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Dasatinib Accordpharma is a brand name for Dasatinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dasatinib Accordpharma is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. Posology Adult patients The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily. 4). Paediatric population (Ph+ CML-CP and Ph+ ALL) Dosing for children and adolescents is on the basis of body weight (see Table 1).
Dasatinib is administered orally once daily in the form of either Dasatinib Accordpharma film-coated tablets or Dasatinib powder for oral suspension. The dose should be recalculated every 3 months based onMedicinal product no longer authorised 4 changes in body weight, or more often if necessary.
The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients. Dose increase or reduction is recommended based on individual patient response and tolerability. There is no experience with Dasatinib Accordpharma treatment in children under 1 year of age.
Dasatinib Accordpharma film-coated tablets and Dasatinib powder for oral suspension are not bioequivalent. Patients who are able to swallow tablets and who desire to switch from Dasatinib powder for oral suspension to Dasatinib Accordpharma tablets or patients who are not able to swallow tablets and who desire to switch from tablets to oral suspension, may do so, provided that the correct dosing recommendations for the dosage form are followed.
The recommended starting daily dosage of Dasatinib Accordpharma tablets in paediatric patients is shown in Table 1.
Table 1:
Dosage of Dasatinib Accordpharma tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a Daily dose (mg) 10 to less than 20 kg 40 mg 20 to less than 30 kg 60 mg 30 to less than 45 kg 70 mg at least 45 kg 100 mg a The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
Treatment duration In clinical studies, treatment with dasatinib in adults with Ph+ CML-CP, accelerated, myeloid or lymphoid blast phase (advanced phase) CML, or Ph+ ALL and paediatric patients with Ph+ CML-CP was continued until disease progression or until no longer tolerated by the patient.
5] has not been investigated. In clinical studies, treatment with dasatinib in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years.
Summary of the safety profile The data described below reflect the exposure to dasatinib as single-agent therapy at all doses tested in clinical studies (N=2,900), including 324 adult patients with newly diagnosed chronic phase CML, 2,388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 188 paediatric patients.
2 months). In a randomized trial in patients with newly diagnosed chronic phase CML, the median duration of therapy was approximately 60 months. 9 months). 2 months). 6 months). 6 months). The majority of dasatinib -treated patients experienced adverse reactions at some time.
In the overall population of 2,712 dasatinib-treated adult subjects, 520 (19%) experienced adverse reactions leading to treatment discontinuation. 5%) experienced adverse reactions leading to treatment discontinuation. Tabulated list of adverse reactions The following adverse reactions, excluding laboratory abnormalities, were reported in patients treated with dasatinib used as single-agent therapy in clinical studies and post-marketing experience (Table 5).
These reactions are presented by system organ class and by frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 5:
Tabulated summary of adverse reactions Infections and infestations Very common infection (including bacterial, viral, fungal, non-specified) Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus - CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes) Not known hepatitis B reactivation Blood and lymphatic system disorders Very common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia) Common febrile neutropaenia Uncommon lymphadenopathy, lymphopaenia Rare aplasia pure red cellMedicinal product no longer authorised 14 Immune system disorders Uncommon hypersensitivity (including erythema nodosum) Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders Common appetite disturbancesa, hyperuricaemia Uncommon tumour lysis syndrome, dehydration, hypoalbuminemia, hypercholesterolemia Rare diabetes mellitus Psychiatric disorders Common depression, insomnia Uncommon anxiety, confusional state, affect lability, libido decreased Nervous system disorders Very common headache Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia Eye disorders Common visual disorder (including visual disturbance, vision blurred, and visual acuity reduced), dry eye Uncommon visual impairment, conjunctivitis, photophobia, lacrimation increased Ear and labyrinth disorders Common tinnitus Uncommon hearing loss, vertigo Cardiac disorders Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis Not Known atrial fibrillation/atrial flutter Vascular disorders Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis Rare deep vein thrombosis, embolism, livedo reticularis Not known thrombotic microangiopathy Respiratory, thoracic and mediastinal disorders Very common pleural effusion*, dyspnoea Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma, chylothorax* Rare pulmonary embolism, acute respiratory distress syndrome Not known interstitial lung disease Gastrointestinal disorders Very common diarrhoea, vomiting, nausea, abdominal pain Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorderMedicinal product no longer authorised 15 Uncommon pancreatitis (including acute pancreatitis), upper gastrointestinal ulcer, oesophagitis, ascites*, anal fissure, dysphagia, gastroesophageal reflux disease Rare protein-losing gastroenteropathy, ileus, anal fistula Not known fatal gastrointestinal […]
Clinically relevant interactions Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4. 5). g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice) may increase exposure to dasatinib.
