20 mg & 50 mg & 70 mg & 80 mg & 100 mg & 140 mg film-coated tablets
dasatinib
What Dasatinib STADA is and what it is used for
Dasatinib Stada contains the active substance dasatinib. Dasatinib Stada is used to treat Philadelphia chromosome-positive (Ph +) acute lymphocytic leukemia (ALL) in adults who have not responded to previous treatment and in adolescents and children older than 1 year. Leukemia is a cancer of white blood cells. The white blood cells usually help the body fight infection. ALL is a form of leukemia in which the white blood cells called lymphocytes are formed too fast and live too long. Dasatinib Stada inhibits the growth of these leukemic cells.
Ask your doctor if you are wondering how Dasatinib Stada works or why this medicine has been prescribed for you.
Dasatinib contained in Dasatinib Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Dasatinib STADA
Do not take Dasatinib Stada:
- 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 cautions
Talk to your doctor or pharmacist before taking Dasatinib Stada.
- if you are being treated with medicines that are blood-thinning or prevent blood clots (see “Other medicines and Dasatinib Stada”)
- if you have a liver or heart disease, or if you have had one
- if you experience difficulty breathing, chest pain, or cough while taking Dasatinib Stada. 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 may be due to changes in the blood vessels that supply the lungs
- if you have ever had or may have a hepatitis B infection. The reason for this is that Dasatinib Stada 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.
- contact your doctor if you experience bruising, bleeding, fever, tiredness, and confusion while taking Dasatinib Stada. 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 if Dasatinib Stada has the desired effect. You will also have regular blood tests when taking Dasatinib Stada.
Children and young people
Do not give this medicine to children under 1 year of age. Experience with dasatinib treatment in this age group is limited. Skeletal bone growth and development will be monitored in children treated with Dasatinib Stada.
Other medicines and Dasatinib STADA
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Dasatinib Stada is mainly processed in the liver. Some medicines may affect the effect of Dasatinib Stada when used at the same time.
The following medicines should not be used at the same time as Dasatinib Stada:
- ketoconazole, itraconazole – these are medicines for fungal diseases
- erythromycin, clarithromycin, telithromycin – these are antibiotics
- ritonavir – this is a medicine for viral diseases
- phenytoin, carbamazepine, phenobarbital – these are for the treatment of epilepsy
- rifampicin – this is for the treatment of tuberculosis
- famotidine, omeprazole – these are drugs that inhibit gastric 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 Dasatinib Stada.
Tell your doctor if you are taking medicines that are blood thinners or prevent blood clots.
Dasatinib Stada with food and drink
Do not take Dasatinib Stada with grapefruit or grapefruit juice.
Pregnancy and breastfeeding
If you are pregnant or think you may be pregnant, tell your doctor immediately. Dasatinib Stada should not be used during pregnancy unless clearly necessary. Your doctor will discuss the possible risks of taking dasatinib during pregnancy.
Both women and men will be recommended to use effective contraception during treatment.
Tell your doctor if you are breast-feeding. Breast-feeding should be discontinued if you are being treated with Dasatinib Stada.
Driving and using machines
If you experience side effects such as dizziness and blurred vision, take special care when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Dasatinib STADA contains lactose and sodium
Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Dasatinib STADA
Dasatinib Stada will only be prescribed to you by a doctor who has experience in the treatment of leukemia. Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dasatinib Stada is prescribed for adults and children over 1 year of age.
The recommended starting dose for adult patients with Ph + ALL is 140 mg once daily.
Dosage one for children with Ph + ALL is based on body weight.
Medicines containing dasatinib are taken orally once a day either as tablets or as a powder for oral suspension. Dasatinib Stada tablets are not recommended for patients weighing less than 10 kg. Powders for oral suspension should be used in patients weighing less than 10 kg and in patients unable to swallow tablets. A dose change may be needed when switching between the formulations (tablets or powder for oral suspension ), so do not switch from one formulation to another.
Your doctor will determine the correct dose based on your weight, any side effects, and your response to treatment. The starting dose of Dasatinib Stada for children is calculated based on body weight as follows:
| Bodyweight (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 Dasatinib Stada for children under 1 year of age.
