Usual Adult Dose for Primary Immunodeficiency Syndrome

Ramp up dosing:

First infusion/week 1: One quarter of full maintenance dose, subcutaneously
Second infusion/week 2: One half of full maintenance dose, subcutaneously

Infusion rates for first 2 infusions:

• Administer the hyaluronidase at an initial rate per site of approximately 1 to 2 mL/min, or as tolerated.
• Administer immune globulin at the following rates:
• 5 mL/hr (<88 lbs) or 10 mL/hr (88 lbs or higher) over the first 5 to 15 minutes
• Increase rate to 10 mL/hr (<88 lbs) or 30 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
• Increase rate to 20 mL/hr (<88 lbs) or 60 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
• Increase rate to 40 mL/hr (<88 lbs) or 120 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
• Infuse at 80 mL/hr (<88 lbs) or 240 mL/hr (88 lbs or higher) for the remainder of the infusion

Third infusion/week 4: Three quarters of full maintenance dose, subcutaneously
Fourth infusion/week 7/maintenance dose: Full maintenance dose, subcutaneously

Infusion rates for third to fifth infusions:

• Administer the hyaluronidase at an initial rate per site of approximately 1 to 2 mL/min, or as tolerated.
• Administer immune globulin at the following rates:
• 10 mL/hr (all weights) over the first 5 to 15 minutes
• Increase rate to 20 mL/hr (<88 lbs) or 30 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
• Increase rate to 40 mL/hr (<88 lbs) or 120 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
• Increase rate to 80 mL/hr (<88 lbs) or 240 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
• Infuse at 160 mL/hr (<88 lbs) or 300 mL/hr (88 lbs or higher) for the remainder of the infusion

Maintenance dose:

Naive to IgG treatment or switching from Immune Globulin Subcutaneous (Human) [IGSC]:

• 300 to 600 mg/kg subcutaneously at 3 to 4 week intervals, after initial ramp-up.

Switching from Immune Globulin Intravenous (Human) [IGIV] treatment:

• Use same dose and frequency as previous intravenous treatment after the initial ramp-up

Infusion rate:

• Administer the hyaluronidase at an initial rate per site of approximately 1 to 2 mL/min, or as tolerated.
• If the patient tolerated the ramp up infusions at the full dose and maximum rate, adjust both the time intervals and number of rate changes of the ramp-up used for successive infusions at the discretion of the physician and patient.

Site selection:

• The suggested site(s) for the infusion are the abdomen and thighs.
• If two sites are used, they should be on opposite sides of the body.
• Avoid bony prominences, or areas that are scarred, inflamed, or infected.

Volume per site:

• Administer up to 300 mL (<88 lbs) or 600 mL (88 lbs or higher) per site.
• Use a second site, at physician and patient discretion, based on tolerability and total volume.
• If using a second site, administer half of total volume in each site.

Comments:

• Safety and efficacy have not been established in conditions other than primary immunodeficiency.
• For patients previously on another IgG treatment, administer the first dose approximately one week after the last infusion of their previous treatment.
• Increase the dose and frequency from a 1 week dose to a 3 or 4 week dose (see ramp-up dose).
• Initiating treatment at a full monthly dose was not evaluated in the clinical trial.

Use: Treatment of Primary Immunodeficiency (PI) in adults.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

• Calculate the difference between the patient's serum IgG trough level during treatment with this product and the IgG trough level during the previous IgG treatment or the desired trough IgG.
• Increase or decrease the dose (in mL) based on patient weight and desired change in IgG trough level:

If the difference between desired trough and actual trough is x mg/dL, adjust dose by y mL:

• Weight: 10 kg

100 mg/dL: 3 mL, 200 mg/dL: 6 mL, 300 mg/dL: 9 mL, 400 mg/dL: 12 mL

• Weight: 20 kg

100 mg/dL: 6 mL, 200 mg/dL: 12 mL, 300 mg/dL: 18 mL, 400 mg/dL: 24 mL

• Weight: 30 kg

100 mg/dL: 9 mL, 200 mg/dL: 18 mL, 300 mg/dL: 27 mL, 400 mg/dL: 36 mL

• Weight: 40 kg

100 mg/dL: 12 mL, 200 mg/dL: 24 mL, 300 mg/dL: 36 mL, 400 mg/dL: 48 mL

• Weight: 50 kg

100 mg/dL: 15 mL, 200 mg/dL: 30 mL, 300 mg/dL: 45 mL, 400 mg/dL: 61 mL

• Weight: 60 kg

100 mg/dL: 18 mL, 200 mg/dL: 36 mL, 300 mg/dL: 55 mL, 400 mg/dL: 73 mL

• Weight: 70 kg

100 mg/dL: 21 mL, 200 mg/dL: 42 mL, 300 mg/dL: 64 mL, 400 mg/dL: 85 mL

• Weight: 80 kg

100 mg/dL: 24 mL, 200 mg/dL: 48 mL, 300 mg/dL: 73 mL, 400 mg/dL: 97 mL

• Weight: 90 kg

100 mg/dL: 27 mL, 200 mg/dL: 55 mL, 300 mg/dL: 82 mL, 400 mg/dL: 109 mL

• Weight: 100 kg

100 mg/dL: 30 mL, 200 mg/dL: 61 mL, 300 mg/dL: 91 mL, 400 mg/dL: 121 mL

• Weight: 110 kg

100 mg/dL: 33 mL, 200 mg/dL: 67 mL, 300 mg/dL: 100 mL, 400 mg/dL: 133 mL

• Weight: 120 kg

100 mg/dL: 36 mL, 200 mg/dL: 73 mL, 300 mg/dL: 109 mL, 400 mg/dL: 145 mL

• Weight: 130 kg

100 mg/dL: 39 mL, 200 mg/dL: 79 mL, 300 mg/dL: 118 mL, 400 mg/dL: 158 mL

• Weight: 140 kg

100 mg/dL: 42 mL, 200 mg/dL: 85 mL, 300 mg/dL: 127 mL, 400 mg/dL: 170 mL

• Adjust the frequency and number of infusion sites based on volume, total infusion time, and tolerability.
• Adjust the frequency as needed so that the patient receives the same weekly equivalent dose.
• If this drug is administered at a different interval than the previous treatment, do not use the above schedule; adjust, if necessary, based on clinical response.

Precautions

US BOXED WARNING:
THROMBOSIS:

• Thrombosis may occur with immune globulin products, including this one.
• Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
• Administer at the minimum dose and infusion rate practicable in at risk patients.
• Ensure adequate hydration in patients before administration.
• Monitor for signs and symptoms of thrombosis.
• Assess blood viscosity in patients at risk of hyperviscosity.

CONTRAINDICATIONS:

• Anaphylactic or severe systemic reactions to IgG administration
• IgA deficiency with antibodies to IgA and a history of hypersensitivity
• Systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase
• Systemic hypersensitivity to human albumin (in they hyaluronidase solution)

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May be administered by a healthcare professional, caregiver or self-administered by the patient after appropriate training.
• Requires an infusion pump capable of infusion rates up to 300 mL/hr/site.
• Pump must be able to titrate the flow rate up or down if required.
• To ensure maximum flow rates, use a 24 gauge subcutaneous needle set labeled for high flow rates.
• Infuse the two components of the product sequentially, beginning with the hyaluronidase.
• Infuse the immune globulin through the same needle set within approximately 10 minutes of the hyaluronidase.
• For each full or partial vial of immune globulin used, administer the entire contents of the hyaluronidase vial.
• If a dose is missed, administer the missed dose as soon as possible then resume scheduled treatments.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility:

• Do not mix or administer with other products.
• Do not mix the 2 components together.