WARNINGS
The most common side effects of WAINUA include decreased vitamin A and vomiting.
These are not all of the possible side effects of WAINUA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
USES
What is WAINUA?
WAINUA is a prescription medicine used to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis.
It is not known if WAINUA is safe and effective in children.
HOW TO USE
How should I take WAINUA?
Read the detailed Instructions for Use that come with your WAINUA single-dose autoinjector.
Your healthcare provider will show you or your caregiver how to inject WAINUA the first time.
If you or your caregiver have any questions, ask your healthcare provider.
WAINUA is injected under your skin (subcutaneously) in your stomach area (abdomen), or the front of your upper legs (thighs) by you or a caregiver. A caregiver may also give you an injection of WAINUA in the outer area of your upper arm.
Follow your healthcare provider’s instructions on when to inject WAINUA.
WAINUA should be injected 1 time on the same day of each month.
If you miss a dose, take the missed dose as soon as possible. Then inject WAINUA 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your schedule, ask your healthcare provider.
What are the possible side effects of WAINUA?
WAINUA may cause side effects, including:
Low vitamin A level. Low vitamin A level is a serious, but common side effect of treatment with WAINUA. Your healthcare provider should tell you to take vitamin A supplements while using WAINUA. Do not take more than the amount of vitamin A your healthcare provider has recommended. Call your healthcare provider if you develop eye problems such as difficulty seeing at night or in low lit areas (night blindness), or dry eyes. If you develop eye problems while receiving treatment with WAINUA, your healthcare provider should send you to see an eye doctor (ophthalmologist).
The most common side effects of WAINUA include decreased vitamin A and vomiting.
These are not all of the possible side effects of WAINUA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of WAINUA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use WAINUA for a condition for which it was not prescribed. Do not give WAINUA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about WAINUA that is written for health professionals.
What are the ingredients in WAINUA?
Active ingredient: eplontersen sodium.
Inactive ingredients: dibasic sodium phosphate, anhydrous; monobasic sodium phosphate, dihydrate; sodium chloride; water for injection, and may include hydrochloric acid and sodium hydroxide for pH adjustment.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
If you miss a dose, take the missed dose as soon as possible. Then inject WAINUA 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your schedule, ask your healthcare provider.
STORAGE
How should I store WAINUA?
Store WAINUA in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C) in the original carton.
WAINUA can also be kept at room temperature that is no higher than 86-degrees F (30-degrees C) in the original carton for up to 6 weeks.
Do not let WAINUA reach temperatures above 86-degrees F (30-degrees C).
If you do not use WAINUA kept at room temperature within 6 weeks, throw it away.
Do not freeze.
Do not expose WAINUA to heat.
Protect from light.
Keep WAINUA and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 12/2023
Prescribing Information: revision date 04/2025
No clinical drug-drug interaction studies have been performed with eplontersen. In vitro studies show that eplontersen is not a substrate or inhibitor of transporters, does not interact with highly plasma protein bound drugs, and is not an inhibitor or inducer of cytochrome P450 (CYP) enzymes. Oligonucleotide therapeutics, including eplontersen, are not typically substrates of CYP enzymes. Therefore, eplontersen is not expected to cause or be affected by drug-drug interactions mediated through drug transporters, plasma protein binding or CYP enzymes.
Before you take WAINUA, tell your healthcare provider if you:
are pregnant or plan to become pregnant. It is not known if WAINUA can harm your unborn baby. Changes in vitamin A levels and vitamin A supplementation related to use of WAINUA may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant while taking WAINUA.
are breastfeeding or plan to breastfeed. It is not known if WAINUA can pass into your breast milk or harm your baby. Talk with your healthcare provider about the best way to feed your baby while you are using WAINUA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take:
Vitamin A or beta-carotene supplements.
Ask your healthcare provider or pharmacist if you are not sure if you take any of these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
