Tivicay PD (Page 9 of 9)
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
©2021 ViiV Healthcare group of companies or its licensor.
TVC:16PI
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:
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:
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Before you take TIVICAY or TIVICAY PD, tell your healthcare provider about all of your medical conditions, including if you:
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.
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.
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How should I take TIVICAY or TIVICAY PD?
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What are the possible side effects of TIVICAY or TIVICAY PD?
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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?
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 |
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
©2020 ViiV Healthcare group of companies or its licensor.
Made in Japan
Rev. 7/2020
62000000053856
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
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
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
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Labeler — ViiV Healthcare Company (027295585) |
Revised: 07/2021 ViiV Healthcare Company
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