A note about nausea1

  • If women experienced nausea, it was most likely to occur after the first dose. This improved for most patients by the second dose, declining to 3% after subsequent doses
  • The median onset of nausea was within 1 hour postdose and lasted about 2 hours in duration
  • 8% of women taking Vyleesi discontinued due to nausea
  • 13% of Vyleesi patients received antiemetic therapy; consider prescribing an antiemetic for those patients who are bothered by nausea but wish to continue with treatment

Setting patient expectations

Blood pressure1

  • Patients using Vyleesi experienced a transient increase in systolic blood pressure (max increase of 6 mm Hg) and diastolic blood pressure (max increase of 3 mm Hg) that peaked between 2-4 hours post dose; there was a corresponding reduction in heart rate up to 5 beats per minute
  • Blood pressure and heart rate returned to baseline usually within 12 hours post dose
  • Vyleesi is contraindicated in women who have uncontrolled hypertension or known cardiovascular disease
  • Before initiating Vyleesi, consider the patient’s baseline cardiovascular risk and ensure blood pressure is well controlled, and advise patients not to take more than 1 Vyleesi dose within 24 hours

Focal hyperpigmentation1

  • In the clinical trials, focal hyperpigmentation of the face, gingiva, and breasts was reported in 1% of patients who received up to 8 doses per month of Vyleesi compared to no placebo-treated patients
  • In another clinical study, 38% of patients developed focal hyperpigmentation after receiving Vyleesi daily for 8 days; 14% developed new focal pigmentary changes after 8 additional days of treatment
  • Patients with dark skin were more likely to develop focal hyperpigmentation, which did not always resolve following discontinuation of Vyleesi
  • Consider discontinuing Vyleesi if hyperpigmentation develops, and advise patients to take no more than 8 doses per month

Drug interactions1

  • Vyleesi may reduce the rate and extent of absorption of concomitantly administered oral medications, likely due to slowing gastric motility
  • However, with the exception of naltrexone and indomethacin, Vyleesi did not affect absorption of the tested oral medications to a clinically relevant degree
  • Vyleesi may significantly decrease the systemic exposure of orally-administered naltrexone; patients should avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction
  • There were no clinically relevant drug interactions between Vyleesi and oral contraceptives or antidepressants; patients are recommended to use contraception while taking Vyleesi
  • There are no restrictions on alcohol consumption with Vyleesi