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Dasatinib Accord is a brand name for Dasatinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dasatinib Accord is indicated for the treatment of adult patients with: Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Dasatinib Accord is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ ALL in combination with chemotherapy.
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. 4). Paediatric population (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 Accord film-coated tablets or Dasatinib powder for oral suspension.
The dose should be recalculated every 3 months based on 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 Accord treatment in children under 1 year of age. Dasatinib Accord film-coated tablets and Dasatinib powder for oral suspension are not bioequivalent.
Medicinal product no longer authorised 4 The recommended starting daily dosage of Dasatinib Accord tablets in paediatric patients is shown in Table 1.
Table 1:
Dosage of Dasatinib Accord tablets for paediatric patients with 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+ ALL 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.
To achieve the recommended dose, Dasatinib Accord 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 Ph+ ALL patients, dose escalation to 180 mg once daily (Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
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. Medicinal product no longer authorised 12 These reactions are presented by system organ class and by frequency.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from available post-marketing data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 3:
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 cell 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 disordersMedicinal product no longer authorised 13 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 disorder 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 […]
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. 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose escalation is not recommended for paediatric patients with Ph+ ALL, as Dasatinib Accord 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 2. 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 < 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. Medicinal product no longer authorised 5 4.
If cytopaenia is related to leukaemia,consider dose escalation to 180 mg once daily. ANC: absolute neutrophil count For paediatric patients with Ph+ ALL, no dose modification is recommended in cases of haematologic Grade 1 to 4 toxicities.
If neutropaenia and/or thrombocytopaenia result in delay of the next block of treatment by more than 14 days, dasatinib should be interrupted and resumed at the same dose level once the next block of treatment is started. If neutropaenia and/or thrombocytopaenia persist and the next block of treatment is delayed another 7 days, a bone marrow assessment should be performed to assess cellularity and percentage of blasts.
5 x 109/L), at which time treatment may be resumed at full dose. If marrow cellularity is >10%, resumption of treatment with dasatinib may be considered. Non-haematologic adverse reactions If a moderate, grade 2, non-haematologic adverse reaction develops with dasatinib, treatment should be interrupted until the adverse reaction has resolved or returned to baseline.
The same dose should be resumed if this is the first occurrence and the dose should be reduced if this is a recurrent adverse reaction. If a severe grade 3 or 4, non-haematologic adverse reaction develops with dasatinib, treatment must be withheld until the adverse reaction has resolved.
Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction. For patients with Ph+ ALL who received 140 mg once daily, dose reduction to […]
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 andMedicinal product no longer authorised 8 older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive […]