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Nilotinib Oral capsule

It targets a specific protein within cancer cells and stops the cells from growing

Generic Name: nilotinib  |  Brand Name: Tasigna

Brand Names: Tasigna

There is an FDA Alert for this drug. Click here to view it.

    QT Interval Prolongation and Sudden Death
  • Prolongs QT interval. ECG monitoring recommended at baseline, 7 days after initiation, following any dosage adjustments, and periodically thereafter. (See Prolongation of QT Interval under Cautions.)
  • Sudden deaths reported in patients receiving nilotinib.
  • Contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypokalemia or hypomagnesemia prior to administration; periodically monitor electrolytes.
  • Avoid concomitant administration of drugs known to prolong the QT interval and potent CYP3A4 inhibitors. (See Interactions.)
  • Avoid food 2 hours before and 1 hour after taking dose. (See Absorption under Pharmacokinetics.)
  • Dosage reduction recommended in patients with hepatic impairment. (See Hepatic Impairment under Cautions and also under Dosage and Administration.)

REMS:

FDA approved a REMS for nilotinib to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of nilotinib and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

NILOTINIB (nil OT i nib) is a chemotherapy drug. It targets a specific protein within cancer cells and stops the cells from growing. This medicine is used to treat chronic myelogenous leukemia (CML).

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • heart disease
  • history of irregular heartbeat
  • history of pancreatitis
  • liver disease
  • low magnesium or potassium levels in the body
  • QT prolongation
  • total gastrectomy
  • an unusual or allergic reaction to nilotinib, lactose, gelatin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food or with grapefruit juice. Take H2-blockers at least 10 hours before or 2 hours after this medicine. Avoid taking antacids within 2 hours of taking this medicine. Do not cut, crush, or chew this medicine. If you cannot swallow the capsules whole, you may open the capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce. Immediately swallow the mixture. Do not store for future use.

Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, do not make up the missing dose. Take your next dose as scheduled. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • amoxapine
  • astemizole
  • bupivacaine
  • cisapride
  • clozapine
  • cyclobenzaprine
  • disopyramide
  • droperidol
  • flecainide
  • grapefruit or grapefruit juice
  • halofantrine
  • haloperidol
  • maprotiline
  • methadone
  • perphenazine
  • pimozide
  • quinidine
  • ranolazine
  • risperidone
  • sunitinib
  • tacrolimus
  • terfenadine
  • thioridazine
  • ziprasidone

This medicine may also interact with the following medications:

  • antacids
  • antiviral medicines for HIV or AIDS
  • certain antibiotics like clarithromycin, erythromycin, telithromycin, troleandomycin
  • dexamethasone
  • medicines for blood pressure, heart disease, irregular heart beat
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for fungal infections like ketoconazole, itraconazole, voriconazole, fluconazole
  • medicines for seizures like carbamazepine, phenobarbital, phenytoin
  • medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole
  • medicines for sleep
  • mifepristone
  • propoxyphene
  • rifabutin
  • rifampin
  • rifapentine
  • St. John's Wort
  • tamoxifen
  • warfarin
  • zafirlukast


Last Updated: July 12, 2013
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