Posology : מינונים

5 DOSAGE AND ADMINISTRATION

5.1 Recommended Dosage
CALQUENCE TABLETS as Monotherapy
For patients with MCL, CLL, or SLL, the recommended dosage of CALQUENCE TABLETS is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity.

CALQUENCE TABLETS in Combination with Obinutuzumab

For patients with previously untreated CLL or SLL, the recommended dosage of CALQUENCE TABLETS is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity. Start CALQUENCE TABLETS at Cycle 1 (each cycle is 28 days). Start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing.
Administer CALQUENCE TABLETS prior to obinutuzumab when given on the same day.

Advise patients to swallow tablet whole with water. Advise patients not to chew, crush, dissolve, or cut the tablets. CALQUENCE TABLETS may be taken with or without food. If a dose of CALQUENCE TABLETS is missed by more than 3 hours, it should be skipped and the next dose should be taken at its regularly scheduled time. Extra tablets of CALQUENCE TABLETS should not be taken to make up for a missed dose.

5.2 Recommended Dosage for Drug Interactions
Dosage Modifications for Use with CYP3A Inhibitors or Inducers

These are described in Table 1 [see Drug Interactions (10)].
Table 1: Recommended Dosage Modifications for Use with CYP3A Inhibitors or Inducers 
CYP3A         Co-administered Drug            Recommended CALQUENCE TABLETS use Avoid co-administration.
If these inhibitors will be used short-term (such as anti-infectives for up to seven days), interrupt
Strong CYP3A inhibitor          CALQUENCE TABLETS.

Inhibition                                    After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of
CALQUENCE TABLETS.

Reduce the CALQUENCE TABLETS 100 mg every 12
Moderate CYP3A inhibitor hours dosage to 100 mg once daily.

Avoid co-administration.
Induction     Strong CYP3A inducer             If co-administration is unavoidable, increase CALQUENCE TABLETS dosage to 200 mg approximately every 12 hours.

5.3 Dosage Modifications for Adverse Reactions
Recommended dosage modifications of CALQUENCE TABLETS for Grade 3 or greater adverse reactions are provided in Table 2.
Table 2: Recommended Dosage Modifications for Adverse Reactions

Adverse              Dosage Modification
Event                              Reaction             (Starting dose = 100 mg approximately every 12 Occurrence           hours)
Interrupt CALQUENCE TABLETS.
Once toxicity has resolved to Grade 1 or baseline
First and Second     level, CALQUENCE TABLETS may be
Grade 3 or greater non- hematologic toxicities,                                 resumed at 100 mg approximately every 12 hours.
Grade 3 thrombocytopenia with bleeding,                                          Interrupt CALQUENCE TABLETS.
Grade 4 thrombocytopenia or                             Once toxicity has resolved to Grade 1 or baseline Third                level, CALQUENCE TABLETS may be
Grade 4 neutropenia lasting longer than 7 days                                      resumed at a reduced frequency of 100 mg once daily.

Fourth               Discontinue CALQUENCE TABLETS.
Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

Refer to the obinutuzumab prescribing information for management of obinutuzumab toxicities.

6 DOSAGE FORMS AND STRENGTHS
Film coated Tablets:100 mg acalabrutinib, orange, oval, film-coated, biconvex, debossed with ‘ACA 100’ on one side and plain on the other.