Starting TEGSEDI® (inotersen)

When my husband started using TEGSEDI, we saw his polyneuropathy symptoms improve.

Quote taken from actual caregiver of a patient taking TEGSEDI

This case represents one patient’s experience. Individual results may vary.

Image is not of actual patients

How TEGSEDI works

In patients with the polyneuropathy of hATTR, TEGSEDI targets the disease at its source

Nerve damage from hereditary ATTR amyloidosis results from amyloid buildup which damages organs and tissues. Amyloid is made up of clusters of the TTR protein. TEGSEDI prevents the creation of TTR proteins, reducing the amount of amyloid that builds up.

  • In a clinical trial, people who received TEGSEDI experienced significant reductions in TTR protein levels

Before TEGSEDI

Step by step process of what happens in patients with hATTR amyloidosis before taking TEGSEDI® (inotersen)Step by step process of what happens in patients with hATTR amyloidosis before taking TEGSEDI® (inotersen)

With TEGSEDI

TEGSEDI® (inotersen) helps block TTR protein from being madeTEGSEDI® (inotersen) helps block TTR protein from being made

TEGSEDI significantly reduced TTR protein levels by 75%-79%

Results with TEGSEDI

With TEGSEDI, some people saw improvements in symptoms

TEGSEDI was studied in a clinical trial of 173 people with nerve damage from hereditary ATTR amyloidosis

Results from the NEURO-TTR clinical study

The safety and effectiveness of TEGSEDI were tested in a pivotal study called NEURO-TTR. NEURO-TTR studied TEGSEDI in measures of both nerve pain (neuropathy) and quality of life.

  • One hundred seventy-three adults with the polyneuropathy of hATTR were randomly assigned to receive either treatment with TEGSEDI (112 people)* or placebo (no treatment [60 people]) for 15 months
  • Nerve damage was evaluated using a tool called the modified Neuropathy Impairment Scale +7 (mNIS+7).
    The NIS objectively measures deficits in cranial nerve function, muscle strength, reflexes, and sensations, and the Modified +7 assesses heart rate response to deep breathing, postural blood pressure, quantitative sensory testing (touch-pressure and heat-pain), and peripheral nerve electrophysiology
  • Quality of life was measured with the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) questionnaire, a 35-item questionnaire used to assess the impact of neuropathy on a patient such as impaired walking, abnormal sensations in limbs, and difficulty bathing and dressing oneself
  • Patients had statistically significant improvement at the 66 week mark in nerve function and quality of life compared to those who were not taking treatment
  • 97% of people who finished the trial chose to continue taking TEGSEDI in an extension study

*112 patients in the TEGSEDI arm received at least 1 dose of the drug.

At 15 months, patients treated with TEGSEDI experienced the following benefits vs those who received placebo

Improvement or stabilization in symptoms of nerve damage

Improved quality of life†

Benefits with TEGSEDI were seen as early as 8 months

† People who received TEGSEDI saw a significant improvement in their ability to do certain tasks, such as walk, button a shirt, and go to work on their own, compared with people who did not receive treatment.

Since using TEGSEDI, I am glad to take a more active role in raising our grandkids.

This case represents one person’s experience, individual results may vary

Quote taken from actual patient living with polyneuropathy of hereditary ATTR amyloidosis taking TEGSEDI

Image is not of actual patients

It’s a practical, once-per-week injection that I usually do in the evening, in addition to the routine weekly lab monitoring, which is required for my safety.

This case represents one person’s experience, individual results may vary

Quote taken from actual patient living with polyneuropathy of hereditary ATTR amyloidosis taking TEGSEDI

Image is not of actual patient

TEGSEDI is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS)

TEGSEDI REMS is a set of safeguards put in place in order to mitigate the potential risk of serious bleeding due to severe thrombocytopenia and glomerulonephritis associated with TEGSEDI.

