| Product Specs | Description |
|---|
| Manufacturer Name | Kedrion |
| Indications | RYPLAZIM (plasminogen, human-tvmh) is plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). |
| Contraindications | RYPLAZIM is contraindicated in patients with known hypersensitivity to plasminogen, or other components of RYPLAZIM. |
| Manufacturing Method | Manufacturing process encompasses a series of chromatography adsorbents to purify plasminogen and includes multiple steps and controls to ensure that the purified plasminogen is essentially free of known adventitious agents. First, 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. Second, the plasma used in this process is Human Source Plasma from FDA approved collection centers; thus, there is minimal risk of contamination that could cause transmissible spongiform encephalopathies. Lastly, the product is tested for microbial and endotoxin levels throughout the process. |
| Viral Safety Process | All plasma used in the manufacturing of RYPLAZIM is tested using serological assays for hepatitis B virus (HBV) surface antigen and antibodies to human immunodeficiency virus-1/2 (HIV-1/2) and hepatitis C virus (HCV). The plasma is also tested via nucleic acid amplification testing for HBV, HCV, HIV-1, hepatitis A virus (HAV) and human parvovirus B19 virus. Only plasma pools negative for HIV-1, HCV, HBV, and HAV, and containing levels of human parvovirus B19 DNA ≤ 10 IU/mL are used for the manufacture of RYPLAZIM. |
| Product Half-Life Plasminogen Activity Levels for Adults: | - First Dose – 32.4 (13.1) hours
- Week 12 – 38.5 (7.1) hours
|
| Product Half-Life Plasminogen Activity Levels for Pediatric: | - First Dose – 36.3 (10.0) hours
- Week 12 – hours 40.3 (5.0)
|
| 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.
- Once reconstituted, RYPLAZIM must be administered within 3 hours.
- Do not refrigerate after reconstitution.
- Store diluent and syringe disc filters at 20°C to 25°C (68°F to 77°F).
- Do not use RYPLAZIM or diluent after the expiration date on the carton and vial labels.
|
| Shelf Life | Expiration date on the carton and vial labels |
| Nominal Vial Size and Diluent Volume | 5.5 mg/mL of plasminogen in a colorless and clear to slightly opalescent solution. |
