Generic name: HUMAN IMMUNOGLOBULIN G 5g in 100mL
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on Mar 27, 2020.
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)|
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. If a patient has been exposed to measles, a dose of 400 mg/kg (8 mL/kg) should be administered as soon as possible after exposure. 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
Treatment of Primary Humoral Immunodeficiency
- GAMMAPLEX 5% 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 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.
- 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)].
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- Drug class: immune globulins