Safety and side effects

TEGSEDI has a manageable safety profile

Because TEGSEDI can cause serious side effects, including low platelet count (thrombocytopenia) and kidney inflammation (glomerulonephritis), it is only available through the TEGSEDI REMS Program

  • The TEGSEDI REMS (Risk Evaluation and Mitigation Strategy) is a restricted program that provides a series of safeguards to catch serious side effects early. Talk to your healthcare provider about how to enroll in the TEGSEDI REMS Program
  • Other serious side effects include stroke, inflammatory and immune system problems, liver effects, allergic reactions, and eye problems (low vitamin A levels)
  • The most common side effects were injection site reactions (such as redness or pain at the injection site), nausea, headache, tiredness, low platelet count (thrombocytopenia), and fever
  • Talk to your doctor about possible side effects with TEGSEDI
  • While not everyone will experience these side effects, your doctor can help you create a plan to manage them if they occur
  • While you are receiving TEGSEDI, you will be closely monitored to check how well your liver and kidneys are working and the amount of platelets in your blood

You may need to take a vitamin A supplement

  • TEGSEDI can lower vitamin A levels in your blood
  • Your doctor will tell you how much supplemental vitamin A to take each day

 

Talk to your doctor about possible side effects with TEGSEDI

Monitoring

Build your TEGSEDI routine

While you are receiving TEGSEDI, you will be monitored closely

Your doctor is required to regularly test your blood and urine to measure how well your liver and kidneys are working and the amount of platelets in your blood. Platelets help with normal blood clotting (for example, they help your body stop bleeding if you get a cut).

Blood tests

  • You will need to take a blood test once a week or more, depending on what your doctor recommends
  • Your healthcare provider should do laboratory tests to check your liver before you start TEGSEDI and monthly while you are using itd

Urine tests

  • You will need to take a urine test once every 2 weeks

If your healthcare provider has you stop taking TEGSEDI, you will need to continue to get your blood and urine tested for 8 more weeks after treatment. Your dosage of TEGSEDI may need to be adjusted or stopped based on your monitoring results.

dPatients who have a history of liver transplant should refer to the Medication Guide for additional monitoring information.

Special measures are in place to help you stay safe during treatment. TEGSEDI is only available through a distribution program known as a REMS (Risk Evaluation and Mitigation Strategy). If you are taking or plan to take TEGSEDI, talk to your doctor about enrolling in TEGSEDI REMS–and learn about it yourself as well. Nurse Case Managers are also available to answer questions about TEGSEDI REMS.

Tracking your treatment with TEGSEDI is another way you can actively take control of your care

  • Use the Treatment Tracker to record your injections and lab results, remember doctor’s appointments, and track your personal goals. Together, you and your doctor can better manage your health

How to use TEGSEDI

You choose when and where to take your weekly TEGSEDI injection–decide for yourself how TEGSEDI will become part of your routine

TEGSEDI is an injection you have the independence to give yourself once per week

  • Before your first injection, you will be trained on how to inject TEGSEDI
  • TEGSEDI arrives ready to inject, already filled in the syringe
  • You have the choice of injecting yourself or having a caregiver or doctor help you
  • After your first dose, you do not need to take TEGSEDI in a hospital or a doctor’s office—you can take the injection anywhere
  • TEGSEDI should be refrigerated, (2° C to 8° C [36° F to 46° F]), but can be stored for up to 6 weeks at room temperature (up to 30° C [86° F]). Do not freeze.

You can decide how TEGSEDI fits into your routine and your lifestyle

  • Take your TEGSEDI injection at the same time every week
  • Receive lab monitoring every week, or as your doctor has instructed
  • Consider choosing an event that usually happens at the same time every week to help you remember when to take your injection and when to receive blood and urine tests (such as a family dinner, religious service, or weekly appointment)

Your Nurse Case Manager through AKCEA® CONNECT can help with your treatment plan and ongoing injection training

Important Safety Information
INDICATION

TEGSEDI is a medicine that treats the polyneuropathy caused by hereditary transthyretin-mediated amyloidosis. TEGSEDI is for use in adults only.

IMPORTANT SAFETY INFORMATION

TEGSEDI can cause serious side effects including:

Low platelet counts (thrombocytopenia): TEGSEDI may cause the number of platelets in your blood to be reduced at any time during treatment. This is a common side effect of TEGSEDI. When your platelet count is too low, your body cannot form clots. You could have serious bleeding that could lead to death. Call your healthcare provider immediately if you have:

  • Unusual bruising or a rash of tiny reddish-purple spots, often on the lower legs
  • Bleeding from skin cuts that does not stop or oozes
  • Bleeding from your gums or nose
  • Blood in your urine or stools
  • Bleeding into the whites of your eyes
  • Sudden severe headaches or neck stiffness
  • Vomiting or coughing up blood
  • Abnormal or heavy periods (menstrual bleeding)

