GAMMAPLEX Solution for infusion (2020)
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Bio Products Laboratory Limited
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BOXED WARNING SECTION
<b>WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE</b> <b>Thrombosis may occur with immune globulin products, including GAMMAPLEX 10%. Risk factors may include: advanced age, prolonged immobilization, ...
1. Indications and Usage
1.1 Primary Humoral Immunodeficiency (PI) GAMMAPLEX 10% is an Immune Globulin Intravenous (Human), 10% Liquid indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric ...
2. Dosage and Administration
<b>For Intravenous Use Only</b> 2.1 Dosage <b>Table 1. Recommended Dosage and Administration for GAMMAPLEX 10%:</b> Indication Dose Initial infusion rate Maintenance infusion rate (if tolerated) ...
3. Dosage Forms and Strengths
GAMMAPLEX 10% is a liquid solution containing 10% IgG (100 mg/mL).
4. Contraindications
GAMMAPLEX 10% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin GAMMAPLEX 10% is contraindicated in IgA-deficient patients ...
5. Warnings and Precautions
5.1 Renal Dysfunction/Failure Acute renal dysfunction/failure, osmotic nephropathy, and death<sup>1</sup> may occur upon use of human IGIV products. Ensure that patients are not volume depleted before ...
6. Adverse Reactions
The safety information for GAMMAPLEX 10% is based on the clinical trial evaluating the bioequivalence of GAMMAPLEX 10% to GAMMAPLEX 5% in subjects with PI. The safety of GAMMAPLEX 10% has not been established ...
6.1. Clinical Trials Experience
<em>Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of ...
6.2. Postmarketing Experience
<em>Because adverse reactions are voluntarily reported post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship ...
7. Drug Interactions
Transitory rise of the various passively transferred antibodies in the patients blood after infusion of immunoglobulin may yield positive serological testing results, with the potential for misleading ...
8.1. Pregnancy
Risk Summary Animal reproduction studies have not been conducted with GAMMAPLEX 10%. It is also not known whether GAMMAPLEX 10% can cause fetal harm when administered to a pregnant woman or can affect ...
8.2. Lactation
Risk Summary Use of GAMMAPLEX 10% has not been evaluated in breast-feeding mothers.
8.4. Pediatric Use
In pediatric subjects 3 years of age and older, the pharmacokinetics, dosage and safety are similar to those in adults. Treatment of Primary Humoral Immunodeficiency GAMMAPLEX 10% was evaluated in 13 pediatric ...
8.5. Geriatric Use
Use caution when administering GAMMAPLEX 10% to patients aged 65 years and over who are judged to be at increased risk of developing renal insufficiency or thrombotic events <em>[see Boxed Warning, Warnings ...
10. Overdosage
Overdosage may lead to fluid overload and hyperviscosity, particularly in the elderly and in patients with renal impairment.
11. Description
GAMMAPLEX 10% is a ready to use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 10% ...
12.1. Mechanism of Action
Treatment of Primary Humoral Immunodeficiency GAMMAPLEX 10% is a replacement therapy for primary humoral immunodeficiency. GAMMAPLEX 10% acts through a broad spectrum of opsonic and neutralizing IgG antibodies ...
12.3. Pharmacokinetics
Treatment of Primary Humoral Immunodeficiency In the cross-over clinical trial assessing bioequivalence, safety and tolerability between GAMMAPLEX 10% and GAMMAPLEX 5% in PI, the pharmacokinetics (PK) ...
14. Clinical Studies
14.1 Treatment of Primary Humoral Immunodeficiency Pharmacokinetics, Safety and Tolerability study A cross-over clinical trial assessed bioequivalence, safety and tolerability between GAMMAPLEX 10% and ...
15. References
Gupta N, Ahmed I, Nissel-Horowitz S, Patel D, Mehrotra B. Intravenous gammaglobulin-associated acute renal failure. Am J Hematol 2001; 66:151-152. Dalakas MC. High-dose intravenous immunoglobulin and serum ...
16.1. How Supplied
GAMMAPLEX 10% is supplied in a single use, clear Type II glass bottle, closed with a stopper and oversealed with a tamper-evident cap. The components used in the packaging for GAMMAPLEX 10% are not made ...
16.2. Storage and Handling
When stored between 2°C [35.6°F] and 25°C [77°F]), GAMMAPLEX 10% has a shelf life of 36 months. Keep GAMMAPLEX 10% in its original carton to protect it from light. Do not shake. Do not use GAMMAPLEX 10% ...
17. Patient Counseling Information
Inform patients to immediately report the following signs and symptoms to their healthcare professional: Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath <em> ...