dasatinib

Generic Name: dasatinib (da SAT in ib)Brand Names: Sprycel

What is dasatinib?

Dasatinib is a cancer medication that slows the growth and spread of cancer cells in the body.

Dasatinib is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) when other cancer treatments have not been effective.

Dasatinib may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about dasatinib?

Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using dasatinib, tell your doctor if you have liver disease, low levels of potassium or magnesium in your blood, heart disease or a heart rhythm disorder, or if you have a personal or family history of "Long QT syndrome."

Do not crush, chew, or break a dasatinib tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

There are many other medicines that can interact with dasatinib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Dasatinib can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

What should I discuss with my health care provider before taking dasatinib?

You should not use dasatinib if:

• you have not first received a medication called imatinib (Gleevec); or

• if you are pregnant or planning to become pregnant during treatment with dasatinib.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using dasatinib, tell your doctor if you have:

• liver disease;

• low levels of potassium or magnesium in your blood;

• heart disease or a heart rhythm disorder; or

• a personal or family history of "Long QT syndrome."

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use dasatinib without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are taking dasatinib, whether you are a man or a woman. Dasatinib use by either parent may cause birth defects. If you are a man taking dasatinib, use a condom during any sexual activity.

It is not known whether dasatinib passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Taking dasatinib may affect your ability to have children whether you are a man or a woman. Talk to your doctor about your specific risk.

Dasatinib tablets contain lactose. Talk to your doctor before using this medication if you are lactose-intolerant.

How should I take dasatinib?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medicine is usually taken once in the morning and once in the evening. Follow your doctor's instructions. You may take the medication with or without food.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Do not crush, chew, or break a dasatinib tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. Do not use a tablet that has been accidentally broken. The medicine from a crushed or broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If you must handle a broken tablet, ask your doctor or pharmacist how to safely handle and dispose of the tablet.

Dasatinib can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Store dasatinib at room temperature away from moisture and heat.

See also: Dasatinib dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a dasatinib overdose are unknown.

What should I avoid while taking dasatinib?

Avoid using antacids without your doctor's advice while you are taking dasatinib. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb dasatinib.

If you take an antacid, take it at least 2 hours before or 2 hours after taking dasatinib.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Dasatinib side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• pale skin, weakness;

• easy bruising or bleeding (nosebleeds, bleeding gums);

• fever, chills, body aches, flu symptoms;

• black, bloody, or tarry stools;

• vomit that looks like blood or coffee grounds;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• swelling in your hands, ankles, or feet; or

• uneven heartbeats.

Less serious side effects may include:

• headache, tiredness;

• mild skin rash;

• nausea, vomiting, stomach pain, diarrhea; or

• muscle or joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dasatinib Dosing Information

Usual Adult Dose for Leukemia:

Chronic phase CML: Initial dose: 100 mg once dailyAccelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL: Initial dose: 140 mg/day administered orally in two divided doses (70 mg twice daily), one in the morning and one in the evening with or without a mealTablets should not be crushed or cut. They should be swallowed whole.In clinical studies, treatment with dasatinib was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment after the achievement of a complete cytogenetic response has not been investigated.

What other drugs will affect dasatinib?

Before taking dasatinib, tell your doctor if you are using any of the following drugs:

• a blood thinner such as warfarin (Coumadin);

• fentanyl (Actiq, Duragesic, Fentora)

• heart rhythm medication;

• nefazodone (Serzone);

• rifabutin (Mycobutin);

• rifampin (Rifater, Rifamate, Rimactane)

• dexamethasone (Decadron, Hexadrol);

• St. John's wort;

• cisapride (Propulsid), pimozide (Orap);

• quinidine (Cardioquin, Quinidex, Quinaglute);

• sirolimus (Rapamune), tacrolimus (Prograf);

• cyclosporine (Neoral, Sandimmune, Gengraf);

• HIV medicine such as atazanavir (Reyataz), indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase), nelfinavir (Viracept);

• ketoconazole (Nizoral) or itraconazole (Sporanox);

• antibiotics such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), telithromycin (Ketek), or clarithromycin (Biaxin);

• seizure medication such as carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton);

• ergot medicine such as methysergide (Sansert), ergotamine (Ergomar), dihydroergotamine (D.H.E., Migranal Nasal Spray); or

• stomach acid reducers such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), rabeprazole (Aciphex), or ranitidine (Zantac).

This list is not complete and there may be other drugs that can interact with dasatinib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about dasatinib.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.08. Revision Date: 08/03/2009 10:54:42 AM.