Axitinib is used to treat advanced renal cell carcinoma after failure of one prior systemic therapy.

Axitinib tablets (LuciAxi) simple instructions

Please use under the guidance of a physician

Product Name: LuciAxi

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Axitinib tablets

English name: Axitinib tablets

Drug approval number: 08 L 1161/24

 

【Indications】

LuciAxi is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.

 

【Usage and Dosage】

•The starting dose is 5 mg orally twice daily. The dose can be adjusted based on individual safety and tolerability.

• Take LuciAxi doses approximately 12 hours apart, with or without food.

•LuciAxi tablets should be swallowed whole.

•If a strong CYP3A4/5 inhibitor is required, reduce the LuciAxi dose by approximately half.

•For patients with moderate hepatic impairment, reduce the starting dose by approximately half.

 

【Specification】

5mg/tablet, 60 tablets/box.

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Hypertension, including hypertensive crisis, has been observed. Blood pressure should be well controlled prior to initiating LuciAxi. Monitor for hypertension and treat as needed. Reduce LuciAxi dose in patients with persistent hypertension despite antihypertensive medications.

• Arterial and venous thrombotic events, which may be fatal, have been observed. Use with caution in patients at increased risk for these events.

• Bleeding events, including fatal events, have been reported. LuciAxi has not been studied in patients with brain metastases or recent active GI bleeding, so there is insufficient evidence to recommend its use in these patients.

• Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula.

• Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function prior to initiating treatment with LuciAxi and periodically throughout treatment.

• Stop LuciAxi at least 24 hours before planned surgery.

• Reversible posterior leukoencephalopathy syndrome (RPLS) has been observed. Permanently discontinue LuciAxi if signs or symptoms of RPLS occur.

• Monitor proteinuria prior to initiating and periodically throughout treatment with LuciAxi. For moderate to severe proteinuria, reduce the dose or temporarily interrupt LuciAxi treatment.

• Elevations in liver enzymes have been observed during LuciAxi treatment. Monitor ALT, AST, and bilirubin prior to initiating treatment with LuciAxi and periodically throughout treatment.

• If used in patients with moderate hepatic impairment, the starting dose of LuciAxi should be reduced. LuciAxi has not been studied in patients with severe hepatic impairment.

• Based on its mechanism of action, LuciAxi may cause fetal harm when taken by a pregnant woman. Women of childbearing age should be informed of the potential harm to the fetus when taking LuciAxi and should avoid pregnancy.

【Adverse Reactions】

The most common adverse reactions (≥20%) were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation.

 

【Drug Interactions】

• Avoid use of strong CYP3A4/5 inhibitors. If unavoidable, reduce LuciAxi dose.

• Avoid use of strong CYP3A4/5 inducers.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.