Posology : מינונים

3        DOSAGE AND ADMINISTRATION

3.1      Recommended Dosage
The recommended dosage of JAYPIRCA is 200 mg orally once daily until disease progression or unacceptable toxicity.
Advise patients of the following:
•    Swallow tablets whole with water. Do not cut, crush, or chew tablets.
•    Take JAYPIRCA at the same time each day. JAYPIRCA may be taken with or without food.
•    If a dose of JAYPIRCA is missed by more than 12 hours, do not make up the dose and take the next dose as scheduled.

3.2      Dosage Modifications for Adverse Reactions
Recommended dosage modifications of JAYPIRCA for adverse reactions are presented in Table 1 [see Warnings and Precautions (6.1, 6.2, 6.3, and 6.4)].
Table 1: Recommended Dosage Modification of JAYPIRCA for Adverse Reactions Adverse Reaction                       Occurrences Requiring        Modification Dosage Modification          (Starting Dosage: 200 mg once daily)
•   Grade 3 or greater non-            First occurrence             Interrupt JAYPIRCA until recovery to Grade 1 or hematologic toxicity a                                          baseline; restart at original dosage (200 mg once •   Absolute neutrophil count < 1 to                                daily)a.
0.5 x 109/L with fever and/or      Second occurrence            Interrupt JAYPIRCA until recovery to Grade 1 or infection                                                       baseline; restart at 100 mg once daily.
•    Absolute neutrophil count < 0.5            Third occurrence                  Interrupt JAYPIRCA until recovery to Grade 1 or x 109/L lasting 7 or more days                                               baseline; restart at 50 mg once daily.
•    Platelet count < 50 to 25 x 109/L
Fourth occurrence                 Discontinue JAYPIRCA.
with bleeding
•    Platelet count < 25 x 109/L
Dose modification is not recommended for asymptomatic lymphocytosis. Asymptomatic lipase increase may not necessarily warrant dose modification.
a
Evaluate the benefit-risk before resuming treatment at the same dose for a Grade 4 non-hematological toxicity.

3.3        Dosage Modifications for Patients with Severe Renal Impairment For patients with severe renal impairment (eGFR 15-29 mL/min), reduce the JAYPIRCA dose to 100 mg once daily if the current dose is 200 mg once daily otherwise reduce the dose by 50 mg. If the current dosage is 50 mg once daily, discontinue JAYPIRCA [see Use in Specific Populations (9.7), Clinical Pharmacology (12.3)]. No dosage adjustment of JAYPIRCA is recommended in patients with mild to moderate renal impairment (eGFR 30-89 mL/min).

3.4        Dosage Modifications for Concomitant Use with Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with JAYPIRCA [see Drug Interactions (8.1), Clinical Pharmacology (12.3)]. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the JAYPIRCA dose by 50 mg. If the current dosage is 50 mg once daily, interrupt JAYPIRCA treatment for the duration of strong CYP3A inhibitor use. After discontinuation of a strong CYP3A inhibitor for 5 half-lives, resume the JAYPIRCA dose that was taken prior to initiating the strong CYP3A inhibitor.

3.5        Dosage Modifications for Concomitant Use with CYP3A Inducers Avoid concomitant use of strong or moderate CYP3A inducers with JAYPIRCA [see Drug Interactions (8.1), Clinical Pharmacology (12.3)]. If concomitant use with moderate CYP3A inducers is unavoidable and the current dosage of JAYPIRCA is 200 mg once daily, increase the dose to 300 mg. If the current dosage is 50 mg or 100 mg once daily, increase the dose by 50 mg.

4          DOSAGE FORMS AND STRENGTHS
Tablets:
Each 50 mg tablet is blue, arc-triangle shaped, film-coated, and debossed with “Lilly 50” on one side and “6902” on the other side.
Each 100 mg tablet is blue, round, film-coated, and debossed with “Lilly 100” on one side and “7026” on the other side.