For HIV-1. See Full Indication.
DOSING AND DRUG INTERACTIONS FOR TIVICAY AND TIVICAY PD
*Rilpivirine dose is 25 mg once daily for those switching to dolutegravir plus rilpivirine and must be taken with food.
†Administer TIVICAY or TIVICAY PD 2 hours before or 6 hours after taking antacids, polyvalent cation-containing products or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY and supplements containing calcium or iron can be taken with food.
DTG: AN INSTI WITH FLEXIBILITY
IN PRESCRIBING OPTIONS
‡For adults and pediatric patients 4 weeks and older weighing at least 3 kg.
§With rilpivirine 25 mg for adults who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen for ≥6 months.
ARV=antiretroviral; DTG=dolutegravir; INSTI=integrase strand transfer inhibitor.
Pregnancy testing is recommended before initiation of TIVICAY or TIVICAY PD in adolescents and adults of childbearing potential
Dosing recommendations for TIVICAY tablets in combinations with other ARV agents in adult patients
1 tablet (50 mg),
once daily
Treatment-naïve or treatment-experienced INSTI-naïve or virologically suppressed (HIV-1 RNA <50 copies/mL) adults switching to dolutegravir plus rilpivirineǁ
1 tablet (50 mg),
twice daily
Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with certain UGT1A or CYP3A inducers
1 tablet (50 mg),
twice daily
INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance¶
IIRilpivirine dose is 25 mg once daily for those switching to dolutegravir plus rilpivirine and must be taken with a meal.
¶Alternative combinations that do not include metabolic inducers should be considered where possible.
TIVICAY PD tablets and TIVICAY tablets are not interchangeable on a milligram-per-milligram basis due to differing pharmacokinetic profiles
Recommended dosage of TIVICAY PD tablets in combination with other ARV agents in pediatric patients 4 weeks and older weighing 3 kg to <14 kg
5 mg (one 5-mg tablet), once daily#
3 kg to <6 kg
15 mg (three 5-mg tablets), once daily#
6 kg to <10 kg
20 mg (four 5-mg tablets), once daily#
10 kg to <14 kg
TIVICAY PD tablets for oral suspension may be swallowed whole or dispersed in drinking water.
For pediatric patients weighing ≥14 kg, administer either TIVICAY PD tablets or TIVICAY tablets. Do not administer TIVICAY tablets in patients weighing <14 kg. See recommendations below
Recommended dosage of TIVICAY PD tablets in combination with other ARV agents in pediatric patients 4 weeks and older weighing ≥14 kg
25 mg (five 5-mg tablets), once daily#
14 kg to <20 kg
30 mg (six 5-mg tablets), once daily#
≥20 kg
TIVICAY PD tablets for oral suspension may be swallowed whole or dispersed in drinking water.
Recommended dosage of TIVICAY tablets in combination with other ARV agents in pediatric patients 4 weeks and older weighing ≥14 kg
40 mg (four 10-mg tablets), once daily#
14 kg to <20 kg
50 mg (one 50-mg tablet), once daily#
≥20 kg
Do not interchange TIVICAY and TIVICAY PD on a milligram-per-milligram basis due to differing pharmacokinetic profiles.
#If certain UGT1A or CYP3A inducers are coadministered, then administer TIVICAY PD or TIVICAY twice daily (see Drug Interactions [7.2 and 7.3] in the Prescribing Information).
Dosing considerations with other medications
Dofetilide
Coadministration is contraindicated with TIVICAY or TIVICAY PD
Metabolic inducers (eg, efavirenz, fosamprenavir/r, tipranavir/r, rifampin, or carbamazepine)
Adjust dose of TIVICAY to 50 mg twice daily in treatment-naïve or treatment-experienced, INSTI-naïve adult patients
In pediatric patients, increase the weight-based dose of TIVICAY or TIVICAY PD to twice daily (see dosing recommendations for pediatric patients)
Use alternative combinations that do not include metabolic inducers where possible for INSTI-experienced patients with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance**
Medications containing polyvalent cations (eg, Mg or AI):
- Cation-containing antacids or laxatives
- Sucralfate
- Buffered medications
Administer TIVICAY or TIVICAY PD 2 hours before or 6 hours after taking medications containing polyvalent cations
Oral calcium or iron supplements, including multivitamins containing calcium or iron
When taken with food, TIVICAY and supplements or multivitamins containing calcium or iron can be taken at the same time. Under fasting conditions, TIVICAY or TIVICAY PD should be taken 2 hours before or 6 hours after taking supplements containing calcium or iron
Oxcarbazepine, phenytoin, phenobarbital, St John’s wort (Hypericum perforatum)
Avoid coadministration with TIVICAY or TIVICAY PD because there are insufficient data to make dosing recommendations
Metformin
Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of TIVICAY or TIVICAY PD and metformin
Etravirine
Use of TIVICAY or TIVICAY PD with etravirine without coadministration of atazanavir/r, darunavir/r, or lopinavir/r is not recommended
Nevirapine
Avoid coadministration with nevirapine because there are insufficient data to make dosing recommendations
Potassium channel blocker: Dalfampridine
Elevated levels of dalfampridine increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with TIVICAY or TIVICAY PD should be considered against the risk of seizures in these patients
**The lower dolutegravir exposures observed in INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) upon coadministration with certain inducers may result in loss of therapeutic effect and development of resistance to TIVICAY or other coadministered ARV agents.
