Sprycel (Dasatinib)

Usual dose:

The usual dose for chronic phase CML is 100 mg once a day, either in the morning or in the evening.

The usual dose for accelerated or blast crisis CML or Ph+ALL is 140 mg once daily, either in the morning or in the evening.

The tablets should be swallowed whole, not crushed. They can be taken with or without food. Try to take SPRYCEL at the same time each day.

Avoid taking grapefruit juice since it may increase the blood levels of SPRYCEL.

Overdose:

In case of drug overdosage, contact a healthcare practitioner (e.g. doctor) hospital emergency department or regional poison control centre, even if there are no symptoms.

Missed dose:

If you miss a dose of SPRYCEL, take your next scheduled dose at its regular time. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.

Most patients taking SPRYCEL will experience some mild to moderate side effects. Most side effects can be managed by your doctor through additional medications, dose adjustments, or other measures.

The following information describes the most important side effects of which you must be aware. It is not a comprehensive list of all side effects recorded in clinical trials with SPRYCEL. You should report any unusual symptoms to your doctor.

Common side effects of SPRYCEL therapy include diarrhea, fever, headache, fatigue, nausea, skin rash, shortness of breath, cough, vomiting, pain, stomach pain, infection, upper respiratory tract infection, muscle aches, joint aches, and bone and extremity pain.

Other important common side effects include:

• Low Blood Counts: As with many leukemia drugs, therapy with SPRYCEL can be associated with low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your doctor will monitor your blood counts frequently after you start SPRYCEL, and may adjust your dose of SPRYCEL or withhold the drug temporarily in the event your blood counts drop too low, or administer additional supportive medicines to help your body regain normal blood levels. In the most severe cases, you may need to receive transfusions of red blood cells or platelets. If you develop a fever while your blood counts are depressed, you should notify your doctor immediately.
• Bleeding: Therapy with SPRYCEL may be associated with bleeding from a variety of sources. The most serious bleeding events observed in clinical studies included bleeding from the gastrointestinal tract and, bleeding into the brain. Bleeding into the brain resulted in the death of nine patients (less than 1% of all patients in clinical trials). The serious bleeding events were associated with very low platelet counts. Less severe bleeding events included bleeding from the nose, the gums, bruising of the skin and excessive menstrual bleeding. Your doctor will monitor your blood counts regularly, but you should notify your physician immediately should you experience bleeding or easy bruising, no matter how mild.
• Fluid Retention: Therapy with SPRYCEL may be associated with fluid building up under the skin of your lower extremities and around your eyes. In more severe cases, fluid may accumulate in the lining of your lungs, the sac around your heart, or your abdominal cavity. If you experience swelling, weight gain, or increasing shortness of breath it could be the result of fluid retention and you should report these events immediately to your doctor. Your doctor can manage fluid retention in a variety of ways while you are receiving SPRYCEL.
• Heart Rhythm Change: SPRYCEL has the potential to induce changes in heart rhythm in susceptible individuals who have certain inherited cardiac syndromes, take medication to control heart rhythm, or are prone to low levels of potassium or magnesium in their blood. Your doctor can assess your risk by reviewing the complete list of medications that you are taking and by monitoring the potassium and magnesium levels in your blood and electrocardiogram.

Other important uncommon side effects include:

• Liver Toxicity: Liver problems such as liver inflammation and increased liver enzyme levels

Other important rare side effects include:

• Pulmonary Arterial Hypertension (increase in blood pressure in the arteries supplying the lungs): SPRYCEL has been associated with an increase in blood pressure in the arteries supplying the lungs. Your doctor will assess your lung and heart function before and during the treatment of SPRYCEL.
• Severe Reaction Involving Skin and Other Organs: A serious skin reaction known as Stevens-Johnson syndrome has been reported with SPRYCEL. Very rarely, severe forms of this reaction may lead to death. Serious cases of another skin reaction known as erythema multiforme have also been reported with SPRYCEL. Stop taking the drug and seek immediate medical attention if you develop any combination of fever, sore mouth or throat, and blistering and/or peeling of your skin or mucous membranes (Stevens-Johnson syndrome) or raised red or purple skin patches with itching, burning pustular eruption (erythema multiforme).

BEFORE you use SPRYCEL talk to your doctor or pharmacist if you:

• are pregnant or planning to become pregnant. SPRYCEL can harm the fetus when given to a pregnant woman. Women should not become pregnant while undergoing treatment with SPRYCEL.

• are breast-feeding. Do not breast-feed if you are taking SPRYCEL.

• are a sexually active male or female. Men and women who take SPRYCEL are advised to use highly effective contraception.

• have a liver problem.

• have a heart problem, such as arrhythmia, long QT syndrome (a hereditary disorder of the heart electrical rhythm).

• have ever had or might now have a hepatitis B infection (an infection of the liver). This is because SPRYCEL could cause the hepatitis B virus to become active again, which can be fatal in some cases. Your doctor will check for signs of this infection before treatment with SPRYCEL is started. If the hepatitis B virus is found, you will be monitored closely during and for several months after treatment with SPRYCEL.

• are lactose intolerant or have been diagnosed with an intolerance to some sugars.

• are taking medicines to thin the blood or prevent clots. SPRYCEL may cause bleeding.

Talk to you doctor or pharmacist if you have:

• muscle aches/pains or weakness, or dark-colored urine

SPRYCEL may interact with other drugs, including those you take without a prescription. You must tell your doctor or pharmacist about all drugs, including prescription and non-prescription drugs, herbal products (e.g. St. John's Wort) and supplements you are taking or planning to take before you take SPRYCEL.

• Examples of medicines that increase the level of SPRYCEL in your bloodstream include ketoconazole, SPORANOX (itraconazole), erythromycin, BIAXIN (clarithromycin).
• Examples of medicines that decrease the amount of SPRYCEL in your bloodstream include dexamethasone, phenytoin, carbamazepine, rifampicin, and phenobarbital.
• Examples of a medicine whose blood levels might be altered by SPRYCEL include SANDIMMUNE/NEORAL (cyclosporine), simvastatin.

The absorption of SPRYCEL from your stomach into your bloodstream is best accomplished in the presence of stomach acid. You should avoid taking medicines that reduce stomach acid such as cimetidine, famotidine, ranitidine, or omeprazole while taking SPRYCEL. Medicines that neutralize stomach acid, such as aluminium hydroxide/magnesium hydroxide, calcium carbonate or calcium carbonate and magnesia may be taken up to 2 hours before or 2 hours after SPRYCEL.

Since SPRYCEL therapy may be associated with bleeding events, tell your doctor if you are regularly using blood thinners, including medications such as warfarin sodium or aspirin.