Kidney inflammation (glomerulonephritis): Your kidneys may stop working properly. Glomerulonephritis can lead to severe kidney damage and kidney failure that need dialysis. Call your healthcare provider immediately if you have:

  • Puffiness or swelling in your face, feet, or hands
  • New onset or worsening shortness of breath and coughing
  • Blood in your urine or brown urine
  • Foamy urine (proteinuria)
  • Passed less urine than usual

Because of the risk of serious bleeding caused by low platelet counts and because of the risk of kidney problems, TEGSEDI is available only through a restricted program called the TEGSEDI Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider about how to enroll in the TEGSEDI REMS Program.

Do not use TEGSEDI if you have:

  • A platelet count that is low
  • Had kidney inflammation (glomerulonephritis) caused by TEGSEDI
  • Had an allergic reaction to inotersen or any of the ingredients in TEGSEDI. See the end of the Medication Guide for a complete list of ingredients in TEGSEDI

Before you start TEGSEDI, tell your healthcare provider about all of your health issues, including if you:

  • Have or had bleeding problems
  • Have or had kidney problems
  • Have received a liver transplant
  • Are pregnant or plan to become pregnant. It is not known if TEGSEDI can harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if TEGSEDI can pass into your breast milk or harm your baby. Talk with your healthcare provider about the best way to feed your baby while you are taking TEGSEDI

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take vitamin A or beta-carotene supplements, blood thinners (anticoagulants), or drugs that affect blood clotting.

Required monitoring

Your healthcare provider will test your blood and urine to check your platelet counts and kidney and liver function before you start TEGSEDI. While you are receiving TEGSEDI, you will be monitored closely for symptoms, which includes checking your platelet counts every week (or more frequently as needed), kidney function every 2 weeks, and liver function monthly. If your healthcare provider has you stop taking TEGSEDI, you will need to continue to get your blood and urine tested for 8 more weeks after treatment.

TEGSEDI may cause serious side effects, including:

Stroke. TEGSEDI may cause a stroke. One person taking TEGSEDI had a stroke, which occurred within 2 days after the first dose. Get emergency help immediately if you have symptoms of stroke, including sudden numbness or weakness, especially on one side of the body; severe headache or neck pain; confusion; problems with vision, speech, or balance; droopy eyelids.

Inflammatory and immune system problems. Some people taking TEGSEDI had serious inflammatory and immune system problems. Symptoms of inflammatory and immune system problems included unexpected change in walking, weakness and spasms in legs, back pain, weight loss, headache, vomiting, and problems with speech.

Liver Effects. TEGSEDI may cause liver problems. Your healthcare provider should do laboratory tests to check your liver before you start TEGSEDI and monthly while you are using it. Stop taking TEGSEDI and tell your healthcare provider if you have symptoms that your liver may not be working right, which could include unexpected nausea and vomiting, stomach pain, being not hungry, yellowing of the skin, or having dark urine.

Allergic reactions. TEGSEDI may cause serious allergic reactions. These allergic reactions often occur within 2 hours after injecting TEGSEDI. Get emergency help immediately if you have any symptoms of a serious allergic reaction, including joint pain, chills, redness on palms of hands, muscle pain, chest pain, flushing, tremor or jerking movements, flu-like symptoms, high blood pressure, or difficulty swallowing.

Eye problems (low vitamin A levels). Treatment with TEGSEDI will lower the vitamin A levels in your blood. Your healthcare provider will tell you how much supplemental vitamin A to take every day; only take the amount they tell you to take. Call your healthcare provider if you get eye problems, such as having difficulty seeing at night or in low-lit areas (night blindness).

The most common side effects of TEGSEDI include injection site reactions (such as redness or pain at the injection site), nausea, headache, tiredness, low platelet counts (thrombocytopenia), and fever. These are not all of the possible side effects of TEGSEDI. Talk to your healthcare provider about any side effects you may be experiencing.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Medication Guide and full Prescribing Information, including boxed WARNING.

References: 1. TEGSEDI [package insert]. Boston, MA: Akcea Therapeutics, Inc; 2020.  2. Benson MD, Waddington-Cruz M, Berk JL, et al. Inotersen treatment for patients with hereditary transthyretin amyloidosis. N Engl J Med. 2018;379(1):22-31. doi:10.1056/NEJMoa1716793.

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