Chronic Phase CML (100 mg QD)

Starting Dose

This dose offers:

• Comparable efficacy with less toxicity than 70 mg BID*
• Simple and convenient once-daily dosing

*The dosage used in these studies is not recommended any longer for this patient population in the EU. The recommended starting dosage in the EU for chronic phase CML has been optimised to a 100 mg once-daily regimen, reflecting a more favourable safety profile with comparable efficacy.¹

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Dosing Adjustments^†

SPRYCEL dose adjustments for chronic phase CML patients resistant or intolerant to prior therapy including imatinib

†Progression was defined by any one of the following: development of accelerated phase CML; development of blast phase CML; or loss of MCyR, loss of complete haematologic response (CHR), or an increasing white blood cell count.¹⁷

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Modifying the Dose

In clinical trials of adult CML and Ph+ ALL patients, dose escalation to 90 mg BID (chronic phase CML) or 100 mg BID (accelerated and blast phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response.¹² Please see dose reduction and escalation recommendations below.

• If a severe non-haematologic adverse event develops with SPRYCEL, treatment must be withheld until the event has resolved
• Thereafter, treatment may be resumed as appropriate at a reduced dose, depending on the initial severity of the event

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Administration of SPRYCEL¹

• Patients should take SPRYCEL whole (not crushed or cut)
• Patients can take SPRYCEL with or without a meal
• In clinical trials, it was recommended that treatment with imatinib be discontinued at least 7 days before starting treatment with SPRYCEL
• SPRYCEL treatment can continue as long as patients tolerate the treatment and the disease does not progress

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Handling an Overdose¹

• Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases. The highest reported dosage ingested was 280 mg per day for 1 week, with no associated clinical symptoms
• Since SPRYCEL is associated with severe myelosuppression, patients who ingest more than the recommended dosage should be closely monitored for myelosuppression, and appropriate supportive treatment should be given

Please see the complete list of adverse events for SPRYCEL in the European Summary of Product Characteristics.

^‡About 30% of patients developed the same toxicity as with imatinib; these cases were usually of lower severity and did not lead to discontinuation of dasatinib.

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