Applies to the following strength(s): 70 mg ; 20 mg ; 50 mg ; 100 mg ; 80 mg ; 140 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Leukemia
Chronic Phase CML:
100 mg orally once a day
Duration of therapy: Until disease progression or patient is intolerant.
Accelerated Phase CML, Myeloid or Lymphoid Blast Phase CML, Ph+ ALL:
140 mg orally once a day
Duration of therapy: Until disease progression or patient is intolerant
-This drug should be used at the lowest effective dose in order to achieve therapeutic efficacy and minimize adverse effects.
-The effect of discontinuing therapy after complete cytogenetic response is achieved has not been investigated.
Uses: Chronic phase, accelerated phase, or myeloid or lymphoid blast phase Philadelphia chromosome-positive chronic myelogenous leukemia; Philadelphia chromosome-positive acute lymphoblastic leukemia
Renal Dose Adjustments
Data are not available; however, renal insufficiency is not expected to affect clearance as renal excretion accounts for less than 4% of this drug's elimination.
Liver Dose Adjustments
No adjustment recommended. Caution is recommended when using in patients with liver impairment.
Dose Adjustments for Neutropenia or Thrombocytopenia:
Chronic Phase CML:
1.) Stop therapy until the ANC is greater than or equal to 1.0 x 10(9)/L and platelets are greater than or equal to 50 x 10(9)/L.
2.) Resume treatment at the original starting dose if recovery occurs in less than or equal to 7 days.
3.) If platelets are less than 25 x 10(9)/L and/or recurrence of ANC less than 0.5 x 10(9)/L for greater than 7 days, repeat Step 1 and resume drug at a reduced dose of 80 mg once a day (second episode) or for a third episode, further reduce dose to 50 mg once a day (for newly diagnosed patients) or discontinue this drug (for patients resistant or intolerant to prior therapy including imatinib).
Accelerated Phase CML, Blast Phase CML and Ph+ ALL:
1.) Check if cytopenia is related to leukemia (marrow aspirate or biopsy).
2.) If cytopenia is unrelated to leukemia, stop this drug until the ANC is greater than or equal to 1.0 x 10(9)/L and platelets are greater than or equal to 20 x 10(9)/L and resume at the original starting dose.
3.) If recurrence of cytopenia, repeat Step 1 and resume this drug at a reduced dose of 100 mg once a day (second episode) or 80 mg once a day (third episode).
4. If cytopenia is related to leukemia, consider dose escalation to 180 mg once a day.
Dose Adjustment with Non-hematological Adverse Reactions:
If a severe non-hematological adverse reaction develops, treatment must be withheld until the event has resolved or improved. Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the event.
In clinical studies of adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML and Ph+ ALL) was allowed in patients who did not achieve a hematologic or cytogenetic response at the recommended dosage.
Dose Adjustment with concomitant Strong CYP450 3A4 Inducers:
The use of strong CYP450 3A4 inducers should be avoided. If this drug is used with an inducer, the dose of this drug should be increased followed by careful monitoring for adverse reactions.
Dose Adjustment with concomitant Strong CYP450 3A4 Inhibitors:
The use of strong CYP450 3A4 inhibitors should be avoided. If this drug is used with an inhibitor, a dose decrease should be considered. Patients taking 100 mg orally once daily should have dose decreased to 20 mg and patients taking 140 mg orally once daily should have dose decreased to 40 mg. Following dose reduction, if this drug is not tolerated, either the strong CYP450 3A4 inhibitor should be discontinued or this drug should be discontinued until treatment with the inhibitor is discontinued. After the strong inhibitor is discontinued, a washout period of approximately 1 week should be allowed to transpire prior to increasing the dasatinib dose.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Swallow tablets whole. Do not crush, break, or cut tablets.
-Take with or without food.
-Take consistently in the morning or evening.
-Cardiovascular: Monitor for signs and symptoms of cardiac dysfunction.
-Hematologic: Monitor blood counts weekly for the first 2 months and then monthly thereafter, or as clinically indicated.
-Hepatic: Monitor for signs of increased drug exposure or toxicity when administering with CYP450 3A4 inhibitors.
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Other brands: Sprycel