Pitobrutinib is a new generation BTK inhibitor that provides an important treatment option for patients with drug-resistant B-cell malignancies, but strict monitoring of liver function and infection risk is required.

1、 Drug name and main ingredients

1. Common name: Pirtobrutinib

2. Product Name: JAYPIRCA ™

3. Dosage form: Oral film coated tablets

4. Main ingredients: Each tablet contains 50mg or 100mg of pirtobrutinib (active ingredient).

2、 Indications

Recurrent or refractory mantle cell lymphoma (MCL): Used to treat adult patients with recurrent or refractory MCL who have previously received at least two systemic treatments, including a BTK inhibitor. This indication is based on accelerated approval and requires further validation of clinical benefits.

3、 Specifications and characteristics

1. Specification: 50mg (blue curved triangular piece, engraved with "Lilly50" and "6902"); 100mg (blue circular tablet engraved with "Lilly100" and "7026").

2. Packaging: 30 tablets/bottle (50mg) or 60 tablets/bottle (100mg), equipped with child safety bottle caps.

4、 Usage and dosage

1. Recommended dosage: 200mg orally, once daily, until disease progression or intolerable toxicity occurs.

2. Usage: Swallow the whole tablet, it can be taken with food or on an empty stomach, and take the medication at a fixed time every day.

3. Omission treatment: If missed for more than 12 hours, skip and take according to the original plan the next day; No need to take additional medication after vomiting.

5、 Dose adjustment

1. First dose reduction: 100mg once daily;

2. Secondary reduction: 50mg once daily;

3. Permanent discontinuation of medication: unable to tolerate a dose of 50mg.

4. Adjustment basis:

(1) Severe kidney injury (eGFR15-29mL/min): Reduce to 100mg once daily;

(2) Combined use of strong CYP3A inhibitors: reduce dosage by 50mg;

(3) Combined use of moderate CYP3A inducer: Increase to 300mg once daily (at the original dose of 200mg).

6、 Medication precautions

1. Infection risk: 17% of patients develop grade 3 or higher infections and require monitoring and prophylactic use of anti infective drugs.

2. Bleeding risk: 2.4% of patients experience severe bleeding, avoid using anticoagulants in combination.

3. Hyperglycemia monitoring: fasting blood glucose is detected regularly, and diabetes patients need to strengthen management.

4. Skin cancer risk: 3.8% of patients develop non melanoma skin cancer, sun protection is recommended.

7、 Medication for special populations

1. Pregnant women: prohibited (animal experiments show embryotoxicity).

2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and within one week of discontinuation of medication.

3. Renal insufficiency: Severe kidney injury requires reduction in dosage.

4. Elderly: No need to adjust dosage, but need to strengthen monitoring of adverse reactions.

8、 Adverse reactions

1. Common (≥ 20%): fatigue (27%), musculoskeletal pain (26%), diarrhea (20%), bruising (20%).

2. Serious reactions: pneumonia (14%), neutropenia (16%), bleeding (3.1%).

9、 Contraindications

There are no absolute contraindications, but avoid using strong CYP3A inducers (such as rifampicin) in combination.

10、 Drug interactions

1. Strong CYP3A inhibitors (such as itraconazole): need to be reduced;

2. Sensitive CYP2C8/2C19 substrates (such as regorazine): may increase the toxicity of the latter.

11、 Storage method

Store at room temperature (20-25 ° C) and keep the original bottle away from light and moisture.

Note: If severe infection, bleeding, or arrhythmia occurs, seek medical attention immediately. Regular monitoring of blood routine and liver function is required during the treatment period.

Pirtobrutinibinformation