Leaders in IVIG Therapy

Refrigeration: 2° to 8°C (36° to 46°F) for 36 mths.
Room temperature 25°C (77°F) for up to 24 mths.
Do not return to refrigeration if removed for room temp. Do not freeze or shake. Protect from light.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Initial: 1mg/kg/min
Maximum: Double the infusion rate every 30 minutes (if tolerated) up to 8mg/kg/min.

Initial Infusion Rate from 2nd Infusion: 2mg/kg/min.
Maximum: Double the infusion rate every 15 minutes (if tolerated) up to 8mg/kg/min.

Do not dilute.

Infuse using a separate infusion line.

Refrigerate between 2 to 8° C (36 to 46°F) for up to 36 mths.
Within the first 24 mths, may be stored at RT (77*F) for up to 4 weeks. After storage at RT, must be used or discarded.
Do not freeze or heat. Do not shake.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Initial: 0.5mg/kg/min for the first 15 minutes

Maintenance Infusion Rate (if tolerated): Increase every 15 minutes by 0.8mg/kg/min up to 6mg/kg/min. (max recommended rate: 4.8ml/kg/hr)

Do not dilute.

Infuse using a separate line by itself, without mixing with other intravenous fluids or medications the patient may be receiving.

Refrigerate between 2 to 8° C (36 to 46°F) for up to 36 mths.
Within the first 24 mths, may be stored at RT (77*F) for up to 4 weeks.
After storage at RT, must be used or discarded.
Do not freeze or heat. Do not shake.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Initial: 0.5mg/kg/min for the first 10 minutes

Maintenance Infusion Rate (if tolerated): Increase every 20 minutes by 0.8mg/kg/min up to 6mg/kg/min. (max recommended rate: 3.6ml/kg/hr)

Do not dilute.

Infuse using a separate line by itself, without mixing with other intravenous fluids or medications the patient may be receiving.

Refrigerate between
2 to 8° C (36 to 46°F) for up to 36 mths. May be stored at RT (77*F) for up to 9 mths without being refrigerated again.
Do not freeze or heat. Do not shake.

History of anaphylactic or severe systemic reactions to human immunoglobulin or other components of Cutaquig.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Initial:
17y and older: 20mL/hr/site
2-16y: up to 15mL/hr/site

Subsequent infusions:
17y and older: 52mL/hr/site
2-16y: up to 25mL/hr/site

Maximum infusion rates:
17y and older: 52mL/hr/site
2-16y: up to 25mL/hr/site

Do not mix with other products.

Refrigeration: 2° to 8°C (36° to 46°F) for 36 mths.
Room temperature 25°C (77°F) for up to 24 mths.
Do not return to refrigeration if removed for room temp. Do not freeze or shake. Protect from light.

History of anaphylactic or severe systemic hypersensitivity reaction to the subcutaneous administration of human immune globulin.

IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human immune globulin treatment.

First 2 infusions: recommended infusion rate is 10-20 mL/hr/site.

For subsequent infusions, the infusion rate may be increased to 60 mL/hr/site as tolerated (e.g., 60 mL/hr/site x 2 sites = 120 mL/hr).

For patients utilizing 4 infusion sites, the maximum infusion rate for all sites combined is 240 mL/hr.

Do not mix with other products.

Do not dilute.

Refrigeration: 2° to 8°C (36° to 46°F) for 36 mths.
Room temperature 25°C (77°F) for up to 24 mths.
Do not freeze. Do not shake.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficiency with antibodies to IgA

Intravenous (IV):
Initial: 0.8mg/kg/min
Maximum: 8-9mg/kg/min

Subcutaneous (SC):
Initial: 1.37 x current IV dose in mg/kg per IV dose interval in weeks
Maximum: 20 to 30mL/hr/site

Infuse product by separate line without mixing other IV fluids or medications.

Do not use NS 0.9% as a diluent.

Not to exceed 25°C (77°F),
Avoid freezing. Do not shake.

Selective IgA deficiency where IgA deficiency is only abnormality of concern.

Patients who tolerate the 5% solution at up to 4 mL/kg/hr can be infused with 10% solution starting at 0.5 mL/kg/hr up to 8 mL/kg/hr.

Administer separately from other drugs/medications.

Not to exceed 25°C (77°F),
Avoid freezing. Do not shake.

Selective IgA deficiency where IgA deficiency is only abnormality of concern.

Use a 5% solution at 0.5 mL/kg/hr.

Administer separately from other drugs/medications.

Refrigeration: 2° to 8°C (36°to 46°F) for 36 mths.
May be stored at 25°C (77°F) for up to 6 mths any time during the 36 mth shelf life, after which must be used immediately or discarded.
Do not freeze.

IgA deficiency with antibodies to IgA

PID
Intravenous (IV):
Initial: 1mg/kg/min
Maximum: 8mg/kg/min

Subcutaneous (SC):
Initial: 1.37 x current IV dose in mg/kg per IV dose interval in weeks
Maximum: 20mL/hr/site

ITP & CIDP
Intravenous (IV):
ITP Initial: 1mg/kg/min
CIDP Initial: 2mg/kg/min
Maximum: 8mg/kg/min

Infuse product by separate line without mixing with other IV fluids or medications. If administered through indwelling catheter, flush with D5W or NS before and after infusing product.

Room temperature 25°C (77°F) – 36 mths
Do not freeze. Do not shake.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Initial: 0.5mg/kg/min (.005mL/kg/min) for 15 mins, Increase gradually every 15 mins to 8mg/kg/min (0.08 mL/kg/min)

Administer separately from other drugs/medications.

