GaoruiZhe Golidocitinib Capsules

1. Indications and Usage
Golidocitinib capsules are indicated as a single agent for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least one prior systemic therapy.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 150 mg taken orally once daily. Treatment should continue until disease progression or unacceptable toxicity.
Administration: Capsules must be swallowed whole and should not be opened, chewed, or dissolved. They may be taken with or without food.
Missed Dose: If a dose is missed, it should be taken within 12 hours of the scheduled time. If more than 12 hours have elapsed, the dose should be skipped and the next dose taken at the regular time.
Dose Modifications: Dose interruptions or reductions (to 100 mg or 50 mg once daily) are required based on the severity of adverse reactions.
3. Mechanism of Action
Golidocitinib is a highly selective, reversible inhibitor of Janus kinase 1 (JAK1). It blocks the JAK/STAT signaling pathway, inhibiting the phosphorylation of STAT3/5 and subsequent signal transduction in tumor cells, thereby suppressing cell proliferation and survival.
4. Safety and Warnings
Serious Infections: Patients are at risk for serious infections, including pneumonia, viral reactivation (e.g., herpesvirus, hepatitis B), and Pneumocystis jirovecii pneumonia (PJP).
Hematologic Toxicity: Neutropenia, thrombocytopenia, leukopenia, and anemia are frequent adverse reactions requiring regular blood count monitoring.
Hepatotoxicity: Elevations in liver enzymes (ALT, AST) and bilirubin can occur. Liver function tests must be monitored regularly.
Embryo-fetal Toxicity: This drug can cause fetal harm based on its mechanism of action.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include neutrophil count decreased, thrombocytopenia, leukocyte count decreased, lymphocyte count decreased, alanine aminotransferase increased, and aspartate aminotransferase increased.
Clinical Research: Efficacy was established in the JACKPOT8 study (Part B), a Phase II single-arm international trial evaluating golidocitinib in patients with r/r PTCL.
6. Drug Interactions
Strong CYP3A Inhibitors: Co-administration with strong CYP3A inhibitors (e.g., itraconazole) may increase golidocitinib exposure and requires dose adjustment.
Strong CYP3A Inducers: Co-administration with strong CYP3A inducers may decrease golidocitinib exposure and should be avoided.
7. Pharmaceutical Information
Composition: The active ingredient is golidocitinib.
Appearance: Available as 150 mg capsules.
Storage: Store at controlled room temperature in the original container to protect from moisture.