GAMMAGARD LIQUID —
intravenous and subcutaneous administration1
What is the pH of
What is osmolality?
The term osmolality is used to describe the number of particles in a solution, or solute concentration. Osmolality is the concentration of a solution expressed in osmoles of solute particles per kilogram of solvent (mOsmol/kg).2 The osmolality of
GAMMAGARD LIQUID be stored?
- Example 1: If the product is taken out of the refrigerator after 2 months from date of manufacture, it can be stored for 22 months at room temperature. Total storage time is 24 months.
- Example 2: If the product is taken out of the refrigerator after 21 months from the date of manufacture, it can be stored for 3 months at room temperature. Total storage time is 24 months.1
Is using an administration set with a filter required for infusion
An in-line filter is optional for
Why is the rate of infusion important to consider?
The rate of infusion is an important variable that could influence the occurrence of adverse reactions.3 Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in recurrence of the symptoms.1
For patients at risk of thrombosis or renal dysfunction, administer
Adverse reactions may occur more frequently in patients receiving immune globulin for the first time, upon switching brands or if there has been a long interval since the previous infusion.4 In such cases, start at lower infusion rates and gradually increases as tolerated.
What steps are taken to improve the margin of safety of
Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of
To further improve the margin of safety, three dedicated, independent and effective virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,5 35nm nanofiltration, and a low pH incubation at elevated temperature 30°C-32°C. The S/D process includes treatment with an organic mixture of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18°C to 25°C for a minimum of 60 minutes.
In vitro spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, these virus clearance studies were performed under extreme conditions (e.g., at minimum S/D concentrations, incubation time and temperature for the S/D treatment).
Virus clearance studies for
- S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.1
- 35 nm nanofiltration removes lipid-enveloped viruses to below detection limits and reduces the non-lipid enveloped viruses Hepatitis A virus (HAV) and B19 virus (B19V). As determined by a polymerase chain reaction assay, nanofiltration reduced B19V by a mean log10 reduction factor of 4.8 genome equivalents.1
- Treatment with low pH at elevated temperature of 30°C to 32°C inactivates lipid enveloped viruses and encephalomyocarditis virus (EMCV, model for HAV) to below detection limits, and reduces mice minute virus (MMV, model for B19V).1
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
What are the most common adverse reactions observed with intravenous administration of
In the phase III, multicenter, clinical trial, adverse reactions occurring in ≥5% of study subjects (rate by infusion), were1,a: headache (5.2%), fatigue (1.8%), pyrexia (1.5%), nausea (0.9%), chills (0.8%), rigors (0.8%), pain in extremity (0.7%).
This is not a complete list. Please see
There were 400 non-serious adverse reactions. Of these, 217 were rated as mild (transient discomfort that resolves spontaneously or with minimal intervention), 164 were rated as moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae), and 19 were rated as severe (marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae).1
Fifteen adverse reactions in 8 subjects were serious. Of these, two episodes of aseptic meningitis in one patient were deemed possibly related to the infusion of
GAMMAGARD LIQUID 10% be diluted to a 5% concentration?
What is the recommended rate of infusion when giving a patient
GAMMAGARD LIQUID for the first time?
During the clinical study,
- Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
- Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue
GAMMAGARD LIQUIDif renal function deteriorates.
- For patients at risk of renal dysfunction or thrombotic events, administer
GAMMAGARD LIQUIDat the minimum infusion rate practicable.1
What are the most common adverse reactions observed with subcutaneous administration of
In the clinical study, adverse reactionsa occurring in the ≥5% of study subjects were: local infusion site reactions, such as swelling, redness, or pain (2.4% of infusions), headache (1.4%), fatigue (0.5%), heart rate increase (0.5%), pyrexia (0.5%), and upper abdominal pain (0.4%).1
This is not a complete list. Please see
When should the first subcutaneous dose of
GAMMAGARD LIQUID be administered?
Start the initial subcutaneous dose approximately one week after the last intravenous infusion in a patient who has been on stable intravenous treatment.1
What are the recommendations for selecting subcutaneous infusion sites?1
Suggested areas for subcutaneous infusion of
What is the recommended volume per site?
The recommended maximum volume is 30 mL/site for patients weighing 40 kg (88 lbs) or more and 20 mL/site for patients under 40 kg (88 lbs). The weekly dose (mL) should be divided by 30 or 20, based on patient weight above, to determine the number of sites required.1
What is the recommended rate of infusion?
Patients 40 kg (88 lbs) and greater: for the first infusion, the recommended maximum rate of infusion if
What is the recommended initial subcutaneous dose of
GAMMAGARD LIQUID for a patient who has been on intravenous immunoglobulin?
The recommended starting subcutaneous dose of
Adjust dose according to IgG levels and clinical response, as the frequency and dose of immunoglobulin may vary from patient to patient. The patient’s clinical response should be the primary consideration in dose adjustment.1
To see patient examples, visit our Dosing page.
GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 μg/mL in a 5% solution
Is using an administration set with a filter required for infusion of GAMAMGARD S/D?
Yes. GAMMAGARD S/D is supplied with an administration set which contains an integral airway and a 15 micron filter, along with directions for use. If another administration set is used, ensure that the set contains a similar filter.7
Will GAMMAGARD S/D IgA less than 1 μg/mL in a 5% solution still be available for patients?
Baxter will continue to provide GAMMAGARD S/D for patients who require a low IgA content in their IV treatment.6,7
Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure have occurred in patients receiving GAMMAGARD S/D, including patients who tolerated previous treatments with GAMMAGARD S/D, even though it contains low levels of IgA.
In order to simplify the process for patients, as well as healthcare providers and pharmacists like you, we no longer require an application for access to GAMMAGARD S/D with IgA < 1 μg/mL in a 5% solution. Moving forward, please call Baxter Customer Service at 1-800-423-2090 to place your orders as you do for other BioScience products.
Your patients can receive support from experienced Patient and Nurse Advocates, useful tools, and up-to-date information with our GAMMAGARD Patient Support Program.
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