Ruconest (Conestat alfa): Uses, Side Effects and Dosage

Step 1: Assemble supplies from medication box on a clean flat surface.

• 2 single-use vials of RUCONEST
• Sterile Water for Injection (diluent), 14mL per vial of RUCONEST to be reconstituted.
• Antiseptic wipes
• 1 syringe, 30 mL
• Needle-free, vented or non-vented vial adapters (or large bore needle). Use a new vial adapter for each vial of RUCONEST and diluent.

Step 2: Inspect the RUCONEST vial. Do not use if:

• The protective cap is missing
• The expiration date (see label) has passed

Step 3: Wash hands.

• Thoroughly wash and dry your hands

RECONSTITUTION

The procedures below are provided as general guidelines for the reconstitution of RUCONEST.

Step 1: Ensure that the RUCONEST vials and the diluent vial are at room temperature (range of 68°F - 77°F or 20°C - 25°C).

The RUCONEST vial is for single

Step 2: Place the 2 RUCONEST vials and the diluent vial on a flat surface and remove the flip caps on each vial

• Wipe the vial stoppers with the antiseptic wipes provided and allow to dry for 30 seconds.
• Do not blow on the stoppers after wiping.
• Do not touch the stopper with your hands, or allow it to touch any surface.

Step 3: Peel back the covers from the clear plastic vial adapter packages.

• Leave the adapters in their packages.

Step 4: While holding the adapter in its package, place the first adapter over the diluent vial and press down until the device snaps into place.

• Leave the package on the adapter until you are ready to attach the syringe.

Step 5: Now, place a 2nd adapter over a RUCONEST vial and press down until it snaps into place.

Repeat if your dose requires a 2nd RUCONEST vial.

Step 7: Remove syringe from package and withdraw sterile water for injection from the diluent vial.

• With vial on a flat surface, attach syringe to adapter on diluent vial by rotating syringe clockwise.
• Turn diluent vial upside down and slowly withdraw either 14 mL (if using 1 RUCONEST vial) or 28 mL (if using 2 RUCONEST vials) of diluent into syringe by gently pulling back on the plunger.
• There will still be some diluent left in the vial.
• Place the diluent vial back on a flat surface and detach syringe by gently pulling the syringe and rotating counterclockwise.

Step 8: Transfer the diluent to the RUCONEST vial.

• Remove the package from the adapter connected to one of the RUCONEST vials.
• Attach the syringe holding the diluent to the adapter on the RUCONEST vial by inserting the tip into the adapter opening while firmly pushing and rotating the syringe clockwise.
• Slowly press 14 mL of diluent into the RUCONEST vial.
• Add the diluent slowly to avoid forceful impact on the powder.
• Note: Leave the syringe attached to the vial after adding the diluent.

Step 9: Swirl the vial to mix. Do this slowly to avoid foaming.

Repeat Steps 8 and 9 if you are using a second RUCONEST vial. Remove syringe from the first RUCONEST vial prior to attaching to the second vial.

Step 10: Inspect RUCONEST vial(s) visually.

• After reconstitution and prior to administration, inspect the RUCONEST vials visually for particulate matter and discoloration.
• The reconstituted solution should be colorless, clear, and free from visible particles.
• Do not use the vial if it looks cloudy, contains particles, or has changed color.

Step 11: With the syringe still connected to the RUCONEST vial, turn the vial upside down.

• Slowly withdraw your dose of RUCONEST by gently pulling back on the plunger.
• Once you have withdrawn your dose, turn the vial right side up and place on a flat surface. Disconnect the syringe by gently pulling and rotating counterclockwise.

Step 12: Repeat Step 11 and withdraw additional reconstituted RUCONEST from the second RUCONEST vial (if needed).

• Withdraw only as much as is needed based on your body weight.
• Disconnect the syringe, for use as described in the next section.

SELF-ADMINISTRATION (intravenous injection)

Your healthcare provider will teach you how to safely administer RUCONEST. It is important that you inject RUCONEST directly into a visible vein. Do not inject into surrounding tissues or an artery. Once you learn how to self-administer, follow the instructions provided below. The reconstituted solution should be used within 8 hours and should be cooled but not be frozen.

Step 1: Assemble supplies.

• Gather the RUCONEST syringe, the following disposable supplies (not provided with RUCONEST), and other items:

  • Standard butterfly catheter infusion set (IV administration set with winged adapter and needle)
  • Sterile syringe
  • Tourniquet
  • Sterile gauze and tape or transparent dressing
  • Bandage (adhesive dressing)
  • Gloves (if recommended by your healthcare provider)
  • Antiseptic wipe for cleaning skin
• Other items (not shown)
• Clock or stopwatch to monitor time
• Sharps or other disposal container
• Treatment diary

Step 2: Clean surface.

• Thoroughly clean a table or other flat surface using one or more of the antiseptic wipes.

Step 3: Prime the infusion set.

As instructed by your healthcare provider:

• To prime (fill) the infusion tubing, connect the syringe filled with RUCONEST to the infusion set tubing and gently push on the syringe plunger to fill the tubing with RUCONEST.

Step 4: Prepare the approved IV injection site.

• Apply a tourniquet above the site of the infusion.
• Prepare the injection site by wiping the skin well with an antiseptic wipe, beginning at the center and working outward in a circular motion.
• Allow the site to dry.

Step 5: Start infusion.

Follow the instructions provided by your healthcare provider.

• Take off the needle sheath.
• Hold both wings of the butterfly between the thumb and the index finger with the obliquely cut (slanted) opening of the butterfly needle pointing upward.
• Insert the butterfly needle of the infusion set into your vein (insert as flat to skin surface as possible).
• Use sterile gauze and tape or transparent dressing to hold the needle in place.

• Make sure the needle is in a vein:

  • Gently pull back on the syringe plunger and check to see if blood is in the tubing.
  • If there is blood present, then the needle is in a vein.
  • If there is no blood, remove the needle and repeat this step using a new needle, new administration tubing, and a different injection site.
• Remove the tourniquet.
• Note: Inject RUCONEST slowly over approximately 5 minutes.

Step 6: Cover the injection site and clean up.

After all of the RUCONEST has been infused:

• Withdraw the butterfly needle along the line that it was inserted.
• Cover the injection site with a bandage, holding pressure on the site for a few minutes.
• Dispose of all unused solution, empty vials, and used needles and syringe in an appropriate container used for medical waste.

POST-ADMINISTRATION

The procedures below are provided as general guidelines for after the infusion of RUCONEST.

Record each injection into treatment journal.

• Record the lot number from the RUCONEST vial label.
• Enter the date and time of your injection.