Gaorui Zhe Golidocitinib Capsules

1. Indications and Usage
Recurrent or Refractory Peripheral T-Cell Lymphoma (r/r PTCL):
Indicated for the treatment of adult patients with recurrent or refractory peripheral T-cell lymphoma (PTCL) who have received at least one prior systemic therapy.
2. Dosage and Administration
Recommended Dosage:
Dose: 150 mg orally once daily.
Schedule: Continue daily until disease progression or unacceptable toxicity.
Administration: Swallow capsules whole with water at approximately the same time every day. Do not open, break, or chew. Can be taken with or without food.
Missed Dose:
If a dose is missed, it may be taken as soon as possible within 12 hours of the scheduled time. If >12 hours have passed, skip the missed dose and resume at the next scheduled time.
Dose Modifications:
Toxicity: Interrupt treatment for Grade ≥ 3 toxicities (e.g., infection, neutropenia, thrombocytopenia, liver dysfunction); resume at reduced dose upon recovery.
3. Mechanism of Action
JAK1 Inhibition:
Golidocitinib is a potent and selective inhibitor of Janus kinase 1 (JAK1).
Physiological Effect:
It inhibits the JAK-STAT signaling pathway, thereby suppressing the proliferation and survival of malignant T-cells.
4. Safety and Warnings
Serious Infections:
Serious infections have been reported, including infectious pneumonia (some fatal), viral infections/reactivations (e.g., Herpesvirus, Hepatitis B), and Pneumocystis jirovecii pneumonia (PJP).
Hematologic Toxicity:
Neutropenia, thrombocytopenia, leukopenia, and lymphopenia can occur. Monitor complete blood counts (CBC) regularly.
Hepatic Toxicity:
Elevated transaminases (AST/ALT) and fibrinogen abnormalities have been observed. Monitor liver function tests (LFTs).
Thrombotic Events:
Increased risk of cardiovascular thrombosis (e.g., myocardial infarction) and hypertension may occur.
5. Adverse Reactions
Most Common:
Neutropenia, thrombocytopenia, leukopenia, lymphopenia, increased AST/ALT, increased creatinine, anemia, and infections.
6. Drug Interactions
Strong CYP3A Inhibitors:
May significantly increase Golidocitinib exposure. Avoid concomitant use with strong CYP3A inhibitors (e.g., itraconazole, ritonavir).

Strong CYP3A Inducers:
May significantly decrease Golidocitinib exposure. Avoid concomitant use with strong CYP3A inducers (e.g., rifampin).
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Golidocitinib.
Storage:
Store at room temperature. Keep in original package to protect from moisture.