If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
U-500R is available in a colorless solution as a
3 mL Pen (prefilled, 1,500 units of insulin), and
20 mL vial (containing 10,000 units of insulin).1
The prescribed TDI of U-500R will determine how many Pens or vials will be needed per month.
Do not freeze U-500R. Do not use U-500R if it has been frozen.1
Protect U-500R from heat and light.
Do not store the Pen with the needle attached to prevent
blocking the needle
forming air bubbles, and
air entering the Pen.2
Store unopened Pens and vials in the refrigerator.1
Do not use U-500R after the expiration date (Table 1. Storage Conditions and Expiration Dates for U-500R).1
Table 1. Storage Conditions and Expiration Dates for U-500R
Abbreviations: Pen = KwikPen®; U-500R = Humulin® R U-500 (insulin human injection) 500 units/mL.
a An insulin product is considered in-use (open) once the stopper or septum has been punctured with a needle.
b Do not store the in-use U-500R Pen in the refrigerator.
c The storage and stability guidelines for insulin Pens differ from those for vials. This is based on differences in the expected usage patterns for these insulin products. The stability (in-use dating period) guideline established for Pens took into account the increased convenience of a Pen. This increased convenience may lead to patients exposing his or her insulin to thermal (heat) and agitation conditions that would be greater than the exposure for insulin in vials.
Product Quality Assessment
If an insulin product is exposed to temperatures outside the recommend storage and handling range, Lilly personnel can perform a product quality assessment to determine potential impact to the quality of product. This product quality assessment is not intended to replace the recommended storage or handling conditions for the insulin product.
Lilly can assess the potential impact of any temperature exposure to the product only after the event has occurred and only on a case-by-case basis.
You must be able to provide amount of time and what temperatures the insulin was exposed to outside the recommended storage and handling conditions.
The product quality assessment must occur after the temperature exposure has ended and the products have been stored as per recommended storage conditions.
Enclosed Prescribing Information
Lilly = Eli Lilly and Company
Pen = KwikPen®
TDI = total daily insulin dose
U-500R = Humulin® R U-500 (insulin human injection) 500 units/mL
Date of Last Review: January 17, 2019