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SPRYCEL
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SPRYCEL
 
Package(a):
FILM COATED TABLETS: 60 x 20 mg.
Dosage(a):
The recommended starting dosage for chronic phase CML is 100 mg 1 x daily, administered orally, consistently either in the morning or in the evening. The recommended starting dosage for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ALL is 70 mg 2 x daily administered orally, one tablet in the morning and one in the evening. 
Tablets must not be crushed or cut, they must be swallowed whole. Can be taken with or without a meal. Dose increase or reduction is recommended based on patient response and tolerability.
Treatment duration: In clinical trials, treatment was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment after the achievement of a complete cytogenetic response (CCyR) has not been investigated.
Dose escalation: In clinical trials of adult CML and Ph+ ALL patients, dose escalation to 140 mg 1 x daily (chronic phase CML) or 100 mg 2 x daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a hematologic or cytogenetic response at the recommended starting dosage.
Dose adjustment for undesirable effects: Myelosuppression: In clinical trials, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Platelet transfusion and red cell transfusion were used as appropriate. Hematopoetic growth factor has been used in patients with resistant myelosuppression. See prescribing information for full details.
Pediatrics: Not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Elderly patients: No specific dose recommendation is necessary in the elderly.
Hepatic impairment: Since dasatinib is mainly metabolised through the liver, exposure to dasatinib is expected to increase if liver function is impaired and treatment should therefore be with caution in patients with moderate to severe hepatic impairment.
Renal impairment: Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Prescribing Restrictions:  None

Package(b):
FILM COATED TABLETS: 60 x 50 mg.
Dosage(b):
The recommended starting dosage for chronic phase CML is 100 mg 1 x daily, administered orally, consistently either in the morning or in the evening. The recommended starting dosage for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ALL is 70 mg 2 x daily administered orally, one tablet in the morning and one in the evening. 
Tablets must not be crushed or cut, they must be swallowed whole. Can be taken with or without a meal. Dose increase or reduction is recommended based on patient response and tolerability.
Treatment duration: In clinical trials, treatment was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment after the achievement of a complete cytogenetic response (CCyR) has not been investigated.
Dose escalation: In clinical trials of adult CML and Ph+ ALL patients, dose escalation to 140 mg 1 x daily (chronic phase CML) or 100 mg 2 x daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a hematologic or cytogenetic response at the recommended starting dosage.
Dose adjustment for undesirable effects: Myelosuppression: In clinical trials, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Platelet transfusion and red cell transfusion were used as appropriate. Hematopoetic growth factor has been used in patients with resistant myelosuppression. See prescribing information for full details.
Pediatrics: Not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Elderly patients: No specific dose recommendation is necessary in the elderly.
Hepatic impairment: Since dasatinib is mainly metabolised through the liver, exposure to dasatinib is expected to increase if liver function is impaired and treatment should therefore be with caution in patients with moderate to severe hepatic impairment.
Renal impairment: Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Prescribing Restrictions:  None

Package(c):
FILM COATED TABLETS: 60 x 70 mg.
Dosage(c):
The recommended starting dosage for chronic phase CML is 100 mg 1 x daily, administered orally, consistently either in the morning or in the evening. The recommended starting dosage for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ALL is 70 mg 2 x daily administered orally, one tablet in the morning and one in the evening. 
Tablets must not be crushed or cut, they must be swallowed whole. Can be taken with or without a meal. Dose increase or reduction is recommended based on patient response and tolerability.
Treatment duration: In clinical trials, treatment was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment after the achievement of a complete cytogenetic response (CCyR) has not been investigated.
Dose escalation: In clinical trials of adult CML and Ph+ ALL patients, dose escalation to 140 mg 1 x daily (chronic phase CML) or 100 mg 2 x daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a hematologic or cytogenetic response at the recommended starting dosage.
Dose adjustment for undesirable effects: Myelosuppression: In clinical trials, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Platelet transfusion and red cell transfusion were used as appropriate. Hematopoetic growth factor has been used in patients with resistant myelosuppression. See prescribing information for full details.
Pediatrics: Not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Elderly patients: No specific dose recommendation is necessary in the elderly.
Hepatic impairment: Since dasatinib is mainly metabolised through the liver, exposure to dasatinib is expected to increase if liver function is impaired and treatment should therefore be with caution in patients with moderate to severe hepatic impairment.
Renal impairment: Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Prescribing Restrictions:  None


Indications:
Treatment of adults with chronic, accelerated or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate. Treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions:
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukemia.
Pregnancy and lactation: Should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the fetus. The effect of dasatinib on sperm is unknown, therefore both sexually active men and women should use effective methods of contraception during treatment. Breast-feeding must be stopped during treatment.
Side Effects:
Very common: Headache, neuropathy (including peripheral neuropathy), pleural effusion, dyspnea, cough. Diarrhea, nausea, vomiting. Skin rash, musculoskeletal pain. Infection (including bacterial, viral, fungal, non-specific). Hemorrhage, superficial edema, fatigue, pyrexia. Common: Febrile neutropenia. GI bleeding, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension. Pruritus, arthralgia, myalgia, anorexia. Pain, asthenia, chest pain.
Drug Interactions:
CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin). CYP3A4 inducers (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, (St. John's Wort). CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine). H2 blocker (e.g. famotidine), proton pump inhibitor (e.g. omeprazole), aluminium hydroxide/magnesium hydroxide.