Pirfenidone 267 mg/1
Pirfenidone · TABLET, COATED · EXELAN PHARMACEUTICALS INC.
Pirfenidone is an oral prescription medication used to treat idiopathic pulmonary fibrosis, a progressive lung disease that causes scarring of lung tissue. It works by reducing inflammation and fibrosis in the lungs to help slow disease progression.
Key Facts
- Brand Name
- Pirfenidone
- Generic Name
- Pirfenidone
- NDC Code (Product)
76282-717- Manufacturer
- EXELAN PHARMACEUTICALS INC.
- Strength
- 267 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212078
- Drug Class
- Pyridone [EPC]
- Marketing Start
- 08/02/2022
Recall History
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take with food. Recommended dosage: 801 mg three times daily (2,403 mg/day). (2) Upon initiation of treatment, titrate to the full dosage of 2,403 mg/day over a 14-day period as follows: Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1,602 mg/day) Days 15 onward 801 mg three times daily (2,403 mg/day) Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions. ( 2.3 , 5.1 , 5.2 , 5.3 , 5.4 ) Prior to treatment, conduct liver function tests. ( 2.1 ) 2.1 Testing Prior to Pirfenidone Capsules Administration Conduct liver function tests prior to initiating treatment with pirfenidone capsules [see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage The recommended daily maintenance dosage of pirfenidone capsule is 801 mg three times daily for a total of 2,403 mg/day. Doses should be taken with food at the same time each day. Upon initiation of treatment, titrate to the full dosage of 2,403 mg/day over a 14-day period as follows: Table 1: Dosage Titration for Pirfenidone Capsules in Patients with IPF Treatment days Dosage Days…
Contraindications
4 CONTRAINDICATIONS None. None
Drug Interactions
7 DRUG INTERACTIONS Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone and may alter the adverse reaction profile of pirfenidone. Discontinue fluvoxamine prior to administration of pirfenidone or reduce to 267 mg three times a day. Consider dosage reduction with use of ciprofloxacin. ( 7.1 ) 7.1 CYP1A2 Inhibitors Pirfenidone is metabolized primarily (70% to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1. Strong CYP1A2 Inhibitors The concomitant administration of pirfenidone and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to pirfenidone [see Clinical Pharmacology (12.3)]. Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of pirfenidone and avoided during pirfenidone treatment. In the event that fluvoxamine or other strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended. Monitor for adverse reactions and consider discontinuation of pirfenidone as needed [ see Dosage and Administration (2.4) ] .…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions (5.1) ] Photosensitivity Reaction or Rash [see Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Gastrointestinal Disorders [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of pirfenidone has been evaluated in more than 1,400 subjects…
Frequently Asked Questions
What is Pirfenidone used for?
Pirfenidone is an oral prescription medication used to treat idiopathic pulmonary fibrosis, a progressive lung disease that causes scarring of lung tissue. It works by reducing inflammation and fibrosis in the lungs to help slow disease progression.
Is Pirfenidone a controlled substance?
Pirfenidone is not classified as a controlled substance by the DEA.
What is the generic name for Pirfenidone?
The generic name for Pirfenidone is Pirfenidone. There are 3 other brand versions of Pirfenidone.
What is the NDC code for Pirfenidone 267 mg/1?
The NDC (National Drug Code) for Pirfenidone 267 mg/1 is 76282-717, listed by EXELAN PHARMACEUTICALS INC..