SPRYCEL 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets

All fields of application by the manufacturer

To this, with SPRYCEL 20 mg / – 50 – 70 mg, mg / application related – 80 mg – 100 mg / – 140 mg film-coated tablets in combination is there more detailed information:

Cancer (General)

Variant comparison

In the following variants SPRYCEL available – 70 mg / – 80 mg / – 100 mg, mg / – 140 mg film-coated tablets 20 mg / – 50:

Other components

The following substance not effective components are part of the drug:

• Hyprolose
• Hypromellose
• Magnesium stearate
• microcrystalline cellulose
• Titanium dioxide (E 171)
• Croscarmellose sodium
• Lactose monohydrate
• MACROGOL 400

So SPRYCEL is 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets

SPRYCEL 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets contain the active ingredient of Dasatinib. Learn more about the applications and the action of Dasatinib below. Read also the information about the active group of cytostatics, among which the active ingredient of Dasatinib. Please note the special effect of SPRYCEL is 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets also

Application of the active substance: Dasatinib

Dasatinib is used to treat of adults with blood cancer. Cause of the disease is the change and subsequent propagation of a single haematopoietic bone marrow cell. In almost all cases can be found in the genetic make-up of these cells a break and exchange of chromosomes pieces. This change is visible as the abbreviated chromosome 22, as so-called “Philadelphia chromosome”. Dasatinib is used, if the blood cancer

• the Philadelphia chromosome has just been found is still in the chronic phase, and so slowly and slowly progressing (chronic myelogenous leukemia, CML)
• in chronic, of fast-advancing phase in the blast crisis (with a massive formation of immature blood cells) or is a previous treatment with Imatinib, was invalid or was not tolerated
• has the acute form (acute lymphocytic leukemia, ALL) and the Philadelphia chromosome has or is a lymphatic blast crisis, where a previous therapy was ineffective or was not tolerated.

Following applications of Dasatinib, in-depth information is available:

• Cancer (General)

Effect of Dasatinib

The starting point of a blood cancer disease is the change and subsequent propagation of a single haematopoietic bone marrow cell. In almost all cases can be found in the genetic make-up of these cells a break and exchange of chromosomes pieces. But a change in the function of the genetic material is: one of the affected genes affects the enzyme tyrosine kinase, which plays an important role in controlling cell growth and reproduction. Through the exchange of chromosome fragments, the tyrosine kinase is permanently activated. But this leads to an increased and uncontrolled proliferation of the affected cell.

Dasatinib inhibits mainly the tyrosine kinase in their activity, blocked but other enzymes involved in the cancer process. Thus, an essential prerequisite for the reproduction and growth of blood cancer cells is removed.

Special features of the effect of SPRYCEL 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets

Notes to the dosage instructions on the packaging and in the patient information:

The medicine contains the active ingredient of Dasatinib in the form of Dasatinib monohydrate. 20 Mg of Dasatinib comply with 20,74 milligrams Dasatinib monohydrate. 50 Mg of Dasatinib match 51,85 milligrams Dasatinib monohydrate. 70 Milligrams of Dasatinib correspond to 72,58 milligrams of Dasatinib monohydrate. 80 Milligrams of Dasatinib correspond to 82.95 milligrams Dasatinib monohydrate. 100 Mg of Dasatinib correspond to 103,69 milligrams of Dasatinib monohydrate. 140 Mg of Dasatinib correspond to 145,17 milligrams of Dasatinib monohydrate.

Areas of application according to the manufacturer’s specifications

blood slowly developing newly identified chronic cancer with a special genetic characteristics (Philadelphia chromosome positive (Ph +) chronic myelogenous leukemia) in adults

Chronic blood cancer (chronic myelogenous leukemia), which develops insidiously or faster or produces large quantities of underdeveloped blood cells (blast crisis), in which a previous treatment including Imatinib was invalid or was not tolerated

Acute blood cancer with a special genetic characteristics (Philadelphia chromosome positive (Ph +) acute lymphoblastic leukemia) or chronic blood cancer, which produces large amounts of undeveloped blood cells (blast crisis) – ineffectiveness or incompatibility of previous treatment

Warnings & precautions

During treatment with the drug, side effects such as dizziness or blurred vision can occur, making dangerous driving and using machines.

The treatment with the drug is a doctor to start from, who is experienced in the diagnosis and treatment of blood cancer.

Aluminium and magnesium products of acid binding in the stomach should be taken up to two hours before and two hours after the, not to reduce its effect.

The drug contains lactose (milk sugar), which is poorly tolerated by some patients.

