Vial

Hulio® is an approved biosimilar of adalimumab. The Hulio® vial is mainly for use in the paediatric population.

The Hulio® vial is a glass vial with a rubber stopper. It is supplied as a pack of 2 boxes. Each box contains 1 vial, 1 sterile injection syringe, 1 sterile needle, 1 sterile vial adapter and alcohol pads. Each vial contains one 40 mg dose of adalimumab1. Hulio® is also available as a pre-filled syringe or a pre-filled pen. The Hulio® vial is for paediatric use and the caregiver should know the prescribed amount for injection.1

One should not attempt to self-inject until understanding how to use the vial. Healthcare professionals should provide information to patients on using the vial. Caregivers should adhere to such instructions.1

Before injection

Hulio® pack should be stored in the refrigerator (2°C-8°C). A single vial box should be removed from the refrigerator at least 30 minutes before using it, so as to allow the contents to reach room temperature. The caregiver should check for expiry date on the vial, change in colour and particles in the solution.1

During and after injection

Step 1 - Choose and prepare injection site

Hulio® is for subcutaneous injection. It should be injected into the thigh or abdomen.

You should rotate and change the injection site each time, staying at least 3 cm from the previous site used.

If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.

  • DO NOT inject into skin that is red, hard, bruised, or tender.
  • DO NOT inject into scars or stretch marks.
  • If your child has psoriasis, DO NOT inject into any raised, thick, red, or scaly skin patches, or lesions.
  • DO NOT inject through clothes. Roll back any clothing that may interfere with the injection site.

Step 2 - Wash hands

Wash your hands thoroughly with soap and water.

Step 3 – Partially open syringe and needle packaging

Partially peel open the syringe package from the end closest to the white plunger rod. Peel the clear plastic just far enough to expose the white plunger rod, but DO NOT take the syringe out of the package. Partially peel open the needle package from the end closest to the yellow syringe connector. Peel the clear plastic just far enough to expose the yellow connector, but DO NOT take the needle out of the package.

Step 4 - Uncap vial and wipe vial stopper

Pop off the white plastic cap from the vial to expose the vial stopper.

Use one of the alcohol pads to wipe the stopper and then place the vial on a flat surface.

  • DO NOT touch the vial stopper after wiping with the alcohol pad.

Step 5 - Attach vial adapter to vial

Peel the cover off the vial adapter package but DO NOT take the adapter out of the package.

With the vial adapter still in the clear package, attach it to the vial stopper by pushing the adapter over the vial until it snaps in place.

When you are sure the adapter is attached to the vial, lift off the packaging.

Gently set the connected vial and adapter down on a flat work surface. Be careful that it does not fall over.

Step 6 - Pull plunger to dose + 0.1 ml

Hold the syringe package and SLOWLY pull the white plunger to 0.1 ml beyond the prescribed dose (for example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).

  • DO NOT pull the white plunger rod completely out of the syringe.

If the white plunger rod is pulled out of the syringe, discard the syringe and contact your Hulio® provider for a replacement. DO NOT try to reinsert the white plunger rod.

Step 7 - Attach syringe to vial adapter and push plunger rod

Hold the syringe on the graduated area and remove it from the packaging.

  • DO NOT hold the syringe by the white plunger rod.
  • Insert the syringe tip into the vial adapter and twist it clockwise until firmly attached.
  • DO NOT over-tighten.
  • Push the plunger rod all the way down. This step is important to get the proper dose.

Step 8 - Pull plunger to draw dose + 0.1 ml

Keep the plunger rod pressed down and turn the connected syringe and vial upside down.

SLOWLY pull the plunger rod to draw the Hulio® solution into the syringe. Pull the plunger to 0.1 ml beyond the prescribed dose (for example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).

You will set the volume to the prescribed dose in a later step.

If there are air bubbles in the syringe, push the plunger rod all the way back in to push the solution back into the vial.

Repeat this step to draw the solution back into the syringe again, pulling the plunger rod SLOWLY.

If you see air bubbles in the solution again, you may repeat this step up to 3 times.

  • DO NOT hold the syringe by the plunger rod.
  • DO NOT shake the syringe.
  • If the white plunger rod is pulled out of the syringe, discard the syringe and contact your Hulio® provider for a replacement. DO NOT try to reinsert the white plunger rod.

Step 9 - Detach syringe from vial adapter and attach needle

Remove the vial adapter by twisting it off the syringe.

  • DO NOT touch the top of the syringe.
  • DO NOT hold the syringe by the white plunger rod.

Attach the needle to the syringe by inserting the syringe tip into the yellow syringe connector on the needle. Twist the syringe until the needle is firmly attached.

Once syringe is firmly attached to the needle, remove the clear needle packaging.

Step 10 - Flip down pink needle cover and remove needle cap

Hold the syringe with the needle pointing up.

Flip down the pink needle cover and remove the needle cap by pulling it straight up. DO NOT twist the needle cap.

  • DO NOT touch the needle.
  • DO NOT put the needle cap back on the needle after it has been removed.

Step 11 - Check and set prescribed dose

Hold the syringe at eye-level with the needle pointing up to see the amount of solution clearly.

Recheck the doctor’s prescription for the correct prescribed amount.

Push the plunger rod gently in until the syringe contains the prescribed amount. Excess solution may come out of the needle while pushing the plunger rod in. Be careful not to squirt the solution into your eye.

Gently place the syringe on a clean, flat surface.

  • DO NOT wipe the needle or syringe.

Step 12 - Prepare injection site

Wipe the skin at the chosen injection site with a new alcohol swab.

  • Wait for the skin to dry on its own, do not blow it dry.
  • DO NOT touch this area again before giving the injection.

Step 13 - Squeeze injection site

Gently squeeze the cleaned area of skin and hold firmly.

At a 45° angle to the injection site, use a quick, short motion and push the needle all the way into skin.

Step 14 - Push plunger to inject solution

Let go of the squeezed skin.

Push the white plunger rod to inject the Hulio® solution until the syringe is empty.

Step 15 - End of injection, remove syringe, engage needle cover

When the syringe is empty, remove syringe and needle from the skin.

After injection, if slight bleeding occurs from the injection site, lightly press a gauze or cotton ball against the site for a few seconds.

  • DO NOT rub the injection site. Gently flip the pink needle cover over the needle and snap into place. Set the syringe with covered needle on the work surface.
  • DO NOT put the clear needle cap back on the needle.

Step 16 - Dispose syringe & needle

Each vial, syringe, vial adapter and needle are for single-use only. These must NEVER be re-used.

Put the used syringe, needle, vial and vial adapter in a sharps disposal container after use.

  • DO NOT throw the sharps container in your household bin.
  • DO NOT recycle your used sharps disposal container.
  • Always keep your sharps container out of the sight and reach of children.
  • Throw away all other used items and empty packaging into your regular household waste.

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Report side effects

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. In order to support effective tracking and traceability of biologics including biosimilars, it is recommended that the brand name and batch number are recorded and used when reporting adverse events.

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