Patient information: uses, side effects, how to take - Redemplo

What is REDEMPLO?

REDEMPLO is an injectable prescription medicine used together with a low-fat diet to reduce triglycerides (fat in the blood) in adults with a condition that keeps the body from breaking down fats called familial chylomicronemia syndrome (FCS).
It is not known if REDEMPLO is safe and effective in children.

Before using REDEMPLO, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if REDEMPLO can harm your unborn baby. Tell your healthcare provider if you become pregnant while using REDEMPLO.
are breastfeeding or plan to breastfeed. It is not known if REDEMPLO passes into your breast milk and if it can harm your baby. Talk with your healthcare provider about the best way to feed your baby while using REDEMPLO.

Tell your healthcare provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use REDEMPLO?

Read the Instructions for Use that comes with your REDEMPLO pre-filled syringe.
Your healthcare provider will show you and/or your caregiver(s) how to inject REDEMPLO the first time.
REDEMPLO is injected under the skin (subcutaneous use) in the front of your upper legs (thighs) or in your stomach area (abdomen). Only your healthcare provider or caregiver(s) may give you an injection in the outer area of your upper arm.
REDEMPLO should be injected 1 time every 3 months.
If you miss a dose, take the missing dose as soon as possible. Then inject REDEMPLO 3 months from the date of your last dose to get back on the every-3-month dosing schedule.
Stay on a low-fat diet (less than or equal to 20 grams of fat each day) while using REDEMPLO.

What are the possible side effects of REDEMPLO?

The most common side effects of REDEMPLO include:

high blood sugar (hyperglycemia)
headache
nausea
injection site reaction (pain, redness, or swelling)

These are not all of the possible side effects of REDEMPLO. Tell your healthcare provider if you have any of the above side effects. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by calling 1-844-REDEMPLO (1-844-733-3675) or via https://arrowheadpharma.com/safetyreporting.

How should I store REDEMPLO?

Store REDEMPLO prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton, until you are ready to use.
REDEMPLO can also be stored at room temperature between 68°F to 77°F (20°C to 25°C) in the original carton for up to 30 days.
Throw away the REDEMPLO prefilled syringe if kept at room temperature longer than 30 days.

General information about the safe and effective use of REDEMPLO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use REDEMPLO for a condition for which it was not prescribed. Do not give REDEMPLO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about REDEMPLO that is written for health professions.

What are the ingredients in REDEMPLO?

Active ingredients: plozasiran sodium

Inactive ingredients: sodium chloride, water for injection

Distributed by:

Arrowhead Pharmaceuticals, Inc.

Pasadena, CA 91105

This Instructions for Use has been approved by the U.S. Food and Drug Administration.	Approved: 11/2025
INSTRUCTIONS FOR USE REDEMPLO^®[ree-DEM-plo] (plozasiran) injection, for subcutaneous use single-dose prefilled syringe 25 mg/0.5 mL
This Instructions for Use contains information on how to inject REDEMPLO (plozasiran). Read this Instructions for Use before you start using your REDEMPLO prefilled syringe 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 or your treatment. Your healthcare provider should show you or your caregiver how to use your REDEMPLO prefilled syringe the right way. Call your healthcare provider or pharmacist if you have any questions.
Guide to Parts

Each carton contains a single-dose REDEMPLO (plozasiran) Injection prefilled syringe for single use under the skin (subcutaneous) injection.
Important Information You Need to Know Before Injecting REDEMPLO
REDEMPLO is for subcutaneous injection only Each carton contains a 1-time (single-dose) REDEMPLO (plozasiran) prefilled syringe. Do not use your REDEMPLO single-dose prefilled syringe if the carton appears damaged or the tamper evident seal on the carton is broken. Do not remove the gray needle cap until you are ready to inject (Step 6). Do not use if the single-dose prefilled syringe appears damaged. Throw away (dispose of) your REDEMPLO prefilled syringe in a sharps disposal container right away after use (Step 10: Disposing of REDEMPLO).

