety, tolerability, and efficacy of TIVICAY or TIVICAY PD in combination treatment regimens in HIV-1–infected infants, children, and adolescents aged at least 4 weeks to 18 years. Subjects were stratified by 5 age cohorts: Cohort 1, aged 12 to less than 18 years; Cohort 2A, aged 6 to less than 12 years; Cohort 3, aged 2 to less than 6 years; Cohort 4, aged 6 months to less than 2 years; and Cohort 5, aged 4 weeks to less than 6 months. Seventy-five subjects received the recommended dose (determined by weight and age) of TIVICAY or TIVICAY PD [see Dosage and Administration (2.3, 2.4, 2.5)].

These 75 subjects had a median age of 27 months (range: 1 to 214), were 59% female, and 68% were black or African American. At baseline, mean plasma HIV-1 RNA was 4.4 log₁₀ copies per mL, median CD4+ cell count was 1,225 cells per mm³ (range: 1 to 8,255), and median CD4+% was 23% (range: 0.3% to 49%). Overall, 33% had baseline plasma HIV-1 RNA greater than 50,000 copies per mL and 12% had a CDC HIV clinical classification of category C. The majority (80%) of subjects were treatment-experienced, but all were INSTI-naïve. Most subjects had previously used at least 1 NNRTI (44%) or 1 PI (76%).

Virologic outcomes from IMPAACT P1093 include subjects who received either TIVICAY tablets or TIVICAY PD tablets for oral suspension as per the dosing recommendations for their weight band and who had reached Week 24 (n = 58) or Week 48 (n = 42). At Week 24, 62% of subjects achieved HIV-1 RNA less than 50 copies per mL and 86% achieved HIV-1 RNA less than 400 copies per mL (Snapshot algorithm). The median CD4 count (percent) increase from baseline to Week 24 was 105 cells per mm³ (5%). At Week 48, 69% of subjects achieved HIV-1 RNA less than 50 copies per mL and 79% achieved HIV-1 RNA less than 400 copies per mL (Snapshot algorithm). The median CD4 count (percent) increase from baseline to Week 48 was 141 cells per mm³ (7%).

16 HOW SUPPLIED/STORAGE AND HANDLING

TIVICAY tablets, 10 mg, are white, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “10” on the other side. Bottle of 30 tablets with child-resistant closure and containing a desiccant. NDC 49702-226-13.

Store and dispense the 10-mg tablets in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.

TIVICAY tablets, 25 mg, are pale yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “25” on the other side. Bottle of 30 tablets with child-resistant closure. NDC 49702-227-13.

TIVICAY tablets, 50 mg, are yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “50” on the other side. Bottle of 30 tablets with child-resistant closure. NDC 49702-228-13.

Store TIVICAY tablets at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

TIVICAY PD tablets for oral suspension, 5 mg, are white, round, strawberry cream flavored, film-coated, biconvex tablets debossed with “SV H7S” on one side and “5” on the other side. Bottle of 60 tablets with child-resistant closure containing a desiccant. Each bottle is packaged with one 30-mL dosing cup and one 10-mL oral dosing syringe with 1-mL gradations. NDC 49702-255-37.

Store TIVICAY PD tablets for oral suspension below 30°C (86°F). Store and dispense the 5-mg tablets in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Drug Interactions

TIVICAY or TIVICAY PD may interact with other drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John’s wort [see Contraindications (4), Warnings and Precautions (5.4), Drug Interactions (7)].

Hypersensitivity Reactions

Advise patients to immediately contact their healthcare provider if they develop rash. Instruct patients to immediately stop taking TIVICAY or TIVICAY PD and other suspect agents, and seek medical attention if they develop a rash associated with any of the following symptoms, as it may be a sign of a more serious reaction such as severe hypersensitivity: fever; generally ill feeling; extreme tiredness; muscle or joint aches; blisters or peeling of the skin; oral blisters or lesions; eye inflammation; facial swelling; swelling of the eyes, lips, tongue, or mouth; breathing difficulty; and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools or bowel movements, nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on the right side below the ribs) [see Warnings and Precautions (5.1)].

Hepatotoxicity

Inform patients that hepatotoxicity has been reported with dolutegravir [see Warnings and Precautions (5.2)]. Advise patients that laboratory monitoring for hepatoxicity during therapy with TIVICAY or TIVICAY PD is recommended, especially for patients with liver disease, such as hepatitis B or C.

