Dasatinib (da-SA-ti-nib)

Treats leukemia.

Brand Name(s):

Sprycel

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not cut, crush, break, or chew it.
• Do not handle crushed or broken tablets. Wear disposable gloves if you need to handle broken tablets. This is especially important for pregnant women.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose, and then go back to your regular schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dasatinib works. Tell your doctor if you are using any of the following:
  • Ketoconazole, rifampin, St John's wort
  • Blood thinner
  • Heartburn or stomach medicine (including famotidine, omeprazole)
• If you use an antacid, take it at least 2 hours before or after you take this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective birth control to keep from getting pregnant during treatment with this medicine and for at least 30 days after your last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 30 days after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, heart rhythm problems, or lung or breathing problems. Tell your doctor if you are lactose intolerant.
• This medicine can cause the following problems:
  • Increased risk of bleeding, which may be life-threatening
  • Fluid retention, including pleural effusion (fluid build-up around your lungs)
  • Heart rhythm problems, including QT prolongation
  • Heart or blood vessel problems (including heart attack, stroke)
  • Pulmonary arterial hypertension (high blood pressure in your lungs)
  • Serious skin reactions (including Stevens-Johnson syndrome, erythema multiforme)
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
  • Liver problems
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, or lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Muscle or bone pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Slowed growth in children
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088