Tegsedi

Generic name: Inotersen
Drug class: Miscellaneous metabolic agents

Usage of Tegsedi

Tegsedi 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.

Tegsedi injection is used to treat polyneuropathy (damage of multiple nerves throughout the body) in adults with hATTR. Tegsedi can help reduce symptoms such as pain, numbness, tingling, abnormal heartbeats, diarrhea, constipation, weakness, and problems with movement in your arms or legs.

Tegsedi is available only from a certified pharmacy under a special program.

Tegsedi side effects

Get emergency medical help if you have signs of an allergic reaction to Tegsedi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

sudden numbness or weakness (especially on one side of the body), slurred speech, drooping eyelids, problems with vision or balance;

puffy eyes, swelling in your hands or feet, shortness of breath;

vomiting, weight loss;

back pain, muscle weakness;

easy bruising, unusual bleeding (from your nose, gums, or a cut), purple or red spots under your skin;

heavy menstrual bleeding;

signs of bleeding inside your body severe headache, neck stiffness, bleeding in the whites of your eyes, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds;

liver problems - loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); 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 Tegsedi side effects may include:

bleeding or bruising;

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.

Before taking Tegsedi

You should not use Tegsedi if you are allergic to Inotersen, or if you have:

low levels of platelets in your blood (your doctor will test you for this); or

kidney problems caused by using Tegsedi in the past.

To make sure Tegsedi is safe for you, tell your doctor if you have:

a liver transplant;

a bleeding or blood clotting disorder; or

kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Tegsedi on the baby.

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How to use Tegsedi

Usual Adult Dose of Tegsedi for Amyloidogenic Transthyretin Amyloidosis:

284 mg suBCutaneously once a week Comments: If a dose is missed and it is not within 2 days of next scheduled dose, the dose should be administered as soon as possible; if the missed dose is within 2 days of next scheduled dose, skip the missed dose and take the next scheduled dose on the scheduled day. Use: For the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Warnings

Tegsedi 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.

Bleeding may also happen inside your body. Call your doctor at once if you have signs such as severe headache, neck stiffness, bleeding in the whites of your eyes, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

What other drugs will affect Tegsedi

Tegsedi can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

a blood thinner - warfarin, Coumadin, Jantoven; or

medicine used to prevent blood clots - such as adenosine, clopidogrel, prasugrel, ticagrelor, ticlopidine, and others.

This list is not complete. Other drugs may interact with inotersen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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