Dosage & Administration
For Intravenous Use Only
| Indication | Dose | Initial infusion rate | Maintenance infusion rate (if tolerated) |
|---|---|---|---|
| PI | 300-800 mg/kg (6-16 mL/kg) every 3-4 weeks | 0.5 mg/kg/min (0.01 mL/kg/min) for 15 minutes | Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/min) |
| ITP | 1 g/kg (20 mL/kg) for 2 consecutive days | 0.5 mg/kg/min (0.01 mL/kg/min) for 15 minutes | Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/min) |
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Gammaplex Prescribing Information
- Thrombosis may occur with immune globulin products, including GAMMAPLEX 5%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors [see Warnings and Precautions (5.2), Patient Counseling Information (17)].
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive immune globulin intravenous (lGIV) products, including GAMMAPLEX 5%1.
- Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65 years, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs [see Warnings and Precautions (5.1)]. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAPLEX 5% does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer GAMMAPLEX 5% at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].
Primary Humoral Immunodeficiency (PI)
GAMMAPLEX 5% is an Immune Globulin Intravenous (Human), 5% Liquid indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia (XLA), congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Chronic Immune Thrombocytopenic Purpura (ITP)
GAMMAPLEX 5% is indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.
For Intravenous Use Only
Dose
| Indication | Dose | Initial infusion rate | Maintenance infusion rate (if tolerated) |
|---|---|---|---|
| PI | 300-800 mg/kg (6-16 mL/kg) every 3-4 weeks | 0.5 mg/kg/min (0.01 mL/kg/min) for 15 minutes | Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/min) |
| ITP | 1 g/kg (20 mL/kg) for 2 consecutive days | 0.5 mg/kg/min (0.01 mL/kg/min) for 15 minutes | Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/min) |
Treatment of Primary Humoral Immunodeficiency
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 5% for patients with PI is 300 to 800 mg/kg (6 to 16 mL/kg), administered every 3 to 4 weeks. If a patient has been exposed to measles, it may be prudent to administer an extra dose of Immune Globulin Intravenous as soon as possible and within 6 days of exposure. A dose of 400 mg/kg should provide a serum level > 240 mIU/mL of measles antibodies for at least two weeks. If a patient is at risk of future measles exposure and receives a dose of less than 530 mg/kg every 3-4 weeks, the dose should be increased to at least 530 mg/kg. This should provide a serum level of 240 mIU/mL of measles antibodies for at least 22 days after infusion. Adjust the dosage over time to achieve the desired serum trough levels and clinical response. 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.
Treatment of Chronic Immune Thrombocytopenic Purpura
The recommended dose of GAMMAPLEX 5% for patients with ITP is 1 g/kg (20 mL/kg) on 2 consecutive days, providing a total dose of 2 g/kg. Carefully consider the relative risks and benefits before prescribing the high dose regimen (i.e. 1 g/kg/day for 2 days) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload [see Warnings and Precautions (5)]. Adequate data on the platelet response to the low dose regimen (e.g. 400 mg/kg per day for 5 consecutive days) are not available for GAMMAPLEX 5%.
Preparation and Handling
- GAMMAPLEX 5% is a clear or slightly opalescent, colorless or pale yellow liquid. 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 5% should be at room temperature (up to 25°C [77°F]) at the time of administration.
- Do not use GAMMAPLEX 5% beyond the expiration date on the product label.
- The GAMMAPLEX 5% vial is for single use only. Due to the absence of anti-microbial preservatives, promptly administer GAMMAPLEX 5% after piercing the cap. Dispose of partially used or unused product.
- Infuse GAMMAPLEX 5% using a separate infusion line.
- Do not mix GAMMAPLEX 5% 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 5% are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 2 hours after pooling.
Administration
- Hydrate the patient adequately prior to the initiation of infusion.
- Due to the absence of anti-microbial preservatives, promptly administer GAMMAPLEX 5% after piercing the cap.
- Infuse GAMMAPLEX 5% intravenously using an intravenous infusion set. See Table 1 for recommended infusion rates.
- Monitor vital signs throughout the infusion.
- Slow or stop the infusion if adverse reactions occur.
- If symptoms subside, the infusion may be resumed at a lower rate that is comfortable for the patient.
- The observation time of patients after GAMMAPLEX 5% administration may vary. If the patient (a) has not received GAMMAPLEX 5% 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 5% infusion.
- Certain severe adverse reactions may be related to the rate of infusion. Slowing or stopping the infusion often allows the reaction to disappear.
- Ensure that patients with pre-existing renal insufficiency are not volume depleted.
- For patients at increased risk of renal dysfunction, thrombotic events, or volume overload, administer GAMMAPLEX 5% at the minimum infusion rate practicable. Consider discontinuing GAMMAPLEX 5% administration if renal function deteriorates [see Boxed Warning, Warnings and Precautions (5.1, 5.2, 5.8)].
GAMMAPLEX 5% is a liquid solution containing 5% IgG (50 mg/mL).
Pregnancy
Risk Summary
Animal reproduction studies have not been conducted with GAMMAPLEX 5%. It is also not known whether GAMMAPLEX 5% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. GAMMAPLEX 5% should be given to a pregnant woman only if clearly needed. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation.12
Lactation
Risk Summary
Use of GAMMAPLEX 5% has not been evaluated in nursing mothers.
Pediatric Use
Treatment of Primary Humoral Immunodeficiency
GAMMAPLEX 5% was evaluated in six pediatric patients with primary humoral immunodeficiency in one study (2 between ages of 9 and 10, and 4 between ages 12 and 16), and 25 patients in a second study (3 between ages of 2 to 5, 12 between ages of 6 to 11, and 10 between ages of 12 to 16). No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels [see Clinical Studies (14)].
Safety and efficacy of GAMMAPLEX 5% was not evaluated and established in pediatric patients below the age of 2 years.
Fourteen subjects (56%) had an AR at some time during the pediatric clinical trial that was considered product-related. Of these 14 subjects, two had ARs that were considered definitely related to GAMMAPLEX 5% including headache, fatigue and myalgia. Seven subjects with the 21-day infusion cycle had at least one AR (7 of 14 subjects, 50%), as did seven subjects with the 28-day infusion cycle (7 of 11 subjects, 64%).
Treatment of Chronic Immune Thrombocytopenic Purpura
GAMMAPLEX 5% was evaluated in three pediatric subjects with chronic immune thrombocytopenic purpura (two aged 6 and one aged 12). This number of pediatric patients was too small for separate evaluation from the adult patients for efficacy, however 31 pediatric patients have received GAMMAPLEX 5% in the PI studies demonstrating safety in this population [see Clinical Studies (14)].
Geriatric Use
Use caution when administering GAMMAPLEX 5% to patients aged 65 years and over who are judged to be at increased risk of developing renal insufficiency or thrombotic events [see Boxed Warning, Warnings and Precautions (5.1, 5.2)]. Do not exceed recommended doses, and administer GAMMAPLEX 5% at the minimum infusion rate practicable.
Eight patients with primary humoral immunodeficiency at or over the age of 65 years were included within the clinical evaluation of GAMMAPLEX 5%. This number of geriatric patients was too small for separate evaluation from the younger patients for safety or efficacy [see Clinical Studies (14)].
- GAMMAPLEX 5% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
- GAMMAPLEX 5% is contraindicated in patients with hereditary intolerance to fructose, also in infants and neonates for whom sucrose or fructose tolerance has not been established.
- GAMMAPLEX 5% is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.