DAURISMO™ Dosage and Administration

(glasdegib)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage and Schedule

The recommended dosage of DAURISMO is 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control. For patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response.

Administer DAURISMO with or without food. Do not split or crush DAURISMO tablets. Administer DAURISMO about the same time each day. If a dose of DAURISMO is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of DAURISMO is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses of DAURISMO within 12 hours.

2.2 Monitoring and Dosage Modifications

Assess complete blood counts, electrolytes, renal, and hepatic function prior to the initiation of DAURISMO and at least once weekly for the first month. Monitor electrolytes and renal function once monthly for the duration of therapy. Obtain creatine phosphokinase (CPK) levels prior to initiating DAURISMO and as indicated clinically thereafter (e.g., if muscle symptoms are reported). Monitor electrocardiograms (ECGs) prior to the initiation of DAURISMO, approximately one week after initiation, and then once monthly for the next two months to assess for QTc prolongation. Repeat ECG if abnormal. Certain patients may require more frequent and ongoing ECG monitoring [see Warnings and Precautions (5.2)]. Manage any abnormalities promptly [see Adverse Reactions (6.1)].

See Table 1 for dosage modification guidelines for patients who develop an adverse reaction.

Table 1. Recommended Dosage Modifications for Adverse Reactions
Adverse ReactionRecommended Action
Abbreviations: CPK = creatine phosphokinase, ULN = upper limit of normal.
*
Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening.

QTc interval prolongation on at least 2 separate electrocardiograms (ECGs) [see Warnings and Precautions (5.2)]

QTc interval greater than 480 ms to 500 ms

Assess electrolyte levels and supplement as clinically indicated.
Review and adjust concomitant medications with known QTc interval-prolonging effects [see Drug Interactions (7)].
Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation to less than or equal to 480 ms.

QTc interval greater than 500 ms

Assess electrolyte levels and supplement as clinically indicated.
Review and adjust concomitant medications with known QTc interval-prolonging effects [see Drug Interactions (7)].
Interrupt DAURISMO.
Resume DAURISMO at a reduced dosage of 50 mg once daily when QTc interval returns to within 30 ms of baseline or less than or equal to 480 ms.
Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation.
Consider re-escalating the dosage of DAURISMO to 100 mg daily if an alternative etiology for the QTc prolongation can be identified.

QTc interval prolongation with life-threatening arrhythmia

Discontinue DAURISMO permanently.

Musculoskeletal adverse reactions [see Warnings and Precautions (5.3)]

Grade 3* or serum CPK elevation between 2.5 and 10 times upper limit of normal (ULN)

Obtain CPK and serum creatinine levels at least weekly until resolution of clinical signs and symptoms.

Interrupt DAURISMO until symptoms reduce to mild or return to baseline.

Resume DAURISMO at the same dose level, or at a reduced dose of 50 mg.

If toxicity recurs, discontinue DAURISMO.

Grade 4* or serum CPK elevation greater than 10 times ULN

Discontinue DAURISMO.

Hematologic toxicity [see Adverse Reactions (6.1)]

Platelets less than 10 Gi/L for more than 42 days in the absence of disease

Discontinue DAURISMO and low-dose cytarabine permanently.

Neutrophil count less than 0.5 Gi/L for more than 42 days in the absence of disease

Discontinue DAURISMO and low-dose cytarabine permanently.

Nonhematologic toxicity [see Adverse Reactions (6.1)]

Grade 3*

Interrupt DAURISMO and/or low-dose cytarabine until symptoms reduce to mild or return to baseline.
Resume DAURISMO at the same dose level, or at a reduced dose of 50 mg.
Resume low-dose cytarabine at the same dose level, or at a reduced dose of 15 mg or 10 mg.
If toxicity recurs, discontinue DAURISMO and low-dose cytarabine.
If toxicity is attributable to DAURISMO only, low-dose cytarabine may be continued.

Grade 4*

Discontinue DAURISMO and low-dose cytarabine permanently.

2.3 Dosage Modification for Concomitant Use with Moderate CYP3A4 Inducers

Avoid concomitant use of DAURISMO with moderate CYP3A4 inducers. If concomitant use of moderate CYP3A4 inducers cannot be avoided, increase the DAURISMO dosage as tolerated as shown in Table 2. After the moderate CYP3A4 inducer has been discontinued for 7 days, resume the DAURISMO dose taken prior to initiating the moderate CYP3A4 inducer [see Drug Interactions (7), Clinical Pharmacology (12.3)].

Table 2. Recommended Dosage of DAURISMO with Concomitant Use of Moderate CYP3A4 Inducers
Current DosageAdjusted Dosage

100 mg orally once daily

200 mg orally once daily

50 mg orally once daily

100 mg orally once daily

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage and Schedule

The recommended dosage of DAURISMO is 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control. For patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response.

