Jaypirca(pirtobrutinib，吡托布替尼）

[Jaypirca indications]

Jaypirca is a kinase inhibitor, which is used for treatment.

Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after receiving at least two-line systemic therapy (including a BTK inhibitor).

The indication was accelerated according to the response rate. The continued approval of this indication may depend on the verification and description of clinical benefits in confirmatory trials.

Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) have received at least two treatments before, including a BTK inhibitor and a BCL-2 inhibitor.

The indication was accelerated according to the response rate. The continued approval of this indication may depend on the verification and description of clinical benefits in confirmatory trials.

[recommended dose of Jaypirca]

Recommended dose: 200mg； orally once a day; With or without food, swallow it whole with water. Do not cut, crush or chew tablets.

The toxicity was controlled by interrupting treatment, reducing dosage or stopping medication.

Patients with severe renal dysfunction should reduce the dose.

[Jaypirca is used by special people]

Breastfeeding: It is not recommended to breastfeed.

[Jaypirca drug interaction]

Powerful CYP3A inhibitors: Avoid combination. If combined use is unavoidable, reduce the dosage of Jaypirca.

Strong or moderate CYP3A inducer: Avoid combined use. If moderate CYP3A inducer is unavoidably used at the same time, increase the dosage of Jaypirca.

Sensitive substrates of CYP2C8, CYP2C19, CYP3A, P-gp or BCRP: For the substrates whose minimum concentration changes may increase the risk of adverse reactions, please follow the recommendations provided in the approved product labels for their use with CYP2C8, CYP2C19, CYP3A, P-gp or BCRP inhibitors.

[Jaypirca Warnings and Precautions]

I. Infection

Infection may occur during Jaypirca treatment. These infections can be serious and may lead to death. If your risk of infection increases, your doctor may prescribe some drugs for you. If you develop fever, chills, weakness, flu-like symptoms or any other signs of infection during treatment, please inform your doctor immediately.

Second, the bleeding problem

There may be bleeding problems during the treatment with Jaypirca, which may be serious and even lead to death. If you take blood thinner at the same time, you may increase the risk of serious bleeding. If you have any signs or symptoms of bleeding, please inform your doctor, including: bloody stool or black stool (which looks like asphalt); Pink or brown urine; Accidental bleeding or uncontrollable severe bleeding; Hematemesis or hematemesis that looks like coffee grounds; Coughing up blood or blood clot; Increased congestion; Dizziness; Weakness; Speech confusion; A headache that lasts for a long time

Third, the blood cell count is reduced

The decrease of blood cell count (white blood cells, platelets and red blood cells) in Jaypirca patients is common, but it can also be serious. This may increase the risk of infection, bleeding and anemia. Your doctor should have regular blood tests to check your blood cell count during treatment.

Fourth, the heart rhythm problem

Patients treated with Jaypirca have experienced heart rhythm problems (atrial fibrillation and atrial flutter). If you have high blood pressure or have had heart rhythm problems in the past, your risk of heart rhythm problems may increase. Please tell your doctor if you have any of the following signs or symptoms: rapid or irregular heartbeat (palpitation), dizziness, syncope, chest discomfort and shortness of breath.

Fifth, the second primary cancer

During the treatment of Jaypirca, people developed new cancers, including skin cancer or cancers of other organs. Your doctor will check other cancers for you during the treatment. When you are outdoors in the sun, use sunscreen.

VI. Embryo-fetal toxicity

Jaypirca may harm the fetus. Women with reproductive potential: Your doctor will conduct a pregnancy test before starting treatment, and you should use effective contraceptive measures during treatment and within one week after the last administration. If you are pregnant or think you are pregnant during treatment, please inform your doctor immediately.

[Adverse reaction of Jaypirca]

The most common adverse reactions (≥15%) are fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia and bruising.