Usual Adult Dose for Primary Immunodeficiency Syndrome

Initial weekly dose of Hizentra(R): [Previous IGIV dose (in grams)/number of weeks between IGIV doses] x 1.37
Infusion rate and volume:
First infusion: Rate of 15 mL/hr/site, volume of 15 mL or less per site
Second to fourth infusion: Rate of 25 mL/hr/site, volume of 15 mL or less per site
Fifth infusion: Rate of 25 mL/hr/site, volume of 20 mL or less per site
Sixth infusion and onward: Rate of 25 mL/hr/site, volume of 25 mL or less per site

Initial weekly dose of Cuvitru(R): [Previous IGIV or Hyqvia(R) dose (in grams)/number of weeks between IGIV doses] x 1.30
Infusion rate and volume:
First 2 infusions:

• Patient weight under 40 kg: Rate of 10 to 20 mL/hr/site, volume of 20 mL or less per site
• Patient weight 40 kg or above: Rate of 10 to 20 mL/hr/site, volume of 60 mL or less per site

Subsequent infusions:

• All patients, regardless of weight: Rate of 60 mL/hr/site or less, volume of 60 mL or less per site

Every 2 week dosing: Start 1 or 2 weeks after last IGIV infusion, or 1 week after last weekly subcutaneous immune globulin infusion. Give twice the calculated weekly dose.

Frequent dosing (2 to 7 times/week): Start 1 week after last IGIV or subcutaneous immune globulin infusion; divide calculated weekly dose by desired number of doses per week.

• Administer at regular intervals from daily up to every 2 weeks.
• For subcutaneous infusion only
• Adjust dose based on clinical response and serum IgG trough levels.
• Inject into 1 to 4 injection sites simultaneously, with at least 2 to 4 inches between sites.
• Adjust infusion rates and volumes as tolerate.

Comments:

• Primary humoral immunodeficiency includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Use(s): Primary humoral immunodeficiency

Usual Pediatric Dose for Primary Immunodeficiency Syndrome

2 years and older:

Initial weekly dose of Hizentra(R): [Previous IGIV dose (in grams)/number of weeks between IGIV doses] x 1.37
Infusion rate and volume:
First infusion: Rate of 15 mL/hr/site, volume of 15 mL or less per site
Second to fourth infusion: Rate of 25 mL/hr/site, volume of 15 mL or less per site
Fifth infusion: Rate of 25 mL/hr/site, volume of 20 mL or less per site
Sixth infusion and onward: Rate of 25 mL/hr/site, volume of 25 mL or less per site

Initial weekly dose of Cuvitru(R): [Previous IGIV or Hyqvia(R) dose (in grams)/number of weeks between IGIV doses] x 1.30
Infusion rate and volume:
First 2 infusions:

• Patient weight under 40 kg: Rate of 10 to 20 mL/hr/site, volume of 20 mL or less per site
• Patient weight 40 kg or above: Rate of 10 to 20 mL/hr/site, volume of 60 mL or less per site

Subsequent infusions:

• All patients, regardless of weight: Rate of 60 mL/hr/site or less, volume of 60 mL or less per site

Every 2 week dosing: Start 1 or 2 weeks after last IGIV infusion, or 1 week after last weekly subcutaneous immune globulin infusion. Give twice the calculated weekly dose.

Frequent dosing (2 to 7 times/week): Start 1 week after last IGIV or subcutaneous immune globulin infusion; divide calculated weekly dose by desired number of doses per week.

• Administer at regular intervals from daily up to every 2 weeks.
• For subcutaneous infusion only
• Adjust dose based on clinical response and serum IgG trough levels.
• Inject into 1 to 4 injection sites simultaneously, with at least 2 to 4 inches between sites.
• Adjust infusion rates and volumes as tolerate.

Comments:

• Primary humoral immunodeficiency includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Use(s): Primary humoral immunodeficiency

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosage may be adjusted to achieve desired clinical response and serum IgG levels.

Precautions

US BOXED WARNING(S): THROMBOSIS

• Thrombosis may occur with immune globulin products.
• Risk factors include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, estrogen use, indwelling central venous catheters, hyperviscosity, and cardiovascular risk factors.
• Thrombosis may occur in the absence of known risk factors.

Recommendations:

• For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable.
• Ensure adequate hydration of patients before administration.
• Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available