Dosing and administration

ORAL DOSING

Daily oral dosing for adults with newly diagnosed Ph+ CML-CP

Patients with newly diagnosed PH+ CML-CP: 80mg once daily. There is also an option to take product x 40mg tablets twice a day (AM+PM)

Patients should:

Avoid food consumption for at least 2 hours before and 1 hour after taking SCEMBLIX

Swallow SCEMBLIX whole—do not break, crush, or chew SCEMBLIX tablets

DOSAGE MODIFICATIONS

Dosage reductions and modifications

DOSAGE REDUCTIONS

For the management of ARs, reduce the SCEMBLIX dose as described in the table below.

• First reduction: 40 mg qd OR 20 mg bid¹
• Subsequent reduction: Permanently discontinue SCEMBLIX in patients unable to tolerate 40 mg qd OR 20 mg bid¹

DOSAGE MODIFICATIONS FOR THE MANAGEMENT OF ADVERSE REACTIONS

ANC, absolute neutrophil count; AR, adverse reaction; bid, twice daily; CTCAE, Common Terminology Criteria for Adverse Events; Ph+ CML-CP, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase; PLT, platelets; qd, once daily; ULN, upper limit of normal.
^aBased on CTCAE v4.03.

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Dosing and administration

Daily oral dosing for adults with newly diagnosed Ph+ CML-CP

Patients should:

Dosage reductions and modifications

IMPORTANT SAFETY INFORMATION

INDICATION