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.
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.
| Adverse Reaction | Recommended Action | |
|---|---|---|
| Abbreviations: CPK = creatine phosphokinase, ULN = upper limit of normal. | ||
| ||
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. |
QTc interval greater than 500 ms | Assess electrolyte levels and supplement as clinically indicated. | |
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. |
Grade 4* | Discontinue DAURISMO and low-dose cytarabine permanently. | |
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)].
| Current Dosage | Adjusted Dosage |
|---|---|
100 mg orally once daily | 200 mg orally once daily |
50 mg orally once daily | 100 mg orally once daily |
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.
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.
| Adverse Reaction | Recommended Action | |
|---|---|---|
| Abbreviations: CPK = creatine phosphokinase, ULN = upper limit of normal. | ||
| ||
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. |
QTc interval greater than 500 ms | Assess electrolyte levels and supplement as clinically indicated. | |
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. |
Grade 4* | Discontinue DAURISMO and low-dose cytarabine permanently. | |
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)].
| Current Dosage | Adjusted 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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