questions1. What is the pH of GAMMAGARD LIQUID? Could this
pH cause vein irritation in patients? 1,2
GAMMAGARD LIQUID has a pH of 4.6 to 5.1. Studies have shown that low-pH
IVIG preparations are rapidly neutralized by blood. When a low pH solution
enters the vein, the blood dilutes and reduces the acidity of the solution
to a tolerable level.
2. What is osmolality? 1,2
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). The osmolality of GAMMAGARD LIQUID
is 240-300 mOsmol/kg, which is similar to physiological osmolality of 285
to 295 mOsmol/kg.
3. Why is the rate of infusion important to consider?
1,3,4
The rate of
infusion is an important variable that could influence the occurrence of
adverse reactions. A rate of administration that is too rapid may cause
flushing and changes in pulse rate and blood pressure. Slowing or stopping
the infusion usually results in the prompt disappearance of signs. The infusion
may then be resumed at a rate that is comfortable for the patient.
4. What is the recommended rate of infusion when
giving a patient GAMMAGARD LIQUID for the first time? 1
During the clinical study, GAMMAGARD LIQUID
was infused at the initial rate of 0.5 mL/kg/hour (0.8 mg/kg/minute). The
rate was gradually increased every 30 minutes to a rate of 5 mL/kg/hour
(8.9 mg/kg/minute) if it was well tolerated. It is recommended that patients
who are judged to be at risk of renal dysfunction or thrombotic complications
be gradually titrated to a more conservative maximal rate of less than
3.3mg/IgG/kg/minute (2 mL/kg/hour).
5. Is there any information regarding the rate
of administration for patients switching from GAMMAGARD S/D 5% to GAMMAGARD
LIQUID 10%? 1
In general, it
is recommended that patients beginning IVIG therapy or switching from one
IVIG product to another be started at the lower rates and then advanced
to the maximal rate if they have tolerated several infusions at intermediate
rates of infusion. It is important to individualize rates for each patient.
For more information, contact Medical Affairs at 866-424-6724.
6. Can GAMMAGARD LIQUID 10% be diluted to a 5%
concentration?
1
GAMMAGARD LIQUID is available as a 10% solution. If dilution is preferred,
GAMMAGARD LIQUID may be diluted with 5% dextrose in water (D5W). Normal
saline (NS) should not be used as a diluent.
7. How should GAMMAGARD LIQUID be stored?
1
GAMMAGARD LIQUID can be stored
for 36 months at refrigerated temperature 2° - 8° C (36° -
46° F) or for 9 months
at room temperature 25°C (77°F) within the first 24 months of the
date of processing. After 24 months from date of manufacture, the
product cannot be stored at room temperature. The new expiration date must
be recorded on the package when the product is transferred to room temperature.
Do not freeze.
8. Is using an administration set with a filter
required for infusion of GAMMAGARD LIQUID? 1
The use of an in-line filter is optional. GAMMAGARD LIQUID is not supplied
with an administration set.
9. Will GAMMAGARD S/D still be available for patients with IgA sensitivity?
Baxter will continue to provide GAMMAGARD S/D for IgA sensitive patients who require a low IgA content in their IVIG therapy. To insure that your IgA sensitive patients continue to receive GAMMAGARD S/D, you may register your patients by completing the IgA sensitive participant profile form and submitting it for evaluation by the Baxter Professional Services Group. The form includes instructions for completing the patient profile and a Q&A section on registering patients and ordering low IgA GAMMAGARD S/D.