Administer DAURISMO with or without food. Do not split or crush DAURISMO tablets. Administer DAURISMO about the same time each day. If a dose of DAURISMO is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of DAURISMO is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses of DAURISMO within 12 hours.

2.2 Monitoring and Dosage Modifications

Assess complete blood counts, electrolytes, renal, and hepatic function prior to the initiation of DAURISMO and at least once weekly for the first month. Monitor electrolytes and renal function once monthly for the duration of therapy. Obtain creatine phosphokinase (CPK) levels prior to initiating DAURISMO and as indicated clinically thereafter (e.g., if muscle symptoms are reported). Monitor electrocardiograms (ECGs) prior to the initiation of DAURISMO, approximately one week after initiation, and then once monthly for the next two months to assess for QTc prolongation. Repeat ECG if abnormal. Certain patients may require more frequent and ongoing ECG monitoring [see Warnings and Precautions (5.2)]. Manage any abnormalities promptly [see Adverse Reactions (6.1)].

See Table 1 for dosage modification guidelines for patients who develop an adverse reaction.

Table 1. Recommended Dosage Modifications for Adverse Reactions
Adverse ReactionRecommended Action
Abbreviations: CPK = creatine phosphokinase, ULN = upper limit of normal.
*
Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening.

QTc interval prolongation on at least 2 separate electrocardiograms (ECGs) [see Warnings and Precautions (5.2)]

QTc interval greater than 480 ms to 500 ms

Assess electrolyte levels and supplement as clinically indicated.
Review and adjust concomitant medications with known QTc interval-prolonging effects [see Drug Interactions (7)].
Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation to less than or equal to 480 ms.

QTc interval greater than 500 ms

Assess electrolyte levels and supplement as clinically indicated.
Review and adjust concomitant medications with known QTc interval-prolonging effects [see Drug Interactions (7)].
Interrupt DAURISMO.
Resume DAURISMO at a reduced dosage of 50 mg once daily when QTc interval returns to within 30 ms of baseline or less than or equal to 480 ms.
Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation.
Consider re-escalating the dosage of DAURISMO to 100 mg daily if an alternative etiology for the QTc prolongation can be identified.

QTc interval prolongation with life-threatening arrhythmia

Discontinue DAURISMO permanently.

Musculoskeletal adverse reactions [see Warnings and Precautions (5.3)]

Grade 3* or serum CPK elevation between 2.5 and 10 times upper limit of normal (ULN)

Obtain CPK and serum creatinine levels at least weekly until resolution of clinical signs and symptoms.

Interrupt DAURISMO until symptoms reduce to mild or return to baseline.

Resume DAURISMO at the same dose level, or at a reduced dose of 50 mg.

If toxicity recurs, discontinue DAURISMO.

Grade 4* or serum CPK elevation greater than 10 times ULN

Discontinue DAURISMO.

Hematologic toxicity [see Adverse Reactions (6.1)]

Platelets less than 10 Gi/L for more than 42 days in the absence of disease

Discontinue DAURISMO and low-dose cytarabine permanently.

Neutrophil count less than 0.5 Gi/L for more than 42 days in the absence of disease

Discontinue DAURISMO and low-dose cytarabine permanently.

Nonhematologic toxicity [see Adverse Reactions (6.1)]

Grade 3*

Interrupt DAURISMO and/or low-dose cytarabine until symptoms reduce to mild or return to baseline.
Resume DAURISMO at the same dose level, or at a reduced dose of 50 mg.
Resume low-dose cytarabine at the same dose level, or at a reduced dose of 15 mg or 10 mg.
If toxicity recurs, discontinue DAURISMO and low-dose cytarabine.
If toxicity is attributable to DAURISMO only, low-dose cytarabine may be continued.

Grade 4*

Discontinue DAURISMO and low-dose cytarabine permanently.

2.3 Dosage Modification for Concomitant Use with Moderate CYP3A4 Inducers

Avoid concomitant use of DAURISMO with moderate CYP3A4 inducers. If concomitant use of moderate CYP3A4 inducers cannot be avoided, increase the DAURISMO dosage as tolerated as shown in Table 2. After the moderate CYP3A4 inducer has been discontinued for 7 days, resume the DAURISMO dose taken prior to initiating the moderate CYP3A4 inducer [see Drug Interactions (7), Clinical Pharmacology (12.3)].

Table 2. Recommended Dosage of DAURISMO with Concomitant Use of Moderate CYP3A4 Inducers
Current DosageAdjusted Dosage

100 mg orally once daily

200 mg orally once daily

50 mg orally once daily

100 mg orally once daily

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