Consumer Medicine Information
SPRYCEL® (Spry-sell)
Dasatinib (duh-sat-in-ib)
This leaflet answers some common questions about Sprycel.* It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sprycel against the benefits that are expected. This leaflet does not contain everything about Sprycel. Your doctor has been provided with full information and can answer any questions you may have. Follow your doctor's advice even if it differs from what is in this leaflet.
Please read this leaflet carefully and keep it in a safe place so you may refer to it later.
What SPRYCEL is used for
Sprycel is used to treat adults with chronic myeloid leukaemia (CML). It is also used to treat adults who have a particular form of acute lymphoblastic leukaemia (ALL) called Philadelphia chromosome positive or Ph+ ALL. Leukaemia is a cancer of immature white blood cells, which grow in the bone marrow. Under normal circumstances, as these white blood cells mature, they enter the blood stream where they fight infection and maintain the body's immune system. In leukaemia, these immature white blood cells multiply in an uncontrolled manner, occupying the bone marrow space and spilling out into the bloodstream. As a consequence, the production of normal red blood cells (oxygen carrying cells), white blood cells (cells which fight infection), and platelets (cells which help blood to clot) is compromised. Therefore patients with leukaemia are at risk of developing serious anaemia, infections and bleeding.
It is intended that Sprycel be used in patients who are no longer benefiting from other therapies for these diseases (resistance) or in patients who experience severe side effects to other therapies (intolerance). Ask your doctor if you have any questions about why Sprycel was prescribed for you.
This medicine is available only with a doctor's prescription.
Sprycel is not recommended for use in children as its safety and effectiveness in patients under 18 years of age has not been established.
How SPRYCEL works
The active ingredient in Sprycel is dasatinib. Dasatinib acts by inhibiting the activity of proteins within the leukaemia cells of patients with CML or Ph+ ALL. These proteins are responsible for the uncontrolled growth of the leukaemia cells. By inhibiting these proteins, Sprycel kills the leukaemia cells in the bone marrow and allows normal red cell, white cell and platelet production to resume.
Before you take SPRYCEL
When you must not take Sprycel:
- You must not take Sprycel if you have a history of severe allergic reactions to Sprycel or to any of the ingredients listed at the end of this leaflet.
- Do not take Sprycel if you are pregnant or intend to become
pregnant.
Sprycel may cause harm to the unborn baby if it is given to a pregnant woman. - Do not take Sprycel after the expiry date printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well. - Do not take Sprycel if the packaging is torn or shows signs of tampering.
Before you start to take SPRYCEL
Tell your doctor if you have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes.
Tell your doctor if you are breast-feeding or plan to breast-feed.
It is not known if Sprycel can pass into your breast milk.
Tell your doctor if you are a sexually active man.
Men who take Sprycel are advised to use a condom to avoid pregnancy in
their partner.
Tell your doctor if you have or have had any medical conditions, especially the following:
- liver problem
- heart problem
- lactose intolerant
If you have not told your doctor about any of the above, tell them before you take Sprycel.
Taking other medicines
It is especially important to tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. These medicines may be affected by Sprycel or they may affect how well Sprycel works.
Tell your doctor if you are taking:
- Nizoral® (ketoconazole), Sporanox® (itraconazole), Norvir® (ritonavir), Reyataz® (atazanavir), E-Mycin® (erythromycin) or Klacid® (clarithromycin) all may increase the level of Sprycel in your bloodstream.
- Maxidex® (dexamethasone), Dilantin® (phenytoin), Tegretol® (carbamazepine), Rifadin® (rifampicin), and Phenobarbitone tablets may all decrease the levels of Sprycel in your bloodstream.
- Sprycel may alter the blood levels of Sandimmun® (cyclosporin).
- Blood thinning medicines such as Coumadin® (warfarin sodium), aspirin or non steroidal anti-inflammatory drugs (NSAIDs) taken with Sprycel may increase the risk of unwanted bleeding.
- Oral diabetes medicines from the glitazone family of drugs may interact with Sprycel.
You should avoid taking Tagamet® (cimetidine), Pepcidine® (famotidine), Zantac® (ranitidine) or Probitor® (omeprazole) while taking Sprycel as they all reduce stomach acid, which is necessary for the absorption of Sprycel.
Medicines that neutralise stomach acid, such as Mylanta® (aluminium hydroxide/magnesium hydroxide), Andrews Antacid® (calcium carbonate) or Mylanta® (calcium carbonate and magnesium hydroxide) may be taken up to 2 hours before or 2 hours after Sprycel.
Some medicines may be affected by Sprycel, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Sprycel.
Know the medicines you take. Keep a list of your medicines with you to show your doctor or pharmacist.
How to take SPRYCEL
How much to take:
The usual starting dose for chronic phase CML is 100mg once daily, taken either in the morning or the evening.
Some patients may require an alternative starting dose. Your doctor will decide which dose is most appropriate for you.
How to take it:
Swallow your Sprycel tablet whole with a glass of water. Do not break, cut or crush the tablet.
