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Look into these support groups to learn more about PLGD-1, find disease specialists, and access resources for both people living with PLGD-1 and their caregivers.
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APPROVED USE
RYPLAZIM® (plasminogen, human-tvmh) is a medicine used for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
IMPORTANT SAFETY INFORMATION
RYPLAZIM is contraindicated in patients with known hypersensitivity to plasminogen or other components of RYPLAZIM.
- Do not take RYPLAZIM if you have had a severe reaction to RYPLAZIM or another product containing plasminogen.
- Tell your healthcare provider about all of your medical conditions, including any medicines you take, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
- RYPLAZIM may worsen or prolong ongoing bleeding. In addition, if you have abnormal tissue growths because of your low plasminogen level, then you may have bleeding as these growths heal in response to treatment with RYPLAZIM.
- If you vomit blood, have blood from your rectum or black tarry stools or any bleeding that is heavy or does not resolve after 30 minutes of direct pressure seek emergency care and discontinue further use of RYPLAZIM.
- As your lesions heal then they will fall off, known as tissue sloughing, this is in response to treatment with RYPLAZIM. This is also normal response and is not a side effect. Specific examples:
- If you have tissue growths in your airway or lungs you may cough up small amounts of tissue and you may cough up a small amount of blood or blood clots.
- If you have tissue growths in your genitourinary system then you may pass tissue or blood clots in your urine or from your penis or vagina.
- If you have tissue growths in your gastrointestinal system you may have some tissue or blood clots in your stool or you may vomit blood or blood clots.
- If you have eye lesions you may have oozing of blood from the lesions in your eye.
- Notify your healthcare provider if you develop breathing difficulty, wheezing, cough, changes in speech, or pain in the back, abdomen, groin, or pelvic area, because these could be symptoms of tissue from resolving lesions that are obstructing the lungs, the kidneys, the bladder, the uterus and/or vagina, or the intestines.
- 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 may have an allergic reaction while taking RYPLAZIM. Stop treatment and contact your healthcare provider immediately if you develop trouble breathing, wheezing, chest tightness, light headedness, dizziness, swelling in the face or throat, itching, a rash, or hives. Your body may make antibodies against RYPLAZIM that may stop RYPLAZIM from working properly. Your healthcare provider will monitor you periodically for lesions which may be due to a low plasminogen level. If you develop new lesions or a recurrence of a previous lesion, then your healthcare provider will obtain blood to test for plasminogen activity level.
- In clinical trials, the most common (incidence ≥ 10%) side effects associated with the infusion of RYPLAZIM were abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain.
- Female patients who are pregnant or may become pregnant should be aware that the potential effects of RYPLAZIM on pregnancy and breastfeeding are unknown. They should notify their physicians if they become or intend to become pregnant, or if they plan to breastfeed.
- Other side effects are possible. Speak with your healthcare provider about any side effects that do not go away or bother you.
You are encouraged to report negative side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or www.fda.gov/medwatch.
For more details, please see full Prescribing Information and the Patient Information.
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