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

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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.

REVIEW

Step 1

REVIEW the TEGSEDI Prescribing Information.

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COMPLETE

Step 2

COMPLETE the Prescriber Training.

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Review

Step 3

REVIEW the REMS Program Overview.

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COMPLETE AND SUBMIT

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.

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COMPLETE AND SUBMIT

Step 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.

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Complete and submit

Step 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.

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For 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.

Complete and submit

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.

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complete and submit

Step 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.

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complete and submit

Step 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.

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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.

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Step 5

With your patient, COMPLETE AND SUBMIT the TEGSEDI REMS Patient Enrollment Form.

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Step 6

PROVIDE your patient with a TEGSEDI Wallet Card and instruct the patient to carry it at all times.

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Step 7

CUSTOMIZE AND SUBMIT a Letter of Medical Necessity for TEGSEDI with your patient’s information.

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assess

Step 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.

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Questions? Call AKCEA CONNECT at 1-866-AKCEATX (1-866-252-3289) to speak with a Nurse Case Manager

Quote from Jean

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

Quote from Mike

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

TEGSEDI® (inotersen) routine monitoring assessment
TEGSEDI® (inotersen) routine monitoring assessment

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

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Important Safety Information
INDICATION

TEGSEDI is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

IMPORTANT SAFETY INFORMATION
  • Warning: thrombocytopenia and glomerulonephritis
  • Thrombocytopenia
    • TEGSEDI causes reductions in platelet count that may result in sudden and unpredictable thrombocytopenia, which can be life-threatening. One clinical trial patient died from intracranial hemorrhage
    • TEGSEDI is contraindicated in patients with a platelet count below 100 x 109/L
    • Prior to starting TEGSEDI, obtain a platelet count. During treatment, monitor platelet counts weekly if values are 75 x 109/L or greater, and more frequently if values are less than 75 x 109/L
    • If a patient develops signs or symptoms of thrombocytopenia, obtain a platelet count as soon as possible. The patient should not receive additional TEGSEDI unless a platelet count is determined to be interpretable and acceptable by a medical professional
    • Following discontinuation of treatment for any reason, continue to monitor platelet count for 8 weeks, or longer if platelet counts are less than normal, to verify that platelet counts remain above 75 x 109/L
  • Glomerulonephritis
    • TEGSEDI can cause glomerulonephritis that may require immunosuppressive treatment and may result in dialysis-dependent renal failure. One clinical trial patient who developed glomerulonephritis and did not receive immunosuppressive treatment remained dialysis-dependent. In clinical trials, cases of glomerulonephritis were accompanied by nephrotic syndrome, which can have manifestations of edema, hypercoagulability with venous or arterial thrombosis, and increased susceptibility to infection
    • TEGSEDI should generally not be initiated in patients with urinary protein to creatinine ratio (UPCR) of 1000 mg/g or higher
    • Prior to starting TEGSEDI, measure the serum creatinine, estimated glomerular filtration rate (eGFR), urine protein to creatinine ratio (UPCR), and perform a urinalysis. During treatment, monitor serum creatinine, eGFR urinalysis, and UPCR every 2 weeks. TEGSEDI should not be given to patients who develop a UPCR of 1000 mg/g or higher or eGFR below 45 mL/minute/1.73 m2, pending further evaluation of the cause
    • If a dose is held, once eGFR increases to ≥45 mL/minute/1.73 m2, UPCR decreases to below 1000 mg/g, or the underlying cause of the decline in renal function is corrected, weekly dosing may be reinitiated. In patients with UPCR of 2000 mg/g or higher, perform further evaluation for acute glomerulonephritis, as clinically indicated. If acute glomerulonephritis is confirmed, TEGSEDI should be permanently discontinued
  • TEGSEDI REMS Program
    • Because of the risks of serious bleeding caused by severe thrombocytopenia and because of glomerulonephritis, both of which require frequent monitoring, TEGSEDI is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the TEGSEDI REMS Program
CONTRAINDICATIONS

TEGSEDI is contraindicated in patients with

  • Platelet count below 100 x 109/L
  • History of acute glomerulonephritis caused by TEGSEDI
  • History of a hypersensitivity reaction to TEGSEDI
WARNINGS AND PRECAUTIONS
Thrombocytopenia

TEGSEDI causes reductions in platelet count that may result in sudden and unpredictable thrombocytopenia that can be life-threatening. In Study 1, platelet counts below 100 x 109/L occurred in 25% of TEGSEDI-treated patients compared with 2% of patients on placebo. Platelet counts below 75 x 109/L occurred in 14% of TEGSEDI-treated patients compared with no patients on placebo. One patient in a clinical trial experienced a fatal intracranial hemorrhage. Do not initiate TEGSEDI in patients with a platelet count below 100 x 109/L. Follow recommended monitoring and treatment recommendations for platelet count.

Symptoms of thrombocytopenia can include unusual or prolonged bleeding (eg, petechiae, easy bruising, hematoma, subconjunctival bleeding, gingival bleeding, epistaxis, hemoptysis, irregular or heavier than normal menstrual bleeding, hematemesis, hematuria, hematochezia, melena), neck stiffness, or atypical severe headache. Patients and caregivers should be instructed to be vigilant for symptoms of thrombocytopenia and seek immediate medical help if they have concerns.

