National Organization for Rare Disorders’ 2022 Industry Innovation Award awarded to Kedrion Biopharma for bringing RYPLAZIM to patients3
PLASMINOGEN REPLACEMENT THERAPY IS FINALLY AVAILABLE1,2
RYPLAZIM (plasminogen, human-tvmh) is plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (PLGD-1).1
RYPLAZIM IS THE ONLY FDA-APPROVED TREATMENT
for patients with PLGD-1.1,2
RYPLAZIM is a treatment containing human plasminogen and is used to increase plasminogen levels in the blood of people with PLGD-1. Treatment with RYPLAZIM temporarily corrects the plasminogen deficiency to help reduce or resolve lesions.1
CLINICAL TRIAL RESULTS1*:
100%
saw improvement in visible or other measurable lesions†
78%
of external lesions completely resolved
75%
of internal lesions completely resolved
*In a single-arm, open label clinical trial, 15 subjects with PLGD-1 received 6.6 mg/kg RYPLAZIM every 2 to 4 days to achieve more than 10% increase above baseline in trough plasminogen activity levels.
†Improvement defined as a change of 50% or more in lesion number or size or ability to function compared to before starting treatment.
RYPLAZIM IS A TREATMENT OPTION FOR ADULT AND PEDIATRIC PATIENTS WITH PLGD-11
THINGS TO KNOW WHEN CONSIDERING RYPLAZIM1
Do not take Ryplazim if you have had a severe reaction to Ryplazim or any of its components.
Before taking RYPLAZIM, tell your healthcare provider if you:
- Have had other medical problems, particularly bleeding problems.
- Use any medicine, including prescription and over-the-counter drugs, supplements, and herbal remedies.
- Have had reactions to any medications.
- Are pregnant or planning to become pregnant. It is not known whether RYPLAZIM may affect your pregnancy or an unborn baby.
- Are breastfeeding or are planning to breastfeed. It is not known whether RYPLAZIM affects milk production, passes into breast milk and may affect a baby.
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.
Learn about viral safetyPOSSIBLE SIDE EFFECTS
Common side effects of RYPLAZIM (reported in more than 10% of people in clinical studies) are1:
Abdominal pain (16%) Gastric dilation (bloating/feel bloated) (16%) Nausea (16%)
Fatigue (16%) Pain in extremity (16%) Hemorrhage (16%)
Constipation (11%) Dry mouth (11%) Headache (11%)
Dizziness (11%) Arthralgia (11%) Back pain (11%)
You are encouraged to report negative side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch.
TREATMENT WITH RYPLAZIM
RYPLAZIM is given directly into the bloodstream (intravenously).1
You may receive RYPLAZIM at a healthcare facility, or you may receive it at home from a nurse, caregiver, or by infusing it yourself. Your healthcare provider or specialty pharmacy will help coordinate your care.
INFUSING RYPLAZIM AT HOME
If your healthcare provider believes you would be able to infuse RYPLAZIM yourself or with the help of others at home, then you will receive detailed instructions and training on preparation and infusion.
See the Instructions for Use in the full Prescribing Information about how to prepare, infuse, and store RYPLAZIM.
Your healthcare provider will tell you how often to take RYPLAZIM and how much RYPLAZIM to use each time.
Do not attempt an intravenous infusion on yourself unless you or your caregiver has been trained by a healthcare provider. Always follow the specific instructions that your healthcare provider has given you.
Your healthcare provider may order periodic blood tests to check your plasminogen level.
Do not use RYPLAZIM for a condition other than that prescribed by your healthcare provider.
Do not share RYPLAZIM with other people, even if they have the same symptoms that you have.
Do you have questions about the infusion process or about treatment with RYPLAZIM?
Ask a Kedrion Nurse Educator