Orelabrutinib(奥布替尼片)

Introduction of Orelabrutinib

Orelabrutinib, an orally administered highly selective Bruton's tyrosine kinase (BTK) inhibitor, is independently developed by Beijing InnoCare Pharma Tech Co., Ltd. and classified as a National Class I Innovative Drug.

Indications

This product is indicated as monotherapy for:

1.Adult patients with mantle cell lymphoma (MCL) who have received at least one prior treatment.

2.Adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior treatment.

3.Adult patients with marginal zone lymphoma (MZL) who have received at least one prior treatment.

4.The above indications are conditionally approved based on the overall response rate results from a single-arm clinical trial, and full approval will depend on the results of the ongoing confirmatory randomized controlled clinical trial.

Overview

Dosage and Administration

Recommended Dosage

Orelabrutinib Tablets should be used under the guidance of a physician with experience in tumor treatment.

Orelabrutinib should be administered orally, preferably at a fixed time each day. Swallow the tablet whole with water; do not split, crush, or chew it. It can be taken with or without food.

The recommended dosage is 150 mg (3 tablets of 50 mg each) orally once daily, continued until disease progression or the occurrence of intolerable toxicity.

Missed Dose

If a dose is not taken at the scheduled time, it should be taken as soon as possible provided that at least 8 hours remain before the next scheduled dose. Resume taking the medicine at the normal scheduled time on the following day. Do not take an extra dose to make up for the missed one.

Contraindications

This product is contraindicated in:

1.Patients with severe hepatic insufficiency;

2.Patients with known hypersensitivity to orelabrutinib or any of its excipients, such as immediate or accelerated allergic reactions.

Adverse Reactions

Common Adverse Reactions (≥10%)

include neutropenia, thrombocytopenia, leukopenia, hematuria, anemia, upper respiratory tract infection, rash, hemorrhage, infectious pneumonia, pulmonary inflammation, increased alanine aminotransferase, and elevated blood bilirubin.

Special Populations

Hepatic Insufficiency

Orelabrutinib is mainly metabolized in the liver. Dose adjustment is not recommended for patients with mild hepatic insufficiency. Patients with moderate and severe hepatic insufficiency were excluded from clinical studies, so there are no clinical data available on the use of this product in such patients. Patients with moderate hepatic insufficiency need to use this product with caution under the guidance of a physician and be closely monitored for liver function and related adverse reactions. Patients with severe hepatic insufficiency are contraindicated.

Renal Insufficiency

The kidneys are not the main route of elimination of unchanged orelabrutinib. Based on the results of population pharmacokinetic analysis, the pharmacokinetic characteristics of orelabrutinib in patients with mild and moderate renal insufficiency are not significantly different from those in patients with normal renal function in clinical practice. The pharmacokinetic characteristics of orelabrutinib have not been evaluated in patients with severe renal insufficiency or those requiring dialysis. Therefore, dose adjustment is not recommended for patients with mild and moderate renal insufficiency. Patients with severe renal insufficiency need to use this product with caution under the guidance of a physician and be monitored for adverse reactions.

Reproductive-Age Females and Males

Pregnancy Testing

Pregnancy status should be checked in females of childbearing potential before the initiation of treatment with this product.

Contraception

Females: Females of childbearing potential are advised to avoid pregnancy during treatment with this product and for at least 1 month after discontinuation of treatment.

No clinical data are available on the use of this product in pregnant women. Females of childbearing potential must use highly effective contraceptive measures during treatment with this product and for 1 month after the end of treatment. Females using hormonal contraceptive methods must additionally use a barrier contraceptive method. If this product is taken during pregnancy or a patient becomes pregnant while taking this product, the patient should be clearly informed that this product may cause harm to the fetus.

Males: Males are advised to use highly effective contraceptive measures during treatment with this product and for at least 3 months after the end of treatment.

Effects on Ability to Drive and Operate Machinery

No studies have been conducted to evaluate the effects of this product on the ability to drive and operate machinery.

For more detailed drug information, please consult the official package leaflet.

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