Introducing BioRphen

Ready to Use.

Easy to Choose.

The first and only FDA-approved, ready-to-use formulation of phenylephrine HCl injection.

Biorphen is indicated for patients with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

Please see Important Safety Information below and full Prescribing Information.

NO DILUTION OR COMPOUNDING

New Biorphen can be quickly, conveniently administered without compounding.1 Biorphen comes in a ready-to-use formulation (100 mcg/mL),1 unlike concentrated phenylephrine (10,000 mcg/mL) that must be diluted2 to a solution of 100 mcg/mL before use. Prepare Biorphen and adjust dosing to patient requirements.

STANDARDIZE ACROSS YOUR HOSPITAL

With a 3-year shelf life3 and $10 list price, Biorphen can be standardized throughout your hospital without frequent restocking.

Operating Room (OR)

Intensive Care
Unit (ICU)

Emergency
Department (ED)

Ambulatory Surgery Center (ASC)

Crash Carts

ACCORDING TO FDA,
A READY-TO-USE PHENYLEPHRINE CAN HELP MITIGATE CERTAIN RISKS4*

  • Calculation and compounding errors
  • Unsafe sterile technique
  • Unsafe injection practices
*Clinical implications for Biorphen have not been determined. No claims are made about safety implications for Biorphen.

FDA URGING HOSPITALS TO STOP
USING SOME COMPOUNDED DRUGS

The FDA is moving to restrict hospitals’ use of compounded drugs when FDA-approved versions are available, according to a 2018 guidance document.5 Why? Drugs compounded in hospitals or at 503B outsourcing facilities:
Have no FDA premarket review for safety, effectiveness, and quality5*
Have no FDA premarket review of manufacturing quality5*
Can consequently pose higher risks to patients than FDA-approved drugs5
*Compounding facilities are inspected by the FDA for Current Good Manufacturing Practices (CGMP) compliance; however, these are not premarket inspections related to the manufacturing process for a particular product.

References:

  1. Biorphen [Package Insert]. Deer Park, IL: Eton Pharmaceuticals Inc; 2019.
  2. Vazculep [Package Insert]. Chesterfield, MO: Eclat Pharmaceuticals Inc; 2014.
  3. Biorphen data on file. Deer Park, IL: Eton Pharmaceuticals Inc; 2019.
  4. Approval letter of NDA 203826. Drugs@FDA: FDA Approved Drug Products. US Food & Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203826. Accessed November 19, 2019.
  5. Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry. US Food & Drug Administration website. Updated on September 25, 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounded-drug-products-are-essentially-copies-commercially-available-drug-product-under-section. Accessed November 19, 2019.