Patient Safety

Aurinia is committed to serve patients which includes collecting, assessing and reporting all adverse events (AEs, i.e., side effects), other safety findings, and product quality complaints (PQCs) associated with the use of Aurinia’s products. To enable Aurinia to provide up-to date safety information on our products and ensure quality of our medications, your support is pivotal, whether you are a patient, consumer or healthcare provider.

Aurinia follows all world-wide regulations and laws related to safety, side effects (AEs), and PQCs. If you or someone you know or care for experiences an AE or PQC, we request that you report it to Aurinia immediately.

Adverse Events (side effects)

An adverse event is any unexpected side effect, good or bad, that may be related to use of a product. Adverse events include development of new symptoms, onset of new illnesses, worsening of a pre-existing condition, or a laboratory finding that differs from baseline. It is best to report anything, whether you believe it is directly related to the product or not.

Other Safety Findings

All other medical situations related to patient safety should also be reported. The list below contains some examples, but is not meant to cover all possibilities:

  • Any use of an Aurinia product in pregnant and/or breastfeeding women. This also includes situations where a women’s sexual partner is taking or took an Aurinia product.
  • The Aurinia product was taken more frequently than prescribed, or not frequently enough (overdosing or underdosing).
  • The Aurinia product was used by someone that was not prescribed that medication.
  • People taking the Aurinia product who seem to lose the benefits of it, or never have any effect.
  • Any death should, whether or not the Aurinia product is believed to be related.
  • People taking an Aurinia product for a non-indicated or non-intended use.

Product Quality Complaints

Any damage or defects to the product, packaging, and drug containers or damage to the labelling and any inserts should be reported. Anything that makes it difficult to identify the product or affects its durability, safety, or effectiveness should be reported. Again, some examples may include:

  • Packaging that is damaged or opened.
  • Missing labelling or labelling that cannot be read for any reason.
  • Any issues that make the product difficult or impossible to administer.
  • Any unexpected change in the product; for example: the color has changed and is not as reported; damaged product such as leaking or twins (doubles); contamination with foreign matter.

What to Report

When reporting an AE, other medical situations related to safety or PQC, you will be asked to provide the following information, in compliance with local privacy laws:

  • The identifiable patient: the person who has taken or been administered the product (e.g., age, gender, etc.)
  • An identifiable reporter: who reported the event (e.g., patient, consumer, health care provider, friend, etc.)
  • The product: Aurinia product (medication) name, dose details, reason for taking it and lot number if known.
  • The reportable event: description of the AE, other safety finding, or PQC

If you do not have all the required information, you should still make the report and include as much relevant information as possible.

How to Report

All information that pertains to an AE, other safety finding, or PQC must be directed to Aurinia. Important Note: Patients should always inform their doctors and ask for medical advice about any safety concerns.

Please report these by one of the following methods:

Public Users

https://auriniapharma.public.reportum.com

Alternatively, call the Aurinia Pharmaceuticals Call Center on 1-833-672-0028 to report AEs and PQCs.

Login Users

https://quickstart.reportum.com

Note, this access is not available to the public, and only available to users/partners with a login (username and password).

Alternatively, call the Aurinia Pharmaceuticals Call Center on 1-833-672-0028 to report AEs and PQCs.

AEs can also be reported to the FDA's Adverse Event Reporting System MedWatch Online Voluntary Reporting Form or call 1-800-332-1088.