TARGET THE SOURCE OF POLYNEUROPATHY
FROM hereditary ATTR amyloidosis.
Connect patients to what’s important.
TEGSEDI® binds to TTR mRNA to inhibit production of TTR protein. With TEGSEDI, patients can self-administer treatment subcutaneously and spend more time focusing on what matters to them.1START PRESCRIBING
TEGSEDI is indicated for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.1
Please see Important Safety Information for TEGSEDI below and full Prescribing Information, including boxed WARNING regarding the risk of thrombocytopenia and glomerulonephritis.
Abbreviations: ATTR, transthyretin-mediated amyloidosis; TTR, transthyretin.
CONNECT WITH A REPRESENTATIVE
There are important things you need to know about prescribing TEGSEDI, such as how to become a Risk Evaluation and Mitigation Strategy (REMS)–certified prescriber and how to enroll patients in AKCEA CONNECT®, a patient support program. Contact an Akcea representative to learn more.CONTACT NOW
TEGSEDI is available only through a REMS program.a Learn more about certification and enrollment at TEGSEDIrems.com.
Help patients connect to one-on-one support and services from a dedicated Nurse Case Manager. To learn more, visit AkceaConnect.com.
aBecause of the risk of thrombocytopenia and glomerulonephritis, TEGSEDI is available only through a limited program under the REMS. Under the TEGSEDI REMS, only certified healthcare providers and pharmacies may prescribe and distribute TEGSEDI.
PRESCRIBING TEGSEDI® (inotersen)
Follow along with the prescription guide to get started on your own. The guide details all the steps you’ll need to take to begin prescribing TEGSEDI.
Looking for a specific file? Download these frequently used forms.
Complete the TEGSEDI Prescription Start Form to get a new patient started on treatment with TEGSEDI.Download
Complete the AKCEA CONNECT Patient Enrollment Form for your patient to allow for personalized support.Download
Facilitate lab monitoring with Quest Diagnostics by completing the AKCEA CONNECT Lab Monitoring Enrollment Form.Download
Watch videos about the polyneuropathy of hereditary ATTR amyloidosis and TEGSEDI
Be sure to check back for updates to the video library.
Identify the Right Patient for TEGSEDI® (inotersen) (10:01)
Robert Vescio, MD, reviews the polyneuropathy of hereditary ATTR amyloidosis in detail and explains which patients may be appropriate for treatment with TEGSEDI.
The TEGSEDI® (inotersen) Clinical Profile (23:36)
Robert Vescio, MD, describes details about the presentation, diagnosis, and treatment of a patient with the polyneuropathy of hereditary ATTR amyloidosis.
Support Available for Patients Prescribed TEGSEDI® (inotersen) (4:07)
Robert Vescio, MD, describes the patient support services available through AKCEA CONNECT®.
A TEGSEDI® (inotersen) Patient Perspective (8:02)
Meet Chuck—a patient living with the polyneuropathy of hereditary ATTR amyloidosis and receiving treatment with TEGSEDI—and hear his story in his own words.
Abbreviation: ATTR, transthyretin-mediated amyloidosis.
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TEGSEDI is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
IMPORTANT SAFETY INFORMATION
WARNING: THROMBOCYTOPENIA AND GLOMERULONEPHRITIS
- 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
- 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
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
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.
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. In an early access program, reversible rejection has been identified in patients who have had prior liver transplantation and were being treated with TEGSEDI for progressive hATTR disease. 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. Medical judgment should be applied to the need for additional monitoring in patients with prior liver transplant. Treatment with TEGSEDI should be discontinued in patients with prior transplant who develop clinical signs of 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).
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%).
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 for TEGSEDI, including boxed WARNING regarding the risk of thrombocytopenia and glomerulonephritis.
Reference: 1. TEGSEDI [package insert]. Cambridge, MA: Akcea Therapeutics, Inc; 2019.