Ryplazim



RYMPLAZIM

Product Specs RYPLAZIM
Manufacturer Name Kedrion
Indications Indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
Contraindications Contraindicated in patients with known hypersensitivity to plasminogen, or other components of RYPLAZIM.
Source Plasma/manufacturing method Human Source Plasma from FDA-approved collection centers
Viral Removal & Inactivation Process Three orthogonal viral removal/inactivation steps are included: affinity chromatography for removal of enveloped and non-enveloped viruses; solvent/detergent treatment for inactivation of enveloped viruses; and 20 nm nanofiltration for removal of both enveloped and non-enveloped viruses.
Product Half-Life (hours) Combined (pediatric and adult) at 12 weeks of therapy (steady state) was: mean 39.2 (± 6.2) hrs
Dosage 6.6 mg/kg every 2-4 days
Route of Administration IV
Storage Requirements
  • Store RYPLAZIM at temperatures of 2°C to 25°C (36°F to 77°F) in its original carton until ready to use.
  • Do not freeze.
    		•
    Shelf Life from Date of Manufacture 24 months
    Diluent Volume Single-dose vial containing 68.8 mg of plasminogen (human) (5.5 mg/mL after reconstitution with 12.5 mL of Sterile water for injection (SWFI))


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