nstructions for Use).
Neurotoxicity
Advise patients to notify their healthcare provider if they experience new or worseningneurotoxicity. Advise patients not to drive or operate hazardous machinery if they areexperiencing neurologic adverse reactions [see Warnings and Precautions (5.1)].
Hepatotoxicity
Advise patients that they will need to undergo laboratory tests to monitor liver function[see Warnings and Precautions (5.2)].
Embryo-Fetal Toxicity
Advise males and females of reproductive potential of the potential risk to a fetus [see Warningsand Precautions (5.3), Use in Specific Populations (8.1)].
Advise females of reproductive potential to inform their healthcare provider of a known orsuspected pregnancy and to use effective contraception during the treatment with VITRAKVIand for at least 1 week after the final dose [see Use in Specific Populations (8.3)].
Advise males with female partners of reproductive potential to use effective contraception duringtreatment with VITRAKVI and for at least 1 week after the final dose [see Use in SpecificPopulations (8.3)].
Lactation
Advise women not to breastfeed during treatment with VITRAKVI and for 1 week following thefinal dose [see Use in Specific Populations (8.2)].
Infertility
Advise females of reproductive potential that VITRAKVI may impair fertility [See NonclinicalToxicology (13.1)].
Drug Interactions
Advise patients and caregivers to inform their healthcare provider of all concomitantmedications, including prescription medicines, over-the-counter drugs, vitamins, and herbalproducts. Inform patients to avoid St. John’s wort, grapefruit or grapefruit juice while takingVITRAKVI [see Drug Interactions (7.1, 7.2)].
Manufactured for:
Loxo Oncology, Inc.
Stamford, CT 06901
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf |
