Ryplazim Generic Name & Formulations
Legal Class
Rx
General Description
Plasminogen, human-tvmh 68.8mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
How Supplied
Single-dose vial (50mL)—1
Manufacturer
Generic Availability
NO
Ryplazim Indications
Indications
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 Contraindications
Not Applicable
Ryplazim Boxed Warnings
Not Applicable
Ryplazim Warnings/Precautions
Warnings/Precautions
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.
Ryplazim Pharmacokinetics
See Literature
Ryplazim Interactions
Interactions
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
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
See Literature
Ryplazim Note
Not Applicable
Ryplazim Patient Counseling
See Literature