Medicines can cause allergic reactions. Evidence for this can be: redness, runny nose, itching, swelling of the mucous membrane, itching and redness of the eyes, narrowing of the Airways (asthma). In rare cases, there may be allergic shock with loss of consciousness.

Should you perceive signs of an allergic reaction, immediately inform a doctor.

Interactions

What interactions of active substance of Dasatinib in SPRYCEL 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets are known? It is important to note that the interactions can be different depending on the pharmaceutical form of the drug (for example, Tablet, syringe, ointment).

The simultaneous application of Dasatinib and active substances which inhibit the enzyme, which is necessary to reduce, may lead to increased side effects. Therefore substances such as antifungal ketoconazole and itraconazole, the macrolide antibiotics erythromycin, clarithromycin, and telithromycin and the HIV reference ritonavir should apply at the same time.

The simultaneous application of Dasatinib and substances that lead to an increased activity of the degrading enzyme, weaken the effect of Dasatinib. These include the glucocorticoid dexamethasone, epilepsy Rd phenytoin, carbamazepine, and phenobarbital, the TB reference rifampicin or vegetable preparations containing St. John’s wort. They all increase the risk of treatment failure and should be replaced by other active substances by the doctor.

The simultaneous application of Dasatinib and active ingredients, which are mined by the same enzyme in the body leads to a competition. This can be dangerous for active substances, which are quickly overdosed. (H1 antihistamines Astemizole and terfenadine, the Rumsfield cisapride, the Psychopharmakon include pimozide, quinidine (against cardiac arrhythmia), calcium channel blockers Bepridil, and Ergot alkaloids such as ergotamine and Dihydroergotamine).

The simultaneous application of Dasatinib and the Magenmitteln Famotidin (H2 blockers) and omeprazole (proton pump inhibitors) or acid-binding products such as aluminium hydroxide and magnesium hydroxide can reduce the absorption of Dasatinib in the body. Therefore, the application is not recommended by H2 receptor blockers and interactions. Aluminium hydroxide and magnesium hydroxide preparations should be taken up to two hours before and two hours after the application of Dasatinib.

As Dasatinib can change the blood coagulation, as well medical caution (is required if patients are taking active substances that affect blood clotting such as Antiplatelet and anticoagulants).

Dosage

The treatment with the drug is a doctor to start from, who is experienced in the diagnosis and treatment of blood cancer.

The recommended dose for treatment is 100 milligrams of Dasatinib in the chronic phase of chronic myeloid leukemia (CML) once daily. In the phase of accelerated development of the disease or in the blast crisis (mass distribution of immature blood cells) in the chronic or acute blood cancer the recommended dose to the beginning of the therapy is 140 milligrams.

In clinical trials, the treatment with the drug was continued until disease progression or until to the occurrence of incompatibilities in the patient. There is no knowledge about what effect a treatment after a complete recovery has.

In order to achieve the recommended dose, there is the drug in downgraded-dose tablets. Depending on the success and compatibility, the doctor will increase the dose or reduce.

Take the tablets always unzerdrückt or undivided so that no traces of the substance on the skin can get. The capture can be controlled by a meal and should always either take place in the morning or in the evening.

Contra-indications

The following gives details of contra-indications for the purposes of SPRYCEL 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film coated tablets in General, pregnancy & lactation, and children. It is important to note that the contra-indications can be different depending on the pharmaceutical form of the drug (for example, Tablet, syringe, ointment).

When must SPRYCEL not be used 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets?

Dasatinib may be used against the active substance not in hypersensitivity.

Because there are only a few experiences from a study with patients with liver dysfunction, Dasatinib may be applied in this patient population only with medical care.

As Dasatinib can change the blood coagulation, as well medical caution is required when patients tend to bleeding or take active substances that affect blood clotting (anticoagulants, antiplatelet).

For persons over 65 years of age it comes by treatment with Dasatinib rather to accumulation of fluid in the body and breathing problems. Therefore, these patients should be examined more frequently by doctors.

Patients with risk factors for a cardiovascular (for example, with high blood pressure, lipid disorders, diabetes) or pre-existing medical conditions of the heart (such as constriction of the coronary vessels or a previous intervention on the heart) should be carefully monitored by the doctor on chest pain, shortness of breath, and increased perspiration.

What must you consider when pregnancy and breast-feeding?

There are no adequate studies for the use of Dasatinib in pregnant women. Animal identified damage to the unborn child. The potential risk for humans is not known. Therefore, Dasatinib may be used during pregnancy, unless the doctor deems necessary unique.

