Sprycel 70 mg comprimidos recubiertos con pelicula
Introduction
Product Information for the User
SPRYCEL20Film-Coated Tablets
SPRYCEL50Film-Coated Tablets
SPRYCEL70Film-Coated Tablets
SPRYCEL80Film-Coated Tablets
SPRYCEL100Film-Coated Tablets
SPRYCEL140Film-Coated Tablets
dasatinib
Read this entire product information carefully before starting to take this medicine because it contains important information for you.
- Keep this product information, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section4.
1.What is SPRYCEL and for what it is used
2.What you need to know before starting to take SPRYCEL
3.How to take SPRYCEL
4.Possible adverse effects
5.Storage of SPRYCEL
6.Contents of the package and additional information
1. What is SPRYCEL and how is it used
SPRYCEL contains the active ingredient dasatinib. This medication is used to treat chronic myeloid leukemia (CML) in adults, adolescents, and children at least 1 year of age. Leukemia is a type of cancer of the white blood cells. These white blood cells normally help the body fight infections. In patients with CML, a type of white blood cell called granulocytes begin to multiply uncontrollably. SPRYCEL inhibits the growth of these leukemia cells.
SPRYCEL is also used to treat acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positive (Ph+) in adults, adolescents, and children at least 1 year of age and blast crisis in CML in adults who do not benefit from previous treatments. In patients with ALL, a type of white blood cell called lymphocytes multiply too quickly and live too long. SPRYCEL inhibits the growth of these leukemia cells.
If you have any doubts about how SPRYCEL works or why you have been prescribed this medication, consult your doctor.
2. What you need to know before starting SPRYCEL
Do not take SPRYCEL
- if you areallergicto dasatinib or any of the other ingredients of this medication (listed in section6).
If you think you may be allergic, consult your doctor.
Warnings and precautions
Consult your doctor or pharmacist before starting to take SPRYCEL
- if you are takingblood thinnersor medications to prevent blood clots (see SPRYCEL use with other medications)
- if you have or have had any liver or heart problems
- if you start to experiencedifficulty breathing, chest pain, or coughwhile taking SPRYCEL: this may be a sign of fluid buildup in the lungs or chest (which may be more common in patients aged 65years or older) or due to changes in blood vessels that supply blood to the lungs
- if you have ever had or could have hepatitis B infection. This is because SPRYCEL could reactivate hepatitis B, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.
- If you experiencebruising, bleeding, fever, fatigue, and confusionwhile taking SPRYCEL, contact your doctor. This may be a sign of a condition known as microangiopathic thrombotic (MAT) damage to blood vessels.
Your doctor will monitor your condition periodically to check if SPRYCEL is having the desired effect. You will also have blood tests performed periodically while taking SPRYCEL.
Children and adolescents
Do not administer this medication to children under one year of age. Experience with the use of SPRYCEL in this age group is limited. In children taking SPRYCEL, close monitoring of growth and bone development is recommended.
Other medications and SPRYCEL
Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.
SPRYCEL is primarily metabolized by the liver. Some medications may interfere with the effect of SPRYCEL when taken together.
The following medications should not be used during SPRYCEL treatment:
- ketoconazole, itraconazole –antifungal medications
- erythromycin, clarithromycin, telithromycin –antibiotics
- ritonavir – anantiviral medication
- phenytoin, carbamazepine, phenobarbital – treatments forepilepsy
- rifampicin – a treatment fortuberculosis
- famotidine, omeprazole – medications thatblock stomach acid secretion
- St. John's Wort – a plant-based medication available over-the-counter for the treatment ofdepressionand other conditions (also known asHypericum perforatum)
Do not takemedications that neutralize stomach acid (antacidssuch as aluminum hydroxide/magnesium hydroxide) in the2hours before or 2hours after taking SPRYCEL.
Inform your doctorif you are takingblood thinnersor medications to prevent blood clots.
SPRYCEL with food and beverages
Do not take SPRYCEL with grapefruit or grapefruit juice.
Pregnancy and breastfeeding
If you are pregnantor think you may be pregnant,inform your doctor immediately..SPRYCEL should not be used during pregnancyunless it is clearly necessary. Your doctor will inform you of the potential risk of taking SPRYCEL during pregnancy.
It is recommended that both men and women use effective birth control methods during SPRYCEL treatment.
If you are breastfeeding, inform your doctor.You should stop breastfeeding while taking SPRYCEL.
Driving and operating machinery
Be extra cautious when driving or operating machinery if you experience side effects such as dizziness or blurred vision.
SPRYCEL contains lactose
If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.
3. How to take SPRYCEL
Sprycel will only be prescribed by a doctor with experience in treating leukemia.Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Sprycel is prescribed for adults and children at least 1 year old.
The recommended initial dose for adult patients with CML in the chronic phase is 100mg once a day.
The recommended initial dose for adult patients with CML in the accelerated phase or in blast crisis or Ph+ ALL is 140mg once a day.
