Forms and Documents
To download multiple files at once, select the checkbox next to each file you would like to download from the list below then click Download Selected. Documents will be downloaded as a .zip file.
Esbriet Access Solutions Enrollment Forms
The SMN and PAN are required for enrollment in Esbriet Access Solutions.
Other Important Documents
Considerations for Composing a Letter of Medical Necessity
This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.
FDA approval letter (Follow this link and search by the drug name)
Considerations for Composing a Sample Appeal Letter
This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.
FDA approval letter (Follow this link and search by the drug name)
Enrolling in the Genentech Patient Foundation
The Genentech Patient Foundation gives free medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.
Fax Cover Letter
Use this cover sheet when faxing documents to Esbriet Access Solutions.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
SMN=Statement of Medical Necessity.
Important Safety Information & Indication
Indication
Esbriet® (pirfenidone) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Select Important Safety Information
Elevated liver enzymes: ALT, AST, and bilirubin elevations have occurred with Esbriet. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required.
Photosensitivity reaction or rash: Photosensitivity and rash have been noted with Esbriet. Avoid exposure to sunlight and sunlamps, and concomitant medications known to cause photosensitivity. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required.
Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease (GERD), and abdominal pain have occurred with Esbriet. Temporary dosage reductions or discontinuations may be required
Adverse reactions: The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, GERD, sinusitis, insomnia, weight decreased, and arthralgia.
Drug interactions: Moderate (e.g., ciprofloxacin) and strong (e.g., fluvoxamine) CYP1A2 inhibitors increase systemic exposure of Esbriet and may alter its adverse reaction profile. If discontinuation of strong CYP1A2 inhibitors and/or high-dose ciprofloxacin prior to starting Esbriet is not possible, dosage reductions of Esbriet are recommended.
Specific populations:
Hepatic impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. Esbriet is not recommended for use in patients with severe hepatic impairment.
Renal impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. Esbriet is not recommended for use in patients with end-stage renal disease requiring dialysis.
Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of Esbriet.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see full Prescribing Information for additional important safety information at esbriet.com.