Class: Blood Derivatives
Brands: Ryplazim
Introduction
Plasminogen, human-tmvh is a plasma-derived human plasminogen blood derivative.
Uses for Plasminogen, Human-tmvh
Plasminogen, human-tmvh has the following uses:
Plasminogen, human-tmvh is indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). Plasminogen, human-tmvh has been designated an orphan drug by FDA for use in the treatment of this condition.
Efficacy of plasminogen, human-tmvh has been evaluated in an open-label clinical trial in 15 patients (9 adults and 6 pediatric patients 4–16 years of age) with plasminogen deficiency type 1. All patients received plasminogen, human-tmvh 6.6 mg/kg IV every 2–4 days for 48 weeks to achieve an increase in trough plasminogen activity of at least 10% above baseline and to treat clinical manifestations of the disease. All patients with any lesions at baseline achieved at least 50% improvement in the number/size of their lesions. At the end of the 48-week study, 25 of 32 external lesions (78%) and 9 of 12 assessed internal lesions (75%) were resolved; no recurrent or new lesions were observed or identified on imaging studies through week 48.
Plasminogen, Human-tmvh Dosage and Administration
General
Plasminogen, human-tmvh is available in a single-dose 50-mL vial containing 68.8 mg of plasminogen as a lyophilized powder for reconstitution with 12.5 mL of sterile water for injection. After reconstitution, each vial will contain 5.5 mg/mL of plasminogen.
Dosage
It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
For IV use after reconstitution only.
Plasminogen, human-tmvh lyophilized powder should be reconstituted as directed by the manufacturer to provide a 5.5-mg/mL solution. The solution should be prepared within 3 hours of administration. The prep...
