BTK inhibitors
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Jaypirca Dosage

Drug Detail:Jaypirca (Pirtobrutinib)

Generic Name: pirtobrutinib 50mg

Dosage Form: tablet, coated

Drug Class: BTK inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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.

Dosage Modifications for Adverse Reactions

Recommended dosage modifications of JAYPIRCA for adverse reactions are presented in Table 1 [see Warnings and Precautions (5.1, 5.2, 5.3, and 5.4)].

Table 1: Recommended Dosage Modification of JAYPIRCA for Adverse Reactions

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.
Adverse Reaction Occurrences Requiring Dosage Modification Modification
(Starting Dosage: 200 mg once daily)
  • Grade 3 or greater non-hematologic toxicity a
  • Absolute neutrophil count < 1 to 0.5 x 109/L with fever and/or infection
  • Absolute neutrophil count < 0.5 x 109/L lasting 7 or more days
  • Platelet count < 50 to 25 x 109/L with bleeding
  • Platelet count < 25 x 109/L
 First occurrence Interrupt JAYPIRCA until recovery to Grade 1 or baseline; restart at original dosage (200 mg once daily)a.
Second occurrence Interrupt JAYPIRCA until recovery to Grade 1 or baseline; restart at 100 mg once daily.
Third occurrence Interrupt JAYPIRCA until recovery to Grade 1 or baseline; restart at 50 mg once daily.
Fourth occurrence Discontinue JAYPIRCA.

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 (8.7), Clinical Pharmacology (12.3)]. No dosage adjustment of JAYPIRCA is recommended in patients with mild to moderate renal impairment (eGFR 30-89 mL/min).

Dosage Modifications for Concomitant Use with Strong CYP3A Inhibitors

Avoid concomitant use of strong CYP3A inhibitors with JAYPIRCA [see Drug Interactions (7.1), 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.

Dosage Modifications for Concomitant Use with CYP3A Inducers

Avoid concomitant use of strong or moderate CYP3A inducers with JAYPIRCA [see Drug Interactions (7.1), 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.

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