Brand Names: Tegsedi
Generic Name: inotersen
- What is inotersen (Tegsedi)?
- What are the possible side effects of inotersen (Tegsedi)?
- What is the most important information I should know about inotersen (Tegsedi)?
- What should I discuss with my healthcare provider before using inotersen (Tegsedi)?
- How should I use inotersen (Tegsedi)?
- What happens if I miss a dose (Tegsedi)?
- What happens if I overdose (Tegsedi)?
- What should I avoid while using inotersen (Tegsedi)?
- What other drugs will affect inotersen (Tegsedi)?
- Where can I get more information (Tegsedi)?
What is inotersen (Tegsedi)?
Inotersen works by decreasing a protein called transthyretin (TTR, made primarily in the liver). Hereditary transthyretin-mediated amyloidosis (hATTR) is a rare condition in which abnormal deposits of TTR protein build up in many parts of the body, interfering with normal function.
Inotersen is used to treat polyneuropathy (damage of multiple nerves throughout the body) in adults with hATTR. This medicine can help reduce symptoms such as pain, numbness, tingling, abnormal heartbeats, diarrhea, constipation, weakness, and problems with movement in your arms or legs.
Inotersen is available only from a certified pharmacy under a special program.
Inotersen may also be used for purposes not listed in this medication guide.
What are the possible side effects of inotersen (Tegsedi)?
Call your doctor at once if you have:
- easy bruising, unusual bleeding (from your nose, gums, or a cut), purple or red spots under your skin;
- severe headache, neck stiffness;
- sudden numbness or weakness (especially on one side of the body);
- slurred speech, drooping eyelids, problems with vision or balance;
- bloody or tarry stools;
- blood in your urine, urine that looks foamy, little or no urination;
- cough with bloody mucus or vomit that looks like coffee grounds;
- bleeding in the whites of your eyes;
- heavy menstrual bleeding;
- puffy eyes, swelling in your hands or feet, shortness of breath;
- nausea, vomiting, muscle pain, muscle weakness; or
- a reaction within 2 hours after an injection--headache, chest pain, flu-like symptoms, warmth or chills, redness on the palms of your hands, muscle or joint pain, uncontrolled muscle movements.
Common side effects may include:
- low platelets;
- headache; or
- pain, swelling, itching, bruising, redness, bleeding, or a hard lump 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.
What is the most important information I should know about inotersen (Tegsedi)?
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 any bruising or bleeding, severe headache, neck stiffness, bleeding in the whites of your eyes, blood in your urine or stools, heavy menstrual bleeding, cough with bloody mucus, or vomit that looks like coffee grounds.
What should I discuss with my healthcare provider before using inotersen (Tegsedi)?
You should not use inotersen if you are allergic to it, or if you have:
- low levels of platelets in your blood (your doctor will test you for this); or
- kidney problems caused by using inotersen in the past.
Tell your doctor if you have ever had:
- a bleeding or blood clotting disorder; or
- kidney disease.
How should I use inotersen (Tegsedi)?
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using inotersen.
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 weekly. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.
Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
Use this medicine on the same day each week.
Your doctor may recommend that you take a vitamin A supplement while you are taking inotersen. Take only the amount of vitamin A your doctor has prescribed. An overdose of vitamin A can cause vision problems or other serious side effects.
It is especially important to avoid taking too much vitamin A if you are pregnant.
Call your doctor at once if you have vision problems (especially at night) while you are taking vitamin A.
You will need frequent medical tests. Your weekly injections may be delayed based on the results. Inotersen can have long lasting effects on your body. You may also need frequent medical tests for a short time after you stop using this medicine.
Store in the refrigerator. Protect from light and do not freeze. Keep each prefilled syringe in the carton until it is time for your injection.
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.
Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
What happens if I miss a dose (Tegsedi)?
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.
What happens if I overdose (Tegsedi)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using inotersen (Tegsedi)?
Avoid injecting inotersen into skin that is red, bruised, injured, or irritated. Do not inject this medicine into skin areas with scars or tattoos.
What other drugs will affect inotersen (Tegsedi)?
Inotersen can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, or pain or arthritis (including aspirin, Tylenol, Advil, and Aleve).
Tell your doctor about all your other medicines, especially:
- a blood thinner--warfarin, Coumadin, Jantoven;
- medicine used to prevent blood clots--such as adenosine, clopidogrel, prasugrel, ticagrelor, ticlopidine, and others; or
- NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may affect inotersen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information (Tegsedi)?
Your pharmacist can provide more information about inotersen.
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