Golidocitinib Prescribing Information

Update: 05 Feb,2026 Source: Haiou Health Views: 117

Golidocitinib is an oral targeted therapeutic agent indicated for the treatment of relapsed or refractory Peripheral T-Cell Lymphoma (PTCL). It inhibits the JAK/STAT signaling pathway to block the proliferation and survival of tumor cells. The recommended dosage is 200 mg once daily, to be taken on an empty stomach. Common adverse reactions include cytopenias, elevated infection risk and gastrointestinal discomfort. Regular monitoring of complete blood count (CBC), liver function and renal function is required. Administration of live vaccines should be avoided during treatment, and the therapeutic regimen must be strictly adjusted in accordance with medical advice.

Indications

Golidocitinib is indicated for the treatment of relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) in adult patients. This drug is generally used when other standard therapeutic regimens are ineffective or inapplicable, and its use shall be determined by a physician based on the patient’s clinical condition.

Mechanism of Action

As a JAK inhibitor, Golidocitinib mainly targets the JAK/STAT pathway, interferes with the abnormal signal transduction of tumor cells, thereby inhibiting their growth and inducing apoptosis. This mechanism has demonstrated favorable clinical efficacy in specific subtypes of lymphoma.

Dosage and Administration

Standard Dosage

200 mg once daily, administered on an empty stomach (at least 1 hour before a meal or 2 hours after a meal).

Dosage Modification

In the event of severe adverse reactions (e.g., myelosuppression, hepatic injury), the physician may suspend treatment, reduce the dosage or discontinue the drug.

Missed Dose

If the missed dose is within 12 hours of the scheduled time, take the dose immediately; otherwise, skip the missed dose and do not double the next dose.

Adverse Reactions

Common Reactions

Neutropenia, anemia, thrombocytopenia, nausea, diarrhea, fatigue.

Severe Risks

Opportunistic infections (e.g., pneumonia, fungal infections), hepatic dysfunction, bleeding tendency. Seek immediate medical attention if symptoms such as fever, persistent vomiting or jaundice occur.

Precautions

Contraindicated Populations

Patients with hypersensitivity to any ingredient of the drug; pregnant or lactating females (effective contraceptive measures must be implemented).

Drug-Drug Interactions

Concomitant use with strong CYP3A4 inhibitors or inducers may affect the therapeutic efficacy. Inform the physician of the current medication history.

Monitoring Requirements

Complete blood count should be tested every 2 weeks at the initial stage of treatment, and liver and renal function should be evaluated monthly. Enhanced infection prevention is required for patients at high infection risk.

Storage Conditions

Store below 30°C, protected from light, and keep in the original packaging to prevent moisture. Expired or unused drugs shall be disposed of as medical waste to avoid environmental contamination.

Always consult a qualified healthcare professional before treatment initiation. The therapeutic regimen shall be formulated based on individual conditions. Do not adjust the dosage or discontinue treatment without medical guidance.

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