es were conducted with DOVATO. The drug interactions described arebased on studies conducted with dolutegravir or lamivudine when administered alone [seeClinical Pharmacology (12.3)]. Information regarding potential drug interactions withDOVATO are provided in Table 5. These recommendations are based on either drug interactiontrials or predicted interactions due to the expected magnitude of interaction and potential forserious adverse events or loss of efficacy [see Contraindications (4), Clinical Pharmacology(12.3)].
Table 5. Established and Other Potentially Significant Drug Interactions for DOVATO:
Alterations in Dose May Be Recommended Based on Drug Interaction Trials or
Predicted Interactions
Coadministered Drug Class:
Drug Name
Effect on
Concentration Clinical Comment
Antiarrhythmic:
Dofetilide
Dofetilide Coadministration is
contraindicated with DOVATO
[see Contraindications (4)].
Anticonvulsant:
Carbamazepinea
Dolutegravir An additional dolutegravir 50-mg
dose should be taken, separated
by 12 hours from DOVATO [see
Dosage and Administration
(2.3)].
Anticonvulsants:
Oxcarbazepine
Phenytoin
Phenobarbital
Dolutegravir Avoid coadministration with
DOVATO because there are
insufficient data to make dosing
recommendations.
Antidiabetic:
Metformina
Metformin Refer to the prescribing
information of metformin for
assessing the benefit and risk of
concomitant use of DOVATO
and metformin.
Antimycobacterial:
Rifampina
Dolutegravir An additional 50-mg dose of
dolutegravir should be taken,
separated by 12 hours from
DOVATO [see Dosage and
Administration (2.3)].
Herbal Product:
St. John’s wort (Hypericum
perforatum)
Dolutegravir Avoid coadministration with
DOVATO because there are
insufficient data to make dosing
recommendations.
Medications containing
polyvalent cations
(e.g., Mg or Al):
Cation-containing antacidsa
or
laxatives
Sucralfate
Buffered medications
Dolutegravir Administer DOVATO 2 hours
before or 6 hours after taking
medications containing
polyvalent cations.
Oral calcium and iron
supplements, including
multivitamins containing calcium
or irona
Dolutegravir 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.
Sorbitola Lamivudine When possible, avoid use of
sorbitol-containing medicines
with DOVATO.
= Increase, = Decrease.
a
See Clinical Pharmacology (12.3) Table 8 or Table 9 for magnitude of interaction.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposedto DOVATO during pregnancy. Healthcare providers are encouraged to register patients bycalling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
Risk Summary
Preliminary data from an observational study have identified a possible increased risk of neuraltube defects when dolutegravir, a component of DOVATO, is administered at the t |
