Nidanib is a multi-target tyrosine kinase inhibitor that selectively inhibits key signaling pathways such as platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and vascular endothelial growth factor receptor (VEGFR), thereby suppressing cell proliferation, migration, and differentiation during fibrosis.

1、 Drug name and main ingredients

1. Common name: Nintedanib

2. Product Name: OFEV ®

3. Dosage form: Soft capsules

4. Main ingredients: Each capsule contains 150mg or 100mg of nintedanib (in the form of ethyl sulfonate, equivalent to 180.60mg and 120.40mg nintedanib ethyl sulfonate, respectively), and excipients include triglycerides, stearic acid, lecithin (filler), gelatin, glycerol, titanium dioxide, etc. (capsule shell).

2、 Indications

Idiopathic pulmonary fibrosis (IPF): Used to treat adult IPF patients, it can delay the decline of lung function.

3、 Specifications and characteristics

1. Specification: 150mg/capsule (brown opaque capsule with black "150" logo) or 100mg/capsule (peach opaque capsule with black "100" logo).

2. Appearance: The content is a bright yellow powder, which is a uniform suspension after reconstitution.

4、 Usage and dosage

1. Recommended dosage: 150mg twice a day (with an interval of about 12 hours), taken with meals, swallowed whole and not chewed or crushed.

2. Omission treatment: If missed, there is no need to supplement, and the next dose should be taken according to the original plan.

3. Maximum dose: not exceeding 300mg per day.

5、 Dose adjustment

1. Abnormal liver function: pause or reduce ALT/AST to 100mg twice a day when ALT/AST is greater than 3 times ULN; >Permanently discontinue medication at 5 times ULN.

2. Adverse reaction management: In case of severe diarrhea, nausea, or vomiting, the dosage can be reduced to 100mg twice a day or the medication can be temporarily suspended. The symptoms will recover after relief.

6、 Medication precautions

1. Dietary requirements: It should be taken together with food to reduce gastrointestinal irritation.

2. Liver function monitoring: ALT/AST should be monitored monthly before and during treatment, and after 3 months, it should be changed to once every 3 months.

3. Photogenic reaction: No special sun protection measures are required (unlike pirfenidone).

4. Bleeding risk: Avoid using anticoagulants in combination and monitor bleeding symptoms.

7、 Medication for special populations

1. Pregnant women: prohibited (with embryonic fetal toxicity).

2. Breastfeeding period: Stop breastfeeding during the treatment period.

3. Children: Safety has not been established.

4. Liver and kidney dysfunction: Mild liver dysfunction (Child Pugh A) requires monitoring; Moderate to severe (Child Pugh B/C) is prohibited.

8、 Adverse reactions

1. Common (≥ 5%): Diarrhea (62%), nausea (24%), abdominal pain (15%), vomiting (12%), elevated liver enzymes (14%), decreased appetite (11%).

2. Serious reactions: hepatotoxicity (5%), myocardial infarction (1.5%), gastrointestinal perforation (0.3%).

9、 Contraindications

1. Individuals allergic to Nidanib or excipients;

2. Moderate to severe liver dysfunction (Child Pugh B/C).

10、 Drug interactions

1. P-gp/CYP3A4 inhibitors (such as ketoconazole): Increase exposure to nintedanib by 60% and require close monitoring;

2. P-gp/CYP3A4 inducer (such as rifampicin): reduce exposure by 50% and avoid combination use;

3. Anticoagulants: increase the risk of bleeding.

11、 Storage method

Unopened capsules should be stored in a dry and dark place below 25 ° C to avoid high temperatures and humidity.

Note: If there is persistent diarrhea, abnormal liver function, or cardiovascular symptoms during treatment, seek medical attention immediately. Smoking may reduce the effectiveness of medication, it is recommended to quit smoking.

Nintedanibinformation