Lukeda Rocbrutinib Application Scope

Rocbrutinib Tablets are indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have previously received at least two prior systemic therapies, including Bruton’s tyrosine kinase (BTK) inhibitors.

Rocbrutinib Characteristics

Ingredients: The active pharmaceutical ingredient is rocbrutinib.
Properties: Rocbrutinib is supplied as film-coated tablets for oral administration.
Packaging Specification: The product is available in 25 mg tablets and 100 mg tablets, with 30 tablets packaged per bottle.
Storage: The product should be stored below 30°C in a dry place, protected from moisture and direct sunlight.
Expiry Date: The expiry date should be checked on the outer packaging or bottle label before use.
Executive Standard: The executive standard has not yet been publicly disclosed.
Approval Number: The official approval number has not yet been publicly disclosed.
Date of Revision: This document was revised in June 2026.
Manufacturer: Guangzhou Lupeng Pharmaceutical Co., Ltd.

Guidelines for the Use of Lukeda

Dosage and Administration:
- Recommended Dose: The recommended dose should be administered according to the official prescribing information or as directed by a qualified healthcare professional.
- Administration: Rocbrutinib may be taken with or without food and should preferably be taken at the same time each day.
- Missed Dose: If a dose is missed, it should be taken as soon as possible on the same day. If it is close to the next scheduled dose, the missed dose should be skipped. Double dosing is not recommended.
Adverse Reactions:
- Common Adverse Reactions: Common adverse reactions reported in clinical studies include neutropenia, leukopenia, thrombocytopenia, anemia, fatigue, diarrhea, and upper respiratory tract infections.
- Serious Adverse Reactions: Serious adverse reactions may include severe cytopenia, serious infection, hemorrhage, and tumor lysis syndrome. The incidence of atrial fibrillation or atrial flutter reported in clinical trials was low.
Contraindications: Rocbrutinib is contraindicated in patients with known hypersensitivity to Rocbrutinib or any component of the formulation.
Precautions:
- Monitor complete blood counts regularly during treatment.
- Use caution in patients with active infections or a history of recurrent infections.
- Monitor patients for signs of bleeding or hemorrhage during therapy.
- Use with caution in patients with hepatic impairment.
- Women who are pregnant or breastfeeding should consult a healthcare professional before use.
- Effective contraception is recommended during treatment and for a period after discontinuation.
- Patients should inform their physician about all concomitant medications before starting treatment.

Rocbrutinib Interactions

Strong CYP3A inhibitors
Strong CYP3A inducers
Anticoagulants
Antiplatelet agents

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.