1 What is Tasigna?

Brand: Tasigna

Generic: Nilotinib

Tasigna is an antineoplastic used for the treatment of different types of leukemia. Leukemia is a type of cancer wherein there is an overproduction of abnormal white blood cells.

This drug interferes with the growth of cancer cells. Normal cells may also be affected by this drug. Discuss with your healthcare professional about the possible benefits and risks of this drug before you begin treatment with it. This drug requires a prescription.

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2 What to Know Before Using

Before using Tasigna, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies regarding the correlation of age to the effects of Tasigna have not been performed while safety and efficacy have not been established. Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of nilotinib.

Risks to the fetus have been reported in studies of pregnant women but this may be outweighed by the benefits of therapy in a life threatening situation or a serious disease. Infant risk is still undetermined when using this drug during breastfeeding.

Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as Drugs that inhibit or induce Cytochrome P450 3A4 enzymes, Ketoconazole, Rifampicin, Drugs that affect Gastric pH, Drugs that inhibit drug transport systems, or Drugs that may prolong the QT Interval.

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your doctor if you have any other medical problems such as:

3 Proper Usage

Proper usage of Tasigna requires strict adherence to your doctor’s orders. Take this drug on an empty stomach at least 1 hour before or 2 hours after a meal.

The capsule must be swallowed whole with water. The capsules can be opened and the contents can be sprinkled in one teaspoon of applesauce if you have trouble swallowing the capsule. Sprinkling the TasignaВ® on other foods is not recommended.

This mixture must be taken immediately within 15 minutes and should not be stored for later use. If you are taking a stomach drug, take it at least 10 hours before or 2 hours after taking nilotinib. Take this drug at least 2 hours before or 2 hours after if you are taking an antacid that contains aluminum, magnesium, or simethicone.

Eating grapefruit or drinking grapefruit juice is not recommended while you are using this drug as these may change the amount of this drug that is absorbed in the body. The dose of this drug will be variable for different patients.

The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. For the treatment of Ph+ CML-CP and CML-AP in adults, it is recommended to take 400 milligrams two times a day, with about 12 hours between the two doses.

Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional. For the treatment of newly diagnosed Ph+ CML-CP in adults, it is recommended to take 300 milligrams two times a day, with about 12 hours between the two doses. Your healthcare professional may adjust your dose if necessary.

Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Tasigna, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests. This drug has teratogenic potential and it is recommended to use effective forms of birth control to prevent pregnancy.

Inform your healthcare professional immediately if you think you have become pregnant while using this drug. This drug can cause changes in the heart rhythm which can manifest as fast, pounding, or irregular heartbeats. Your healthcare professional will check your heartbeat with an ECG test before, during, and 7 days after starting treatment with this drug.

Cardiovascular problems, such as decreased blood flow to the legs, heart, or brain have been associated with the use of this drug. Check with your healthcare professional immediately if you have chest pain or discomfort, numbness or weakness, change in the color of the legs, leg pain, or problems with walking or speaking.

This drug can cause leukopenia which can increase the chance of getting an infection. This drug can cause thrombocytopenia which can interfere with proper blood clotting.

It is recommended to avoid people with infections. Check with your healthcare professional 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 healthcare professional 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 health care professional, dentist, or nurse may recommend other ways to clean your teeth and gums.

Check with your medical health care professional before having any dental work done. It is not recommended to 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.

It is recommended to limit yourself from contact sports or other situations where bruising or injury can happen. Check with your healthcare professional immediately if have symptoms of a liver problem such as pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin.

Tumor lysis syndrome has been associated with the use of this drug and your healthcare professional may give you a drug to help prevent this. Call your healthcare professional immediately if you have a decrease or change in urine amount, 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.

Inform your healthcare professional immediately if you have symptoms of edema such as bloating or swelling of the face, arms, hands, lower legs, or feet, rapid weight gain, or trouble breathing.

Consult with your healthcare professional before you take any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Tasigna.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • 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 urinatio
  • Irregular heartbeat
  • Recurrent 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
  • Skin rash or itching
  • 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
  • Yellow eyes or ski
  • Coma
  • Decreased urine output
  • Dizziness
  • Fast heartbeat
  • Muscle cramps in the hands, arms, feet, legs, or face
  • Nervousness
  • Numbness and tingling around the mouth, fingertips, or lips
  • Rapid weight gain
  • Tremor
  • 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
  • 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
  • White patches with diaper rash
  • Pain or swelling of the treated skin
  • Rapid, or shallow breathing

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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