Pirfenidone is a novel oral small molecule compound with anti fibrotic, anti-inflammatory, and antioxidant effects, mainly used for the treatment of idiopathic pulmonary fibrosis (IPF).

1、 Drug name and main ingredients

1. Common name: Pirfenidone

2. Product Name: Esbriet ® (Original drug), Pirfenidone Capsules (generic drug)

3. Dosage form: Capsule

4. Main ingredients: Each capsule contains 267mg of pirfenidone (active ingredient), and excipients include capsule shells (gelatin, titanium dioxide, etc.) and fillers.

2、 Indications

Idiopathic pulmonary fibrosis (IPF): Used for the treatment of adult patients with mild to moderate IPF, it can delay the decline of lung function.

3、 Specifications and characteristics

1. Specification: 267mg/capsule (the original drug and generic drug specifications are the same).

2. Appearance: White to off white capsules, with contents ranging from white to pale yellow powder.

4、 Usage and dosage

1. Initial dose: 267mg (1 capsule) each time from day 1-7, 3 times a day; Increase to 534mg (2 capsules) each time from day 8 to day 14, 3 times a day; After the 15th day, maintain 801mg (3 pills) each time, 3 times a day.

2. After meals: It should be taken together with food to reduce gastrointestinal irritation.

3. Omission treatment: If the missed dose time does not exceed 6 hours, it can be supplemented. If it exceeds 6 hours, it will be skipped and the next dose will be given according to the original plan.

5、 Dose adjustment

1. Liver and kidney dysfunction: Mild to moderate liver dysfunction (Child Pugh A/B) or renal dysfunction (eGFR ≥ 30mL/min) do not require adjustment; Severe liver dysfunction (Child Pugh C) is contraindicated.

2. Adverse reaction adjustment: If severe photosensitivity or gastrointestinal intolerance occurs, the dosage can be reduced to 534mg each time, 3 times a day.

6、 Medication precautions

1. Photogenic response: Strict sun protection is required during treatment (use sunscreen with SPF ≥ 50 to avoid direct sunlight);

2. Liver function monitoring: regular testing of ALT/AST before and during treatment;

3. Drug interactions: Avoid using strong CYP1A2 inhibitors (such as fluvoxamine) or inducers (such as smoking) in combination.

7、 Medication for special populations

1. Pregnant women: prohibited (animal experiments show fetal toxicity);

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

3. Children: Safety has not been established;

4. Elderly: Patients aged 65 and above do not need to adjust the dosage.

8、 Adverse reactions

1. Common (≥ 10%): Nausea (32%), rash (28%), fatigue (24%), indigestion (19%), photosensitivity (12%);

2. Serious reactions: Elevated liver enzymes (5%), severe photosensitive dermatitis (2%).

9、 Contraindications

1. Individuals allergic to pirfenidone or excipients;

2. Severe liver dysfunction (Child Pugh C);

3. End stage renal disease (eGFR<30mL/min).

10、 Drug interactions

1. CYP1A2 inhibitors (such as fluvoxamine): increase the blood concentration of pirfenidone and avoid combination therapy;

2. Smoking: Reducing the efficacy of pirfenidone, it is recommended to quit smoking.

11、 Storage method

Unopened capsules should be stored at room temperature of 20-25 ° C, avoiding moisture and light exposure.

Note: If there is persistent liver dysfunction (ALT/AST>3 times ULN) or severe skin reactions during treatment, the medication should be stopped immediately and medical attention should be sought.

Pirfenidoneinformation