There is insufficient evidence to the Elimination of Dasatinib in breast milk of humans and animals, there are suspicions that it may happen but. Because infants at risk cannot be ruled out, breastfeeding is to omit during treatment with the drug.

What is taken into account in children?

The safety and efficacy of Dasatinib in children and adolescents under the age of 18 is so far not yet in studies. The application in this age group is therefore prohibited.

Side effects

What side effects can the active ingredient of Dasatinib in SPRYCEL 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets have? Below, learn the most important thing to possible, well-known side effects of Dasatinib in SPRYCEL 20 mg / – 50 mg / – 70 mg – 80 mg / – 100 mg / – 140 mg film-coated tablets. These side effects should not occur, but can. Because everyone reacts differently to medications. Please also note that the side effects in type and frequency can vary depending on the drug form of the drug (for example, Tablet, syringe, ointment).

Very common adverse reactions: infections (bacteria, viruses, fungi and not specific pathogens), headache, bleeding, Brustfell effusion (pleural effusion), respiratory problems, diarrhea, nausea and vomiting, Bauchschmerz, rash, muscle pain, bone pain, fluid collection, exhaustion, swelling of the skin, fever.

Common side effects: pneumonia (of cause), infection/inflammation of the upper respiratory tract, herpes infection, intestinal inflammation by infection, neutrophils deficiency with fever, lack of all blood cells, food refusal, appetite disorders, depression, insomnia, nervous disorders (including nervous abnormal sensations in the arms and legs), drowsiness, Pptv disorder, drowsiness, visual disturbances (compromised vision, blurred vision, decreased Visual acuity), dry eyes, ringing in the ears, heart muscle weakness, heart failure, heart bag effusion, cardiac arrhythmias (including heart palpitations), heart palpitations, high blood pressure, flying heat (flush), cough, water accumulation in the lungs, Pulmonary hypertension, pneumonia, gastro intestinal bleeding, colitis, gastritis, inflammation of the mucous membrane (also of the mouth), indigestion, abnormal muscle activity in the stomach, constipation, diseases of the Mundschleimhäute, hair loss, Dermatitis (einchließlich eczema), itching, acne, dry skin, hives, excessive sweating, joint pain, muscle pain, muscle inflammation, muscle weakness, general weakness, pain, chest pain, General water retention in the tissue, chills, weight changes, bruises.

Uncommon side effects: blood poisoning (also fatal), neoplasms (benign, malignant and non-specific, including cysts and polyps), renal impairment by Krebszellzerfall (Tumorlysesyndrom), hypersensitivity reaction (including Erythema nodosum), excess of uric acid in the blood, deficiency of blood protein, afraid, confused state, emotional fluctuations, reduced libido, brain hemorrhage, fainting, tremors, memory loss, conjunctivitis, dizziness, heart attack (even fatal), ECG changes (QT prolongation), itis, errors of the Chamber of the heart rhythm, angina pectoris, huge heart, lower blood pressure, blood vessel blockage and – inflammation, bronchial seizures, asthma, pancreatitis, ulcers in the upper alimentary canal, Esophageal inflammation, water belly, anal einrisse, swallowing disorder, liver inflammation, inflammation of the gall bladder, bile congestion, feverish skin disorder, sensitivity to light, disorder of the skin color, fat tissue inflammation, skin ulcers, rough skin diseases, nail diseases, Enpfindungsstörungen in the palms and soles, muscle and skeletal rigidity, decay of muscle tissue (rhabdomyolysis), renal failure, frequent urination, protein in urine, swelling of the breast, errors of menstruation, discomfort, temperature sensitivity, increased blood concentration of phosphokinase.

Rare side effects: malformation of red blood cell, stroke, transient perfusion of the brain, seizures, Sehnerventzündung, Lung heart (Cor pulmonale), Herzmuskelentzündung, disease of the coronary vessels, bluish-purple skin color, acute respiratory distress syndrome, protein loss syndrome, tendinitis.

Side effects of unknown frequency: atrial fibrillation, atrial flutter, blood vessel blockage (including pulmonary embolism, constipation Eisenbahnsysteme of deep leg veins), special form of lung disease (interstitial lung disease), deadly stomach bleeding.

Specialties: Treatment with Dasatinib is associated with anemia and changes of doctors (lack of neutrophils and platelets) in combination. Their occurrence is more frequent in patients with advanced or acute stages of leukaemia than in the chronic phase. In the first two months the doctor should make a complete blood count a week, then once in a month, or if the condition of the patient requires it.