When to take it:
Try to take Sprycel at the same time each day, with or without a meal, as instructed by your doctor.
How long to take it:
You should not stop taking Sprycel, or reduce the dose without first talking to your doctor. Depending on your response and on any side effects that you may experience, your doctor may adjust your dose of Sprycel, upward or downward, or may temporarily discontinue your medicine.
If you forget to take it:
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 doctor or pharmacist if you are not sure what to do.
If you take too much (overdose):
Immediately telephone your doctor or Poisons Information Centre 0800 POISON or 0800 764 766 in New Zealand or go to the Accident and Emergency Department at your nearest hospital, if you or anyone else may have taken too much Sprycel. Do this even if there are no signs of discomfort or poisoning.
While you are taking SPRYCEL
Things you must do:
- You must tell your doctor immediately if you become pregnant while taking Sprycel.
- Tell all of the doctors, dentists and pharmacists who are treating you that you are taking Sprycel.
- If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Sprycel.
- Tell your doctor immediately if you experience bleeding or easy bruising, no matter how mild.
- Have any tests recommended by your doctor done as soon as possible.
Your doctor may order routine laboratory tests to evaluate your blood counts to see how well Sprycel is working. - Notify your doctor immediately if you develop a fever while taking Sprycel.
Things you must not do:
- Do not give Sprycel to anyone else, even if they have the same condition as you.
- Do not use Sprycel to treat any other complaints unless your doctor tells you to.
- Do not stop taking Sprycel, or lower the dosage, without checking with your doctor.
- Do not stop taking Sprycel tablets because you are feeling better unless advised to do so by your doctor.
Things to be careful of:
- Be careful driving or operating machinery until you know how Sprycel
affects you.
Sprycel has been known to cause dizziness or light-headedness in some people. Make sure that you know how you react to Sprycel before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sprycel. Like all medicines, it is possible that Sprycel may have unwanted side effects in some people. There are many side effects caused by medicines used to treat leukaemia. During treatment with Sprycel you will require close medical supervision.
The more common side effects of Sprycel are:
- headache; dizziness; numbness or tingling in arms, legs, fingers or toes; altered taste
- diarrhoea, nausea, vomiting
- shortness of breath, cough, accumulation of fluid in the lungs, pneumonia, chest pain
- infection, fever
- abdominal pain, bloating, flatulence, constipation, indigestion
- high blood pressure
- mouth ulcers
- skin rash, dermatitis (including eczema), dry skin, itching or peeling skin, flushing
- hair loss
- visual disturbances: blurry or diminished vision, dry eye
- fatigue
- swelling of the liver, abdomen, hands, lower legs or feet
- back pain, bone pain, joint pain, pain in fingers or toes, muscle aches or spasm, muscle weakness
- anorexia, weight decrease
- conjunctivitis
- tinnitus (ringing in the ears)
Tell your doctor immediately if you notice any of the following:
- swelling, weight gain, shortness of breath or chest pain
- swelling around your eyes
- skin infection - folliculitis, herpes
Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following:
- changes in the way your heart beats, for example - if you notice it beating faster
- bleeding - for example from: gastrointestinal tract; eye; nose; gums; serious bruising or excessive menstrual bleeding
- infections - urinary tract; eye infection; difficulty breathing; coughing
- fever
The use of Sprycel is also associated with a reduction in certain types of blood cells in the body:
- a reduction in red blood cells, which may result in fatigue or dizziness
- a reduction in white blood cells, which are used to fight infection
- a reduction in cells that help your blood to clot after injury
These are serious side effects. If you have them you may need urgent medical attention.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Product Description:
What it looks like
| Sprycel 20mg tablet | White to off-white, biconvex, round tablet with "BMS" debossed on one side and "527" on the other |
| Sprycel 50mg tablet | White to off-white, biconvex, round tablet with "BMS" debossed on one side and "528" on the other |
| Sprycel 70mg tablet | White to off-white, biconvex, round tablet with "BMS" debossed on one side and "524" on the other |
Ingredients:
Active Ingredient: dasatinib
Inactive Ingredients: lactose, microcrystalline cellulose,
hydroxypropylcellulose, croscarmellose sodium, magnesium stearate and Opadry
White YS-1-18177-A.
Storage
Keep your tablets in the pack until it is time to take them. If you take the tablets out of the bottle or blister pack they may not keep well.
Keep the pack in a cool dry place where the temperature stays below 30°C
Do not store Sprycel or any other medicine in the bathroom or near a sink.
Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
Return any unused medicine to your pharmacist.
Manufacturer
This product is manufactured in the USA and distributed in New Zealand by:
Bristol-Myers Squibb (NZ) Ltd
Auckland
New Zealand
Sprycel* is manufactured by Bristol-Myers Squibb company USA
Where to get further information
Your doctor is the best person to answer any further questions you may have about Sprycel.
Anything your doctor tells you about Sprycel* should be followed even if it is different from what is in this leaflet.
Date of preparation: 12 June 2009.
*SPRYCEL is a registered trademark of Bristol-Myers Squibb Company.