Embryo-Fetal Toxicity

Advise adolescents and adults of childbearing potential, including those actively trying to become pregnant, to discuss the risks and benefits of TIVICAY and TIVICAY PD with their healthcare provider to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy. If pregnancy is confirmed in the first trimester, advise patients to contact their healthcare provider [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Adolescents and adults of childbearing potential taking TIVICAY or TIVICAY PD should be counseled on the consistent use of effective contraception [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any signs or symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when TIVICAY or TIVICAY PD is started [see Warnings and Precautions (5.5)].

Different Formulations Are Not Bioequivalent

Advise patients that TIVICAY and TIVICAY PD are not bioequivalent and are not interchangeable on a milligram-per-milligram basis. Advise patients or their care provider that patients switching from one formulation to the other must adjust the dose for the new dosage formulation [see Dosage and Administration (2.3) and Warnings and Precautions (5.6)].

Pregnancy Registry

Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in those exposed to TIVICAY or TIVICAY PD during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)].

Administration Instructions

To avoid a dosing error from using the wrong formulation of dolutegravir, strongly advise patients and caregivers to visually inspect the tablets to verify the correct formulation each time the prescription is filled [see Dosage and Administration (2), Warnings and Precautions (5.6), How Supplied/Storage and Handling (16)].

Inform patients and caregivers that TIVICAY PD tablets for oral suspension may be swallowed whole or dispersed in drinking water and should not be chewed, cut or crushed. The amount of water needed to disperse the tablet will depend on the dose (number of tablets prescribed).

Instruct patients and caregivers that if a dose of TIVICAY or TIVICAY PD is missed, to take it as soon as they remember. Advise patients and caregivers not to double the next dose or take more than the prescribed dose [see Dosage and Administration (2)].

Storage

Instruct patients and caregivers to store the TIVICAY 10-mg tablets and TIVICAY PD 5-mg tablets for oral suspension in the original package, keep the bottle tightly closed, and protect from moisture. Do not remove desiccant [see How Supplied/Storage and Handling (16)].

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

The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the ViiV Healthcare group of companies. The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products.

Manufactured for:

ViiV Healthcare

Research Triangle Park, NC 27709

by:

GlaxoSmithKline

Research Triangle Park, NC 27709

TVC:17PI

PHARMACIST‑DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

PATIENT INFORMATION
TIVICAY (TIV-eh-kay) (dolutegravir) tablets		TIVICAY PD (TIV-eh-kay Pe De) (dolutegravir) tablets for oral suspension
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.
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 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. Pregnancy Registry. There is a pregnancy registry for individuals who take antiretroviral medicines, including TIVICAY and TIVICAY PD, 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 or TIVICAY PD. • 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 or TIVICAY PD 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 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. • Take TIVICAY or TIVICAY PD with or without food. • 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. • 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? • 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:
	• 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.
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. Manufactured for: by: ViiV Healthcare GlaxoSmithKline Research Triangle Park, NC 27709 Research Triangle Park, NC 27709 TIVICAY and TIVICAY PD are trademarks owned by or licensed to the ViiV Healthcare group of companies. ©2021 ViiV Healthcare group of companies or its licensor. TVC:12PIL
This Patient Information has been approved by the U.S. Food and Drug Administration.			Revised: 03/2021

INSTRUCTIONS FOR USE
TIVICAY PD (TIV-eh-kay Pe De) (dolutegravir) tablets for oral suspension 5 mg
Read this Instructions for Use before giving a dose of medicine. 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 Always give this medicine exactly as your healthcare provider tells you. Talk to your healthcare provider if you are not sure. 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, call 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:
(click image for full-size original)	• 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
(click image for full-size original) 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
(click image for full-size original) Figure B Figure C	• Add the prescribed number of tablet(s) to the water. See Figure B. • Swirl the cup gently for 1 to 2 minutes to disperse the tablet(s). The medicine will become 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 tablet, 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
(click image for full-size original) 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.
(click image for full-size original) 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 Step 4. Clean the dosing items
(click image for full-size original) 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 in 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.
Storage Information Store TIVICAY PD tablets for oral suspension at room temperature below 86°F (30°C) 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.
Disposal Information When all the tablets in the bottle have been taken or are no longer needed, throw away the bottle, cup, and syringe. Dispose of them using your local household waste guidelines. You will get a new cup and syringe in your next pack.
Manufactured for: ViiV Healthcare Research Triangle Park, NC 27709	by: GlaxoSmithKline Research Triangle Park, NC 27709
Trademark is owned by or licensed to the ViiV Healthcare group of companies. ©2020 ViiV Healthcare group of companies or its licensor. TVC:1IFU
This Instructions for Use has been approved by the U.S. Food and Drug Administration.	Issued: 06/2020

PRINCIPAL DISPLAY PANEL

NDC 49702-255-37

Tivicay PD

(dolutegravir) Tablets for Oral Suspension

5 mg

Rx Only

Tivicay and Tivicay PD are not interchangeable.

