Header
Header
Article

DailyMed – ADBRY- tralokinumab-ldrm injection, solution


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 ADBRY prefilled syringes 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 single-dose only.

Important Information You Need to Know Before Injecting ADBRY:

  • Your healthcare provider should show you how to prepare and inject ADBRY using the prefilled syringes before you inject ADBRY for the first time.
  • Do not inject yourself or someone else until you have been shown how to inject ADBRY the right way.
  • Talk to your healthcare provider if you have any questions about how to inject ADBRY the right way.
  • To receive your full prescribed dose, you will need to give more than 1 ADBRY injection.

    • To get your full prescribed initial dose of 600 mg, you will need to give 4 injections at different injection sites within the same body area.
    • To get your full prescribed dose of 300 mg, you will need to give 2 injections at different injection sites within the same body area.
  • It is recommended to rotate the body area with the next set of injections.
  • The ADBRY prefilled syringes have a needle guard that will be activated to cover the needle after the injection is finished.
  • For subcutaneous injection only (inject directly into fatty layer under the skin).
  • Do not remove the needle cover until just before you give the injection.
  • Do not share or reuse your ADBRY prefilled syringes.
  • Do not inject through clothes.

ADBRY prefilled syringe parts (see Figure A):

Figure A

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 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. Throw away (dispose of) syringes if left out of the refrigerator for more than 14 days.
  • Do not freeze ADBRY prefilled syringes. Do not use if they have been frozen.
  • Do not shake the ADBRY prefilled syringe.
  • Do not heat the ADBRY prefilled syringe.
  • Do not put the ADBRY prefilled syringe into direct sunlight.
  • Keep ADBRY prefilled syringes and all medicines out of the reach of children.

Step 1: Setting up ADBRY injection

Figure B

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
  • 1 ADBRY carton that contains 2 ADBRY prefilled syringes
  • An alcohol swab (not included in the carton)
  • Clean gauze pads or cotton balls (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

Figure C

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

Figure D

Figure D

1c: Let the ADBRY prefilled syringes warm up to room temperature (see Figure D)

Set the ADBRY carton on the flat surface and wait 30 minutes before you inject ADBRY to let the prefilled syringes warm up to room temperature 68°F to 86°F (20°C to 30°C). This will help to reduce discomfort and make it easier to inject ADBRY.

  • 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 once they have reached room temperature.

Figure E

Figure E

1d: Remove the ADBRY prefilled syringes from the carton

 
Remove the 2 ADBRY prefilled syringes one by one from the carton by grasping the body (not the plunger rod) of the ADBRY prefilled syringes (see Figure E).

  • 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 syringes until you have reached Step 3 and are ready to inject.

Figure F

Figure F

1e: Inspect the 2 ADBRY prefilled syringes (see Figure F)

  • Make sure the ADBRY appears on the labels.
  • Check the expiration date printed on the syringes.
  • Check the medicine through the viewing windows. The medicine inside should be clear to slightly pearly and colorless to pale yellow.
  • Do not use the ADBRY prefilled syringes, throw away and get new ones if:
    • the expiration date printed on the syringes has passed
    • the medicine is cloudy, discolored, or has particles in it
    • they look damaged or have 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

Figure G

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

  • You may inject into:
    • your stomach area (abdomen)
    • your thighs
    • your upper arm. To inject into your upper arm, you will need a caregiver to give you the injections.
  • Do not inject within 2 inches (5 cm) of your belly button (navel).
  • Rotate the body area with each following set of injections. Do not use the same body area 2 times in a row.
  • Do not inject where the skin is tender, damaged, bruised or scarred.

Figure H

Figure H

2b: Wash your hands and prepare your skin

Step 3: Injecting ADBRY

Figure I

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 syringes.
  • 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

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

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

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: Injecting the next syringe

Figure M

Figure M

To get your full prescribed dose, you will need to give more than 1 injection.

  • To get your full prescribed initial dose of 600 mg, you will need to give 4 injections.
  • To get your full prescribed dose of 300 mg, you will need to give 2 injections.

Get a new ADBRY prefilled syringe and repeat Steps 3 and 5 (see Figure M) for each injection you need to give for your full prescribed dose.

Note

Make sure each injection is at least 1 inch (3 cm) from the prior injection site and within the same body area.

Step 5: Disposing of ADBRY

Figure N

Figure N

  • Put the used ADBRY prefilled syringes in an FDA-cleared sharps disposal container right away after use (see Figure N). Do not throw away the ADBRY prefilled syringes 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 trademark of LEO Pharma A/S.
© 2021 LEO Pharma Inc. All rights reserved.

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

Approved January 2022



Source link

Back to top button