Inotersen (By injection)

Inotersen (in-oh-TER-sen)

Treats polyneuropathy (nerve disease) of hereditary transthyretin-mediated amyloidosis.

Brand Name(s):

Tegsedi

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to inotersen, or if you have thrombocytopenia or a history of swelling of the kidneys (glomerulonephritis).

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, or hard, or with scars or tattoos.
• Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
• Check the liquid in the prefilled syringe or autoinjector. It should be colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, use it as soon as you can. If your next dose is within 2 days, skip the missed dose and go back to your regular dosing schedule.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may store this medicine at room temperature for up to 6 weeks. Throw any unused medicine after 6 weeks.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how inotersen works. Tell your doctor if you are using a blood thinner (including adenosine, aspirin, clopidogrel, heparin, prasugrel, ticagrelor, ticlopidine, warfarin) or an NSAID pain medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, or if you have vitamin A deficiency.
• This medicine may cause the following problems:
  • Kidney problems
  • Inflammatory or immune system problems
  • Increased risk of stroke or arterial dissection (tear in the lining of a brain artery)
  • Liver problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, lower back or side pain, bloody or cloudy urine
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Numbness or weakness in your arm or leg, or on one side of your body
• Spasms in the legs, back pain, weight loss
• Sudden or severe headache, problems with vision, speech, or walking
• Tiny red dots on the skin, especially on the lower legs
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite
• Difficulty seeing at night
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 12/4/2023