Storing REDEMPLO
Keep the REDEMPLO prefilled syringe in the original carton until ready to use. Store the REDEMPLO prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton. REDEMPLO prefilled syringe can also be stored at room temperature between 68°F to 77°F (20°C to 25°C) in the original carton for up to 30 days. Do not let REDEMPLO reach temperatures above 77°F (25°C). Throw away the REDEMPLO prefilled syringe if kept at room temperature and not used within 30 days. If the product is not stored in any of the above conditions, throw away the prefilled syringe in a sharps disposal container and use a new prefilled syringe. Keep REDEMPLO prefilled syringe and all medicine out of reach of children.
Preparing to Inject REDEMPLO
Step 1: Gather all materials needed for your REDEMPLO injection
Figure A	On a clean, well-lit, flat work surface, place: Provided in the carton (see Figure A ): 1 REDEMPLO prefilled syringe Other materials not provided (see Figure A ): Alcohol wipes Cotton ball or gauze pad Adhesive bandage Sharps disposal container

Step 2: Prepare to use REDEMPLO prefilled syringe
Figure B Figure C Figure D	If refrigerated, remove the carton from the refrigerator. Open the carton lid and remove the syringe by the syringe barrel and place on a flat surface (see Figure B ). Do not use the prefilled syringe if tamper evident seal on the carton is broken. Do not pick up or pull the prefilled syringe by the plunger rod or gray needle cap. Check the expiration date on the REDEMPLO prefilled syringe. (see Figure C ). Do not use if the expiration date has passed. Wait 30 minutes for the prefilled syringe to reach room temperature before injecting (see Figure D ). Do not try to warm the prefilled syringe by using a heat source such as hot water or a microwave. Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.

Step 3: Check the medicine and syringe
Figure E Figure F	Check the the REDEMPLO medicine in the prefilled syringe (see Figure E ). The medicine should be clear and colorless to yellow. Do not use the prefilled syringe if the medicine is cloudy, discolored or contains particles. It is normal to see air bubbles in the medicine. Inspect the prefilled syringe (see Figure F ). Do not use the prefilled syringe if any part appears cracked or broken. Do not use the prefilled syringe if the gray needle cap is missing or not securely attached. Do not use the prefilled syringe if it has been dropped onto a hard surface because the syringe may be damaged. In any of the above cases, call 1-844-REDEMPLO or visit www.redemplo.com.

Injecting REDEMPLO
Step 4: Choose your injection site
Figure G	Choose an injection site on the (see Figure G ): Upper leg (thigh) or Stomach (abdomen) except for a 2-inch area right around the belly button (navel). Only your healthcare providers or caregivers can use the outer area of the upper arm (see Figure G ). Do not inject: within 2 inches of the belly button (navel). into skin that is damaged (tender, bruised, red, hard, or cut). into areas with scars, stretch marks.
Step 5: Wash hands and clean the injection site
Figure H Figure I	Wash your hands thoroughly with soap and water (see Figure H ). Clean your injection site with an alcohol wipe. Let your skin dry before injecting (see Figure I ). Do not touch the cleaned skin before injecting.
Step 6: Remove the needle cap
Figure J	Hold the prefilled syringe by the syringe barrel, with the needle facing away from you. Pull the gray needle cap straight up and away from your body (see Figure J ). Do not twist or bend the gray needle cap. Avoid pushing the plunger head before you are ready to inject. Do not let the needle touch any surface. Do not put the needle cap back onto your prefilled syringe.
Step 7: Pinch the skin and Insert the needle
Figure K	Hold your prefilled syringe by the finger flange in one hand. Gently pinch and hold a fold of skin at the injection site with your other hand. Insert needle at a 45°(degree) to 90° angle (see Figure K ). Keep the skin pinched while you are inserting the needle and during injection. Do not place your finger on the plunger head before the injection.

Step 8: Hold skin pinch and Push down the plunger head
Figure L	While pinching the skin, push the plunger head all the way down using slow and constant pressure (see Figure L ).
Step 9: Complete the Injection
Figure M	After the plunger head is pushed all the way down, take the needle out of the skin, by gently lifting the syringe up and off the skin until the needle is completely removed (see Figure M ). Do not pull the plunger head up. Lift the whole syringe straight up. Do not rub 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 pad on the area and apply an adhesive bandage. Place the used cap and syringe in a sharps disposal container right away (see section – “Disposing of REDEMPLO”). Do not put the needle cap back onto the syringe.

Step 10: Disposing of REDEMPLO
Figure N	Do not use any medicine that is left in the used syringe. Put your used syringes and needle cap in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash (see Figure N ). 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 syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. Do not 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, call 1-844-REDEMPLO or visit www.redemplo.com. Distributed by: Arrowhead Pharmaceuticals, Inc. Pasadena, CA 91105 Phone Number: 1-844-REDEMPLO