Jaypirca (Pirtobrutinib)

JAYPIRCA^® is a kinase inhibitor indicated for the treatment of:

• Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. (
  1.1 Mantle Cell Lymphoma

  JAYPIRCA^®is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

  This indication is approved under accelerated approval based on response rate

  [see Clinical Studies ].

  Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  ).
  
  This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (
  1.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

  JAYPIRCA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
  ).
  
  

• Recommended dosage: 200 mg orally once daily; swallow whole with water, with or without food. Do not cut, crush, or chew tablets. (
  2.1 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.
  )
• Manage toxicity using treatment interruption, dosage reduction, or discontinuation. (
  2.2 Dosage Modifications for Adverse Reactions

  Recommended dosage modifications of JAYPIRCA for adverse reactions are presented in Table 1

  [see Warnings and Precautions ]

  .

  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.
  aEvaluate 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 toxicitya 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.
  )
• Reduce dose in patients with severe renal impairment. (
  2.3 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 , Clinical Pharmacology ]

  . No dosage adjustment of JAYPIRCA is recommended in patients with mild to moderate renal impairment (eGFR 30-89 mL/min).
  ,
  8.6 Renal Impairment

  Severe renal impairment (eGFR15-29 mL/min) increases pirtobrutinib exposure

  [see Clinical Pharmacology ]

  . Reduce the JAYPIRCA dosage in patients with severe renal impairment

  [see Dosage and Administration ]

  . No dosage adjustment of JAYPIRCA is recommended in patients with mild (60-89 mL/min) or moderate (30-59 mL/min) renal impairment.
  )

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.

Lactation: Advise not to breastfeed (