Ryplazim

— THERAPEUTIC CATEGORIES —
  • Miscellaneous hematological agents

Ryplazim Generic Name & Formulations

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

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