Terms and Conditions

This Esbriet $5 Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid, Medigap, Veteran's Affairs (VA), Department of Defense (DoD), TRICARE or any other federal or state government program to pay for their medications are not eligible. The Program is not valid for medications that are eligible to be reimbursed in their entirety by private insurance plans or other programs.

Under the Program, the patient will pay a Co-pay. After reaching the maximum Program benefit, the patient will be responsible for all out-of-pocket costs. This Program is not health insurance or a benefit plan. The Program does not obligate the use of any specific product or provider. Patients receiving assistance from charitable assistance programs (such as Genentech Patient Foundation) are not eligible. The Co-pay benefit cannot be combined with any other rebate, free trial, or similar offer for the medication. No party may seek reimbursement for all or any part of the benefit received through this Program.

The Program may be accepted by participating pharmacies, physician offices, or hospitals. Once enrolled, this Program will not honor claims with date of service or medication dispensing that precede Program enrollment by more than 120 days. Use of this Program must be consistent with all relevant health insurance requirements. Participating patients, pharmacies, physician offices, and hospitals are responsible for reporting the receipt of all Program benefits as required by any insurer or by law. Program benefits may not be sold, purchased, traded, or offered for sale, purchase, or trade.

The patient or their guardian must be 18 years or older for the patient to be eligible. This Program is only valid in the United States and U.S. Territories. This Program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g. MA, CA) where applicable. Program eligibility is contingent upon the patient's ability to meet and maintain all requirements set forth by the Program. Genentech reserves the right to rescind, revoke, or amend the Program without notice at any time.

 

Eligible commercially insured patients who are prescribed Esbriet for an FDA-approved use can receive up to $25,000 in assistance per 12-month period.

Indication and Important Safety Information

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. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required.

Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease, 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, gastroesophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.

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.

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 on 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.