Adverse Event Reporting

KyneRx, Adverse Event Reporting

Effective Date: May 5, 2025

Overview

KyneRx takes patient safety seriously. If you experience an adverse event, side effect, or unexpected reaction related to any medication prescribed through KyneRx, report it immediately using the steps below. All reports are reviewed by our Medical Director and documented in your medical record.

Step 1, Medical Emergencies

If you are experiencing a medical emergency, do not contact KyneRx. Call 911 or go to your nearest emergency room immediately.

Serious adverse events requiring immediate emergency attention include:

• Difficulty breathing or shortness of breath
• Chest pain or irregular heartbeat
• Severe allergic reaction including swelling of the face, throat, or tongue
• Loss of consciousness or severe dizziness
• Stroke symptoms including sudden numbness, confusion, or vision changes
• Any condition you believe is immediately life threatening

Emergency: Call 911

Step 2, Non-Emergency Adverse Events

For non-emergency adverse events, contact KyneRx immediately through any of the following:

Phone: (910) 807-3821

Email: support@kynerx.com

Patient Portal: Log in at app.kynerx.com and submit a report through the support section.

Support Hours: Monday to Friday, 9:00 AM to 6:00 PM EST

Step 3, What Happens After You Report

Once your adverse event report is received:

• Our Medical Director reviews the reported event and assesses severity and causality
• The event is documented in your medical record
• A KyneRx provider contacts you to discuss next steps and adjust your protocol if necessary
• If the event is related to a compounded medication, the dispensing pharmacy is notified and the formulation is reviewed
• Where required by law, the event is reported to the FDA MedWatch program

Step 4, FDA MedWatch Direct Reporting

You may also report adverse events directly to the U.S. Food and Drug Administration:

FDA MedWatch Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

By Phone: 1-800-FDA-1088

Reporting to the FDA is voluntary for patients and does not replace reporting to KyneRx. We encourage patients to report to both.

What to Include in Your Report

When contacting KyneRx please provide:

• Your full name and date of birth
• The medication or product involved
• The dose and frequency you were taking
• The date the adverse event began
• A description of the symptoms or reaction
• Whether you sought medical care and where
• Any other medications or supplements you are currently taking
• Photos if applicable such as injection site reactions

Compounded Medication Safety

All medications prescribed through KyneRx are compounded by licensed 503A compounding pharmacies. Compounded medications are not FDA-approved and have not been reviewed by the FDA for safety or efficacy. Patients should:

• Disclose all allergies and sensitivities to their physician before treatment begins
• Report any new or unexpected symptom after beginning a compounded medication immediately
• Never adjust dose or stop taking a medication without consulting their KyneRx physician first

Patient Protection

Reporting an adverse event will never result in termination of your treatment plan, denial of services, or any negative consequences to your patient account. KyneRx maintains a strict no-retaliation policy for all adverse event reports.

Contact Us

For adverse event reporting or questions regarding this policy:

Business Name: KyneRx, Morph NC LLC

Email: support@kynerx.com

Phone: (910) 807-3821

Patient Portal: app.kynerx.com

Hours: Monday to Friday, 9:00 AM to 6:00 PM EST

Emergency: Call 911