nilotinib tartrate 71 mg tablet

Generic name:
Nilotinib tablet - oral

Pronunciation
(nye-LOE-ti-nib)

Brand name(s)
Danziten

Nilotinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Do not use nilotinib if you have a certain heart problem (long QT syndrome). Before using nilotinib, tell your doctor or pharmacist of all the drugs you take and if you have certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), or family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Do not use nilotinib if you have low levels of potassium or magnesium in the blood.

To lower your risk, your doctor will order certain blood tests (potassium/magnesium levels) and a heart test (EKG) before and during treatment with nilotinib. Get medical help right away if you have fast/irregular heartbeat, severe dizziness, or fainting.

Nilotinib is used to treat a certain type of blood cancer (chronic myelogenous leukemia-CML). It works by slowing or stopping the growth of cancer cells.

Read the Medication Guide provided by your pharmacist before you start using nilotinib and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily (about 12 hours apart). Swallow the tablet whole with water. Do not cut, crush, or chew the tablets.

If you have trouble swallowing the tablet whole, place it in a cup with 1 to 2 teaspoonfuls of room temperature liquid (such as water, milk, apple/pineapple/cranberry juice). After 1 minute, swirl the cup before swallowing the mixture. Take the medication within 15 minutes of mixing.

Nilotinib may come in different forms (such as tablet, disintegrating tablet, capsule). Do not switch between different forms without consulting your doctor.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Medications that reduce stomach acid (such as antacids, proton pump inhibitors/PPIs, H2 blockers) may make nilotinib work less well. Do not take PPIs (such as lansoprazole, omeprazole) while using this medication. If you take antacids, take them 2 hours before or 2 hours after nilotinib. If you take H2 blockers (such as famotidine, nizatidine), take them 10 hours before or 2 hours after nilotinib.

The dosage is based on your medical condition, response to treatment, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

See also Warning section.

Nausea, vomiting, headache, tiredness, constipation, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following serious symptoms:

• unusual tiredness
• pale skin
• signs of infection (such as sore throat that doesn't go away, fever, chills)
• easy bruising/bleeding (such as bloody/black stool)

Nilotinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain
• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

Tell your doctor right away if you have any serious side effects, including:

• severe stomach/abdominal pain
• toe/joint pain
• swelling hands/ankles/feet
• unusual/rapid weight gain
• symptoms of high blood sugar (such as increased thirst/urination)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Get medical help right away if you have any very serious side effects, including:

• signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)
• signs of bleeding in the brain (such as sudden severe headache, sudden vision changes, confusion, loss of consciousness)
• signs of blood circulation disease (such as numbness/pain in the legs, leg pain with physical activity, decrease in walking distance)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking nilotinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• pancreatitis
• heart disease (such as coronary artery disease, chest pain, heart attack)
• high blood pressure
• high cholesterol
• diabetes
• stroke (including "mini-strokes" or transient ischemic attacks)
• blood circulation disease (peripheral arterial disease)
• blood vessel disease (hardening of the arteries/atherosclerosis)
• stomach surgery (such as gastrectomy)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Nilotinib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using nilotinib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation. See also Warning section.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nilotinib. Nilotinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about the use of reliable forms of birth control during treatment and for 14 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 14 days after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of nilotinib from your body, which may affect how nilotinib works. Examples include apalutamide, macrolide antibiotics (such as clarithromycin), butalbital, enzalutamide, lumacaftor/ivacaftor, mitotane, rifamycins (such as rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include bosutinib, elacestrant, ensartinib, flibanserin, lefamulin, lemborexant, nirogacestat, repotrectinib, rilzabrutinib, taletrectinib, tolvaptan, zidesamtinib, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: vomiting, drowsiness.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, EKG, blood mineral levels, liver function, lipase levels, uric acid level, cholesterol level, blood sugar) should be done while you are taking this medication.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.