Inotersen

Generic name: Inotersen
Brand names: Tegsedi
Dosage form: subcutaneous solution (284 mg/1.5 mL)
Drug class: Miscellaneous metabolic agents

Usage of Inotersen

Inotersen is used to treat polyneuropathy (damage of multiple nerves throughout the body) in adults with hATTR. inotersen 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.

Inotersen side effects

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

Inotersen may cause serious side effects. 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 side effects of inotersen 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 Inotersen

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 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 inotersen on the baby.

Relate drugs

How to use Inotersen

Usual Adult Dose 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

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. 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 Inotersen

Inotersen 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 affect 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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