Ryplazim is a medicine containing human plasminogen and is used to increase the blood levels of plasminogen in people with plasminogen deficiency type 1 (hypoplasminogenemia). It is injected into a vein.

You should not use Ryplazim if you have had a severe reaction to Ryplazim or another product containing plasminogen.

Before using Ryplazim

Before using 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.

How do I take Ryplazim?

• Ryplazim is given directly into the bloodstream.
• You may receive Ryplazim at a healthcare facility, or you may receive it at home from a nurse, caregiver or by injecting it yourself. If your healthcare provider believes you would be able to inject Ryplazim yourself or with the help of others at home, then you will receive detailed instructions and training on preparation and infusion (see Instructions for Use at the end of this document).
• Your healthcare provider will tell you how often to take Ryplazim and how much Ryplazim to use each time.
• Your healthcare provider may order periodic blood tests to check your plasminogen level.

• Common side effects are:
  • abdominal pain
  • bloating
  • nausea
  • fatigue
  • extremity pain
  • hemorrhage
  • constipation
  • dry mouth
  • headache
  • dizziness
  • joint pain
  • back pain
• 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.
• 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.
• Other side effects are possible. Speak with your healthcare provider about any side effects that do not go away or bother you.

You may report side effects to +1(800) 735-4086 and [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Other drugs may interact with plasminogen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.