Gammaplex

GAMMAPLEX- human immunoglobulin g injection, solution
BioProducts Laboratory

Bio Products Laboratory

Gammaplex®
Immune Globulin Intravenous (Human)5% Liquid

WARNING: ACUTE RENAL DYSFUNCTION and ACUTE RENAL FAILURE

  • Use of Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death.1 Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs (see Warnings and Precautions [5.2] ). Gammaplex does not contain sucrose.
  • For patients at risk of renal dysfunction or failure, administer Gammaplex at the minimum infusion rate practicable (see Dosage and Administration [2.3], Warnings and Precautions [5.2] ).

1 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.

2 DOSAGE AND ADMINISTRATION

For Intravenous Use Only

2.1 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 25°C [77°F]) 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.

2.2 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.

2.3 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]).

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

  • Gammaplex is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
  • Gammaplex is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

5 WARNINGS AND PRECAUTIONS

  • Weigh the potential risks and benefits of Gammaplex against those of alternative therapies in all patients for whom Gammaplex is being considered.
  • Before prescribing Gammaplex, the physician should discuss the risks and benefits of its use with the patient.

5.1 Hypersensitivity

Severe hypersensitivity reactions may occur (see Contraindications [4]). In case of hypersensitivity, discontinue Gammaplex infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions.

Gammaplex contains trace amounts of IgA (<10 μg/mL) (see Description [11]). Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Gammaplex is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reaction (see Contraindications [4]).

5.2 Renal Dysfunction/Failure

Acute renal dysfunction/failure, osmotic nephropathy, and death1 may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering Gammaplex. In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency or predisposition to acute renal failure (such as diabetes mellitus, hypovolemia, overweight, use of concomitant nephrotoxic medicinal products or age of >65 years), administer Gammaplex at the minimum infusion rate practicable (see Dosage and Administration [2.3]).

Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of Gammaplex and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing Gammaplex.

5.3 Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.2

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