20, 50, 70, 80, 100, 140 mg film-coated tablets
dasatinib
What SPRYCEL is and what it is used for
SPRYCEL contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukemia (CML) in adults, adolescents, and children older than 1 year. Leukemia is a cancer of white blood cells. The white blood cells normally help the body fight infection. Chronic myeloid leukemia is a form of leukemia in which the white blood cells called granulocytes begin to form uncontrollably. SPRYCEL inhibits the growth of these leukemia cells.
SPRYCEL is also used to treat Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in adults, adolescents, and children at least 1 year of age, and lymphoid blast CML in adults who have not responded to previous treatment. ALL is a form of leukemia in which the white blood cells called lymphocytes are formed too quickly and live too long. SPRYCEL inhibits the growth of these leukemia cells.
Ask your doctor if you have any questions about how SPRYCEL works or why this medicine has been prescribed for you.
What you need to know before you take SPRYCEL
Do not use SPRYCEL
Do not take SPRYCEL
- if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, ask your doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking SPRYCEL.
- if you are being treated with medicines that thin the blood or prevent blood clots (see “Other medicines and SPRYCEL”)
- if you have or have ever had, liver or heart disease
- if you experience difficulty breathing, chest pain, or cough while taking SPRYCEL. It may be a sign of fluid accumulation in the lungs or chest (which may occur more often in patients 65 years of age or older), or due to changes in the blood vessels that supply the lungs.
- if you have ever had or may now have a hepatitis B infection. This is because SPRYCEL can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment.
- call your doctor if you experience bruising, bleeding, fever, tiredness, and confusion while taking SPRYCEL. This can be a sign of damage to blood vessels, so-called thrombotic microangiopathy (TMA).
You will be checked regularly by your doctor to determine whether SPRYCEL is having the desired effect. You will also have regular blood tests while taking SPRYCEL.
Children and young people
Do not give this medicine to children younger than 1 year. The experience of treatment with SPRYCEL in this age group is limited. Bone growth and development will be monitored in children treated with SPRYCEL.
Other medicines and SPRYCEL
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
SPRYCEL is mainly processed in the liver. Some medicines can affect the effect of SPRYCEL when used at the same time.
The following medicines should not be used at the same time as SPRYCEL:
- ketoconazole, itraconazole – these are drugs against fungal diseases
- erythromycin, clarithromycin, telithromycin – these are antibiotics
- ritonavir – this is a drug against viral diseases
- phenytoin, carbamazepine, phenobarbital – these are for treating epilepsy
- rifampicin – this is for the treatment of tuberculosis
- famotidine, omeprazole – these are drugs that inhibit stomach acid production
- St. John’s wort- an over-the-counter herbal remedy used to treat mild depression and mild anxiety (also known as Hypericum perforatum)
Do not use medicines that neutralize stomach acid ( antacids such as aluminum hydroxide or magnesium hydroxide ) from 2 hours before to 2 hours after taking SPRYCEL.
Tell your doctor if you are taking medicines that thin the blood or prevent blood clots.
SPRYCEL with food and drink
Do not take SPRYCEL with grapefruit or grapefruit juice.
Pregnancy, breastfeeding, and fertility
If you are pregnant or think you may be pregnant, tell your doctor immediately. SPRYCEL should not be used during pregnancy unless necessary. Your doctor will discuss the possible risks of taking SPRYCEL during pregnancy. Both women and men will be advised to use effective contraception during treatment with SPRYCEL.
Tell your doctor if you are breastfeeding. Breast-feeding should be discontinued if you are treated with SPRYCEL.
Driving ability and use of machinery
If you experience side effects such as dizziness and blurred vision, be especially careful when driving or using machinery.
SPRYCEL contains lactose
If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
How to take SPRYCEL
SPRYCEL will only be prescribed to you by doctors experienced in the treatment of leukemia. Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. SPRYCEL is prescribed for adults and children over 1 year of age.
The recommended starting dose for adult patients with CML in the chronic phase is 100 mg once daily.
The recommended starting dose for adult patients with CML in accelerated phase or blast crisis or Ph+ ALL is 140 mg once daily.
Dosage for children with CML in the chronic phase or Ph+ ALL is based on body weight. SPRYCEL is taken by mouth once a day either as tablets or as a powder for oral suspension. SPRYCEL tablets are not recommended for patients weighing less than 10 kg. Powder for oral suspension should be used in patients who weigh less than 10 kg and in patients who cannot swallow tablets. A dose change may be necessary when switching between formulations (tablets or powder to oral suspension ), so do not switch from one formulation to another.
