Golidocitinib Capsules Application Scope

Marketed under the brand name (Gaoruizhe), are approved in China for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) in adult patients who have received at least one prior systemic therapy.

golidocitinib

Golidocitinib Capsules Characteristics

Ingredients: The active ingredient is golidocitinib, a Janus kinase 1 (JAK1) inhibitor.
Properties: Selectively inhibits JAK1, disrupting the JAK-STAT signaling pathway, which is implicated in the pathogenesis of certain lymphomas.
Specification: Each capsule contains 0.15 g.
Packaging Specification: Available in bottles containing 30 capsules each.
Storage: Store in a sealed container at temperatures not exceeding 30°C. Keep out of reach of children.
Expiry Date: 24 months from the date of manufacture.
Executive Standard: YBH12412024.
Approval Number:(specific number to be confirmed).
Date of Revision: June 18, 2024.
Manufacturer: (Dizal (Jiangsu) Pharmaceutical Co., Ltd.).

Guidelines for the Use of Golidocitinib Capsules

Dosage and Administration:
- The recommended dose is 150 mg taken orally once daily, continuing until disease progression or unacceptable toxicity occurs.
Adverse Reactions:
- Common adverse reactions include infections (e.g., pneumonia), hematologic abnormalities (e.g., neutropenia, thrombocytopenia), liver function test elevations (e.g., AST, ALT), fibrinogen abnormalities, and thrombotic or cardiovascular events.
Contraindications:
- Contraindicated in pregnant and breastfeeding women, and in individuals with known hypersensitivity to any component of the product.
Precautions:
- Monitor for signs of serious infections and viral reactivation. Regularly assess liver function and complete blood counts. Use effective contraception during treatment and for a specified period after the last dose.

Golidocitinib Capsules Interactions

Drug Interactions:
- Co-administration with strong CYP3A inhibitors or inducers may affect golidocitinib metabolism; monitor patients accordingly and adjust dosage if necessary.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.