Larotrectinib (Oral Route)

Name: Larotrectinib (Oral Route)

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of larotrectinib in children. Safety and efficacy have been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of larotrectinib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Brain or nerve problems—Use with caution. May make this condition worse.
  • Liver disease, moderate to severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsule, solution):
    • For solid tumors:
      • Adults and children with a body surface area of 1 meter squared (m2) or more—Dose is based on body surface area and must be determined by your doctor. The dose is 100 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
      • Adults and children with a body surface area of less than 1 m2—Dose is based on body surface area and must be determined by your doctor. The dose is 100 milligrams per meter squared (mg/m2) 2 times a day. Your doctor may adjust your dose as needed and tolerated.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If your next regular dose is in 6 hours or less, skip the missed dose and return to your regular dosing schedule.

If you vomit after taking a dose, take the next dose at the regular time.

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