Right Now
At Roxane Laboratories, patient and community safety is our highest priority. We support the work of physicians, pharmacists, and other healthcare providers nationwide through our participation in Risk Evaluation and Mitigation Strategies (REMS) programs. Above all, Roxane is committed to ensuring appropriate and safe use of all our products.
Important safety information: Please click on links below to U.S. full prescribing information for each product to see indications for use and additional important safety information, including boxed warnings.
What are Risk Evaluation and Mitigation Strategies?
Risk Evaluation and Mitigation Strategies (REMS) are U.S. Food and Drug Administration (FDA) regulated safety programs. All prescription medications carry risks, particularly if they are not prescribed or used appropriately. The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the FDA to require a REMS for prescription drugs or biologics with significant known or potential risks. REMS are designed to ensure that the benefits of a drug continue to outweigh the risks of the drug.
What does a REMS consist of?
A REMS program may include different educational components, such as a medication guide or a patient package insert, elements to assure safe use (ETASU), or a communication plan. The specific components a REMS program employs may vary based on the severity of the risks, the population likely to be exposed, and other factors specific to the covered drug. These components may apply to a variety of stakeholders, from the healthcare providers to the pharmacists, the patients, or even the distributors, in order to support the safe use of the product. A REMS also includes assessments to determine if it is meeting its intended goals.
What is a medication guide?
A medication guide is a written document containing FDA-approved information relative to the proper and safe use of a specific drug. A goal of the medication guide is to educate patients on how to avoid serious adverse events associated with the drug. Medication guides can be used as a component of a REMS. In addition, they can be used to provide information on drugs that are not covered under a REMS.
What drugs manufactured by Roxane are subject to a REMS?
Several of Roxane’s prescription medications are currently subject to a REMS, listed in the adjacent “Products with REMS program” tab.
REMS related material available on this website consists of a medication guide, which is appended to the full prescribing information.
What does this mean for patients using Roxane products?
If you use a Roxane product that is subject to a REMS, it is important for you to discuss with your healthcare provider the safe use, storage, and disposal of this drug. It is also important to review all the documents for patients such as the medication guide that you receive with your prescription at the pharmacy and any other information your prescriber may give you. Roxane’s participation in these various REMS programs is representative of our commitment to promote the appropriate and safe use of all our products. Above all, we consider patient and community safety as a highest priority.
