Epifenone (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、 Drug name

1. Common name: Pirfenidone

2. Product Name: Esbriet ® (Original drug)

3. Dosage form: Capsule

2、 Indications

Pirfenidone is suitable for the treatment of idiopathic pulmonary fibrosis (IPF). It delays the decline of lung function by inhibiting the fibrosis process and inflammatory response.

3、 Specifications and characteristics

1. Specification: Each capsule contains 267mg of pirfenidone.

2. Appearance: Capsule, specific color and labeling should refer to the original drug Esbriet ® Appearance (such as capsule color, printing, etc.).

4、 Main components

Active ingredient: Pirfenidone

5、 Usage and dosage

Recommended dose: It should be gradually increased to the maintenance dose according to the patient's tolerance.

Initial dose: Typically 267mg per dose, 3 times daily (total daily dose 801mg).

Incremental plan: Gradually increase to 534mg per dose, 3 times a day (total daily dose of 1602mg) within 2 weeks, ultimately reaching 801mg per dose, 3 times a day (total daily dose of 2403mg).

Medication method: Take with meals to reduce gastrointestinal adverse reactions.

6、 Dose adjustment

If adverse reactions occur (such as nausea, rash, abnormal liver function, etc.), the medication can be temporarily suspended or the dose reduced, and gradually restored to the target dose after the symptoms are relieved.

The specific dosage adjustment strategy should be based on clinical guidance and individual patient conditions.

7、 Medication precautions

1. Medication time * *: Should be taken with meals to reduce gastrointestinal irritation.

2. Missed dose * *: If one dose is missed, it should be taken normally at the time of the next dose, and the dose should not be doubled.

3. Vomiting * *: If vomiting occurs after taking medication, it is not recommended to take it again and wait until the next scheduled medication time.

4. Photosensitivity: Pirfenidone may increase the risk of skin sensitivity to light. It is recommended that patients avoid direct sunlight and use sunscreen and protective clothing.

5. Liver function monitoring * *: Regular monitoring of liver function indicators is required before and during treatment.

8、 Medication for special populations

1. Patients with liver dysfunction * *: Not recommended for patients with moderate to severe liver dysfunction. Mild liver dysfunction patients should use with caution and closely monitor.

2. Patients with renal insufficiency: Mild to moderate renal insufficiency does not require dose adjustment; Severe renal insufficiency (creatinine clearance rate<30mL/min) is contraindicated.

3. Elderly individuals * *: No special dosage adjustment is required, but close monitoring of adverse reactions is necessary.

4. Pregnant and lactating women * *: Lack of safety data, not recommended for use.

5. Children: Safety and efficacy have not yet been established.

9、 Adverse reactions

1. Common adverse reactions include:

Gastrointestinal reactions: nausea, vomiting, diarrhea, indigestion, etc;

Skin reactions: photosensitive dermatitis, rash;

Nervous system: dizziness, fatigue, insomnia;

Abnormal liver function: Elevated transaminase levels.

2. Serious adverse reactions may include liver toxicity, severe skin reactions due to photosensitivity, etc.

10、 Contraindications

Prohibited for individuals allergic to pirfenidone or any excipients;

Individuals with moderate to severe liver dysfunction are prohibited from using it;

Severe renal insufficiency (creatinine clearance rate<30mL/min) is contraindicated.

11、 Drug interactions

1. CYP1A2 strong inhibitors (such as fluvoxamine and enoxacin) may increase the blood concentration of pirfenidone and should be avoided in combination or the dosage adjusted;

2. CYP1A2 inducers (such as smoking) may reduce the efficacy of pirfenidone, and efficacy response needs to be monitored;

3. Other drugs metabolized by CYP1A2 may interact with pirfenidone and should be used with caution.

12、 Storage method

Stored at 20 ° C to 25 ° C (68 ° F to 77 ° F), allowing for short distance transportation in an environment of 15 ° C to 30 ° C (59 ° F to 86 ° F);

Moisture proof, light proof, keep the container sealed.

Pirfenidoneinformation