الأدوية والمكملات الغذائية

Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change the dose or stop using this medicine without checking first with your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

It is best to take this medicine on an empty stomach (at least 1 hour before or 2 hours after a meal).

Swallow the capsule whole with water. If you have trouble swallowing the capsule, open it and sprinkle the contents in one teaspoon of applesauce (puréed apple). Do not sprinkle Tasigna® on other foods. This mixture must be taken right away within 15 minutes and should not be stored for later use.

If you are taking an H2 blocker medicine (eg, famotidine), take it at least 10 hours before or 2 hours after using nilotinib.

If you are taking an antacid that contains aluminum, magnesium, or simethicone, take it at least 2 hours before or 2 hours after using nilotinib.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of the medicine that is absorbed in 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 form (capsules):
  • For the treatment of Ph+ CML-CP and CML-AP after other treatments have failed:
    • Adults—400 milligrams (mg) 2 times a day, at least 12 hours apart. Your doctor may adjust your dose as needed.
    • Children 1 year of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 230 milligrams per squared meter (mg/m2) of BSA, taken 2 times a day, at least 12 hours apart.
      • BSA of 1.64 meter squared (m2) or more—400 mg 2 times a day.
      • BSA of 1.42 to 1.63 m2—350 mg 2 times a day.
      • BSA of 1.20 to 1.41 m2—300 mg 2 times a day.
      • BSA of 0.98 to 1.19 m2—250 mg 2 times a day.
      • BSA of 0.77 to 0.97 m2—200 mg 2 times a day.
      • BSA of 0.55 to 0.76 m2—150 mg 2 times a day.
      • BSA of 0.33 to 0.54 m2—100 mg 2 times a day.
      • BSA of 0.32 m2 or less—50 mg 2 times a day.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.
  • For the treatment of newly diagnosed Ph+ CML-CP:
    • Adults—300 milligrams (mg) 2 times a day, at least 12 hours apart. Your doctor may adjust your dose as needed.
    • Children 1 year of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 230 milligrams per squared meter (mg/m2) of BSA, taken 2 times a day, at least 12 hours apart.
      • BSA of 1.64 meter squared (m2) or more—400 mg 2 times a day.
      • BSA of 1.42 to 1.63 m2—350 mg 2 times a day.
      • BSA of 1.20 to 1.41 m2—300 mg 2 times a day.
      • BSA of 0.98 to 1.19 m2—250 mg 2 times a day.
      • BSA of 0.77 to 0.97 m2—200 mg 2 times a day.
      • BSA of 0.55 to 0.76 m2—150 mg 2 times a day.
      • BSA of 0.33 to 0.54 m2—100 mg 2 times a day.
      • BSA of 0.32 m2 or less—50 mg 2 times a day.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.