Depending on how you respond to treatment, your doctor may recommend a higher or lower dose. The treatment can also be temporarily stopped. For higher or lower dosages, it may be necessary to combine tablets of different strengths.
How to take Dasatinib Stada
Take the tablets at the same time each day. Swallow the tablets whole. Do not crush, divide or chew them. Do not slurry the tablets. You can not be sure that you will get the right dose if you crush, divide, chew or slurry the tablets. Dasatinib Stada can be taken with or without food.
Special instructions for handling Dasatinib Stada
Dasatinib Stada tablets are unlikely to rupture. Should this nevertheless occur, persons other than the patient should wear gloves when handling Dasatinib Stada.
How long to take Dasatinib Stada
Take Dasatinib Stada every day until your doctor tells you to stop. Make sure you take Dasatinib Stada for as long as it is prescribed.
If you use more Dasatinib STADA then you should
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poisons Information Center for risk assessment and advice. You may need medical attention.
If you forget to use Dasatinib STADA
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual according to prescription one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. 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
- if you experience unexpected bleeding or bruising without being injured
- if you notice blood in the vomit, stool, or urine, or if the stool is black
- if you get signs of infection, e.g. fever or severe chills
- if you get a fever, sore mouth or throat, blisters, or flaking of the skin and/or mucous membranes.
Contact your doctor immediately if you notice any of the above.
Very common ( may affect more than 1 user in 10 )
- infection s (including infection s caused by bacteria, viruses,s, and fungi)
- heart and lungs: shortness of breath
- digestive problems: diarrhea, nausea, vomiting
- skin, hair, eyes, general symptoms: rash, fever, swelling of the face, hands, and feet, headache, fatigue or weakness, bleeding
- pain: muscle aches (during or after treatment), abdominal pain (abdomen)
- tests may show low platelet count, low white blood cell count ( neutropenia ), anemia, fluid around the lungs.
Common ( may affect up to 1 in 10 people )
- infection s: pneumonia, herpes virus infection (including cytomegalovirus ( CMV)), upper respiratory infection, a serious infection in the blood or tissue you (including rare cases, fatal)
- heart and lungs: palpitations, irregular heartbeat, heart failure, disturbed heart function, high blood pressure, high blood pressure in the lungs, cough
- indigestion: appetite disturbances, taste disturbances, flatulence or distended abdomen, inflammation of the colon, constipation, heartburn, cold sores, weight gain, weight loss, inflammation of the stomach
- skin, hair, eyes, general: tingling in the skin, itching dry skin, acne, inflammation of the skin, persistent noise in the ears, hair loss, excessive sweating, vision problems (including blurred vision and vision change), dry eyes, bruising, depression, insomnia, hemorrhage, dizziness, bruising, anorexia (loss of appetite), drowsiness, generalized edema
- pain: joint pain, muscle weakness, chest pain, 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 ( 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, constriction of the airways, which can cause breathing difficulties, asthma, increased blood pressure in the pulmonary artery s (blood vessels)
- indigestion: inflammation of the pancreas, stomach ulcers, inflammation of the esophagus, swollen stomach (abdomen), ulcers in the rectal mucosa, swallowing difficulties, inflammation of the gallbladder, blockage of the bile ducts, gastroesophageal reflux (a condition in which acid and other stomach contents return to the throat)
- skin, hair, eyes, general: allergic reaction including soreness, lumpy blush (anxiety), anxiety, confusion, mood swings, decreased sexual drive, fainting, tremors, inflammation of the eye that may cause redness and pain, a skin condition characterized by sore, red, sharply demarcated and raised skin spots with rapid onset of fever and elevated white blood cell count ( neutrophildermatosis ), hearing loss, photosensitivity, visual impairment, increased tear flow, altered skin color, inflammation of the subcutaneous adipose tissue, wounds on the skin, blistering on the skin, nail problems 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 in which skeletal bones die and collapse due to impaired blood supply), joint inflammation, preferably swelling of the body
- pain: inflammation of the blood vessels that can cause redness, tenderness and swelling, tendinitis (tendinitis)
- brain: memory loss
- tests may show: abnormal blood levels and possibly impaired renal function caused by residues of the decaying 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, irregularities in the electrical impulses to the heart, enlarged heart, inflammation of the liver, protein in the urine, elevated levels of creatinine phosphokinase (an enzyme found mainly in the heart, brain, and skeletal muscles), elevated levels of troponin (an enzyme found mainly in the heart and skeletal muscles), elevated gamma-glutamyltransferase (an enzyme found mainly in the liver).
