[Posted 10/11/2011] ISSUE: FDA notified healthcare professionals that dasatinib (Sprycel) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting dasatinib, including after more than one year of treatment.
Information about this risk has been added to the Warnings and Precautions section of the dasatinib drug label.
BACKGROUND: Dasatinib is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).
RECOMMENDATION:Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting dasatinib and also during treatment. If PAH is confirmed, dasatinib should be permanently discontinued. For more information visit the FDA website at: [Web] and [Web].
What is this medicine?
DASATINIB (da SA ti nib) is a chemotherapy drug. It targets specific proteins within cancer cells and stops the cancer cells from growing. It is used to treat some kinds of leukemia.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
Avoid taking antacids containing aluminum, calcium, or magnesium within 2 hours of taking this medicine. You can take such antacids up to 2 hours before or 2 hours after this medicine. Avoid taking all other medicines that reduce stomach acid.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take your next scheduled dose at its regular time. Do not take double or extra doses. Talk to your doctor if you are not sure what to do.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular check ups. Report any side effects. Continue your course of treatment unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.
Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.
This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.
Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine. Males who take this medicine should use a condom to avoid pregnancy in their partner.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep tightly closed. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
The Healthline Site, its content, such as text, graphics, images, search results, HealthMaps, Trust Marks,
and other material contained on the Healthline Site ("Content"), its services, and any information or material
posted on the Healthline Site by third parties are provided for informational purposes only. None of the
foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek
the advice of a physician or other qualified healthcare provider with any questions you may have regarding a
medical condition. Never disregard professional medical advice or delay in seeking it because of something you
have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately.
Please read the Terms of Service
for more information regarding use of the Healthline Site.
