For treatment-naïve and virologically suppressed adults with HIV-1. See Full Indication.
Dosing Of DOVATO
A Complete Regimen Offering Convenient Dosing for Your Adult Patients
ONCE A DAY
TAKEN ANY TIME OF DAY
WITH OR WITHOUT FOOD
Update to Use in Specific Populations (Renal Impairment):
DOVATO is not recommended in patients with creatinine clearance <30 mL/min (previously CrCl <50 mL/min). Because DOVATO is a fixed-dose tablet, it cannot be dose adjusted.
Potential Drug Interactions With DOVATO
Established and Other Potentially Significant Drug to Drug Interactions
AVOID
| Contraindicated |
| Dofetilide |
| Avoid Coadministration | |
| Agent | Recommendations |
Oxcarbazepine Phenobarbital Phenytoin St John's wort (Hypericum perforatum) |
Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations |
| Sorbitol | When possible, avoid use of sorbitol-containing medicines with DOVATO |
- Because DOVATO is a complete regimen, coadministration with other ARVs for the treatment of HIV-1 infection is not recommended
ARVs=antiretrovirals.
CONSIDERATIONS
| Dosing Adjustments and Considerations | |
| Agent | Recommendations |
| Certain UGT1A/CYP3A inducers: carbamazepine or rifampin | An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from DOVATO |
| Metformin |
Refer to the Prescribing Information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin |
| Medications containing polyvalent cations (eg, Mg or Al): cation-containing antacids or laxatives, sucralfate, or buffered medications | Administer DOVATO 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, DOVATO and supplements or multivitamins containing calcium or iron can be taken at the same time. Under fasting conditions, DOVATO should be taken 2 hours before or 6 hours after taking supplements containing calcium or iron |
| Dalfampridine |
Elevated levels of dalfampridine increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with DOVATO should be considered against the risk of seizures in these patients |
- Please see Section 7 of the full Prescribing Information for additional drug interaction information
Al=aluminum; Mg=magnesium.
NO ADJUSTMENTS
Dolutegravir and lamivudine, Components of DOVATO, Have No Clinically Relevant Effects on the Pharmacokinetics of the Following Agents
| Based on available pharmacokinetics drug interaction studies |
|
|
|
| Based on pharmacokinetics, metabolic pathways, and/or available drug interaction studies |
|
Hepatitis C drugs, including1,2: |
|
|
|
Norelgestromin is the active metabolite of norgestimate and no drug interaction is expected with norgestimate.9
References:
- AIDSinfo website. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. Accessed July 16, 2020.
- American Association for the Study of Liver Diseases and Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. https://www.hcvguidelines.org/unique-populations/hiv-hcv. Updated May 24, 2018. Accessed July 16, 2020.
- Harvoni [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017.
- Olysio [package insert]. Titusville, NJ: Janssen Therapeutics; 2017.
- Zepatier [package insert]. Whitehouse Station, NJ: Merck & Co, Inc.; 2018.
- Viekira Pak [package insert]. North Chicago, IL: AbbVie, Inc.; 2018.
- Vosevi [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017.
- Mavyret [package insert]. North Chicago, IL: AbbVie, Inc.; 2018.
- Song IH, Borland J, Chen S, Wajima T, Peppercorn AF, Piscitelli SC. Dolutegravir has no effect on the pharmacokinetics of oral contraceptives with norgestimate and ethinyl estradiol. Ann Pharmacother. 2015;49(7):784–789.
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