Skip to Content

Sprycel Dosage

Generic name: dasatinib 20mg
Dosage form: tablet

Medically reviewed on January 1, 2018.

Dosage of SPRYCEL in Adult Patients

The recommended starting dosage of SPRYCEL for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of SPRYCEL for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg administered orally once daily. Tablets should not be crushed, cut, or chewed; they should be swallowed whole. SPRYCEL can be taken with or without a meal, either in the morning or in the evening.

Dosage of SPRYCEL in Pediatric Patients

The recommended starting dosage for pediatrics is based on body weight as shown in Table 1. The recommended dose should be administered orally once daily with or without food. Recalculate the dose every 3 months based on changes in body weight, or more often if necessary.

Do not crush, cut or chew tablets. Swallow tablets whole. The exposure in patients receiving a crushed tablet is lower than in those swallowing an intact tablet.

Table 1: Dosage of SPRYCEL for Pediatric Patients
Body Weight (kg)a Daily Dose (mg)
a Tablet dosing is not recommended for patients weighing less than 10 kg.

10 to less than 20

40 mg

20 to less than 30

60 mg

30 to less than 45

70 mg

at least 45

100 mg

Dose Modification

Strong CYP3A4 Inducers
Avoid the use of concomitant strong CYP3A4 inducers and St. John’s wort. If patients must be coadministered a strong CYP3A4 inducer, consider a SPRYCEL dose increase. If the dose of SPRYCEL is increased, monitor the patient carefully for toxicity [see Drug Interactions (7.1)].

Strong CYP3A4 Inhibitors
Avoid the use of concomitant strong CYP3A4 inhibitors and grapefruit juice. Recommend selecting an alternate concomitant medication with no or minimal enzyme inhibition potential, if possible. If SPRYCEL must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:

• 40 mg daily for patients taking SPRYCEL 140 mg daily.
• 20 mg daily for patients taking SPRYCEL 100 mg daily.
• 20 mg daily for patients taking SPRYCEL 70 mg daily.

For patients taking SPRYCEL 60 mg or 40 mg daily, stop SPRYCEL until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating SPRYCEL.

These reduced doses of SPRYCEL are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data is not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors. If SPRYCEL is not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or stop SPRYCEL until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before the SPRYCEL dose is increased [see Drug Interactions (7.1)].

Dose Escalation

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 starting dosage.

Escalate the SPRYCEL dose as shown in Table 2 in pediatric patients who do not achieve a hematologic or cytogenetic response at the recommended starting dosage.

Table 2: Dose Escalation for Pediatric CML

Formulation

Dose (maximum dose per day)

Starting Dose

Escalation

Tablets

40 mg

50 mg

60 mg

70 mg

70 mg

90 mg

100 mg

120 mg

Dose Adjustment for Adverse Reactions

Myelosuppression

In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Hematopoietic growth factor has been used in patients with resistant myelosuppression. Guidelines for dose modifications for adult and pediatric patients are summarized in Tables 3 and 4, respectively.

Table 3: Dose Adjustments for Neutropenia and Thrombocytopenia in Adults
* ANC: absolute neutrophil count

Chronic Phase CML

(starting dose 100 mg once daily)

ANC* <0.5 × 109/L
or
Platelets <50 × 109/L

1.
Stop SPRYCEL until ANC ≥1.0 × 109/L and platelets ≥50 × 109/L.
2.
Resume treatment with SPRYCEL at the original starting dose if recovery occurs in ≤7 days.
3.
If platelets <25 × 109/L or recurrence of ANC <0.5 × 109/L for >7 days, repeat Step 1 and resume SPRYCEL 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 SPRYCEL (for patients resistant or intolerant to prior therapy including imatinib).

Accelerated Phase CML, Blast Phase CML and Ph+ ALL

(starting dose 140 mg once daily)

ANC* <0.5 × 109/L
or
Platelets <10 × 109/L

1.
Check if cytopenia is related to leukemia (marrow aspirate or biopsy).
2.
If cytopenia is unrelated to leukemia, stop SPRYCEL until ANC ≥1.0 × 109/L and platelets ≥20 × 109/L and resume at the original starting dose.
3.
If recurrence of cytopenia, repeat Step 1 and resume SPRYCEL at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
4.
If cytopenia is related to leukemia, consider dose escalation to 180 mg once daily.
Table 4: Dose Adjustments for Neutropenia and Thrombocytopenia in Pediatric Patients
*ANC: absolute neutrophil count
** lower tablet dose not available
Dose (maximum dose per day)

1. If cytopenia persists for more than 3 weeks, check if cytopenia is related to leukemia (marrow aspirate or biopsy).

2. If cytopenia is unrelated to leukemia, stop SPRYCEL until ANC* ≥1.0 × 109/L and platelets ≥75 × 109/L and resume at the original starting dose or at a reduced dose.

3. If cytopenia recurs, repeat marrow aspirate/biopsy and resume SPRYCEL at a reduced dose.

Original Starting Dose
One-Level Dose Reduction
Two-Level Dose Reduction

Tablets

40 mg
20 mg
**
60 mg
40 mg
20 mg
70 mg
60 mg
50 mg
100 mg
80 mg
70 mg

For all pediatric patients, if Grade ≥3 neutropenia or thrombocytopenia recurs during complete hematologic response (CHR), interrupt SPRYCEL and resume at a reduced dose. Implement temporary dose reductions for intermediate degrees of cytopenia and disease response as needed.

Non-Hematologic Adverse Reactions

If a severe non-hematologic adverse reaction develops with SPRYCEL use, 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 severity and recurrence of the event [see Warnings and Precautions (5.1)].

2.6 Duration of Treatment

In clinical studies, treatment with SPRYCEL in adults and pediatric patients was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic response (including complete cytogenetic response [CCyR]) or major molecular response (MMR and MR4.5) has not been established.

SPRYCEL is an antineoplastic product. Follow applicable special handling and disposal procedures.1

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide