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

What is ADBRY?

ADBRY is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of the ingredients in ADBRY. See the end of this leaflet for a complete list of ingredients in ADBRY.

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

have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations.
are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby.
Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

See the detailed "Instructions for Use" that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.
Use ADBRY exactly as prescribed by your healthcare provider.
Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
ADBRY is given as an injection under the skin (subcutaneous injection).
If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
If you inject too much ADBRY, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects, including:

Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

breathing problems
swelling of the face, mouth, and tongue
hives
itching

fainting, dizziness, feeling lightheaded (low blood pressure)
skin rash

Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

upper respiratory tract infections
eye and eyelid inflammation, including redness, swelling, and itching
injection site reactions
high count of a certain white blood cell (eosinophilia)

These are not all of the possible side effects of ADBRY.

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

How should I store ADBRY?

Store ADBRY in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store ADBRY in the original carton and protect from light until you are ready to use them.
ADBRY can be stored in the original carton at room temperature up to 86°F (30°C) for up to 14 days. If removed from the refrigerator, write down the date of removal on the back of the carton, and use ADBRY within 14 days. Throw away (dispose of) ADBRY in a sharps disposal container if left out of the refrigerator for more than 14 days.
Do not freeze ADBRY. Do not use if they have been frozen.
Do not shake ADBRY.
Do not heat ADBRY.
Do not put ADBRY into direct sunlight.

Keep ADBRY and all medicines out of the reach of children.

General information about the safe and effective use of ADBRY.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ADBRY for a condition for which it was not prescribed. Do not give ADBRY 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 ADBRY that is written for health professionals.

What are the ingredients in ADBRY?

Active ingredient: tralokinumab-ldrm

Inactive ingredients: acetic acid, polysorbate 80, sodium acetate trihydrate, sodium chloride, and water for injection.

Manufactured by: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

U.S. License No. 2169

ADBRY^®is a registered trademark of LEO Pharma A/S.

For more information about ADBRY, go to www.ADBRY.com or call 1-844-MY-ADBRY (1-844-692-3279).

INSTRUCTIONS FOR USE

ADBRY^®[ad'-bree]

(tralokinumab-ldrm)

injection, for subcutaneous use

This Instructions for Use contains information on how to inject ADBRY.

Read this Instructions for Use before you start using the ADBRY 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.

Keep this Instructions for Use and refer to it as needed.

Each single-dose prefilled syringe contains 150 mg of ADBRY. The ADBRY prefilled syringes are for one time use only.

Important Information You Need to Know Before Injecting ADBRY:

Your healthcare provider should show you or your caregiver how to prepare and inject a dose of ADBRY using the prefilled syringe before you inject ADBRY for the first time. Talk to your healthcare provider if you have any questions about how to inject ADBRY the right way.
ADBRY is given as an injection under the skin (subcutaneous injection).
Do not inject yourself or someone else until you have been shown how to inject ADBRY the right way.
In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
Talk to your healthcare provider about your prescribed dose before injecting ADBRY.
Rotate the injection site each time you give an injection.
The ADBRY prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished.
Do not remove the needle cover until just before you give the injection.
Do not share or reuse your ADBRY prefilled syringe.
Do not inject through clothes.

Storing ADBRY

Store ADBRY prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store ADBRY prefilled syringes in the original carton to protect from light until you are ready to use them.
ADBRY can be stored in the original carton at room temperature up to 86°F (30°C) for up to 14 days.
If left out of the refrigerator for more than 14 days, throw away (dispose of) the ADBRY prefilled syringes.

Do not freeze ADBRY prefilled syringes.
Do not use if they have been frozen.
Do not shake the ADBRY prefilled syringes.
Do not heat the ADBRY prefilled syringes.
Do not put the ADBRY prefilled syringes into direct sunlight.
Keep ADBRY prefilled syringes and all medicines out of the reach of children.

ADBRY prefilled syringe parts (see Figure A):

Figure A

Step 1: Setting up ADBRY injection

Figure B

1a: Gather the supplies needed for your injection. For each ADBRY dose you will need (see Figure B):

A clean, flat, well-lit work surface, like a table
Prescribed number of ADBRY prefilled syringe(s)
An alcohol swab (not included in the carton)
Clean cotton balls or gauze pads (not included in the carton)
A puncture-resistant sharps disposal container (not included in the carton). See Step 5 "Disposing of ADBRY" at the end of this Instructions for Use.

Figure C

1b: Take the ADBRY prefilled syringe carton out of the refrigerator

Check the expiration date (EXP) on the carton (see Figure C). Do not use if the expiration date on the carton has passed.
When using the first prefilled syringe, check to make sure the seal on the ADBRY carton is intact.
Do not use the ADBRY prefilled syringes if the seal on the carton is broken.

