Table 4 Ig replacement therapies for PID approved in Canada [7].

Formulation

Lyophilized

Liquid

Liquid

Liquid

Liquid

Administration

IV

IV

IV

IV

SC

Concentration

5% or 10% upon

reconstitution

9%-11%

9%-11%

10%

16%

Shelf-life

Not specified

36 months

36 months

Not specified

24 months

Storage requirements

Up to 25°C

Do not freeze

2°C-8°C (36 mo),

up to 25°C (6 mo)

Do not freeze

2°C-8°C (36 mo), up to 25°C (for a single period of up to 9 mo within the first 24 mo from date of manufacture)

Do not freeze

Room temperature

(up to 25°C)

Do not freeze

Keep in the original carton to protect it from light

2-8°C (24 mo)

Do not freeze

Keep vials in storage box until use

Do not administer if vial has been opened more than 4 h

Infusion rate and dosage

For 5% solution:

4 mL/kg/h, maximum

(3.3 mg/kg/min, maximum)

For 10% solution:

8 mL/kg/h, maximum (calculated rate:13.3 mg/kg/min, maximum)

0.14 mL/kg/min (14 mg/kg/min, maximum)

8 mL/kg/h

maximum (calculated rate: 13.3 mg/kg/min, maximum)

0.08 mL/kg/ min, maximum (8 mg/kg/min)

100-200 mg/kg weekly; maximum volume of 15 mL per injection site at a rate of 20 mL/h

Previous IV Ig dose ×1.37, then divide into weekly dose based on previous IV Ig interval