PATIENT INSTRUCTIONS FOR USE EXEMPTIATM (ADALIMUMAB) SINGLE- DOSE PREFILLED SYRINGE

Do not try to inject EXEMPTIA yourself until you have been shown the right way to give the injections and have read and understood this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of EXEMPTIA at home, you should receive training on the right way to prepare and inject EXEMPTIA . It is important that you read, understand, and follow these instructions so that you inject EXEMPTIA the right way. It is also important to talk to your doctor to be sure that you understand your EXEMPTIA dosing instructions. To help you remember when to inject EXEMPTIA, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver has any questions about the right way to inject EXEMPTIA.

How should I store EXEMPTIA?

  • Store EXEMPTIA in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original container until it is used. Protect from light.
  • When travelling, EXEMPTIA should be stored in a cool carrier with an ice pack.
  • Do not freeze EXEMPTIA. Do not use EXEMPTIA if frozen, even if it has been thawed.
  • Refrigerated EXEMPTIA may be used until the expiration date printed on the EXEMTIA carton and prefilled syringe.
  • Do not use the prefilled syringe if the liquid is cloudy, discolored or has flakes or particles in it.
  • Keep EXEMPTIA, injection supplies and all other medicines out of the reach of children.
  • Gather the material required for your injection:

    You will need the following material for each injection of EXEMPTIA. Find a clean, flat surface to place the material.

    • Alcohol swab
    • Cotton ball or gauze pad (not included in your EXEMPTIA carton)
    • EEMPTIATM prefilled syringe. See Figure A.

    Check the carton and prefilled syringe:

    • Make sure the name EXEMPTIA appears on the carton and prefilled syringe.
    • Do not use and call your doctor if:
      • The seals on the top or bottom of the carton are broken or missing.
      • The EXEMPTIA labeling has an expiry date. Check the expiration date on your EXEMPTIA carton and do not use if the date has passed.
      • The prefilled syringe has frozen or left in direct sunlight. See the section: “How shoul I store EXEMPTIA” at the beginning of this Instructions for Use.
      • The liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it. Make sure that the liquid is clear and colorless.

    Choose the injection site: wash and dry your hands well. Choose an innjection site on:

    • The front of your thighs or
    • Your lower abdomen (belly). If you choose your abdomen do not use the area 2 inches around your bellu button (navel). See Figure B

    • Choose a different site each time you give yourself an injection. Each new injection should be given at least one inch from a site you used before.
    • Do not inject into the skin that is:
      • Sore (tender)
      • bruised
      • red
      • hard
      • scarred or where you have stretch marks
    • If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin.
    • Do not inject through your clothes.
  • Prepare the injection site:

    • Wipe the injection site with an alcohol swab using a circular motion.
    • Do not touch this area again before giving the injection. Allow skin to dry before injecting. Do not fan or blow on the clean area.

    Prepare the syringe and needle:

    • Always hold the prefilled syringe by the body of the syringe. Hold the syringe with covered needle pointing down. See Figure C.

    • Hold the syringe at eye level
    • The top of the liquid may be curved
    • Remove the needle cover
    • Hold the syringe in one hand. With the other hand gently remove the needle cover. See Figure D.
    • Throw away the needle cover.

    • Do not touch the needle with your fingers or do not let the needle touch anything.
    • Turn the syringe so that needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. Using your other hand, slowly push the plunger in, to push the air out throughout the needle. See Figure E.

    • You may see a drop of liquid at the end of the needle. This is normal.
  • Position the prefilled syringe and inject EXEMPTIA:

    Position the syringe:

    • Hold the body of the prefilled syringe in one hand between the thumb and index finger. Hold the syringe in your hand like a pencil. See Figure F.

    • Do not pull back on the plunger at any time.
    • With our other hand gently squeeze the area of cleaned skin and hold it firmly. See Figure G.


  • Inject EXEMPTIA

    • Using a quick, dart- like motion, insert the needle into the squeezed skin at an angle of about 45degrees. See Figure H.

    • After the needle is in, let go of the skin. Pull back gently on the plunger.
  • If blood appears in the syringe:

    • It means that you have entered a blood vessel.
    • Do not inject EXEMPTIA.
    • Pull the needle out of the skin while keeping the syringe at the same angle.
    • Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. See Figure I.

    • Do not use the same syringe and needle again. Throw away the needle and syringe in your special sharps container.
    • Do not rub the injection site. You may have slight bleeding. This is normal.
    • Repeat all the above steps with a new prefilled syringe.
  • If no blood appears in the syringe:

    • Slowly push the plunger all the way in, until all of the liquid is injected and syringe is empty.
    • Pull the needle out of the skin while keeping the syringe at the same angle.
    • Remove the syringe from the injection site keeping your thumb on the plunger rod.
    • Orienting the needle away from you and others, activate “Preventis” syringe by firmly pushing the plunger rod. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation. Immediately dispose off the syringe in the nearest sharps collector.

    • Press a cotton ball or gauze pad over the injection site for 10 seconds. Do not rub the injection site. You may have slight bleeding. This is normal.

    Keep a record of dates and location of your injection sites. To help you remember when to take EXEMPTIA, you can mark your calendar ahead of time.