Ripretinib is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Ripretinib Capsules (LuciRepo) Simple Instructions

Please use under the guidance of a physician

Product Name: LuciRepo

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

Chinese name: Ripretinib capsules

English name: Repotrectinib capsules

Drug approval number: 02 L 1071/24

 

【Indications】

LuciRepo is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

 

【Usage and Dosage】

• Select patients for treatment of locally advanced or metastatic NSCLC based on the presence of ROS1 rearrangement in tumor specimens.

• Recommended dose: 160 mg orally once daily for 14 days, then increased to 160 mg twice daily, taken with or without food.

 

【Specification】

40mg/capsule, 60 capsules/box.

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Central Nervous System (CNS) Effects: May cause CNS adverse reactions including dizziness, ataxia, and cognitive impairment. Withhold and resume at same or reduced dose upon improvement, or permanently discontinue LuciRepo based on severity.

• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms suggestive of ILD/pneumonitis. Withhold drug immediately in patients with suspected ILD/pneumonitis and permanently discontinue drug if ILD/pneumonitis is confirmed.

• Hepatotoxicity: Monitor liver function tests every 2 weeks during the first month of treatment and as clinically indicated thereafter. Based on severity, withhold and then resume at same or reduced dose, or permanently discontinue.

• Myalgia with elevated creatine phosphokinase (CPK): Monitor serum CPK levels in patients reporting unexplained muscle pain, tenderness, or weakness during treatment. Based on severity, withhold and resume at the same or reduced dose upon improvement.

• Hyperuricemia: Monitor serum uric acid levels prior to initiating treatment and periodically during treatment. Initiate uric acid-lowering medication as clinically indicated. Based on severity, withhold and resume at same or reduced dose, or permanently discontinue.

• Fractures: Promptly evaluate patients with signs or symptoms of fracture (e.g., pain, change in mobility, deformity).

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective non-hormonal methods of contraception.

【Adverse Reactions】

The most common adverse reactions (≥20%) were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, ataxia, fatigue, cognitive impairment, and muscle weakness.

【Drug Interactions】

• Strong and Moderate CYP3A Inhibitors: Avoid concomitant use.

• P-gp inhibitors: avoid concomitant use.

• Strong and moderate CYP3A inducers: Avoid concomitant use.

• Certain CYP3A Substrates: Avoid concomitant use with CYP3A substrates as minimal changes in concentrations can result in reduced efficacy.

• Hormonal contraceptives: avoid concurrent use.

【Use by specific groups】

• Breastfeeding: Breastfeeding is not recommended.

【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.