Ryplazim Generic Name & Formulations
Plasminogen, human-tvmh 68.8mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Single-dose vial (50mL)—1
Plasminogen deficiency type 1 (hypoplasminogenemia).
Ryplazim Dosage and Administration
Adults and Children
<11 months: not established. Give by slow IV over 10–30mins. ≥11 months: 6.6mg/kg every 2–4 days. Calculation of total infusion volume: Infusion volume (mL) = body weight (kg) x 1.2; Number of vials = infusion volume (mL) x 0.08. Determination of dosing frequency: see full labeling.
Ryplazim Boxed Warnings
Risk of bleeding in active mucosal disease-related lesions (eg, GI, hemoptysis, epistaxis, vaginal, hematuria). Other recent history of GI bleed (eg, gastric ulcers). May prolong or worsen bleeding in those with bleeding diatheses; monitor during and for 4hrs after infusion. Risk of tissue sloughing at mucosal sites (eg, respiratory, GI, genitourinary). Confirmed or suspected airway disease; monitor closely. Have trained personnel and support equipment readily available. Monitor at-risk patients for at least 4hrs after first dose. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Discontinue immediately if uncontrolled bleeding or hypersensitivity reactions occur; treat appropriately. Loss of efficacy: monitor and obtain plasminogen activity trough to confirm adequate activity levels achieved. Elevated D-dimer levels may occur; will lack interpretability in screening for venous thromboembolism. Elderly. Pregnancy. Nursing mothers.
May prolong or worsen bleeding when concomitant anticoagulants, antiplatelets, or other agents which may interfere with normal coagulation; monitor during and for 4hrs after infusion.
Ryplazim Adverse Reactions
Abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, back pain; neutralizing antibodies may develop.
Ryplazim Clinical Trials
Ryplazim Patient Counseling