Ryplazim® (plasminogen, human-tvmh) FDA Approved
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ABOUT RYPLAZIM Ordering RYPLAZIM
Pharmacies & distributors | National drug codes | Ordering resources

RYPLAZIM is available through the following specialty pharmacies and distributors

Specialty Distributors

Specialty Pharmacies

National Drug Codes (NDC)1

NDC

Strength

Diluent Volume†

70573-099-01 or 70573-099-02*

68.8 mg

12.5 mL

The provider is responsible for submitting accurate and appropriate diagnostic and billing codes to obtain reimbursement.

*Pricing for RYPLAZIM can be found in price compendia databases under NDC 70573-099-02.

†Diluent not included in package.

RYPLAZIM Billing and Coding Guide (includes plasminogen deficiency ICD10 code)
Billing and coding guide Download

Initiating treatment? Kedrion is here to help.

Kedrion Connects™ provides access assistance, financial support, resources, and training to help patients and caregivers feel confident in their treatment journey.

Complete the New Start and Patient Consent forms to enroll in Kedrion Connects™

RYPLAZIM Enrollment Form
Patient enrollment form Download

Help your patients access RYPLAZIM using the Co-pay Assistance Program

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INDICATIONS AND USAGE

RYPLAZIM® (plasminogen, human-tvmh) is a plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

RYPLAZIM is contraindicated in patients with known hypersensitivity to plasminogen or other components of RYPLAZIM.

WARNINGS AND PRECAUTIONS:

  • Bleeding: RYPLAZIM administration may lead to bleeding at active mucosal disease-related lesion sites or worsen active bleeding not related to disease lesions. Discontinue RYPLAZIM if serious bleeding occurs. Monitor patients during and for 4 hours after infusion when administering RYPLAZIM to patients with bleeding diatheses and patients taking anticoagulants, antiplatelet drugs, or other agents which may interfere with normal coagulation.
  • Tissue Sloughing: Respiratory distress due to tissue sloughing may occur in patients with mucosal lesions in the tracheobronchial tree following RYPLAZIM administration. Please monitor appropriately.
  • Transmission of Infectious Agents: RYPLAZIM is made from human plasma and therefore carries a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent.
  • Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, may occur with RYPLAZIM. If symptoms occur, discontinue RYPLAZIM and administer appropriate treatment.
  • Neutralizing Antibodies: Neutralizing antibodies (inhibitors) may develop, although they were not observed in clinical trials. If clinical efficacy is not maintained (e.g., development of new or recurrent lesions), determine plasminogen activity trough levels in plasma.
  • Laboratory Abnormalities: Patients receiving RYPLAZIM may have elevated blood levels of D-dimer. D-dimer levels will lack interpretability in patients being screened for venous thromboembolism (VTE).

ADVERSE REACTIONS:

The most frequent (incidence ≥ 10%) adverse reactions in clinical trials were abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain.

To report SUSPECTED ADVERSE REACTIONS, contact KEDRION at 1-855-427-6378 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for the RYPLAZIM Full Prescribing Information.

This site is intended for residents of the US only.

Reference:

1. RYPLAZIM [prescribing information]. Kedrion Biopharma Inc. 2024.