Each tablet contains 5 mg of dolutegravir equivalent to 5.26 mg of dolutegravir sodium.

Do not chew, cut, or crush tablet for oral suspension.

Do not accept if membrane seal under cap is missing or broken.

See prescribing information for dosage information.

Contents:

•: 1 Bottle of 60 tablets
•: 1 Oral dosing syringe
•: 1 Dosing cup
•: Prescribing Information
•: Instruction for Use

60 tablets

Made in Japan

Rev. 7/2020

62000000053856

(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 49702-226-13

Tivicay^®

(dolutegravir)

Tablets

Rx Only

10 mg

Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg of dolutegravir.

30 Tablets

Store in original package at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP).

Keep bottle tightly closed; protect from moisture. Do not remove desiccant.

See prescribing information for dosage information.

Manufactured for:

ViiV Healthcare

RTP, NC 27709

by:

GlaxoSmithKline

RTP, NC 27709

Made in Japan

Rev. 5/17

10000000146193

(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 49702-227-13

Tivicay^®

(dolutegravir)

Tablets

Rx Only

25 mg

Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg of dolutegravir.

30 Tablets

Store at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP).

See prescribing information for dosage information.

Manufactured for:

ViiV Healthcare

RTP, NC 27709

by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Japan

Rev. 4/17

10000000146194

(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 49702-228-13

Tivicay^®

(dolutegravir)

Tablets

50 mg

Rx Only

Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir.

30 Tablets

Store at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP).

See prescribing information for dosage information.

Manufactured for:

ViiV Healthcare

RTP, NC 27709

by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Japan

Rev. 6/16

10000000141767

(click image for full-size original)

TIVICAY PD dolutegravir sodium tablet, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49702-255
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOLUTEGRAVIR SODIUM (DOLUTEGRAVIR)	DOLUTEGRAVIR	5 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE DIHYDRATE
CROSPOVIDONE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A CORN
SUCRALOSE
SODIUM STEARYL FUMARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor	STRAWBERRY (Strawberry Cream)	Imprint Code	SV;H75;5
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49702-255-37	1 BOTTLE in 1 CARTON	contains a BOTTLE
1		60 TABLET, FOR SUSPENSION in 1 BOTTLE	This package is contained within the CARTON (49702-255-37)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA213983	06/12/2020

TIVICAY dolutegravir sodium tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49702-226
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOLUTEGRAVIR SODIUM (DOLUTEGRAVIR)	DOLUTEGRAVIR	10 mg

Inactive Ingredients
Ingredient Name	Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A CORN
SODIUM STEARYL FUMARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	SV;572;10
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49702-226-13	30 TABLET, FILM COATED in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204790	06/09/2016

TIVICAY dolutegravir sodium tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49702-227
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOLUTEGRAVIR SODIUM (DOLUTEGRAVIR)	DOLUTEGRAVIR	25 mg

Inactive Ingredients
Ingredient Name	Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A CORN
SODIUM STEARYL FUMARATE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	SV;572;25
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49702-227-13	30 TABLET, FILM COATED in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204790	06/09/2016

TIVICAY dolutegravir sodium tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49702-228
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOLUTEGRAVIR SODIUM (DOLUTEGRAVIR)	DOLUTEGRAVIR	50 mg

Inactive Ingredients
Ingredient Name	Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A CORN
SODIUM STEARYL FUMARATE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	SV;572;50
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49702-228-13	30 TABLET, FILM COATED in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204790	08/13/2013

Labeler — ViiV Healthcare Company (027295585)

Revised: 05/2022 ViiV Healthcare Company

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https://medlibrary.org/lib/rx/meds/tivicay-pd/page/9/

Tivicay PD (Page 9 of 9)

14.3 Pediatric Subjects

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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14.3 Pediatric Subjects

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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