Dosing schedule in children with CML in the chronic phase or Ph+ ALLbased on body weightSprycel is administered orally once a day in both tablets and oral powder for suspension. Tablets are not recommended for patients weighing less than 10kg. Oral powder for suspension should be used in patients weighing less than 10kg and in patients who cannot swallow tablets. A change in dose may be made when switching between formulations (i.e., tablets and oral powder for suspension), so do not switch from one formulation to another.
Your doctor will decide on the correct formulation and dose based on your weight, side effects, and response to treatment. In children, the initial dose of Sprycel is calculated based on body weight as shown below:
Body weight (kg)a | Daily dose (mg) |
10 to less than 20kg | 40mg |
20 to less than 30kg | 60mg |
30 to less than 45kg | 70mg |
At least 45kg | 100mg |
aTablets are not recommended for patients weighing less than 10kg, oral powder for suspension should be used in these patients.
No dosage recommendations are available for Sprycel in children under 1year old.
Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose, or even temporarily stop treatment. To take higher or lower doses, you may need to take combinations of tablets of different concentrations.
Tablets may be presented in blister packs with a calendar.These are blister packs with the days of the week indicated. The arrows indicate the next tablet to be taken according to your treatment schedule.
How to take Sprycel
Take the tablets at the same time every day.Swallow the tablets whole. Do not crush, cut, or chew. Do not take the tablets dissolved. It cannot be guaranteed that you will receive the correct dose if you crush, cut, chew, or disperse the tablets. Sprycel tablets can be taken with or without food.
Special handling instructions for Sprycel
It is unlikely that Sprycel tablets will break, but if they do, people other than the patient should use gloves when handling Sprycel.
For how long to take Sprycel
Take Sprycel daily until your doctor tells you to stop treatment. Make sure to take Sprycel for the time prescribed.
If you take more Sprycel than you should
If you accidentally take too many tablets, consult your doctorimmediately. You may need medical attention.
If you forget to take Sprycel
Do not take a double dose to make up for the missed doses. Take the next scheduled dose at the usual time.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
4. Possible Adverse Effects
The following may be signs of serious side effects:
- If you have chest pain, difficulty breathing, coughing, and fainting
- If you have an unexpected bleeding or bruising without injury
- If you observe blood in vomit, stools, or urine or have black stools
- If you develop symptoms of infection, such as fever, intense chills
- If you have fever, mouth or throat pain, itching, or skin and mucous membrane peeling
Contact your doctor immediatelyif you notice any of the above.
Very common side effects (may affect more than 1 in 10 patients)
- Infections(caused by bacteria, viruses, and fungi)
- Heart and lungs: difficulty breathing
- Digestive problems: diarrhea, feeling unwell (nausea, vomiting)
- Skin, hair, eyes, general: skin rash, fever, swelling in the face, hands, and feet, headache, fatigue or weakness, bleeding
- Pain: muscle pain (during or after stopping treatment), abdominal pain
- Laboratory tests: low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs
Common side effects (may affect up to 1 in 10 patients)
- Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, severe blood or tissue infection (including rare cases with fatal outcomes)
- Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, high blood pressure in the lungs, coughing
- Digestive problems: changes in appetite, changes in taste, abdominal distension or swelling, colon inflammation, constipation, gastroesophageal reflux, mouth ulcers, weight loss, weight gain, gastritis
- Skin, hair, eyes, general: skin tingling, itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, visual disturbances (including blurred vision and distorted vision), dry eyes, petechiae, depression, insomnia, hot flashes, dizziness, bruises (ecchymoses), anorexia, somnolence, generalized edema
- Pain: joint pain, muscle weakness, chest pain, foot and hand pain, chills, muscle stiffness and joint stiffness, muscle spasms
- Laboratory tests: fluid around the heart, fluid in the lungs, heart arrhythmias, febrile neutropenia, gastrointestinal bleeding, elevated blood uric acid levels
Rare side effects (may affect up to 1 in 100 patients)
- Heart and lungs:heart attack (including fatal outcomes), pericarditis, irregular heartbeat, angina due to reduced blood flow to the heart, low blood pressure, narrowing of the airways that could cause breathing difficulties, asthma, high blood pressure in the arteries (vasculature) that go to the lungs
- Digestive problems:pancreatitis, peptic ulcer, intestinal inflammation, abdominal distension, anal skin tear, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastroesophageal reflux (acid and other stomach contents return to the throat)
- Skin, hair, eyes, general:allergic reactions including sensitivity, red bumps on the skin (erythema nodosum), anxiety, confusion, mood swings, low libido, fainting, tremor, eye inflammation that can cause redness or pain, dermatitis neutrophilica, hearing loss, light sensitivity, visual disturbances, corneal ulcers, skin color changes, subcutaneous fat inflammation, skin ulcers, skin blisters, nail changes, hair changes, hand and foot changes, kidney failure, urinary frequency, gynecomastia in men, menstrual changes, general weakness and discomfort, hypothyroidism, balance problems while walking, osteonecrosis (a disease where blood flow to the bones is reduced, causing bone loss and death), arthritis, skin swelling in any part of the body
