Description
Nilotinib is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults and children who are newly diagnosed. It is also given to adults and children with Ph+ CML in chronic phase (CP) or accelerated phase (AP) who have taken other medicines (eg, imatinib, tyrosine-kinase inhibitor) but did not work well. Leukemia is a type of cancer where the body makes too many abnormal white blood cells.
Nilotinib belongs to the general group of medicines known as antineoplastics or cancer medicines. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by nilotinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern.
Before you begin treatment with nilotinib, you and your doctor should talk about the benefits this medicine will do as well as the possible risks of using it.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of nilotinib in children younger than 1 year of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nilotinib 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.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Dronedarone
- Flibanserin
- Fluconazole
- Levoketoconazole
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Nelfinavir
- Piperaquine
- Posaconazole
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Varicella Virus Vaccine, Live
- Ziprasidone
- Zoster Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Acalabrutinib
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfentanil
- Alfuzosin
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asciminib
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Avapritinib
- Azithromycin
- Bacillus of Calmette and Guerin Vaccine, Live
- Bedaquiline
- Benzhydrocodone
- Berotralstat
- Boceprevir
- Bosutinib
- Brigatinib
- Budesonide
- Buprenorphine
- Buserelin
- Capivasertib
- Captopril
- Carbamazepine
- Carvedilol
- Ceritinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
- Pioglitazone
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- food
- Grapefruit Juice
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:
- Ascites (abnormal build-up of water in the stomach) or
- Bleeding problems or
- Blood or bone marrow problems (eg, anemia, neutropenia, thrombocytopenia) or
- Fluid retention or
- Heart or blood vessel problems (eg, congestive heart failure, heart attack, ischemic heart disease, pericardial effusion, peripheral arterial occlusive disease, slow heartbeat, stroke), or history of or
- Hyperkalemia (high potassium in the blood) or
- Hypocalcemia (low calcium in the blood) or
- Hyponatremia (low sodium in the blood) or
- Hypophosphatemia (low phosphate in the blood) or
- Lung disease (eg, pleural effusion, pulmonary edema) or
- Pancreatitis (inflammation of the pancreas), history of—Use with caution. May make these conditions worse.
- Heart rhythm problems (eg, long QT syndrome) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood)—Should not be used in patients with these conditions.
- Lactose intolerance—Use with caution. This medicine contains lactose.
- Liver disease—Use with caution. The effects may be increased because of slower removal of nilotinib from the body.
- Total gastrectomy (surgery that involves the removal of the entire stomach)—The effects of nilotinib may be decreased in patients who had this procedure.
Proper Use
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.
- For the treatment of Ph+ CML-CP and CML-AP after other treatments have failed:
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.
Precautions
If you will be taking this medicine for a long time, it is very important that your doctor check you and your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 14 days after the last dose to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine can cause changes in the heart rhythm, including a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Tell your doctor right away if you or your child have a fast, pounding, or irregular heartbeat. Your doctor will check your heartbeat with an ECG test (electrocardiogram) before, during, and 7 days after starting treatment with nilotinib.
After at least 3 years of treatment with this medicine, your doctor may do certain tests to check if you continue to show no symptoms of your cancer (remission) and may let you stop taking it. This is called treatment free remission (TFR). However, you may need to restart treatment, at a later time, if you are no longer in remission.
This medicine may cause heart or blood vessel problems, including decreased blood flow to the legs, heart, or brain. Check with your doctor right away if you or your child have chest pain or discomfort, numbness or weakness, change in the color of the legs, leg pain, or problems with walking or speaking.
Nilotinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you or your child get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
Pancreatitis and other pancreas problems may occur while you are using this medicine. Check with your doctor right away if you or your child have sudden and severe stomach pain with nausea and vomiting.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you or your child a medicine to help prevent this. Call your doctor right away if you or your child have a decrease or change in the amount of your urine, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
This medicine may cause fluid retention (edema). Tell your doctor right away if you or your child have bloating or swelling of the face, arms, hands, lower legs, or feet, rapid weight gain, or trouble breathing.
This medicine may affect your child's growth and development. Talk to your doctor if you have concerns.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- bone pain
- chest tightness
- chills
- clay-colored stools
- confusion
- cough
- dark urine
- decreased appetite
- difficult or labored breathing
- dry mouth
- fainting
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- hoarseness
- increased hunger
- increased thirst
- increased urination
- irregular heartbeat, recurrent
- itching, skin rash
- loss of appetite
- lower back or side pain
- muscle aches, cramps, or pain
- nausea
- no blood pressure
- no breathing
- no pulse
- numbness, tingling, pain, or weakness in the hands or feet
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- seizures
- sore throat
- stomach pain or tenderness
- stuffy or runny nose
- sweating
- swelling of the hands, ankles, feet, or lower legs
- trembling
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness and heaviness of the legs
- yellow eyes or skin
Less common
- Decreased urine output
- dizziness
- fast heartbeat
- loss of consciousness
- muscle cramps in the hands, arms, feet, legs, or face
- nervousness
- numbness and tingling around the mouth, fingertips, or lips
- rapid weight gain
- tremor
Less common or rare
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- constipation
- cough producing mucus
- depressed mood
- dry skin and hair
- ear congestion
- feeling cold
- frequent urge to urinate
- hair loss
- loss of voice
- muscle stiffness
- pain or tenderness around the eyes and cheekbones
- sensitivity to heat
- slowed heartbeat
- sneezing
- swelling or puffiness of the face
- tender, swollen glands in the neck
- trouble sleeping
- trouble swallowing
- weight changes
- white patches in the mouth or throat or on the tongue
Incidence not known
- Pain or swelling of the treated skin
- rapid, shallow breathing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- burning, itching, and pain in hairy areas
- diarrhea
- difficulty with moving
- joint pain or swelling
- lack or loss of strength
- muscle spasms
- pain in the arms or legs
- pus at the root of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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