Inotersen (Tegsedi)
Inotersen is used in adults to treat polyneuropathy (damage of multiple nerves throughout the body) of hereditary transthyretin-mediated amyloidosis.
Inotersen is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of this medicine.
Inotersen may also be used for purposes not listed in this medication guide.
uses
What is Inotersen (Tegsedi) used for?
- Amyloidogenic Transthyretin Amyloidosis
warnings
What is the most important information I should know about Inotersen (Tegsedi)?
You should not use inotersen if you are allergic to it, or if you have:
- low levels of platelets in your blood; or
- kidney problems caused by using inotersen in the past.
Tell your doctor if you have or have ever had:
- a bleeding or blood clotting disorder; or
- a liver transplant.
It is not known if inotersen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of inotersen on the baby.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Inotersen (Tegsedi)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Inotersen can make it easier for you to bleed, even from a minor injury. Seek medical attention if you have bleeding that will not stop. Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.
Call your doctor at once if you have:
- puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy;
- vision problems (at night or in low lit areas);
- vomiting, weight loss, back pain, weakness and spasms in legs, unexpected change in walking, headache;
- easy bruising, unusual bleeding, purple or red spots under your skin;
- nosebleeds, bleeding gums, any bleeding that will not stop;
- bleeding inside your body--weakness, dizziness, pink or brown urine, abnormal vaginal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- a reaction within 2 hours after an injection--chest pain, flu-like symptoms, chills, redness on the palms of your hands, muscle or joint pain, uncontrolled muscle movements, high blood pressure, trouble swallowing, flushing (sudden warmth, redness, or tingly feeling).
Common side effects may include:
- easy bruising, unusual bleeding, purple or red spots under your skin;
- nausea;
- fever;
- tiredness;
- headache; or
- pain or redness where an injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Inotersen (Tegsedi) if I’m pregnant or breastfeeding?
It is not known if inotersen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of inotersen on the baby.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Inotersen (Tegsedi)?
Avoid injecting into skin that is hard, red, bruised, swollen, or tender.
Dosage Guidelines & Tips
How to take Inotersen (Tegsedi)?
Use Inotersen (Tegsedi) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Inotersen is injected under the skin once a week on the same day.
Your healthcare provider will show you where to inject inotersen. Do not inject into the same place two times in a row.
Ask your doctor or pharmacist if you don't understand how to use an injection.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Your doctor may recommend that you take a vitamin A supplement. Take only the amount of vitamin A your doctor has prescribed.
You will need medical tests before, during, and after you treatment with inotersen.
Store in the refrigerator in the original container. Protect from light and do not freeze.
You can keep this medicine at room temperature (up to 86 degrees Fahrenheit (30 degrees Celsius)) for up to 6 weeks and throw it away if not used within this period.
Take a syringe out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the syringe with hot water, sunlight, or a microwave.
Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 2 days. Do not use two injections at one time.