Starting TEGSEDI® (inotersen)
When Chuck started using TEGSEDI, we saw his polyneuropathy symptoms improve.
Sharell, wife and caregiver of someone living with the polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTR)
How TEGSEDI works
In patients with nerve damage, 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
TEGSEDI significantly reduced the production of TTR protein
Results with TEGSEDI
With TEGSEDI, some people saw improvements in symptoms of nerve damage, such as an impaired sense of touch, and an improved ability to do daily tasks for themselves
TEGSEDI was studied in a clinical trial of 173 people with nerve damage from hereditary ATTR amyloidosis
- The trial studied people with 27 different gene variants
- 113 people in the trial received TEGSEDI while 60 people received placebo
- The trial lasted 15 months. At 8 months, people receiving TEGSEDI were already showing significant improvements compared with people who did not receive treatment
- Results continued to significantly improve through the end of the trial
- Overall, patients had statistically significant improvements 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
Improvements in nerve damage compared with placebo
- At 66 weeks, people who received treatment with TEGSEDI saw a significant 19.7-point improvement in symptoms of nerve damage, such as an impaired sense of touch, compared with people who did not receive treatment
- Many people who received TEGSEDI (37%) even saw improvements in nerve function that was better than when they began the triala
aCompared with 19.2% of people who did not receive treatment.
Improvements in quality of life compared with placebo
- At 66 weeks, people who received TEGSEDI saw a significant 11.7-point 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
- 49% of people who received TEGSEDI said being able to do these tasks improved their quality of life from when they began the trialb
bCompared with 26.9% of people who did not receive treatment.
It’s time to talk about TEGSEDI
To learn more about TEGSEDI, download this brochure and contact your doctor with any questions you may have
Since using TEGSEDI, I am glad to take a more active role in raising our grandkids.
Chuck, living with the polyneuropathy of hereditary ATTR amyloidosis and taking TEGSEDI
Having a treatment that is a weekly injection is empowering to me.
Jean, living with the polyneuropathy of hereditary ATTR amyloidosis and taking TEGSEDI
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.
Mike, living with the polyneuropathy of hereditary ATTR amyloidosis and taking TEGSEDI
Safety and side effects
TEGSEDI has a manageable safety profile
TEGSEDI can cause serious side effects, including low platelet count (thrombocytopenia) and kidney inflammation (glomerulonephritis)
- 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
- Because of the risks of serious bleeding caused by severe thrombocytopenia and glomerulonephritis, TEGSEDI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TEGSEDI REMS Program
- 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; only take the amount they tell you to take
- Call your doctor if you get eye problems, such as difficulty seeing at night or in low-lit areas (night blindness)
TEGSEDI may cause serious allergic reactions
- Allergic reactions often occur within 2 hours after injecting TEGSEDI
- Get emergency help immediately if you have any symptoms of a serious allergic reaction such as 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
Talk to your doctor about possible side effects with TEGSEDI
Build your TEGSEDI routine
Regular monitoring is required to help protect your health
- You will need to take a blood test once a week or more, depending on what your doctor recommends
- If your doctor has asked you to stop taking TEGSEDI, you will need to continue to get your blood and urine tested for 8 more weeks after treatment
- Your healthcare provider should do laboratory tests to check your liver before you start TEGSEDI and every 4 months while you are using itd
- You will need to take a urine test once every 2 weeks
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 TEGSEDI—decide for yourself how TEGSEDI will become part of your routine
TEGSEDI is an injection you have the independence to give in just a few minutes 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, but can be stored for up to 6 weeks at room temperature, so it can travel with you wherever you need to go
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)