- Pain:venous inflammation that can cause redness, sensitivity, and swelling, tendon inflammation
- Brain:memory loss
- Complementary examinations:abnormal blood test results and possibly renal insufficiency caused by tumor breakdown products (tumor lysis syndrome), low albumin levels in blood, low lymphocyte levels in blood, high cholesterol levels in blood, lymph node swelling, cerebral hemorrhage, irregular heart activity, dilated heart, liver inflammation, protein in urine, elevated creatine phosphokinase (an enzyme mainly found in the heart, brain, and skeletal muscle), elevated troponin (an enzyme mainly found in the heart and skeletal muscle), elevated gamma-glutamyl transferase (an enzyme mainly found in the liver), chylous pleurisy (fluid with a milky appearance around the lungs)
Rare side effects (may affect up to 1 in 1000 patients)
- Heart and lungs:right ventricular dilation, myocardial inflammation, acute coronary syndrome (a set of symptoms produced by the blockage of blood flow to the heart muscle), heart attack (interruption of blood flow to the heart) coronary artery disease (of the heart), pericarditis, pulmonary embolism, pulmonary thrombosis
- Digestive problems:loss of vital nutrients such as protein from the digestive apparatus, intestinal obstruction, anal fistula (abnormal opening of the anus to the skin surrounding the anus), renal insufficiency, diabetes
- Skin, hair, eyes, general:seizure, optic nerve inflammation that can cause complete or partial vision loss, blue or purple skin discoloration, hyperthyroidism, thyroid gland inflammation, ataxia (associated with muscle coordination loss), difficulty walking, spontaneous abortion, skin inflammation of the blood vessels, cutaneous fibrosis
- Brain:stroke, transient ischemic attack (a temporary lack of blood flow to the brain), facial nerve paralysis, dementia
- Immune system:severe allergic reactions
- Connective tissue and musculoskeletal:delayed fusion of rounded ends that form joints (epiphysis); slow or delayed growth
Other side effects that have been reported with unknown frequency (cannot be estimated from available data)
- Pulmonary inflammation
- Bleeding in the stomach or intestines that can cause death
- Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection)
- Fever, skin blisters, and mucous membrane ulcers
- Renal disorders with symptoms such as edema and abnormal laboratory test results such as protein in urine and low protein levels in blood
- Damage to blood vessels known as microangiopathic thrombosis (MAT), which includes decreased red blood cell count, decreased platelet count, and blood clot formation.
Your doctor will check if you have any of these side effects during your treatment.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Storage of SPRYCEL
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label of the bottle after CAD. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of SPRYCEL
- The active ingredient is dasatinib. Each film-coated tablet contains 20mg, 50mg, 70mg, 80mg, 100mg or 140mg of dasatinib (as monohydrate).
- The other components are:
- Core of the tablet:lactose monohydrate (see section2 SPRYCEL contains lactose"); microcrystalline cellulose; sodium croscarmellose; hydroxypropyl cellulose; magnesium stearate
- Coating:hypromellose; titanium dioxide (E171); macrogol400
Appearance of the product and contents of the pack
SPRYCEL20mg: the film-coated tablets are white to off-white, biconvex, round, with “BMS” engraved on one face and “527” on the other.
SPRYCEL50mg: the film-coated tablets are white to off-white, biconvex, oval, with “BMS” engraved on one face and “528” on the other.
SPRYCEL70mg: the film-coated tablets are white to off-white, biconvex, round, with “BMS” engraved on one face and “524” on the other.
SPRYCEL80mg: the film-coated tablets are white to off-white, biconvex, triangular, with “BMS80” engraved on one face and “855” on the other.
SPRYCEL100mg: the film-coated tablets are white to off-white, biconvex, oval, with “BMS100” engraved on one face and “852” on the other.
SPRYCEL140mg: the film-coated tablets are white to off-white, biconvex, round, with “BMS140” engraved on one face and “857” on the other.
SPRYCEL20mg, 50mg or 70mg film-coated tablets are available in packs containing 56film-coated tablets in 4blister packs with a calendar of 14film-coated tablets per pack, and in packs with 60x1film-coated tablet in pre-cut single-dose blister packs. They are also available in child-resistant bottles, containing 60film-coated tablets. Each carton contains one bottle.
SPRYCEL80mg, 100mg or 140mg film-coated tablets are available in packs containing 30x1film-coated tablet in pre-cut single-dose blister packs. They are also available in child-resistant bottles, containing 30film-coated tablets. Each carton contains one bottle.
Only some pack sizes may be marketed.
Marketing Authorisation Holder
Bristol‑MyersSquibbPharmaEEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Irlanda
Manufacturer
Swords LaboratoriesUnlimited CompanyT/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Irlanda
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italia
Last update of this leaflet:
The detailed information on this medicine is available on the website of the European Medicines Agency:
http://www.emea.europa.eu. There are also links to other websites on rare diseases and orphan medicines.
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