Usual Adult Dose for Mantle Cell Lymphoma

200 mg orally once daily

Length of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments:

• Swallow tablets whole with water. Do not cut, crush, or chew tablets.
• 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.

Renal Dose Adjustments

• Mild to moderate renal impairment (eGFR 30 mL/min or more): Not recommended
• Severe renal impairment (eGFR 15 to 29 mL/min): Decrease dose from 200 mg once daily to 100 mg once daily. If the current dose is 100 mg once daily, decrease to 50 mg once daily. If the current dose is 50 mg once daily, discontinue therapy

Liver Dose Adjustments

Data not available

Dose Adjustments

• Dose Modification for Specified Adverse Reactions:

• First occurrence: Discontinue therapy until recovery to Grade 1 or baseline, then restart at 200 mg once daily (or original dose).
• Second occurrence: Discontinue therapy until recovery to Grade 1 or baseline, then restart at 100 mg once daily.
• Third occurrence: Discontinue therapy until recovery to Grade 1 or baseline, then restart at 50 mg once daily.
• Fourth occurrence: Discontinue therapy.

• For Grade 4 non-hematologic toxicity: Evaluate the benefit-risk before resuming treatment at the same dose.

• Concomitant use with Strong CYP450 3A Inhibitors:
• Avoid use
• If unavoidable, decrease pirtobrutnib dose by 50 mg.
• If at a current dose of 50 mg once daily, discontinue pirtobrutnib for the duration of strong CYP3A inhibitor treatment.
• After discontinuation of strong CYP3A inhibitor for 5 half-lives, restart pirtobrutinib at the prior dose.

• Concomitant use with CYP450 3A Inducers:
• Avoid use with moderate or strong inducers
• If moderate CYP450 3A inducer use is unavoidable:
• Increase the dose from 200 mg once daily to 300 mg once daily
• Or increase by 50 mg if starting dose is 50 mg or 100 mg once daily

Precautions

CONTRAINDICATIONS: None

Pediatric statement:
Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer with or without food; should not be cut, crushed, or chewed.
• Swallow tablets whole with water.
• Should be taken at the same time daily.
• Monitor complete blood count regularly during treatment with this drug.

• Store at room temperature 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F)

• Read the Patient Information Leaflet.
• Advise patient to report all adverse events, especially fever, shortness of breath, palpitations, weakness, and dizziness.
• Notify patients of bleeding risk while on this drug.
• Discuss the potential for second malignancies especially skin cancers and counsel patients on the frequent use of sunscreen.
• Pregnant women and females of reproductive potential should be counseled on the risk to a fetus.
• Breastfeeding should be discontinued while on this drug and for one week after the last dose.