RYPLAZIM® (plasminogen, human-tvmh) is a plasma-derived human plasminogen used to treat people with plasminogen deficiency type 1 (PLGD-1). It increases plasminogen levels in the blood and is the only FDA-approved treatment for PLGD-1. Talk to your doctor to see if it's right for you.1,2
RYPLAZIM is a treatment for adults and children with PLGD-1, as prescribed by their healthcare provider.1
RYPLAZIM temporarily replaces missing plasminogen in the blood.1 Your doctor can explain how this may help reduce or resolve lesions caused by PLGD-1.
Once reconstituted (adding water), RYPLAZIM is given through a needle into a vein (intravenously, or IV). You may receive RYPLAZIM at a healthcare facility or at home from a nurse, caregiver, or by infusing it yourself after training from a healthcare provider. Do not attempt an IV infusion unless you or your caregiver have been trained.1
The cost of RYPLAZIM varies based on many factors like insurance coverage and individual care needs. Kedrion offers financial support through the RYPLAZIM Co-Pay Assistance Program. Talk to your healthcare provider or care coordinator about co-pay assistance and check out the Plasminogen Deficiency Foundation's Insurance Approval Toolkit for additional information.
FDA-approved dosing for RYPLAZIM is every 2 to 4 days.1 Your healthcare provider will tell you how much and how often to take RYPLAZIM. Please follow your doctor's instructions and see the full Prescribing Information for details.
RYPLAZIM temporarily replaces the plasminogen that your body is missing. Your plasminogen levels will drop between infusions as your body gradually uses and clears the plasminogen from your body. This means you have to consistently replace the plasminogen in your body with regular infusions.1,3
PLGD-1 is a lifelong disease because it's caused by a genetic problem that keeps the body from making working plasminogen.4 RYPLAZIM only works when you use it consistently and as prescribed by your doctor.3
The most common side effects (≥10%) include abdominal pain, bloating, nausea, fatigue, pain in extremity, hemorrhage, constipation, dry mouth, headache, dizziness, joint pain, and back pain. Call your doctor for medical advice about side effects.1
You may report side effects to Kedrion at 1-855-353-7466 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Do not use RYPLAZIM if you are allergic to plasminogen or other components of RYPLAZIM. RYPLAZIM may lead to bleeding at lesion sites or worsen active bleeding not related to lesions; your care team may monitor you during and after infusion in certain situations. Allergic reactions (including anaphylaxis) can occur. Because RYPLAZIM is made from human plasma, there is a risk of transmitting infectious agents. See the Important Safety Information and the full Prescribing Information for more details.1
If your doctor suspects PLGD-1, they will check for visible or internal lesions, ask about your family history, and confirm it’s PLGD-1 with a plasminogen activity test showing that your plasminogen isn’t working as it should. Genetic testing may be done, but isn’t required to confirm a PLGD-1 diagnosis.4,5
Start with your diagnosing doctor and ask about a referral to a hematologist experienced in PLGD-1.
You can request contact from a Kedrion Nurse Educator for educational support on PLGD-1, RYPLAZIM, infusions, and connections to helpful resources.
You can also check out the Plasminogen Deficiency Foundation's "Newly Diagnosed Toolkit" here.
Since PLGD-1 can affect multiple organs, people with PLGD-1 may see different specialists depending on their symptoms. A doctor who specializes in conditions affecting the blood, called a hematologist, often helps patients during treatment with RYPLAZIM.5
You can connect with a Nurse Educator for educational questions and explore community organizations like the Plasminogen Deficiency Foundation and the National Organization for Rare Disorders for support and resources.
Have a question that's not answered here?
Check out the Plasminogen Deficiency Foundation's FAQ Toolkit or connect with a Kedrion Nurse Educator.
APPROVED USE
RYPLAZIM® (plasminogen, human-tvmh) is used for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
IMPORTANT SAFETY INFORMATION
Do not use RYPLAZIM if you are a patient with known hypersensitivity to plasminogen or other components of RYPLAZIM.
- Bleeding: Use of RYPLAZIM may lead to bleeding at disease-related lesion sites or worsen active bleeding not related to disease lesions. Discontinue RYPLAZIM if serious bleeding occurs. If you are treated at a healthcare provider’s office or center, your healthcare provider will need to monitor you during the infusion and for 4 hours afterward, especially if you have a predisposition to bleeding or are taking anticoagulants, antiplatelet drugs, or other medications that may interfere with normal coagulation. If you infuse RYPLAZIM at home, you or your caregiver must also monitor you during and for 4 hours after the infusion under the same circumstances.
- Tissue Sloughing: If you have mucosal lesions in your respiratory tract, especially the tracheobronchial tree, and are treated with RYPLAZIM, respiratory distress may occur due to tissue sloughing. 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. You should consult with your healthcare provider if you have any questions or concerns.
- Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, may occur with RYPLAZIM. Immediately report any of the following signs or symptoms of an allergic reaction to your healthcare provider: swelling of the throat, tightness of the chest, low blood pressure, rash, nausea, vomiting, a tingling or pricking sensation, restlessness, wheezing or shortness of breath.
- Neutralizing Antibodies: Antibodies neutralizing plasminogen (also known as inhibitors) which can make the product less effective or ineffective, may form with the use of RYPLAZIM, although they were not observed in clinical trials. If clinical efficacy is not maintained (e.g., development of new or recurrent lesions), your healthcare provider will determine low levels of plasminogen in your plasma.
- Laboratory Abnormalities: Due to the activity of RYPLAZIM, you may have elevated blood levels of D-dimer that may interfere with screening for venous thromboembolism (VTE) using D-dimer levels.
- 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.
You may report side effects to +1(855)-353-7466 and US_Medicalinfo@kedrion.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more details, please see full Prescribing Information and the Patient Information.
This site is intended for residents of the US only.
References:
1. RYPLAZIM [prescribing information]. Kedrion Biopharma Inc. 2024.
2. FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder. US Food & Drug Administration. Updated June 4, 2021. Accessed February 5, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-plasminogen-deficiency-rare-genetic-disorder
3. Shapiro AD, McDaniel H, Decker RW, et al. Safety and efficacy of long-term treatment of type 1 plasminogen deficient patients with intravenous plasminogen replacement therapy. Haemophilia. 2025;31(3):477-484.
4. Congenital type 1 plasminogen deficiency. NORD. Updated February 6, 2025. Accessed February 5, 2026. https://rarediseases.org/rare-diseases/congenital-plasminogen-deficiency
5. Shapiro AD, Nakar C. How I treat type 1 plasminogen deficiency. Blood. 2025;145(25):2954-2965.