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What is a Notice of Compliance with Conditions (NOC/c)?

An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada.

Products approved under Health Canada’s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.
 

This leaflet is part III of a three-part "Product Monograph" published when SPRYCEL was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about SPRYCEL. Contact your doctor or pharmacist if you have any questions about the drug.

About this medication

What the medication is used for:

SPRYCEL (dasatinib) is used to treat adults who have

• newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
• Ph+ CML who are no longer benefiting from other available therapies for CML, including imatininb mesylate (Gleevec^®).
• a particular form of Ph+ acute lymphoblastic leukemia (ALL)

What it does:

Chronic myeloid leukemia or CML is one form of leukemia. In CML, myeloid white blood cells multiply in an uncontrolled manner. It may take years for CML to progress because it is a slow-growing or chronic cancer. There are three phases of CML: chronic phase, accelerated phase, and blast crisis phase. As CML progresses, patients advance through these phases.

Ph+ acute lymphoblastic leukemia or Ph+ ALL is another form of leukemia. Acute leukemias progress faster than chronic leukemias. In Ph+ ALL, lymphoblastic white blood cells multiply in an uncontrolled manner.

The active ingredient of SPRYCEL is dasatinib. Dasatinib acts by inhibiting the activity of proteins within the leukemia cells of patients with CML. These proteins are responsible for the uncontrolled growth of the leukemia cells.

When it should not be used:

• If you have a history of allergic reactions to dasatinib or to any other ingredients in SPRYCEL (See the “What the important non-medicinal ingredients are” section of this leaflet for a complete list of ingredients in SPRYCEL). Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.

What the medicinal ingredient is:

The active ingredient of SPRYCEL is dasatinib.

What the nonmedicinal ingredients are:

Croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.

What dosage forms it comes in:

SPRYCEL (dasatinib) is available in film coated tablets for oral administration in strengths 20, 50, 70, 80, 100 and 140 mg dasatinib (as monohydrate).

Warnings & Precautions

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

• are pregnant or planning to become pregnant. SPRYCEL may harm the fetus when given to a pregnant woman. Women should avoid becoming pregnant while undergoing treatment with SPRYCEL.
• are breast-feeding. It is not known if SPRYCEL can pass into your breast milk or if it can harm your baby. Do not breast-feed if you are taking SPRYCEL.
• are a sexually active male. Men who take SPRYCEL are advised to use a condom to avoid pregnancy in their partner.
• have a liver problem.
• Have a heart problem, such as arrhythmia, long QT syndrome (a hereditary disorder of the heart electrical rhythm).
• 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

Interactions with this medication

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.

Proper use of this medication

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 grape fruit juice since it may increase the blood levels of SPRYCEL.

Overdose:

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.

Side effects and what to do about them

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 side effects with unknown frequency

• 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.
   

Based on ongoing monitoring after the approval of SPRYCEL, the following events have been reported: inflammation of the lungs, blood clots in the blood vessels, irregular heart rhythm, and deaths from gastrointestinal bleeding.  These events may or may not have been related to SPRYCEL

Serious side effects, how often they happen & what to do about them

This is not a complete list of side effects. For any unexpected effects while taking SPRYCEL, contact your doctor or pharmacist.

How to store it

SPRYCEL (dasatinib) tablets should be stored at room temperature between 15°–30° C. Keep out of the reach and sight of children.

Do not use SPRYCEL after the expiry date which is stated on the label, blister or carton after EXP.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Bristol-Myers Squibb Canada, at 1-866-463-6267.

This leaflet was prepared by Bristol-Myers Squibb Canada.

Last revised: 26 July 2011

* SPRYCEL is a TM of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada.

Other brands listed are the trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.