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Nilotinib is available as a 50 mg, 150 mg, and 200 mg oral capsule.

Nilotinib is a tyrosine kinase inhibitor that is used to treat Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

Nilotinib is a tyrosine kinase inhibitor (TKI). It blocks a certain protein in your body called BCR-ABL tyrosine kinase. This protein is only found on cancer cells like those of CML and not on normal, healthy cells. It causes the cancer cells to grow and multiply. By blocking this protein, it kills cancer cells and stops their spread.

Nilotinib is dosed as follows:

Adults:

• For newly-diagnosed Ph+ CML, the typical starting dose is 300 mg by mouth twice a day (about 12 hours apart)
• If you’ve taken a similar medication before that didn’t work to treat your cancer, the typical dose of Nilotinib is 400 mg by mouth twice a day

Children:

• Dosing will depend on the child’s body surface area (BSA), which takes into account their height and weight. Dosage starts from 50 mg to 400 mg by mouth twice a day (about 12 hours apart)
• Your dose might differ if you’re taking certain medications that interact with Tnilotinib, you’ve had your stomach surgically removed, or if you have liver problems

Nilotinib is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have hypokalemia, hypomagnesemia, or long QT syndrome.

Common side effects of Nilotinib:

• Rash
• Nausea
• Headache
• Tiredness
• Itchy skin
• Vomiting
• Diarrhea
• Fever
• Cold-like symptoms
• Cough
• Sweating at night
• Constipation
• Joint pain
• Pain in arms or legs

Serious side effects are rare with Nilotinib. Contact your healthcare provider immediately if you experience any of the following.

• Irregular heartbeat: fast heartbeat, chest discomfort, dizziness, fainting
• Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool
• Heart problems: chest pain, racing heart, shortness of breath, swelling of legs or feet, sudden weight gain, fatigue
• Stroke: weakness on one side of body, severe headache, problems with vision or speech, confusion
• Abnormal electrolyte levels and kidney problems: racing heart, muscle cramps or spasms, numbness, nausea, vomiting, dark urine, not urinating as much as usual, pain on either side of the lower back

The following medications may interact with Nilotinib:

• Strong CYP3A Inhibitors: Avoid concomitant use with Nilotinib, or reduce
• Nilotinib dose if coadministration cannot be avoided.
• Strong CYP3A Inducers: Avoid concomitant use with Nilotinib
• Proton Pump Inhibitors: Use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors

Various FDA-approved generic manufacturers

Nilotinib can harm your unborn baby. Tell your healthcare provider right away if you are pregnant, or if you become pregnant during treatment with Nilotinib.

In females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Nilotinib.
• Use effective birth control (contraception) during treatment with Nilotinib and for 14 days after the last dose.

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