Room temperature 25°C (77°F) – 36 mths
Do not freeze. Do not shake.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Initial: 0.5mg/kg/min (0.01 mL/kg/min) for 15 mins, increase gradually every 15 mins to 4mg/kg/min (0.08mL/kg/min)

Administer separately from other drugs/medications.

Refrigeration: 2° to 8°C (36°to 46°F) for 36 mths.
May be stored at 25°C (77°F) for up to 6 mths any time during the 36 mth shelf life, after which must be used immediately or discarded.
Do not freeze.

IgA deficiency with antibodies to IgA

PID
Intravenous (IV):
Initial: 1mg/kg/min
Maximum: 8mg/kg/min

Subcutaneous (SC):
Initial: 1.37 x current IV dose in mg/kg per IV dose interval in weeks
Maximum: 20mL/hr/site

ITP & CIDP
Intravenous (IV):
ITP Initial: 1mg/kg/min
CIDP Initial: 2mg/kg/min
Maximum: 8mg/kg/min

Infuse product by separate line without mixing with other IV fluids or medications. If administered through indwelling catheter, flush with D5W or NS before and after infusing product.

Room temperature 25°C (77°F) – 30 mths.
Do not freeze.
Keep vials in storage box until use.

IgA deficiency with antibodies to IgA.

Also contraindicated in hyperprolinemia patients due to stabilizer: L-proline.

Subcutaneous only: Not for intravenous administration.

PID
Initial Infusion: 15mL/hr/inj site.
Subsequent infusions may be increased as tolerated to 25mL/hr/site at a maximum rate of 50mL/hour for all sites combined.

CIDP
Initial Infusion: 20mL/hr/inj site.
Subsequent infusions may be increased as tolerated to 25mL/hr/site at a maximum rate of 50mL/hour for all sites combined.

Should not be mixed with other medicinal products.

Refrigeration: 2° to 8°C (36° to 46°F) for 36 mths.
Room temperature 25°C (77°F) for up to 3 mths during the 1st 24 mths from Mfg date.
Protect from light.
Do not freeze.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of Hyqvia. Known systemic hypersensitivity to human albumin (in the hyaluronidase solution)

1st 2 Infusions:
<88lbs 5mL per site, per hour ramping up 5mL every 5-15 minutes, max 80mL per site, per hour.
>88lbs 10mL per site, per hour ramping up every 5-15 minutes, max 240mL per site, per hour.

Subsequent 2 or 3 infusions:
<88lbs 10mL per site, per hour ramping up 5mL every 5-15 minutes, max 160mL per site, per hour.
>88lbs 10mL per site, per hour ramping up every 5-15 minutes, max 300mL per site per hour.

Do not mix the hyaluronidase and Hyqvia in the same container prior to administration. Do not mix Hyqvia with other products.

2° to 8°C (36° to 46°F) for 36 mths. Can be stored for up to 9 mths any time during the 36 mth shelf life, after which must be used immediately or discarded.
Do not freeze.

IgA deficiency with
antibodies to IgA
History of anaphylactic or severe reactions to human immunoglobulin

ITP
1.0mg/kg/min
Maximum: Up to 12.0mg/kg/min (if tolerated)

DM
1.0mg/kg/min
Maximum: Up to 4mg/kg/min (if tolerated)

Administer separately from other drugs or medications.
Flushing: any normal infusion solution (i.e. D5W/saline).

2° to 8°C (36° to 46°F) for 24 mths
Do not freeze.

IgA deficiency with antibodies to IgA

History of anaphylactic or severe reactions to human immunoglobulin

0.5mg/kg/min

Maintenance infusion rate: max. of 3.33mg/kg/min (if tolerated)

Administer separately from other drugs or medications.

Flushing: any normal infusion solution (i.e. D5W/saline).

2° to 8°C (36° to 46°F)
for 36 mths.
Or 25°C (77°F) for up to 12 mths, after which must be used immediately or discarded.
Do not freeze.

IgA deficiency with antibodies to IgA

History of anaphylactic or severe reactions to human immunoglobulin

PID
Initial: 1mg/kg/minute
Maximum Rate: 14mg/kg/min

ITP
Initial: 1mg/kg/min
Maximum Rate: 8mg/kg/min

CIDP
Initial: 1mg/kg/min
Maximum Rate: 12mg/kg/min

Administer separately from other drugs or medications.

Room temperature (25°C) (77°F) for 36 mths.
Protect from light. Do not freeze. Do not shake.

IgA deficiency with antibodies to IgA.

Also contraindicated in hyperprolinemia patients due to stabilizer: L-proline.

PID
Initial: 0.5mg/kg/min
Maximum: 8mg/kg/min

ITP
Initial: 0.5mg/kg/min
Maximum: 4mg/kg/min

CIDP
Initial: 0.5mg/kg/min
Maximum: 8mg/kg/min

Infuse product by separate line without mixing other medications or fluids.

2° to 8°C (36° to 46°F)
May be stored at temperatures not to exceed 77°F for up to 6 mths anytime prior to expiration date, after which must be used immediately or discarded.
Do not freeze. Do not shake.

History of anaphylactic or severe systemic reactions to human immunoglobulin or ingredients of Xembify such as polysorbate 80.

IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Subcutaneous only: Not for intravenous administration. Infuse at a maximum rate of 25 mL per hour per infusion site using up to 6 infusion sites. Ensure infusion sites are at least 2 inches apart for patients of all ages.

Administer separately from other drugs/medications.