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Gammaplex (Human Immunoglobulin G) - Indications and Dosage

 
 



Bio Products Laboratory

Gammaplex®
Immune Globulin Intravenous (Human)
5% Liquid

INDICATIONS AND USAGE

Gammaplex is an Immune Globulin Intravenous (Human), 5% Liquid indicated for the replacement therapy of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

DOSAGE AND ADMINISTRATION

For Intravenous Use Only

Preparation and Handling

  • Gammaplex is a clear or slightly opalescent, colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is cloudy or turbid, or if it contains particulate matter.
  • Do not freeze, and do not use any solution that has been frozen.
  • DO NOT SHAKE.
  • Gammaplex should be at room temperature (up to 25C [77F]) at the time of administration.
  • Do not use Gammaplex beyond the expiration date on the product label.
  • The Gammaplex vial is for single use only. Due to the absence of anti-microbial preservatives, promptly administer Gammaplex after piercing the cap. Dispose of partially used or unused product in accordance with local requirements.
  • Infuse Gammaplex using a separate infusion line.
  • Do not mix Gammaplex with other intravenous medications (including normal saline) or other IGIV products.
  • An infusion pump may be used to control the rate of administration.
  • If large doses of Gammaplex are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 2 hours after pooling.

Recommended Dose

As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.

The recommended dose of Gammaplex for patients with PI is 300 to 800 mg/kg (6 to 16 mL/kg), administered every 3 to 4 weeks. Adjust the dosage over time to achieve the desired serum trough levels and clinical responses. If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable.

Administration

  • Hydrate the patient adequately prior to the initiation of infusion.
  • Due to the absence of anti-microbial preservatives, promptly administer Gammaplex after piercing the cap.
  • Infuse Gammaplex intravenously using an intravenous infusion set preferably fitted with an in-line 15-20 micron filter.
Table 1: Recommended Infusion Rates for Gammaplex
Indication Initial infusion rate for first 15 minutes Maintenance infusion rate
(if tolerated)
PI 0.5 mg/kg/min
(0.01 mL/kg/min)
Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/min)

Monitor vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.

The observation time of patients after Gammaplex administration may vary. If the patient (a) has not received Gammaplex or another IgG product, (b) is switched from an alternative IGIV product or (c) has had a long interval since the previous infusion, prolong the observation time for adverse reactions after Gammaplex infusion.

Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion often allows the reaction to disappear promptly.

Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombotic events, administer Gammaplex at the minimum infusion rate practicable, and discontinue Gammaplex administration if renal function deteriorates (see Boxed Warning, Warnings and Precautions [5.2] ).

DOSAGE FORMS AND STRENGTHS

Gammaplex is a liquid solution containing 5% IgG (50 mg/mL).

HOW SUPPLIED/STORAGE AND HANDLING

Gammaplex is supplied in a single use, clear Type II glass bottle, closed with a stopper (13% natural rubber) and oversealed with a tamper-evident cap.

The following presentations of Gammaplex are available:

NDC Number Grams and Fill Size
64208-8234-1 2.5g in 50 mL
64208-8234-2 5 g in 100 mL
64208-8234-3 10 g in 200 mL

Each vial has a label with a peel-off strip showing the product name and batch number.

When stored between 2 C [35.6 F] and 25 C [77 F]), Gammaplex has a shelf life of 24 months, as indicated by the expiration date printed on the outer carton and vial label.

Keep Gammaplex in its original carton to protect it from light.

DO NOT FREEZE.

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