Al=aluminum; Mg=magnesium; r=ritonavir.
TIVICAY and TIVICAY PD have no known clinically relevant effects on the pharmacokinetics of the following agents based on available drug interaction studies2
Prednisone
Midazolam
Rilpivirine
Rifabutin
Oral contraceptives containing
norgestimate and
ethinyl estradiol
Proton pump inhibitors (omeprazole)
Please see the Drug Interactions table above for additional drug interaction information
TIVICAY and TIVICAY PD have no known clinically relevant effects on the pharmacokinetics of the following agents based on metabolic pathways and/or available drug interaction studies3,4
Hepatitis C drugs
Sofosbuvir5
Ledipasvir/sofosbuvir6,7
Simeprevir8
Elbasvir/grazoprevir9,10††
Daclatasvir plus sofosbuvir5,11,12
Ombitasvir/paritaprevir/r
plus dasabuvir13,14
Sofosbuvir/velpatasvir15
Sofosbuvir/velpatasvir/
voxilaprevir16
Glecaprevir/pibrentasvir17
Sofosbuvir5
Ledipasvir/sofosbuvir6,7
Simeprevir8
Elbasvir/grazoprevir9,10††
Daclatasvir plus sofosbuvir5,11,12
Ombitasvir/paritaprevir/r
plus dasabuvir13,14
Sofosbuvir/velpatasvir15
Sofosbuvir/velpatasvir/
voxilaprevir16
Glecaprevir/pibrentasvir17
††From Section 7.4 of the full Prescribing Information for TIVICAY and TIVICAY PD.
References: 1. Min S, Song I, Borland J, et al. Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2010;54(1):254-258. 2. Data on file, ViiV Healthcare. 3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. Department of Health and Human Services. Accessed July 16, 2020. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. 4. HCV guidance: recommendations for testing, managing, and treating hepatitis C. American Association for the Study of Liver Diseases and Infectious Diseases Society of America. Accessed July 16, 2020. https://www.hcvguidelines.org/unique-populations/hiv-hcv. 5. Luetkemeyer AF, McDonald C, Ramgopal M, et al. 12 weeks of daclatasvir in combination with sofosbuvir for HIV-HCV coinfection (ALLY-2 study): efficacy and safety by HIV combination antiretroviral regimens. Clin Infect Dis. 2016;62(12):1489-1496. 6. Garrison K, Custodio J, Pang P, et al. Drug interactions between anti-HCV antivirals ledipasvir/sofosbuvir and integrase strand transfer inhibitor-based regimens [abstract 71]. Presented at:16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; May 26-28, 2015; Washington, DC. 7. Harvoni [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017. 8. Olysio [package insert]. Titusville, NJ: Janssen Therapeutics; 2017. 9. Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015;2(8):e319-e327. 10. Yeh W, Feng HP, Guo Z, et al. Drug-drug interaction between HCV inhibitors grazoprevir/elbasvir with dolutegravir [abstract 522]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 23-26, 2015; Seattle, WA. 11. Song I, Jerva F, Zong J, et al. Evaluation of drug interactions between dolutegravir and daclatasvir in healthy subjects [abstract 79]. Presented at: 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; May 26-28, 2015; Washington, DC. 12. Daklinza [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2017. 13. Khatri A, Trinh R, Zhao W, et al. Drug-drug interactions of ombitasvir/paritaprevir/r plus dasabuvir with dolutegravir or abacavir plus lamivudine. Presented at: Clinical Pharmacology of HIV and Hepatitis Therapy; May 26-28, 2015; Washington, DC. 14. Viekira Pak [package insert]. North Chicago, IL: AbbVie Inc.; 2018. 15. Epclusa [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017. 16. Vosevi [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017. 17. Mavyret [package insert]. North Chicago, IL: AbbVie Inc.; 2019.
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