Figure D

1c: Determine how many ADBRY prefilled syringes you need for your dose

If you have been prescribed a 300 mg dose, you will need 2 syringes.

If you have been prescribed a 150 mg dose, you will only need 1 syringe and the remaining syringe should be returned to the refrigerator in its carton.

Remove the ADBRY prefilled syringe(s) by grasping the body (not the plunger rod) of the ADBRY prefilled syringe (see Figure D ).
Do not touch the needle guard clips to keep from activating the safety device (needle guard) too soon.
Do not remove the needle cover on the prefilled syringe until you have reached Step 3 and are ready to inject.

Figure E

1d: Let the ADBRY prefilled syringe(s) warm up to room temperature (see Figure E)

Place the ADBRY prefilled syringe(s) on the flat surface and wait 30 minutes before you inject ADBRY to let the prefilled syringe(s) warm up to room temperature 68°F to 86°F (20°C to 30°C). This will help to reduce discomfort.

Do not microwave the prefilled syringes, run hot water over them, or leave them in direct sunlight.
Do not shake the syringes.
Do not remove the needle cover on the prefilled syringes until you have reached Step 3 and are ready to inject.
Do not put the syringes back in the refrigerator after they have reached room temperature.

Figure F

1e: Inspect the ADBRY prefilled syringe(s) (see Figure F)

Make sure ADBRY appears on the label.
Check the expiration date printed on the syringe.
Check the medicine through the viewing window. The medicine inside should be clear to slightly pearly and colorless to pale yellow.
Do not use the ADBRY prefilled syringe, throw away and get a new one if:
- the expiration date printed on the syringe has passed
- the medicine is cloudy, discolored, or has particles in it
- looks damaged or has been dropped
You may see small air bubbles in the liquid. This is normal. You do not need to do anything about it.

Step 2: Choosing and preparing injection area

Figure G

2a: Choose the area for your injection (see Figure G)

You may inject into your thighs or your stomach area (abdomen), but not within 2 inches (5 cm) of your belly button (navel).
The upper arm can also be used if a caregiver gives the injection.
Inject your dose into a different body area each time you inject ADBRY.
If you need more than 1 injection for your dose, inject into the same body area, but at least 1 inch (3 cm) apart from each other.
Do not inject where the skin is tender, damaged, bruised or scarred.

Figure H

2b: Wash your hands and prepare your skin

Wash your hands with soap and water.
Clean the injection area with an alcohol swab using a circular motion (see Figure H ).
- Let the area dry completely.
- Do not blow or touch the cleaned area before injecting.

Step 3: Injecting ADBRY

Figure I

3a: Pull off the ADBRY needle cover

Hold the ADBRY prefilled syringe body with one hand, pull the needle cover straight off with your other hand (see Figure I ) and throw it away in the sharps container.

Do not try to recap the ADBRY prefilled syringe.
Do not hold the plunger rod or plunger head while removing the needle cover.
You may see a drop of liquid at the end of the needle. This is normal.
Do not touch the needle, or let it touch any surface. If either of these occur, throw away the syringe and get a new one.

Figure J

3b: Insert the needle

With one hand, gently pinch and hold a fold of skin where you cleaned the injection area. With the other hand, insert the needle completely at about a 45-degree angle into your skin (see Figure J ).

Figure K

3c: Inject the medicine

Use your thumb to firmly push down the plunger head all the way down (see Figure K ). All the medicine is injected when you cannot push the plunger head any further.

Figure L

3d: Release and remove

Lift your thumb off the plunger head. The needle will automatically move back inside the syringe body and lock into place (see Figure L ).

Place a dry cotton ball or gauze pad over the injection site for a few seconds. Do not rub the injection site. If needed, cover the injection site with a small bandage.
There may be a small amount of blood or liquid where you injected. This is normal.

Throw away the used ADBRY prefilled syringe in the sharps disposal container. See Step 5 "Disposing of ADBRY".

Step 4: Repeating for multiple injections

Figure M

If you need to give multiple injections for your prescribed dose, repeat step 3. The other injection(s) should be given into the same body area, but at least 1 inch (3 cm) away from each other.

Step 5: Disposing of ADBRY syringe(s)

Figure N

Put the used ADBRY prefilled syringe(s) in an FDA-cleared sharps disposal container right away after use (see Figure N ). Do not throw away the ADBRY prefilled syringe(s) in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of 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 recycle your used sharps disposal container.

For more information go to www.ADBRY.com or call 1-844-692-3279. If you still have questions, call your healthcare provider.

Manufactured by: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

U.S. License No. 2169

ADBRY^®is a registered trademark of LEO Pharma A/S.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised 12/2023