Your doctor will determine the right dose based on your weight, any side effects, and your response to treatment. The starting dose of SPRYCEL for children is calculated based on body weight as below:
| Body weight (kg) a | Daily dose (mg) |
| 10 – under 20 kg | 40 mg |
| 20 – under 30 kg | 60 mg |
| 30 – under 45 kg | 70 mg |
| 45 kg and over | 100 mg |
Tablets are not recommended for patients weighing less than 10 kg; powder for oral suspension should be used in these patients.
There is no recommended dose of SPRYCEL for children younger than 1 year.
Depending on how you respond to treatment, your doctor may recommend a higher or lower dose. The treatment can also be temporarily interrupted. For higher or lower dosages, it may be necessary to combine tablets of different strengths.
The tablets may be packed in calendar blisters. These are blisters that show the days of the week. Arrows show which tablet you should take next according to your treatment schedule.
How to take SPRYCEL
Take the tablets at the same time each day. Swallow the tablets whole. Do not crush, split or chew them. Do not slurp up the tablets. You cannot be sure that you will get the correct dose if you crush, split, chew, or slurp up the tablets. SPRYCEL tablets can be taken with or without food.
Special instructions for handling SPRYCEL
SPRYCEL tablets are unlikely to break. If this should still occur, people other than the patient should use gloves when handling SPRYCEL.
How long take SPRYCEL
Take SPRYCEL every day until your doctor tells you to stop. Make sure you take SPRYCEL for as long as prescribed.
If you have taken too much SPRYCEL
Contact your doctor immediately if you accidentally take too many tablets. You may need medical attention.
If you forget to take SPRYCEL
Do not take a double dose to make up for a missed dose. Take the next dose as usual according to prescription one.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following may be signs of serious side effects:
- if you have chest pain, difficulty breathing, cough, fainting spells
- if you experience unexpected bleeding or bruising without having injured yourself
- if you notice blood in vomit, stool, or urine, or if the stool is black
- if you get signs of infection, eg fever or severe chills
- if you develop a fever, sore mouth or throat, blisters, or scaling of the skin and/or mucous membranes
Contact your doctor immediately if you notice any of the above.
Very common side effects (may affect more than 1 in 10 people)
- Infections ( including infections caused by bacteria, viruses, and fungi)
- Heart and lungs: shortness of breath
- Problems with digestion: diarrhea, nausea, vomiting
- Skin, hair, eyes, general symptoms: rash, fever, swelling of the face, hands, and feet, headache, tiredness or weakness, bleeding
- Pain: muscle pain (during or after treatment), pain in the stomach (abdomen)
- Tests may show low platelet count, low white blood cell count ( neutropenia ), anemia, and fluid around the lungs.
Common side effects (may affect up to 1 in 10 people)
- Infections: pneumonia, a herpes virus infection (including cytomegalovirus – CMV ), upper respiratory tract infection, a serious infection of blood or tissue (including rare cases with fatal outcomes)
- Heart and lungs: palpitations, irregular heartbeats, heart failure, impaired heart function, high blood pressure, increased blood pressure in the lungs, cough
- Digestive problems: appetite disturbances, taste disturbances, flatulence or distended abdomen, inflammation of the colon, constipation, heartburn, mouth ulcers, weight gain, weight loss, gastritis
- Skin, hair, eyes, general symptoms: tingling of the skin, itching, dry skin, acne, inflammation of the skin, persistent ringing in the ears, hair loss, excessive sweating, vision problems (including blurred vision and changes in vision), dry eyes, bruising, depression, insomnia, flushing, dizziness, bruising, anorexia (loss of appetite), sleepiness, generalized edema
- Pain: joint pain, muscle weakness, pain in the chest, pain around hands and feet, chills, stiffness in muscles and joints, muscle cramps
- Tests may show: fluid around the heart, fluid in the lungs, irregular heartbeat, febrile neutropenia, bleeding in the gastrointestinal tract, high levels of uric acid in the blood
Uncommon side effects (may affect up to 1 in 100 people)
- Heart and lungs: heart attack (sometimes fatal), inflammation of the pericardium, irregular heartbeat, chest pain due to reduced blood supply to the heart (angina), low blood pressure, narrowing of the airways which can cause breathing difficulties, asthma, increased blood pressure in the arteries of the lungs (blood vessel)
- Problems with digestion: inflammation of the pancreas, stomach ulcer, inflammation of the esophagus, swollen stomach (abdomen), ulceration of the lining of the rectum, difficulty swallowing, inflammation of the gallbladder, blockage of the bile ducts, gastroesophageal reflux (a condition where acid and other stomach contents come back up into the throat )