Glomerulonephritis and Renal Toxicity

TEGSEDI can cause glomerulonephritis that may result in dialysis-dependent renal failure. In Study 1, glomerulonephritis occurred in 3 (3%) TEGSEDI-treated patients compared with no patients on placebo. One patient did not receive immunosuppressive treatment and remained dialysis-dependent. If glomerulonephritis is suspected, pursue prompt diagnosis and initiate immunosuppressive treatment as soon as possible. Follow recommended monitoring and treatment recommendations for renal parameters. TEGSEDI should generally not be initiated in patients with a UPCR of 1000 mg/g or greater. If acute glomerulonephritis is confirmed, TEGSEDI should be permanently discontinued.

TEGSEDI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TEGSEDI REMS Program because of risks of serious bleeding caused by severe thrombocytopenia and because of glomerulonephritis.

Stroke and Cervicocephalic Arterial Dissection

TEGSEDI may cause stroke and cervicocephalic arterial dissection. In clinical studies, 1 of 161 (0.6%) TEGSEDI-treated patients experienced carotid artery dissection and stroke. Educate patients on the symptoms of stroke and central nervous system arterial dissection. Instruct patients to seek help as soon as possible if symptoms of stroke or arterial dissection occur.

Inflammatory and Immune Effects

Inflammatory and immune changes are an effect of some antisense oligonucleotide drugs, including TEGSEDI. In clinical studies, serious inflammatory and immune adverse reactions occurred in TEGSEDI-treated patients, including immune thrombocytopenia and glomerulonephritis, as well as a single case of antineutrophil cytoplasmic autoantibody (ANCA)–positive systemic vasculitis.

Liver Injury

In clinical studies, 8% of TEGSEDI-treated patients had an increased alanine aminotransferase (ALT) at least 3 times the upper limit of normal (ULN) compared with 3% of patients on placebo; 3% of TEGSEDI-treated patients had an ALT at least 8 times the ULN compared with no patients on placebo. Monitor ALT, aspartate aminotransferase, and total bilirubin at baseline and every 4 months during treatment with TEGSEDI. If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction, promptly measure serum transaminases and total bilirubin and interrupt or discontinue treatment with TEGSEDI, as appropriate.

Liver Transplant Rejection

In a clinical study, cases of liver transplant rejection were reported 2-4 months after starting TEGSEDI in patients whose liver allografts had previously been clinically stable (for over 10 years) prior to starting TEGSEDI. In these cases, the patients clinically improved and transaminase levels normalized after glucocorticoid administration and cessation of TEGSEDI.

In patients with a history of liver transplant, monitor ALT, AST, and total bilirubin monthly. Discontinue TEGSEDI in patients who develop signs of liver transplant rejection.

Hypersensitivity Reactions/Antibody Formation

TEGSEDI can cause hypersensitivity reactions. In clinical studies, 6 of 161 (4%) TEGSEDI-treated patients stopped treatment because of a hypersensitivity reaction. These reactions generally occurred within 2 hours of administration of TEGSEDI. Antibodies to TEGSEDI were present when the reactions occurred. If a hypersensitivity reaction occurs, discontinue administration of TEGSEDI and initiate appropriate therapy. Do not use in patients who have a history of hypersensitivity reactions to TEGSEDI.

Uninterpretable Platelet Counts: Reaction Between Antiplatelet Antibodies and Ethylenediaminetetraacetic acid (EDTA)

In Study 1, 23% of TEGSEDI-treated patients had at least 1 uninterpretable platelet count caused by platelet clumping compared with 13% of patients on placebo. If there is suspicion of EDTA-mediated platelet clumping, perform a repeat platelet count using a different anticoagulant (eg, sodium citrate, heparin) in the blood collection tube. Recheck the platelet count as soon as possible if a platelet measurement is uninterpretable. Hold TEGSEDI dosing until an acceptable platelet count is confirmed with an interpretable blood sample.

Reduced Serum Vitamin A Levels and Recommended Supplementation

TEGSEDI treatment leads to a decrease in serum vitamin A levels. Supplementation at the recommended daily allowance of vitamin A is advised for patients taking TEGSEDI. Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (eg, night blindness).

ADVERSE REACTIONS

The most common adverse reactions that occurred in at least 20% of TEGSEDI-treated patients and more frequently than in those on placebo were injection site reactions, nausea, headache, fatigue, thrombocytopenia, and fever. Serious adverse reactions were more frequent in TEGSEDI-treated patients (32%) than in patients on placebo (21%).

DRUG INTERACTIONS

Because of the risk of thrombocytopenia, caution should be used when using antiplatelet drugs (including nonprescription products that affect platelets) or anticoagulants concomitantly with TEGSEDI. Because of the risk of glomerulonephritis and renal toxicity, caution should be used when using nephrotoxic drugs and other drugs that may impair renal function concomitantly with TEGSEDI.

Please see full Prescribing Information, including boxed WARNING regarding the risk of thrombocytopenia and glomerulonephritis.

Reference: 1. TEGSEDI [package insert]. Boston, MA: Akcea Therapeutics, Inc; 2019.

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