Connect patients to treatment with TEGSEDI® (inotersen)
Overview
What to know about prescribing TEGSEDI
- TEGSEDI is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS), which requires ongoing lab monitoring.
- First, enroll to become certified as a prescriber. Once you are certified to prescribe TEGSEDI, there are steps you must follow with every new patient.
- AKCEA® CONNECT supports patient safety through various services such as free lab monitoring and provides resources patients can trust.
Abbreviation: hATTR-PN, hereditary transthyretin-mediated amyloidosis with polyneuropathy.

AKCEA CONNECT
AKCEA CONNECT can partner with your patients to provide support and resources
Get personalized, dedicated support for patients and their caregivers
Integrated connectivity between AKCEA CONNECT and the specialty pharmacy with direct contact to patients and your office
Individualized self-injection training for patients reinforced through multiple patient touch points
Reimbursement navigation and financial assistance across all patient services, including commercial, government, and uninsured
Meet patients wherever they are at no cost, with mobile phlebotomy and access to more than 2200 lab monitoring locations
Shared commitment to patient safety, assistance with scheduling, reminders, follow-ups, and compliance with laboratory adherence protocols
Help your patients and their caregivers connect to personalized one-on-one support with AKCEA CONNECT

Enrolling your practice
Get certified to become a TEGSEDI prescriber
To become certified in the TEGSEDI REMS Program, each prescriber must complete the following 6 steps. Once you have finished, you will receive a notification of successful enrollment and a username and password to log in to the TEGSEDI REMS Program to view your enrolled patients.
Return all completed forms to AKCEA CONNECT at akceaconnect@akceatx.com or send them with Fax Form 2 to 1-866-252-3239.
If you are looking for a specific form, visit the Resources page to see all available downloads.
Step 4
COMPLETE AND SUBMIT (ONLINE OR VIA FAX) the Prescriber Knowledge Assessment. Type or print and write your responses and follow the directions for submission on the form.
OpenStep 5
COMPLETE AND SUBMIT (ONLINE OR VIA FAX) the Prescriber Enrollment Form. Type or print and write your responses and follow the directions for submission on the form.
OpenStep 6
COMPLETE AND SUBMIT (ONLINE OR VIA FAX) the AKCEA CONNECT Lab Monitoring Enrollment Form. Type or print and write your responses and follow the directions for submission on the form.
OpenFor more information about the REMS program, visit TEGSEDIrems.com

Starting new patients
Enrolling new patients prescribed TEGSEDI
With every new patient for whom you prescribe TEGSEDI, complete the following steps. Return all completed forms to AKCEA CONNECT at akceaconnect@akceatx.com or send them with Fax Form 2 to 1-866-252-3239.
If you are looking for a specific form, visit the Resources page to see all available downloads.
Step 1
COMPLETE AND SUBMIT the AKCEA CONNECT Patient Enrollment and Authorization Form. Type or print and write your responses and follow the directions for submission on the form.
OpenStep 2
COMPLETE AND SUBMIT the TEGSEDI Prescription Start Form. Type or print and write your responses and follow the directions for submission on the form.
OpenStep 3
COMPLETE AND SUBMIT a Quest Lab Monitoring Requisition Form, which you should have received in the mail when you were enrolled. Follow the directions for submission on the form.
Step 4
REVIEW the TEGSEDI REMS Patient Guide with your patient. Counsel your patient about the risks associated with TEGSEDI, including serious bleeding caused by severe thrombocytopenia and the risk of glomerulonephritis.
OpenStep 6
PROVIDE your patient with a TEGSEDI Wallet Card and instruct the patient to carry it at all times.
OpenStep 7
CUSTOMIZE AND SUBMIT a Letter of Medical Necessity for TEGSEDI with your patient’s information.
OpenStep 8
ASSESS your patient’s platelet count and kidney function for appropriateness of initiating treatment. If the results are within the acceptable range and all previous steps have been completed, your patient is now ready to start receiving treatment.
Questions? Call AKCEA CONNECT at 1-866-AKCEATX (1-866-252-3289) to speak with a Nurse Case Manager

I am pleased with my experience with TEGSEDI, because I like that I am in control of my treatment schedule with the freedom that it allows for me to inject at home, once a week. I can continue to spend time with my grandchildren and enjoy my social life.
Jean | Patient living with the polyneuropathy of hereditary ATTR amyloidosis and taking TEGSEDI

The routine lab monitoring is pretty straightforward. It’s once a week; it’s very convenient.
Mike | Patient living with the polyneuropathy of hereditary ATTR amyloidosis and taking TEGSEDI
Required monitoring
Required monitoring for your patients can be confidently delivered1
AKCEA CONNECT can manage required weekly lab monitoring for your patients at no cost
Ongoing lab monitoring is a required safeguard put in place in order to mitigate the potential risk of thrombocytopenia and glomerulonephritis.1 AKCEA CONNECT can manage the weekly lab monitoring for your patients and provide updates about their lab values.
Required routine monitoring
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; eGFR, estimated glomerular filtration rate; UPCR, urine protein to creatinine ratio.
aIf platelet count declines to <100 × 109/L, follow monitoring as indicated in the Prescribing Information.1
bMore frequent liver function monitoring may be required in patients who have a history of liver transplant.1