Rare ( may affect up to 1 in 1,000 people )
- heart and lungs: enlarged upper ventricles, myocarditis, the combined effect of various conditions that block the blood supply to the heart ( acute heart syndrome), cardiac arrest (blockage of blood flow from the heart), coronary heart disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots the lungs
- indigestion: decreased absorption of important nutrients, such as protein, from the gastrointestinal tract, intestinal knots, anal fistula (an abnormal opening from the anus to the skin around the anus), impaired kidney function, diabetes
- skin, hair, eyes, general: convulsions, inflammation of optic nerve which may 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 muscular 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 decreased blood flow, facial paralysis, dementia
- Immune system: severe allergic reaction
- Muscles, bones, and connective tissue: the delayed interconnection of the bone ends that form joints (epiphyses); slower or delayed growth.
Has been reported ( occurs 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 have previously had hepatitis B (a liver infection)
- a reaction with fever, blisters on the skin, and ulcers on the mucous membranes
- kidney disease with symptoms including edema and abnormal laboratory test results such as protein in the urine and low protein content in the blood
- damage to blood vessels, so-called thrombotic microangiopathy (TMA), including decreased number of red blood cells, decreased number of platelets, and blood clot formation.
Your doctor will check if you have any of these side effects during your treatment.
5. How to store Dasatinib STADA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, blister, or carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg of dasatinib.
Other ingredients are
Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see section 2 “What you need to know before you take Dasatinib Stada”), croscarmellose sodium, hydroxypropyl cellulose (E463, magnesium stearate (E470b)
Film coating : poly (vinyl alcohol) (E1203), titanium dioxide (E171), talc (E553b), glyceryl monostearate (E471), sodium lauryl sulphate
What the medicine looks like and the contents of the pack
Dasatinib Stada 20 mg: white to off-white, biconvex, round film-coated tablet with “20” debossed on one side and smooth on the other side, with a diameter of 6.1 mm.
Dasatinib Stada 50 mg: white to off-white, biconvex, oval film-coated tablet with “50” debossed on one side and smooth on the other side, measuring 10.9 mm x 5.8 mm.
Dasatinib Stada 70 mg: white to off-white, biconvex, round film-coated tablet with “70” debossed on one side and smooth on the other side, 8.9 mm in diameter.
Dasatinib Stada 80 mg: white to off-white, biconvex, triangular film-coated tablet with “80” debossed on one side and smooth on the other side, measuring 10.3 mm x 10.0 mm.
Dasatinib Stada 100 mg: white to off-white, biconvex, oval film-coated tablet with “100” debossed on one side and smooth on the other side, with dimensions 14.8 mm x 7.2 mm.
Dasatinib Stada 140 mg: white to off-white, biconvex, round film-coated tablet with “140” debossed on one side and smooth on the other side, with a diameter of 11.8 mm.
Dasatinib Stada 20 mg, 50 mg, 70 mg film-coated tablets
Aluminum OPA / Alu / PVC blisters (perforated single dose blisters).
HDPE jar with child-resistant polypropylene closure and a plastic (HDPE) capsule containing silica gel.
Carton containing 60×1 or 100×1 film-coated tablets in perforated unit dose blisters.
Carton containing a jar of 60 film-coated tablets.
Dasatinib Stada 80 mg, 100 mg, 140 mg film-coated tablets
Aluminum OPA / Alu / PVC blisters (perforated single dose blisters).
HDPE jar with child-resistant polypropylene closure and a plastic (HDPE) capsule containing silica gel.
Carton containing 30×1, 60×1, or 100×1 film-coated tablets in perforated unit dose blisters.
Carton containing a bottle of 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Remedica Ltd.
Sharon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Centrafarm Services BV
New Donk 9
4879 AC Etten-Leur
Netherlands
STADAPHARM GmbH,
Feodor-Lynen-Strasse 35
30625 Hanover
Germany
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark