Esbriet Application Scope

Is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults. IPF is a chronic, progressive lung disease characterized by the buildup of scar tissue in the lungs, which leads to reduced lung function and difficulty breathing

Esbriet Characteristics

Ingredients: Pirfenidone
Properties: Pharmacological Category: Pyridone
Packaging Specification: Available in 801 mg tablets
Storage: Store at room temperature (25°C or 77°F). Keep in a tightly closed containe
Expiry Date: Refer to the packaging for the specific expiry date.
Executive Standard: Complies with applicable pharmacopoeial standards and regulatory requirements in the region of sale
Approval Number: Specific approval numbers vary by country; consult local regulatory authorities for details.
Date of Revision: Refer to the latest product monograph for the most current details.
Manufacturer: Genentech, Inc., a member of the Roche Group

Guidelines for the Use of Esbriet

Dosage and Administration:
- Recommended Dose: The recommended full daily dose of Esbriet is 801 mg (three 267 mg capsules) taken three times daily with food, totaling 2,403 mg per day.
- Administration:Take capsules with food to reduce gastrointestinal side effects.
- Missed Dose:If a dose is missed, take it with food as soon as remembered. Do not double the dose to make up for a missed dose.
Adverse Reactions:
- Common Adverse Reactions: Nausea, rash, abdominal pain, upper respiratory infection, diarrhea, fatigue, headache, dyspepsia (indigestion), dizziness, vomiting, anorexia, gastroesophageal reflux disease (GERD), sinusitis, insomnia, weight decreased, arthralgia (joint pain)
- Serious Adverse Reactions:
  - Liver enzyme elevations and drug-induced liver injury: May manifest as symptoms like fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice (yellowing of skin or eyes). Regular monitoring of liver function (ALT, AST, bilirubin) is required.
  - Photosensitivity and severe skin rash: Can include serious sunburn and skin reactions.
  - Gastrointestinal disorders: Severe stomach pain, vomiting, diarrhea.
  - Angioedema (post-marketing reports): Swelling beneath the skin, potentially of the face, lips, tongue, throat.
Contraindications:
- Hypersensitivity to pirfenidone or any component of the formulation.
- History of angioedema related to pirfenidone use.
Precautions:
- Monitor liver function tests regularly during treatment.
- Avoid exposure to sunlight and UV light; use protective clothing and sunscreen.
- Use caution when operating machinery or driving until you know how Esbriet affects you.
- Adjust dosage in cases of hepatic impairment; consult prescribing information for specific recommendations.

Esbriet Interactions

Metabolism: Pirfenidone is primarily metabolized by the liver enzyme CYP1A2, with minor contributions from CYP2C9, CYP2C19, CYP2D6, and CYP2E1.
Drug Interactions: Concomitant use with strong CYP1A2 inhibitors (e.g., fluvoxamine) may increase pirfenidone plasma concentrations; dose adjustments may be necessary.
Combination Therapy: The safety and efficacy of combining Esbriet with other IPF treatments, such as Ofev® (nintedanib), have not been established.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.