Linperlisib Application Scope

For adult patients with relapsed or refractory follicular lymphoma (R/R FL) who have received at least two prior systemic therapies.

An additional indication under review: treatment of relapsed/refractory peripheral T-cell lymphoma (R/R PTCL).

Linperlisib Characteristics

Ingredients: Linperlisib
Properties: A yellow or yellowish film-coated tablet
Packaging Specification: 20 mg/tablet
Storage: Store sealed at a temperature not exceeding 30°C in a dry place
Expiry Date: Refer to the packaging for the specific expiry date
Executive Standard: Chinese Pharmacopoeia standard or NMPA-registered standard
Approval Number: National Drug Approval Number H20220030
Date of Revision: Refer to the latest prescribing information for the most recent revision date
Manufacturer: Jiangsu XuanTai Pharmaceutical Co., Ltd.

Guidelines for the Use of Linperlisib

Dosage and Administration:
- Recommended Dose: The recommended dosage is 80mg (four 20mg tablets) once daily
- Administration: It can be taken orally before or after meals. Treatment is continued until disease progression or unacceptable toxicity occurs.
- Missed Dose: If a dose is missed, take it as soon as remembered on the same day. Do not take two doses on the same day to make up for a missed dose.
Adverse Reactions:
- Common Adverse Reactions:
  
  The most common adverse reactions (≥20%) include:
  - Decreased neutrophil count (47.8%)
  - Decreased white blood cell count (35%)
  - Hypertriglyceridemia (25%)
  - Elevated ALT (24%)
- Serious Adverse Reactions:
  - Serious and sometimes fatal lung infections (12%), including fatal Pneumocystis jirovecii pneumonia.
  - Serious and sometimes fatal interstitial lung disease (4%).
Contraindications: Contraindicated in patients with known hypersensitivity to linperlisib or any component of the product.
Precautions:
- Serious Infections: Serious and fatal infections (including pulmonary infections) have occurred. Monitor for signs and symptoms of infection. Withhold or discontinue linperlisib based on severity.
- Interstitial Lung Disease (ILD): Serious and fatal ILD/pneumonitis has occurred. Monitor for pulmonary symptoms. Interrupt or discontinue linperlisib if ILD is suspected.
- Hematologic Toxicities: Neutropenia, leukopenia, and thrombocytopenia can occur. Monitor blood counts regularly during treatment.
- Hepatotoxicity: Elevations in liver enzymes (e.g., ALT, AST) can occur. Monitor liver function tests.
- Embryo-Fetal Toxicity: Based on animal studies, linperlisib can cause fetal harm. Advise patients of potential risks to the fetus and to use effective contraception.

Yintarui Interactions

Linperlisib is eliminated primarily in unchanged (parent) form via urine and partly metabolized by CYP3A4 and secondarily by CYP2C8.
Use caution with strong inhibitors or inducers of CYP3A4, as they may alter exposure. Public clinical‐interaction data is limited.
No comprehensive clinical studies yet published on all possible drug interactions.

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.