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Pirfenidone (ESBRIET) is an oral pyridone anti-fibrotic drug that slows down the decline of lung function and improves the quality of life in patients with idiopathic pulmonary fibrosis (IPF) by inhibiting the synthesis of pro-fibrotic cytokines, reducing oxidative stress and regulating inflammatory pathways.
1. Common name: Pirfenidone (Pirfenidone)
2. Trade name: Esbriet® (original drug)
3. Dosage form: Capsules
Pirfenidone is suitable for the treatment of idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis, IPF). It delays the decline of lung function by inhibiting the fibrosis process and inflammatory response.
1. Specifications: Each capsule contains 267 mg of pirfenidone.
2. Characteristics: For capsules, the specific color and logo should refer to the appearance of the original drug Esbriet® (such as capsule color, printing, etc.).
Active ingredient: Pirfenidone
1. Recommended dose: It needs to be gradually increased to the maintenance dose according to the patient's tolerance.
2. Starting dose: Usually 267mg each time, 3 times a day (total daily dose 801mg).
3. Increasing plan: Gradually increase to 534mg each time, 3 times a day (total daily dose 1602mg) within 2 weeks, and finally reach 801mg each time, 3 times a day (total daily dose 2403mg).
4. How to take the medicine: Take it with meals to reduce gastrointestinal adverse reactions.
If adverse reactions (such as nausea, rash, abnormal liver function, etc.) occur, the administration can be suspended or the dose can be reduced, and the dose can be gradually restored to the target dose after the symptoms are relieved.
The specific dosage adjustment strategy needs to be based on the guidance of the clinician and the individual patient's situation.
1. Medication time: It needs to be taken with meals to reduce gastrointestinal irritation.
2. Missed dose: If you miss a dose, you should take it at the normal time of the next dose and do not double the dose.
3. Vomiting: If you vomit after taking the medicine, it is not recommended to take a supplement. You should wait until the next planned dose.
4. Photosensitivity: Pirfenidone may increase the risk of skin sensitivity to light. Patients are advised to avoid direct sunlight and use sunscreen and protective clothing.
5. Liver function monitoring: Liver function indicators need to be monitored regularly before and during treatment.
1. Patients with hepatic insufficiency: It is contraindicated in patients with moderate to severe hepatic insufficiency. Patients with mild hepatic impairment should use it with caution and monitor closely.
2. Patients with renal insufficiency: Patients with mild to moderate renal insufficiency do not need to adjust the dose; patients with severe renal insufficiency (creatinine clearance <30mL/min) are contraindicated.
3. Elderly people: No special dose adjustment is required, but adverse reactions need to be closely monitored.
4. Pregnant and lactating women: Lack of safety data, use is not recommended.
5. Children: Safety and effectiveness have not been established.
1. Common adverse reactions include:
Gastrointestinal reactions: nausea, vomiting, diarrhea, indigestion, etc.;
Skin reactions: photosensitivity dermatitis, rash;
Nervous system: dizziness, fatigue, insomnia;
Abnormal liver function: elevated transaminases.
2. Serious adverse reactions may include liver toxicity, photosensitivity, severe skin reactions, etc.
It is contraindicated in patients who are allergic to pirfenidone or any excipients;
it is contraindicated in patients with moderate to severe hepatic insufficiency;
it is contraindicated in patients with severe renal insufficiency (creatinine clearance <30mL/min).
1. Strong inhibitors of CYP1A2 (such as fluvoxamine, enoxacin) may increase the plasma concentration of pirfenidone, so combination use or dose adjustment must be avoided;
2. CYP1A2 inducers (such as smoking) may reduce the efficacy of pirfenidone, and the efficacy response needs to be monitored;
3. Other drugs metabolized by CYP1A2 may interact with pirfenidone and must be used together with caution.
Stored at 20°C to 25°C (68°F to 77°F), short-distance transportation allowed at 15°C to 30°C (59°F to 86°F);
Protect against moisture and light, and keep the container tightly closed.