Eplontersen (ep-lon-TER-sen)

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

Brand Name(s):

Wainua

When This Medicine Should Not Be Used:

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. It is usually given in your thighs, stomach, or upper arm.
• 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 bruised, damaged, red, hard, tender, or areas with scars.
• Allow 30 minutes for the autoinjector to warm up to room temperature. Do not warm using heat sources (including hot water or microwave)
• Check the liquid in the autoinjector. It should be clear and colorless to yellow. Do not use the medicine if is cloudy, discolored, or has particles in it. Do not use the autoinjector if it looks damaged or if the clear cap is missing or not attached.
• You may also be given vitamin A supplements as needed.
• Autoinjector:
  • Wash your hands with soap and water before and after using this medicine.
  • Hold the autoinjector by the middle with the clear cap facing away from you. Remove the clear cap by pulling it straight off. Do not twist it off. The needle is inside the orange needle shield.
  • Do not recap the autoinjector. Do not push the orange needle shield against your hand or finger.
  • Hold the autoinjector in one hand. Place the orange needle shield at a 90 degree angle against your skin. Push firmly and hold the autoinjector straight against your skin. You will hear a click as the injection starts. You may hear a second click, which is normal. The injection is not finished.
  • Hold the autoinjector against the skin for 10 seconds to make sure full dose has been given. Do not move, turn, or change the angle of the autoinjector during the injection.
  • Check that the orange plunger rod has moved down to fill the entire viewing window. If you do not see the orange plunger rod, you may not have received the full dose.
  • Remove the autoinjector by lifting it straight up. The orange needle shield will lock into place and cover the needle.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, inject it as soon as possible Then, inject the next dose 1 month from the date of your last dose to get back on your monthly scheduled time.
• 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 away 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.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have vitamin A deficiency.
• This medicine may cause eye or vision problems.
• 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
• Blurred vision, night blindness
• Dry skin or eyes

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

• Redness, itching, bump, swelling, or any changes in your skin where the shot was given
• Vomiting

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