Hereditary angioedema agents
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Haegarda Dosage

Drug Detail:Haegarda (C1 esterase inhibitor subcutaneous (human) [ c1 es-ter-ase-in-hib-it-or ])

Generic Name: HUMAN C1-ESTERASE INHIBITOR 2000[iU] in 4mL;

Dosage Form: lyophilized powder in a single-use vial

Drug Class: Hereditary angioedema agents

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

After reconstitution, for subcutaneous use only.

HAEGARDA is intended for self (or caregiver)-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer HAEGARDA.

HAEGARDA is provided as a freeze-dried powder for reconstitution with Sterile Water for Injection, USP.

Preparation and Handling

  • Check the expiration date on the product vial label. Do not use beyond the expiration date.
  • Work on a clean surface and wash hands before performing the following procedures.
  • Prepare and administer using aseptic techniques [see Dosage and Administration (2.2)].
  • Use a silicone-free syringe for reconstitution and administration.
  • Each vial of HAEGARDA is for single-dose only. Promptly use the reconstituted solution. The solution must be used within 8 hours. Discard partially used vials. HAEGARDA contains no preservative.
  • Do not freeze the reconstituted solution.

Reconstitution and Administration

Use either the Mix2Vial® transfer set provided with HAEGARDA or a commercially available double-ended needle and vented filter spike [see How Supplied/Storage and Handling (16)].

Reconstitution

The procedures below are provided as general guidelines for the reconstitution and administration of HAEGARDA.

HAEGARDA Reconstitution Instructions

1.
Ensure that the HAEGARDA vial and Sterile Water for Injection (diluent) vial are at room temperature.
2.
Place the HAEGARDA vial, diluent vial and Mix2Vial transfer set on a flat surface.
3.
Remove flip caps from the HAEGARDA and diluent vials.
4.
Wipe the stoppers with an alcohol swab and allow to dry prior to opening the Mix2Vial transfer set package.
5.
Open the Mix2Vial transfer set package by peeling away the lid (Figure 1). Do not remove the device from the package.
Figure 1
Figure 1
6.
Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial (Figure 2).
Figure 2
Figure 2
7.
Carefully remove the clear package from the Mix2Vial transfer set. Do not remove the Mix2Vial transfer set or touch the exposed end of the device (Figure 3).
Figure 3
Figure 3
8.
With the HAEGARDA vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the HAEGARDA vial (Figure 4). The diluent will automatically transfer into the HAEGARDA vial.
Figure 4
Figure 4
9.
With the diluent and HAEGARDA vial still attached to the Mix2Vial transfer set, gently swirl the HAEGARDA vial to ensure that the powder is fully dissolved (Figure 5). Do not shake the vial.
Figure 5
Figure 5
10.
With one hand, grasp the HAEGARDA side of the Mix2Vial transfer set and with the other hand grasp the blue diluent side of the Mix2Vial transfer set, and unscrew the set into two pieces (Figure 6).
Figure 6
Figure 6
11.
Draw air into an empty, sterile syringe. Use a silicone-free syringe. While the HAEGARDA vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the HAEGARDA vial.
12.
While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly (Figure 7).
Figure 7
Figure 7
13.
Disconnect the filled syringe by unscrewing it from the Mix2Vial transfer set (Figure 8). The reconstituted solution should be colorless, clear, and free from visible particles. Do not use if particles or discoloration are observed.
Figure 8
Figure 8
14.
Use immediately or within 8 hours of reconstitution. Store reconstituted solution at room temperature. Do not refrigerate.
15.
If the dose requires more than one vial, use a separate, unused Mix2Vial transfer set and diluent vial for each product vial. Repeat steps 10-12 to pool the contents of the vials into one syringe.

Administration

For subcutaneous injection only.

  • Train the patient or caregiver on how to self-administer HAEGARDA.
  • Do not mix HAEGARDA with other medicinal products.
  • Visually inspect the final solution for particles and discoloration prior to administration, and whenever solution and container permit. Do not use if particles or discoloration is observed.
  • Attach the syringe containing the reconstituted HAEGARDA solution to a hypodermic needle or subcutaneous infusion set and administer by subcutaneous injection. Adapt the rate of administration to the comfort level of the patient.
  • Inject in the abdominal area or other subcutaneous injection sites. Rotate injection sites so that the same site is not used repeatedly.
  • Administer HAEGARDA at room temperature and within 8 hours after reconstitution. Following administration, discard any unused solution and all administration equipment in an appropriate manner as per local requirements.
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