Wainua (Eplontersen): Uses, Side Effects and Dosage

INSTRUCTIONS FOR USE

WAINUA [way-noo’-ah]

(eplontersen)

injection, for subcutaneous use

Single-dose autoinjector

45 mg/0.8 mL

This Instructions for Use contains information on how to inject WAINUA using the autoinjector.

Read this Instructions for Use before you start using the WAINUA autoinjector and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition and your treatment.

Your healthcare provider should show you or your caregiver how to use the autoinjector the right way. If you or your caregiver have any questions, talk to your healthcare provider.

• Important information you need to know before using WAINUA
• Keep your autoinjector and all medicines out of the sight and reach of children.

• WAINUA is for use by injection under the skin (subcutaneous use) only.
• Each WAINUA autoinjector contains 1 dose and can only be used 1 time.
• Do not share your autoinjector with anyone.

• Do not use the autoinjector if it has:

  • been frozen
  • been dropped, damaged, or appears to be tampered with
  • passed the expiration date (EXP)
• Storing the WAINUA autoinjector
• Store the WAINUA autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze.
• If needed, the WAINUA autoinjector may be stored at room temperature up to 86°F (30°C) for up to a maximum of 6 weeks protected from light.
• If you do not use the WAINUA autoinjector within 6 weeks at room temperature, throw it away in an FDA-cleared sharps disposal container.

• Keep the autoinjector in the carton until ready to use.

  Keep your autoinjector and all medicines out of the sight and reach of children.

Overview of your WAINUA autoinjector

Do not remove the cap until just before you give the injection.

Do not touch the orange needle guard.

How does the WAINUA autoinjector work?

Make sure you read the entire instructions before uncapping and injecting.

The injection starts automatically when the orange needle guard is pushed against the skin.

The autoinjector must be held firmly against the skin to allow it to deliver the full dose of the medicine.

The injection is complete only when the orange plunger rod fills the viewing window (See “Overview of your WAINUA autoinjector”, After use).

Preparing to inject WAINUA using the autoinjector

Step 1 – Gather supplies for your injection

Step 2 – Wait 30 minutes

Keep the autoinjector in the original carton after removing it from the refrigerator and allow to come to room temperature for 30 minutes before injecting.

• Do not warm up in any other way. For example, do not warm it in a microwave or hot water, or near other heat sources.
• Keep it away from light or direct sunlight.

Step 3 – Remove from the carton and check the autoinjector and medicine

Check the autoinjector for damage.

• Do not use if damaged.

Check the expiration (EXP) date.

• Do not use if the expiration date has passed.

Check the liquid through the viewing window.

• It is normal to see small air bubbles in the liquid.
• The liquid should be clear and colorless to slightly yellow.
• Do not use if the liquid is cloudy, discolored, or contains large particles.

Injecting with your autoinjector

Step 4 – Choose an injection site

You or your caregiver can inject in the front of your thigh or your stomach (abdomen).

A caregiver may inject you in the back of your upper arm.

Do not try to inject yourself in the back of your upper arm.

For each injection, choose an injection site that is at least 1 inch (3 cm) away from where you last injected.

Do not inject:

• into the 2-inch (5-cm) area around your belly button
• where the skin is red, warm, tender, bruised, scaly, or hard
• into scars, damaged, discolored, or tattooed skin
• through clothing

Step 5 – Wash your hands and clean the injection site

Wash your hands well with soap and water.

Clean the injection site with an alcohol wipe or with soap and water. Let the site air dry.

• Do not touch the cleaned area before injecting.

Step 6 – Pull off the cap

Hold the autoinjector body with 1 hand, and carefully pull the cap straight off with your other hand. Do not twist it off. The orange needle guard is now exposed and the needle is hidden underneath.

• Throw away (dispose of) the cap.
• Do not touch the needle or push on the orange needle guard with your finger.
• Do not recap the autoinjector. This could cause the medicine to come out too soon or damage the autoinjector.

Step 7 – Inject WAINUA using the autoinjector

Inject the medicine using the autoinjector by following the steps in figures a, b, c and d.

When injecting, press and hold the autoinjector for 10 seconds until the orange plunger fills the viewing window. You may hear a first ‘click’ at the start of the injection and a second ‘click’ at the end of injection. This is normal.

Do not move or change the position of the autoinjector after the injection has started.

Position the autoinjector.

• Place the orange needle guard flat against your skin (90-degree angle).
• Make sure you can see the viewing window.

Step 8 – Check the viewing window

Check the viewing window to make sure all the medicine has been injected.

If the orange plunger rod does not fill the viewing window, you may not have received the full dose.

If this happens or if you have other concerns, contact your healthcare provider.

Step 9 – Check the injection site

There may be a small amount of blood or liquid where you injected. This is normal.

If needed, press a cotton ball or gauze on the area and apply a small bandage.

Step 10 – Throw away (dispose of) the used autoinjector

Put the used autoinjector in an FDA-cleared sharps disposal container right away after use.

Do not throw away the autoinjector in your household trash.

Disposal guidelines

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and autoinjectors. For more information about safe sharps disposal, and for specific information about sharps disposal in the area that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container.

For more information, go to https://www.wainua.com or call 1-800-236-9933. If you still have questions, contact your healthcare provider.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

©AstraZeneca 2025