List of Chinese instructions for Pirfenidone/Asreli tablets

1. Name: Pirfenidone,Pirfenidone, Esbriet, Pirespa

2. Indications:

Pirfenidone Tablets/Pirfenidone is suitable for the treatment of idiopathic pulmonary fibrosis (IPF).

3. Usage and dosage:

1. Before use: Perform liver function tests before starting treatment with pirfenidone.

2. Recommended dose: The recommended daily maintenance dose of pirfenidone is 801 mg three times a day, totaling 2403 mg/day, which should be taken with food. After initiating treatment, titrate to the full dose of 2403 mg/day over 14 days, with the dose on days 1 to 7 being 267 mg three times daily (801 mg/day); on days 8 to 14 the dose is 534 mg three times daily (1602 mg/day); starting on day 15, the dose is 801 mg three times daily (2403 mg/day). Doses above 2403mg/day are not recommended for any patient. Patients should not take two doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day.

2. Dose adjustment: Patients who miss 14 or more days of pirfenidone should restart treatment by receiving an initial 2-week titration schedule until the full maintenance dose is reached. For patients who interrupt treatment for less than 14 days, the dose before the interruption may be resumed.

(1) Drug interactions: For strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin), reduce pirfenidone to 267 mg three times daily (801 mg/day); for moderate CYP1A2 inhibitors (e.g., ciprofloxacin), reduce pirfenidone to 534 mg three times daily (1602 mg/day).

4. Adverse reactions:

In clinical studies of pirfenidone, the most common adverse reactions were rash, nausea, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, indigestion, vomiting, insomnia, weight loss, and joint pain. After the drug was put on the market, adverse events such as agranulocytosis (blood and lymphatic system disease), drug-induced liver injury (hepatobiliary disease), angioedema (immune system disease), and severe skin reactions including scarring (skin and subcutaneous tissue) also occurred.

5. Supply and storage:

Pirfenidone film-coated tablets containingPirfenidone 267 mg and 801 mg, available in vials, stored at 25°C (77°F); excursions allowed to 15-30°C (59-86°F). Keep the bottle tightly closed. Do not use if bottle seal is broken or missing. Safely throw away any pirfenidone that is expired or no longer needed.

6. Special groups:

1. Smokers: Smoking reduces pirfenidone exposure, which may alter its efficacy. Instruct patients to quit smoking before receiving pirfenidone and to avoid smoking while using it.

7. Mechanism of action:

Pirfenidone treatmentThe mechanism of action of IPF has not been determined.

8. Overdose:

Clinical experience with pirfenidone overdose is limited. During a 12-day dose escalation process, healthy adult volunteers took five 267 mg pills three times a day and multiple doses of pirfenidone, with a maximum tolerated dose of 4005 mg per day. If overdose is suspected, provide appropriate supportive medical care, including monitoring vital signs and observation of the patient's clinical condition.