Terms and Conditions

By using the Esbriet $5 Co-pay Program, the patient acknowledges and confirms that, at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described.

This Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who are taking the medication for a Food and Drug Administration (FDA)-approved indication. Patients using Medicare, Medicaid, or any other government-funded program to pay for their medications are not eligible. Patients who start utilizing their government coverage during their enrollment period will no longer be eligible for the program.

This Co-pay Program is not health insurance or a benefit plan. Distribution or use of the Co-pay Program does not obligate use or continuing use of any specific product or provider. Patient or guardian is responsible for reporting the receipt of all Co-pay Program benefits or reimbursement received to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Co-pay Program, as may be required.

The Co-pay Program is not valid for medications the patient receives for free or that are eligible to be reimbursed by private insurance plans or other health care or pharmaceutical assistance programs (such as Genentech® Access to Care Foundation (GATCF) or any other charitable organization) that reimburse the patient in part or for the entire cost of his/her Genentech medication. Patient, guardian, pharmacist, prescriber, and any other person using the Co-pay Program agree not to seek reimbursement for all or any part of the benefit received by the recipient through the offer.

The Co-pay Program will be accepted by participating pharmacies, physician offices, or hospitals. To qualify for the benefits of this Co-pay Program, the patient may be required to pay out-of-pocket expenses for each treatment. Once enrolled, this Co-pay Program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 120 days. This Co-pay Program is only available with a valid prescription and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Use of this Co-pay Program must be consistent with all relevant health insurance requirements and payer agreements. Participating patients, pharmacies, physician offices, and hospitals are obligated to inform third-party payers about the use of the Co-pay Program as provided for under the applicable insurance or as otherwise required by contract or law. The Co-pay Program may not be sold, purchased, traded, or offered for sale, purchase, or trade. The Co-pay Program is limited to 1 per person during this offer period and is not transferable. Program eligibility period is contingent upon patient's ability to meet and maintain all requirements as set forth by the program. Genentech will periodically verify eligibility and will terminate patients without obligation to pay claims if change to status is detected. This program is not valid where prohibited by law, and shall follow state restrictions in relation to AB-rated generic equivalents where applicable (e.g. MA, CA).

The patient or their guardian must be 18 years or older to receive Co-pay Program assistance. This Co-pay Program is (1) void where prohibited by law; (2) only valid in the United States and Puerto Rico; and (3) only valid for Genentech products. Health care providers may not advertise or otherwise use the program as a means of promoting their services or Genentech's products to patients. Genentech reserves the right to rescind, revoke, or amend the program without notice at any time.

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.