Dasatinib (Oral Route)

CML is a disease in which your body makes too many abnormal white blood cells, which can cause you to become sick more often and to feel weak or tired. Dasatinib helps your body stop making these abnormal white blood cells.

Dasatinib is also used to treat other conditions such as Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Before you begin treatment with dasatinib, 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 usually used in patients who have already taken other cancer medicines (e.g., imatinib [GleevecA®]).

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

This product is available in the following dosage forms:

• Tablet

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 dasatinib 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 dasatinib in the elderly. However, some elderly patients may be more sensitive than younger adults to the effects of dasatinib.

Pregnancy

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

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.

• Atazanavir


• Carbamazepine


• Cimetidine


• Clarithromycin


• Dexamethasone


• Esomeprazole


• Famotidine


• Indinavir


• Itraconazole


• Ketoconazole


• Lansoprazole


• Nefazodone


• Nelfinavir


• Nizatidine


• Omeprazole


• Pantoprazole


• Phenobarbital


• Phenytoin


• Rabeprazole


• Ranitidine


• Rifabutin


• Rifampin


• Ritonavir


• Saquinavir


• St John`s Wort


• Telithromycin


• Voriconazole

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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Calcium


• Calcium Carbonate


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Simvastatin


• Sodium Bicarbonate

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.

• 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:

• Anemia or


• Bleeding problems or


• Edema (fluid retention or swelling) or


• Heart rhythm problems (e.g., QTc prolongation)a€”Use with caution. May make these conditions worse.

• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood)a€”These conditions should be treated first before taking dasatinib.

• Infectiona€”Dasatinib may decrease your body`s ability to fight infection.

• Lactose intolerancea€”Use with caution. This medicine contains lactose .

• Liver diseasea€”Use with caution. Effects may be increased because of slower removal of dasatinib from the body .

Proper Use

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Keep using this medicine for as long as your doctor has told you to. Do not change your dose or stop taking this medicine without first talking with your doctor .

You may take this medicine with or without food.

Swallow the tablet whole. Do not crush, break, or chew it.

Grapefruits and grapefruit juice may increase the effects of dasatinib by increasing the amount of this medicine in your body . You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

If you are using antacids (e.g., aluminum hydroxide, magnesium hydroxide, MaaloxA®, TumsA®, or RolaidsA®), take it at least 2 hours before or 2 hours after you take dasatinib.

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 (tablets):
  
  
  
  • For the treatment of chronic phase CML:
    
    
    
    • Adultsa€”100 milligrams (mg) once a day given either in the morning or in the evening. Your doctor may adjust your dose as needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For the treatment of accelerated or blast crisis CML or Ph+ ALL:
    
    
    
    • Adultsa€”140 milligrams (mg) per day given in two divided doses (70 mg two times a day, one in the morning and one in the evening). Your doctor may adjust your dose as needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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

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

Using this medicine while you are pregnant can harm your unborn baby . If you think you have become pregnant while using the medicine, tell your doctor right away.

Use an effective form of birth control to keep from getting pregnant . Some forms of birth control include condoms, diaphragms, or birth control pills. Men using this medicine should use a condom to avoid pregnancy in their partner .

Dasatinib 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 or vitamin supplements.

Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Dasatinib may cause fluid retention. Check with your doctor right away if you have a decrease in amount of urine; noisy or rattling breathing; shortness of breath; swelling of the fingers, hands, feet, or lower legs; troubled breathing at rest; or weight gain.

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

• Bloody or black, tarry stools


• Body aches or pain


• Burning, tingling, numbness or pain in the hands, arms, feet, or legs


• Chest pain


• Constipation


• Coughing up blood


• Cough or hoarseness


• Decrease in the amount of urine


• Difficulty with breathing


• Dizziness


• Ear congestion


• Fainting


• Fast, slow, or irregular heartbeat


• Fever or chills


• Full or bloated feeling


• Headache


• Loss of voice


• Lower back or side pain


• Nasal congestion


• Noisy or rattling breathing


• Painful or difficult urination


• Pale skin


• Paralysis


• Pressure in the stomach


• Runny nose


• Sensation of pins and needles


• Severe stomach pain


• Shortness of breath


• Sneezing


• Sore throat


• Stabbing pain


• Swelling of the abdominal or stomach area


• Swelling of the face, fingers, hands, feet, or lower legs


• Tightness in the chest


• Troubled breathing


• Ulcers, sores, or white spots in the mouth


• Unsteadiness or awkwardness


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vomiting of blood or material that looks like coffee grounds


• Weakness in the arms, hands, legs, or feet


• Weight gain


• Wheezing

Less common

• Bloating


• Blue lips and fingernails


• Chest discomfort


• Coughing that sometimes produces a pink frothy sputum


• Decreased urine output


• Difficult or fast breathing


• Dilated neck veins


• Increased sweating


• Irregular breathing


• Irregular heartbeat


• Nausea


• Swelling


• Swelling in the legs and ankles

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

• Abdominal or stomach pain


• Bleeding gums


• Cracked lips


• Diarrhea


• Difficulty with moving


• Difficulty with swallowing


• Increased menstrual flow or vaginal bleeding


• Itching skin


• Lack or loss of strength


• Loss of appetite


• Muscle aching or cramping


• Muscle or bone pain


• Muscle stiffness


• Nose bleeds


• Pain


• Pain in the joints


• Prolonged bleeding from cuts


• Red or dark brown urine


• Skin rash


• Swelling or inflammation of the mouth


• Swollen joints


• Vomiting


• Weight loss

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.