Nilotinib

Nilotinib

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

  • Abdominal or stomach pain or tenderness
  • Black, tarry stools
  • Bleeding gums
  • Blood in the urine or stools
  • Blurred vision
  • Bone pain
  • Clay colored stools
  • Confusion
  • Convulsions
  • Cough or hoarseness
  • Dark urine
  • Decreased appetite
  • Difficult or labored breathing
  • Dry mouth
  • Fainting
  • Fever or chills
  • Flushed, dry skin
  • Fruit-like breath odor
  • Headache
  • Increased hunger
  • Increased thirst
  • Increased urination
  • Irregular heartbeat, recurrent
  • Itching
  • Loss of appetite
  • Lower back or side pain
  • Muscle aches, cramps, or pain
  • Nausea and vomiting
  • 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
  • Shortness of breath
  • Skin rash
  • Sore throat
  • Stuffy or runny nose
  • Sweating
  • Swelling of the hands, ankles, feet, or lower legs
  • Tightness in the chest
  • Trembling
  • Troubled breathing with exertion
  • 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
  • Wheezing
  • Yellow eyes or skin

Less common

  • Coma
  • Decreased urine output
  • Dizziness
  • Fast heartbeat
  • Mood or mental changes
  • Muscle cramps in the hands, arms, feet, legs, or face
  • Nervousness
  • Numbness and tingling around the mouth, fingertips, or lips
  • Tremor

Less common or rare

  • Bladder pain
  • Bloody or cloudy urine
  • Body aches or pain
  • Constipation
  • Cough producing mucus
  • Depressed mood
  • Difficult, burning, or painful urination
  • Dry skin and hair
  • Ear congestion
  • Feeling cold
  • Frequent urge to urinate
  • Hair loss
  • Loss of voice
  • Muscle stiffness
  • Nasal congestion
  • 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 with sleeping
  • Trouble with swallowing
  • Weight gain
  • Weight loss
  • White patches in the mouth or throat or on the tongue
  • White patches with diaper rash

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
  • Lack or loss of strength
  • Muscle spasms
  • Pain in the arms or legs
  • Pain in the joints
  • Pus at the root of the hair
  • Swollen joints

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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Check with your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

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 immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately 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.

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 (St. John’s wort) or vitamin supplements.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

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. Ask your pharmacist for the medication guide if you do not have one.

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, the capsules can be opened and the contents can be sprinkled in one teaspoon of applesauce. This mixture must be taken immediately within 15 minutes.

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) two times a day, with about 12 hours between the two doses. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For the treatment of newly diagnosed Ph+ CML-CP:
      • Adults—300 milligrams (mg) two times a day, with about 12 hours between the two doses. Your doctor may adjust your dose as needed.
      • Children—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.

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 the pediatric population. 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

  • Dronedarone
  • Posaconazole

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.

  • Arsenic Trioxide
  • Atazanavir
  • Carbamazepine
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Crizotinib
  • Dexamethasone
  • Dexlansoprazole
  • Dofetilide
  • Droperidol
  • Esomeprazole
  • Gatifloxacin
  • Ibutilide
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lansoprazole
  • Lapatinib
  • Levofloxacin
  • Lumefantrine
  • Mesoridazine
  • Methadone
  • Midazolam
  • Moxifloxacin
  • Nefazodone
  • Nelfinavir
  • Omeprazole
  • Paliperidone
  • Pantoprazole
  • Pazopanib
  • Phenobarbital
  • Phenytoin
  • Pimozide
  • Quetiapine
  • Quinidine
  • Rabeprazole
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • Sodium Phosphate
  • Sotalol
  • St John’s Wort
  • Sunitinib
  • Telavancin
  • Telithromycin
  • Toremifene
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Voriconazole
  • Ziprasidone

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:

  • Blood or bone marrow problems (e.g., anemia, neutropenia, thrombocytopenia) or
  • Heart disease 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
  • Pancreatitis (inflammation of the pancreas), history of—Use with caution. May make these conditions worse.
  • Heart rhythm problems (e.g., 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.

Description

Nilotinib belongs to the group of medicines called antineoplastics. It is used to treat a type of cancer called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) and accelerated phase (AP) after other treatments, such as imatinib (Gleevec®), have failed. CML is a disease where your body makes too many abnormal white blood cells. This can cause you to become sick more often and to feel weak or tired. Nilotinib helps your body stop making these abnormal white blood cells.

This medicine is also used to treat newly diagnosed chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML-CP).

Nilotinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, 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 good this medicine will do as well as the possible risks of using it.

This medicine is available only with your doctor’s prescription.

Leave a Reply