Pronunciation:

ep-lon-TER-sen

Brand Names:

• Wainua

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Antisense Oligonucleotide

Uses of This Medicine:

Eplontersen injection is used to treat polyneuropathy (nerve disease) caused by hereditary transthyretin-mediated amyloidosis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of eplontersen injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eplontersen injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Vitamin A deficiency—Use with caution. May make this condition worse.

Proper Use of This Medicine:

This medicine is given as a shot under the skin of your thigh, stomach, or upper arm. It may be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 scarred.

Your doctor should tell you to take vitamin A supplements while using this medicine. Do not take more vitamin A than your doctor has recommended.

Allow 30 minutes for the autoinjector to warm up to room temperature. Do not warm using heat sources (eg, 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.

To use the 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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage forms (autoinjector):
  • For polyneuropathy (nerve disease):
    • Adults—45 milligrams (mg) injected under the skin on the same day of each month.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

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.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store 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.

Throw away used autoinjector in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may lower the vitamin A levels in your body, which may cause eye or vision problems (eg, night blindness, blurred vision, difficulty with reading, or any other change in vision). Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blindness

blurred vision

cloudy urine

decreased vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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