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Pirfenidone is a new oral small molecule compound with anti-fibrotic, anti-inflammatory and antioxidant effects. It is mainly used to treat idiopathic pulmonary fibrosis (IPF).
1. Generic name : Pirfenidone (Pirfenidone)
2. Trade name : Esbriet® (original drug), Pirfen idoneCapsules (generic drug)
3. Dosage form : Capsule
4. Main ingredient : Each capsule contains 267mg pirfenidone (active ingredient), and excipients include capsule shells (gelatin, titanium dioxide, etc.) and fillers.
Idiopathic pulmonary fibrosis (IPF) : It is used to treat adult patients with mild to moderate IPF and can delay the decline of lung function.
1. Specifications of : 267mg/tablet (the specifications of the original drug and generic drug are the same).
2. Characteristics : White to off-white capsule, the content is white to light yellow powder.
1. Initial dose of : On days 1-7, 267 mg (1 capsule) each time, 3 times a day; on days 8-14, increase to 534 mg (2 capsules) each time, 3 times a day; after the 15th day, maintain 801 mg (3 capsules) each time, 3 times a day.
2. Take after meals: It needs to be taken with food to reduce gastrointestinal irritation.
3. Treatment of missed doses : If the missed dose does not exceed 6 hours, you can take it again. If it exceeds 6 hours, skip it. Next time, the dose will be administered according to the original plan.
1. Hepatic and renal insufficiency : Mild to moderate hepatic insufficiency (Child-PughA/B) or renal insufficiency (eGFR≥30mL/min) does not require adjustment; severe hepatic insufficiency (Child-PughC) does not require adjustment.
2. Adverse reaction adjustment : If severe photosensitivity reaction or gastrointestinal intolerance occurs, the dose can be reduced to 534 mg each time, 3 times a day.
1. Photosensitivity reaction : Strict sun protection is required during treatment (use SPF≥50 sunscreen and avoid direct sunlight);
2. Liver function Able to monitor :Detect ALT/AST regularly before and during treatment;
3. Drug interactions :Avoid the combined use of strong CYP1A2 inhibitors (such as fluvoxamine) or inducers (such as smoking).
1. U200c during pregnancy: Disabled (animal experiments show fetal toxicity);
2. U200c during lactation: Stop breastfeeding during treatment;
3. Children : Safety has not been established;
4. Elderly : Patients ≥65 years old do not need to adjust the dosage.
1. Common (≥10%) : Nausea (32%), rash (28%), fatigue (2 4%), indigestion (19%), photosensitivity reaction (12%);
2. Severe reactions : Elevated liver enzymes (5%), severe photosensitivity dermatitis (2%).
1. Those allergic to pirfenidone or excipients;
2. Severe liver insufficiency (Child-PughC);
3. End-stage renal disease (eGFR<30mL/min).
1. CYP1A2 inhibitor (such as fluvoxamine): increases the plasma concentration of pirfenidone, so combined use should be avoided;
2. Smoking : reduces the efficacy of pirfenidone, and it is recommended to quit smoking.
Store unopened capsules at room temperature of 20-25°C, away from moisture and light.
Note : If persistent liver function abnormalities (ALT/AST>3 times ULN) or severe skin reactions occur during treatment, the drug should be discontinued immediately and seek medical treatment.