Product Safety

Part of Sentynl’s mission to serve patients includes collecting, reviewing, and reporting all adverse events, other safety findings, and product complaint information associated with the use of Sentynl’s marketed products.

It is Sentynl’s policy to comply with all regulations and laws relating to reporting adverse events, other safety finding and product complaints. Individuals subject to this policy are required to report adverse events, other safety finding and product complaints within one business day.

Adverse Events (AE)

An AE is any untoward medical occurrence in a patient administered a Sentynl product and which is not necessarily caused by the Sentynl product. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, combination product, or medical device, whether or not considered related to the product. This includes:

• Any clinically significant worsening of a pre-existing condition; or
• An AE that has been associated with the discontinuation of the use of a product

Other Safety Findings

The following are considered Other Safety Findings regardless of whether they are associated with an AE and they must be reported to Sentynl:

• Use of an Sentynl product while pregnant and/or breast feeding. This includes pregnancies in women whose sexual partner took, or is taking, an Sentynl product
• Medication errors
• Overdose
• Underdose
• Misuse
• Abuse
• Addiction
• Transmission of an infectious agent through a contaminated Sentynl product
• Accidental Exposure
• Occupational Exposure
• Lack or loss of therapeutic efficacy
• Missed dose, if not taken prior to the next scheduled
• Reports of patient “death” after exposure to Sentynl’s product where no other details are provided (e.g., fatal outcomes)
• Off-label use of an Sentynl product defined as the intentional use of a product in a manner inconsistent with the locally approved label, i.e., a different dose, use, indication or patient population than that approved in the local label. U.S. Commercial field staff are not required to report off-label use unless the off-label use is associated with an AE. However, US Commercial field staff must report all other AEs, PCs and OSFs irrespective of whether the event is from on-label or off-label use

Product Complaints (PC)

Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a drug, combination product, or device after it is released for distribution by either: (1) Sentynl or (2) distributors or partners for whom Sentynl manufactures the material. This includes all components distributed with the drug, such as packaging, drug containers, delivery system, labelling, and inserts. Examples include:

• Missing or illegible labeling
• Product with an unexpected color, appearance, or particles

What to Report

When reporting an AE, other safety finding or product complaint, you will need to have the following information ready:

• The identifiable patient:
  • The person who has taken or been administered the product (e.g. age, gender, etc.), in compliance with local privacy laws
• An identifiable reporter:
  • The source that reported the event (e.g. patient, health care provider, friend, etc.), in compliance with local privacy laws
• The medicinal product:
  • Sentynl product name, indication and lot number if known
• The reportable event:
  • Description of the AE, other safety finding or product complaint

You should still report AE, other safety findings and product complaints even if you do not have all the required information. Please report as much relevant information as possible.

It does not matter whether the reportable event is thought to be caused or not thought to be caused by taking an Sentynl product – all AEs, other safety findings and product complaints must be reported. Report a reportable event even though it is listed in the approved company prescribing information as a possible side effect. When in doubt, report it.

How to Report

All information that pertains to an AE, other safety finding or product complaint must be directed to Sentynl for review and analysis as appropriate. Report adverse events, other safety findings, and product complaints related to any Sentynl product to Sentynl by calling 888-507-5206.

AEs can also be reported to the FDA’s MedWatch system or call +1 800-332-1088.

U.S. Residents
For information about known risks and benefits of specific Sentynl products, please visit our U.S. product websites to review prescribing information, including important safety information.