- Skin, hair, eyes, general symptoms: allergic reaction including soreness, lumpy reddening of the skin (rubella), anxiety, confusion, mood swings, decreased sex drive, fainting, tremors, inflammation of the eye which can cause redness and pain, a skin disease characterized by sore, red, sharply demarcated and raised skin patches with rapid onset of fever and elevated levels of white blood cells ( neutrophil dermatosis ) hearing loss, light sensitivity, vision loss, increased tear flow, change in skin color, inflammation of the fatty tissue of the skin, wounds on the skin, blistering on the skin, nail problems, hair disorders, hand-foot syndrome, kidney failure, affected urination frequency, breast enlargement in men, menstrual disorders, general weakness and discomfort, low thyroid function, balance problems when walking, osteonecrosis (a condition where skeletal bones die and collapse due to reduced blood supply), joint inflammation, skin swelling anywhere on the body
- Pain: inflammation of the blood vessels which can cause redness, tenderness and swelling, tendonitis (tendinitis)
- Brain: memory loss
- Tests may show: abnormal blood levels and possibly impaired kidney function caused by residual products of the disintegrating tumor (tumor lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell ) in the blood, high cholesterol levels, swollen lymph nodes, bleeding in the brain, irregular electrical impulses to the heart, enlarged heart, inflammation of the liver, protein in the urine, increased levels of creatinine phosphokinase (an enzyme mainly found in the heart, brain, and skeletal muscle), increased levels of troponin (an enzyme mainly found in the heart and skeletal muscles), increased gamma-glutamyltransferase (an enzyme mainly found in the liver), milky fluid around the lungs (chylothorax)
Rare side effects (may affect up to 1 in 1,000 people)
- Heart and lungs: enlarged upper chamber of the heart, inflammation of the heart muscle, the combined effect of various conditions that block the blood supply to the heart ( acute cardiac syndrome), cardiac arrest (stopping of blood flow from the heart), coronary artery disease, inflammation of the tissue that covers the heart and lungs, blood clots, blood clots in the lungs
- Problems with digestion: reduced absorption of important nutrients, such as protein, from the gastrointestinal tract, irritable bowel, anal fistula (an abnormal opening from the anus to the skin around the anus), impaired kidney function, diabetes
- Skin, hair, eyes, general symptoms: convulsions, inflammation of optic nerve one which can cause a complete or partial loss of vision, blue-violet spots on the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (a condition associated with lack of muscle coordination), difficulty walking, miscarriage, inflammation of the blood vessels of the skin, skin fibrosis
- Brain: stroke, temporary events of the disturbed function of the nervous system caused by reduced blood flow, facial paralysis, dementia
- Immune system: severe allergic reaction
- Muscles, bones, and connective tissue: delayed joining of the bone ends that form joints (epiphyses); slower or delayed growth
Other reported side effects are with no known frequency (occurring in an unknown number of users )
- inflammatory changes in the lungs
- bleeding in the stomach or intestines that can lead to death
- recurrence (reactivation) of hepatitis B infection when you previously had hepatitis B (a liver infection)
- a reaction with fever, blisters on the skin, and sores on the mucous membranes
- Kidney disease with symptoms including edema and abnormal laboratory test results such as protein in the urine and low protein in the blood.
- Damage to blood vessels, so-called thrombotic microangiopathy (TMA), including reduced number of red blood cells, reduced number of blood platelets, and blood clot formation.
Your doctor will check if you have any of these side effects during your treatment.
How to store SPRYCEL
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can label, blister or carton after “EXP” or “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).
- Other ingredients are:
- Tablet core: lactose monohydrate (see section 2 “SPRYCEL contains lactose”), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate
- Film coating : hypromellose, titanium dioxide (E171), macrogol 400
Appearance and package sizes of the medicine
SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round, and marked with “BMS” on one side and “527” on the other side.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval, and marked with “BMS” on one side and “528” on the other side.
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round, and marked with “BMS” on one side and “524” on the other side.
SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular, and debossed with “BMS 80” on one side and “855” on the other side.
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval, and marked with “BMS 100” on one side and “852” on the other side.
SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round, and marked with “BMS 140” on one side and “857” on the other side.
SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each, and in cartons containing 60 x 1 film-coated tablets in perforated unit-dose blisters. They are also available in a jar with a child-resistant closure containing 60 film-coated tablets. Each carton contains one can.
SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablets in perforated single-dose blisters. They are also available in a jar with a child-resistant closure containing 30 film-coated tablets. Each carton contains one can.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bristol‑Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
CATALENT ANAGNI SRL
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italy