ESBRIET 801 mg/1
PIRFENIDONE · TABLET, COATED · Genentech, Inc.
ESBRIET is a tablet, coated containing pirfenidone at 801 mg/1, taken oral. Manufactured by Genentech, Inc..
Key Facts
- Brand Name
- ESBRIET
- Generic Name
- PIRFENIDONE
- NDC Code (Product)
50242-123- Manufacturer
- Genentech, Inc.
- Strength
- 801 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA208780
- Drug Class
- Pyridone [EPC]
- Marketing Start
- 01/11/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET 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 (2403 mg/day). ( 2 ) Upon initiation of treatment, titrate to the full dosage of 2403 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 (1602 mg/day) Days 15 onward 801 mg three times daily (2403 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 ESBRIET Administration Conduct liver function tests prior to initiating treatment with ESBRIET [see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage The recommended daily maintenance dosage of ESBRIET is 801 mg three times daily for a total of 2403 mg/day. Doses should be taken with food at the same time each day. Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows: Table 1. Dosage Titration for ESBRIET in Patients with IPF Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) 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 ESBRIET and may alter the adverse reaction profile of ESBRIET. Discontinue fluvoxamine prior to administration of ESBRIET 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 ESBRIET and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to ESBRIET [see Clinical Pharmacology (12.3) ]. Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of ESBRIET and avoided during ESBRIET 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 ESBRIET as needed [ see Dosage and Administration (2.4) ] . Moderate CYP1A2 Inhibitors Con…
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 Genentech at 1-888-835-2555 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 1400 subject…
Frequently Asked Questions
What is ESBRIET used for?
ESBRIET contains PIRFENIDONE. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is ESBRIET a controlled substance?
ESBRIET is not classified as a controlled substance by the DEA.
What is the generic name for ESBRIET?
The generic name for ESBRIET is PIRFENIDONE. There are 11 other brand versions of PIRFENIDONE.
What is the NDC code for ESBRIET 801 mg/1?
The NDC (National Drug Code) for ESBRIET 801 mg/1 is 50242-123, listed by Genentech, Inc..