Esbriet Distribution
Authorized Specialty Distributors and Specialty Pharmacies
Esbriet Access Solutions works with specialty pharmacies (SPs) to help patients receive their medicines.
An SP may provide the following services:
- Reimbursement resources
- Clinical services to support patients throughout their treatment
- The
ability to manage the specialty handling and shipping needs linked
with many specialty therapies
You can work with your preferred SP or contact Esbriet Access
Solutions to learn which SP the patient’s health insurance plan
requires.
Distributors for Federal Accounts
Distributors for Hospitals
Distributors for Authorized Specialty Pharmacies
Distributors for Puerto Rico
Specialty Pharmacies
Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item.
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.