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Revised 9/2013
3036429/3036430
DOSAGE AND ADMINISTRATION
Intravenous Administration Only: ITP and CIDP
Indication
Dose
Initial Infusion Rate
Maintenance Infusion Rate
(if tolerated)
ITP (2.3)
2 g/kg
1 mg/kg/min
8 mg/kg/min
CIDP (2.4)
loading dose
2 g/kg
maintenance dose
1 g/kg
2 mg/kg/min
8 mg/kg/min
Every 3 weeks
•
•
Ensure that patients with pre-existing renal insufficiency are not volume depleted;
discontinue GAMMAKED if renal function deteriorates. (5.2)
For patients at risk of renal dysfunction or thrombosis, administer GAMMAKED at the
minimum infusion rate practicable. (5.2, 5.4)
Intravenous or Subcutaneous Administration: PI (2.2)
DO NOT ADMINISTER SUBCUTANEOUSLY FOR ITP PATIENTS (5.10)
Route of
Administration
Intravenous (IV)
Dose*
Infusion Rate
300-600 mg/kg
1 mg/kg/min
8 mg/kg/min
Every 3-4 weeks
20 mL/hr/site
Not determined during
the clinical study
Subcutaneous (SC) 1.37 x current IV dose in
mg/kg/IV
dose interval in weeks
*
Maintenance Infusion Rate
(if tolerated)
See section 2.2.
DOSAGE FORMS AND STRENGTHS
GAMMAKED is supplied in 1 g, 2.5 g, 5 g, 10 g, or 20 g single use bottles. (3)
1g
10 mL
2.5 g
25 mL
5g
50 mL
10 g
100 mL
20 g
200 mL
CONTRAINDICATIONS
•
•
Anaphylactic or severe systemic reactions to human immunoglobulin (4.1)
IgA deficient patients with antibodies against IgA and a history of hypersensitivity (4.2)
2