5). g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure.
5). Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate. 5). g. g. omeprazole), or aluminium hydroxide/magnesium hydroxide may reduce the exposure to dasatinib. 5). 2). Due to the limitations of this clinical study, caution is recommended when administering dasatinib to patients with hepatic impairment.
Important adverse reactions Myelosuppression Treatment with dasatinib is associated with anaemia, neutropaenia and thrombocytopaenia. Their occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML.
In adult patients with advanced phase CML or Ph+ ALL treated with dasatinib as monotherapy, complete blood counts (CBCs) should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated. In adult and paediatric patients with chronic phase CML, complete blood counts should be performed every 2 weeks for 12 weeks, then every 3 months thereafter or as clinically indicated.
In paediatric patients with Ph+ ALL treated with dasatinib in combination with chemotherapy, CBCs should be performed prior to the start of each block of chemotherapy and as clinically indicated. 8). Myelosuppression is generally reversible and usually managed by withholding dasatinib temporarily or by dose reduction.
Bleeding In patients with chronic phase CML (n=548), 5 patients (1%) receiving dasatinib had grade 3 or 4 haemorrhage. In clinical studies in patients with advanced phase CML receiving the recommended dose of dasatinib (n=304), severe central nervous system (CNS) haemorrhage occurred in 1% of patients.
1
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In patients that receive a subsequent stem cell transplantation, dasatinib can be administered for an additional year post-transplantation. To achieve the recommended dose, Dasatinib Accordpharma is available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg film-coated tablets.
Dose increase or reduction is recommended based on patient response and tolerability. Dose escalation In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
The following dose escalations shown in Table 2 are recommended in paediatric patients with Ph+ CML-CP who do not achieve a haematologic, cytogenetic and molecular response at the recommended time points, per current treatment guidelines, and who tolerate the treatment.
Table 2:
Dose escalation for paediatric patients with Ph+ CML-CP Dose (maximum dose per day) Starting dose Escalation Tablets 40 mg 50 mg 60 mg 70 mg 70 mg 90 mg 100 mg 120 mgMedicinal product no longer authorised 5 Dose escalation is not recommended for paediatric patients with Ph+ ALL, as Dasatinib Accordpharma is administered in combination with chemotherapy in these patients.
Dose adjustment for adverse reactions Myelosuppression In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Platelet transfusion and red cell transfusion were used as appropriate.
Haematopoietic growth factor has been used in patients with resistant myelosuppression. Guidelines for dose modifications in adults are summarised in Table 3 and in paediatric patients with Ph+ CML-CP in Table 4. Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the tables.
5 x 109/L and/or platelets <50 x 109/L 1. 0 x 109/L and platelets ≥ 50 x 109/L. 2. Resume treatment at the original starting dose. 3. 5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue (for patients resistant or intolerant to prior therapy including imatinib). 5 x 109/L and/or platelets <10 x 109/L 1. Check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
2. 0 x 109/L and platelets ≥ 20 x 109/L and resume at the original starting dose. 3. If recurrence of cytopaenia, repeat step 1 and resume treatment at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
4. If cytopaenia is related to leukaemia,consider dose escalation to 180 mg once […]
One case was fatal and was associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopaenia. Grade 3 or 4 gastrointestinal haemorrhage occurred in 6% of patients with advanced phase CML and generally required treatment interruptions and transfusions.
Other grade 3 or 4 haemorrhage occurred in 2% of patients with advanced phase CML. 8). Additionally, in vitro and in vivo platelet assays suggest that dasatinib treatment reversibly affects platelet activation. Caution should be exercised if patients are required to take medicinal products that inhibit platelet function or anticoagulants.
Fluid retention Dasatinib is associated with fluid retention. 8). In all dasatinib treated patients with chronic phase CML, severe fluid retention occurred in 32 patients (6%) receiving dasatinib at the recommended dose (n=548). In clinical studies in patients with advanced phase CML or Ph+ ALL receiving dasatinib at the recommended dose (n=304), grade 3 or 4 fluid retention was reported in 8% of patients, including grade 3 or 4 pleural and pericardial effusion reported in 7% and 1% of patients, respectively.
In these patients grade 3 or 4 pulmonary oedema and pulmonary hypertension were each reported in 1% of patients. Patients who develop symptoms suggestive of pleural effusion such as dyspnoea or dry cough should be evaluated by chest X-ray.
Grade 3 or 4 pleural effusion may require thoracocentesis and oxygen therapy. 8). Patients aged 65 years and older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive heart failure, and should be monitored […]