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Nintedanib is a multi-target tyrosine kinase inhibitor that inhibits cell proliferation, migration and differentiation during fibrosis by selectively inhibiting key signaling pathways such as platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and vascular endothelial growth factor receptor (VEGFR).
1. Common name : Nintedanib (Nintedanib)
2. Trade name : OFEV®
3. Dosage form : Soft capsule< /p>
4. Main ingredient :Each capsule contains 150mg or 100mg of nintedanib (in the form of ethanesulfonate, equivalent to 180.60mg and 120.40mg of nintedanib ethanesulfonate respectively). The excipients include triglyceride, stearin, lecithin (filler) and gelatin, glycerin, titanium dioxide, etc. (capsule shell).
Idiopathic pulmonary fibrosis (IPF) : It is used to treat adult patients with IPF and can delay the decline of lung function.
1. Specifications : 150mg/capsule (brown opaque capsule, printed with black "150" logo) or 100mg/capsule (peach opaque capsule, printed with black "100" logo).
2. Characteristics of : The content is bright yellow powder, which becomes a uniform suspension after reconstitution.
1. Recommended dosage of : 150 mg twice a day (about 12 hours apart), take with meals. Swallow the whole tablet without chewing or crushing.
2. Treatment of missed doses : If you miss a dose, there is no need to make up for it. Take the next dose according to the original plan.
3. Maximum dose of : Do not exceed 300mg per day.
1. Abnormal liver function : Suspend or reduce the dose to 100mg twice a day when ALT/AST>3 times ULN; permanently discontinue when ALT/AST>5 times ULN.
2. Adverse reaction management : In case of severe diarrhea, nausea or vomiting, the dose can be reduced to 100 mg twice a day or the administration can be suspended until the symptoms are relieved and resumed.
1. Dietary requirements : Need to be taken with food to reduce gastrointestinal irritation.
2. Liver function monitoring : Monitor ALT/AST every month before and during treatment, and then change to once every 3 months after 3 months.
3. Photosensitivity : No special sun protection measures are required (unlike pirfenidone).
4. Bleeding risk : Avoid combined use of anticoagulant drugs and monitor bleeding symptoms.
1. Pregnant women : Disabled (embryo-fetal toxicity).
2. Lactation : Stop breastfeeding during treatment.
3. Children : Safety has not been established.
4. Liver and renal insufficiency : Mild hepatic insufficiency (Child-PughA) requires monitoring; moderate and severe hepatic insufficiency (Child-PughB/C) is contraindicated.
1. Common (≥5%) : Diarrhea (62%), nausea (24%), abdominal pain (15%), vomiting (12%), elevated liver enzymes (14%), decreased appetite (11%).
2. Severe reactions : Hepatotoxicity (5%), myocardial infarction (1.5%), gastrointestinal perforation (0.3%).
1. Those allergic to nintedanib or excipients;
2. Moderate to severe liver insufficiency (Child-PughB/C).
1. P-gp/CYP3A4 inhibitor (such as ketoconazole): Increases nintedanib exposure by 60% and requires close monitoring; p>
2. P-gp/CYP3A4 inducer (such as rifampin): Reduce exposure by 50% and avoid combined use;
3. Anticoagulant : increase the risk of bleeding.
Store unopened capsules in a dry place below 25°C, away from light, and avoid high temperature and humidity.
Note : If persistent diarrhea, abnormal liver function or cardiovascular symptoms occur during treatment, you should seek medical attention immediately. Smoking may reduce the efficacy of the drug, so it is recommended to quit smoking.