Relapsed or refractory mantle cell lymphoma

Active Ingredient: Pirtobrutinib

Indication for Pirtobrutinib

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Pirtobrutinib as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.

For this indication, competent medicine agencies globally authorize below treatments:

200 mg once daily

For:

Dosage regimens

Oral, 200 milligrams pirtobrutinib, once daily.

Detailed description

The recommended dose is 200 mg pirtobrutinib once daily (QD).

Pirtobrutinib dosing should be interrupted until recovery to Grade 1 or baseline when the patient experiences the following event:

  • Grade 3 neutropenia with fever and/or infection
  • Grade 4 neutropenia lasting ≥7 days
  • Grade 3 thrombocytopenia with bleeding
  • Grade 4 thrombocytopenia
  • Grade 3 or 4 non-haematologic toxicity

Asymptomatic lymphocytosis is not regarded as an adverse reaction, and patients experiencing this event should continue taking pirtobrutinib.

In the clinical study, adverse events in a limited number of patients were managed by dose reduction.

Treatment should be continued until disease progression or unacceptable toxicity.

Missed dose

If more than 12 hours have passed after a patient has missed a dose, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken. If vomiting occurs, the patient should not take an additional dose but continue with the next scheduled dose.

Dosage considerations

It can be taken with or without food. Patients should take the dose at approximately the same time every day.

Active ingredient

Pirtobrutinib

Pirtobrutinib is a reversible, noncovalent inhibitor of BTK. BTK is a signalling protein of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. Pirtobrutinib binds to wild type BTK as well as BTK harboring C481 mutations leading to inhibition of BTK kinase activity.

Read more about Pirtobrutinib

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