Gammaked Background

Dosing & Administration for Gammaked

TAKE CARE WITH FLEXIBLE DOSING

IV doses and infusion rates for all 3 indications1:

IV Doses

  • It is recommended that the initial infusion rate be used for the first 30 minutes. If well tolerated, the rate may be gradually increased to a maximum of 0.08 mL/kg per minute (8 mg/kg per minute)1
  • Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly1
  • Ensure patients with pre-existing renal insufficiency are not volume depleted; discontinue if renal function deteriorates1
  • For patients at risk of renal dysfunction or thromboembolic events, administer at the minimum infusion rate practicable1


SUBCUTANEOUS (SC) DOSING AND INFUSION RATE FOR PI.1 DO NOT ADMINISTER SUBCUTANEOUSLY FOR ITP & CIDP PATIENTS.

 

In an SC dosing study:

  • The mean duration of infusion time ranged from 1.2 to 3.4 hours2
  • Mean volume per infusion site was 34 mL (17-69 mL)1

Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. Monitor the patient's clinical response and repeat the dose adjustment as needed.1


 

Gammaked is not approved for subcutaneous use in patients with ITP or CIDP. Due to potential risk of hematoma formation, Gammaked should not be administered subcutaneously in patients with ITP. 


References: 1. GAMMAKED [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2013. 2. Wasserman RL, Irani A-M, Tracy J, et al. Pharmacokinetics and safety of subcutaneous immune globulin (human), 10% caprylate/chromatography purified in patients with primary immunodeficiency disease. Clin Exp Immunol. 2010;161(3):518-526.