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Gammaked
Gammaplex Bivigam Privigen Hizentra Flebogamma Gammagard Liquid Gammagard S/D Octagam
Product Specifics: Gamunex-C

Sizes 2.5g, 5g, 10g 5g, 10g 5g, 10g, 20g 1g, 2g, 4g 2.5g, 5g, 10g 1g, 2.5g, 5g, 10g, 20g 2.5g, 5g, 10g 1g, 2.5g, 5g, 10g, 20g 1g, 2.5g, 5g, 10g

Refridgerate between
Room temperature (25°C) (77°F) - Room temperature (25°C) (77°F) Room temperature (25°C) (77°F)
2 to 8° C (36 to 46°F) 2° to 25°C (36° to 77°F) 2° to 8°C (36°to 46°F) Not to exceed 25°C (77°F), 2° to 8°C (36°to 46°F). 2° to 8°C (36° to 46°F)
Storage 24 months Protect from light. Do not freeze. Do not freeze. Keep vials in
Do not freeze or heat. DO not Do not freeze. Do not shake. Do not freeze. Do not shake. Avoid freezing. Do not shake. Do not freeze. for 24 months.
Do not freeze. Do not shake. Do not shake. storage box until use.
shake.

Form Liquid Liquid Liquid Liquid Liquid Liquid Lyophilized Liquid Liquid

Reconstitution Fluid N/A N/A N/A N/A N/A N/A Sterile Water for Injection N/A N/A

Concentration Options 5% 10% 10% 20% 5% or 10% 10% 5% or 10% 10% 5%

PID + ITP + CLL +

Indications PID PI PID + ITP PID PID PID PID + ITP + CIDP PID
Kawasaki disease

History of anaphylactic or severe History of anaphylactic or severe

IgA deficiency with IgA deficiency with History of anaphylactic or severe
systemic reactions to human systemic reactions to human IgA deficiency with
antibodies to IgA. antibodies to IgA. systemic reactions to human Selective IgA deficiency where IgA
immunoglobulin. immunoglobulin. antibodies to IgA. IgA deficiency with IgA deficiency with
Contraindications Also contraindicated in Also contraindicated in immunoglobulin. deficiency is only abnormality of
IgA deficient patients with IgA deficient patients with Patient intolerant to sorbitol (ie. antibodies to IgA antibodies to IgA
hyperprolinemia patients due to hyperprolinemia patients due to IgA deficiency with concern.
antibodies against IgA and a antibodies against IgA and a Intolerant to fructose).
stabilizer: L-proline. stabilizer: L-proline. antibodies to IgA
history of hypersensitivity. history of hypersensitivity.

Subcutaneous only: Not for Intravenous (IV): Intravenous (IV):

intravenous administration. Initial: 0.8mg/kg/min Initial: 1mg/kg/min
Initial: 0.5mg/kg/min for the first
Injection sites: abdomen, thighs, Maximum: 8.9mg/kg/min Use a 5% solution at 0.5 Maximum: 8mg/kg/min
Initial: 0.5 mg/kg/min (0.01 10 minutes
upper arms, and/or lateral hip. mL/kg/hr. Patients who tolerate
Infusion Rates mL/kg/min) Maintenance Infusion Rate (if Initial:0.5mg/kg/min 0.01 mL/kg body weight/minute 0.01 mL/kg/minute
Initial Infusion: 15mL/hr/inj. site. Subcutaneous (SC): the 5% solution at up to 4 Subcutaneous (SC):
(Refer also to full prescribing Maximum: 4mg/kg/min tolerated): Increase every 20 Maximum: 4mg/kg/min (0.5 mg/kg body weight/minute) (0.5 mg/kg/minute)
Subsequent infusions may be Initial: 1.37 x current IV dose in mL/kg/hr can be infused with 10% Initial: 1.37 x current IV dose in
information). (0.08mL/kg/min) minutes by 0.8mg/kg/min up to
increased as tolerated to mg/kg per IV dose interval in solution starting at 0.5 mL/kg/hr. mg/kg per IV dose interval in
6mg/kg/min.
25/mL/site at a maximum rate of weeks weeks
50mL/hour for all sites combined. Maximum: 20 to 30mL/hr/site Maximum: 20mL/h/site

Warm to room temperature if If dilution is required, may be

Infuse product at approximately If dilution is required, may be
Other Allow refrigerated product to come If dilution is required, may be Warm to room temperature. refrigerated. Use pooled product diluted with 5% dextrose in water
room temperature. Infuse with set diluted with 5% dextrose in water If refrigerated, warm to room Warm to room temperature if
Administration to room temperature before diluted in 5% dextrose in water Discard unused product promptly (may transfer into empty (D5/W). May be pooled in either
preferable fitted with an in-line 15- (D5/W). Warm to room temperature prior to infusion. refrigerated prior to infusion.
Information infusing. (D5/W). immediately after use. sterile IV container using aseptic glass or plastic. Warm to room
20 micron filter. temperature before infusing.
technique). temperature prior to infusion.

Infuse product by separate line

Do not dilute.
Infuse using a serparate line by
Administer separately from other
Compatibility Issues itself, without mixing with other
drugs/medications.
intravenous fluids or medications
the patient may be receiving.
Do not dilute with other IV fluids. without mixing with other IV fluids
Infuse product by separate line Administer separately from other
Infuse product by separate line Do not add any medications or IV or medications. Not compatible
Should not be mixed with other without mixing other IV fluids or Administer separately from other drugs or medications.
without mixing other medications fluids to product infusion with saline. If administered
medicinal products. medications. drugs/medications. Flushing: any normal infusion
or fluids. container. through indwelling catheter, flush
Do not use NS 0.9% as a diluent. solution (i.e. D5W/saline).
Infuse by separate IV line. with D5/W before and after
infusing product.

typically <4µg/ml
IgA Content ≤200 µg/mL ≤25 mcg/mL ≤50mcg/ml <50 µg/ml 37 µg/ml ≤2.2 µg/ml (5% concentration) 46 µg/ml <200 µg/mL
specification ≤10mg/ml

No sugar; stabilized with a

Sugar Content 5% D-Sorbitol No sugar; stabilized with glycine nonessential amino acid: None 5% D-Sorbitol No sugar; stabilized with glycine. 2% glucose (5% concentration) No sugar; stabilized with glycine. Maltose 100mg/mL
250 mmol/L L-proline

Approximately 8.5 mg/mL

Sodium Content 30-50mmol/L .100-0.140 M Sodium Chloride Trace amounts Trace Amounts <3.2 mEq/L (<0.02%) None detected Trace amounts ≤30 mmol/L
sodium chloride

320 m0smol/kg 636 m0smol/L (5%)

Osmolarity / Osmolality 460-500m0sm/kg 370-510 mOsm/kg 380 m0smol/kg 240-370 m0smol/kg 240-300 m0smol/kg 258 m0smol/kg 310-380 m0smol/kg
(240 to 440 range) 1250 m0smol/L (10%)

Latex in
Latex free Latex free Latex free Latex free Latex free Latex free Latex free Latex free Latex free
product stopper

Latex in
N/A N/A N/A N/A N/A N/A Contains Latex N/A N/A
diluent stopper

IMPORTANT NOTICE - The information provided herein is a summary of available information only. This summary is to be used as a general educational tool and is not intended for use as a guideline for clinical evaluations. Such evaluations (including, but not limited to, initial and/or subsequent dosing, conversion from specific product brands, etc) should utilize a thorough review of appropriate clinical data.
Product package inserts are the primary source of information. Please see full Prescribing Information before prescribing.