Is Ryplazim approved by the FDA?
Ryplazim, with the generic name plasminogen, human-tvmh, is an injectable medication used to treat plasminogen deficiency type 1 (hypoplasminogenemia). Ryplazim was approved by the U.S. Food and Drug Administration (FDA) on June 4, 2021. This approval marked a significant milestone as Ryplazim is the first therapy approved for treating plasminogen deficiency type 1, providing an essential treatment option for patients suffering from this rare disorder.
Indications and Usage
Ryplazim is specifically indicated to increase the blood levels of plasminogen in individuals with plasminogen deficiency type 1. The medication is administered directly into the bloodstream, either in a healthcare facility or at home under appropriate supervision.
Administration
The administration of Ryplazim involves:
- Intravenous Infusion: Given directly into a vein, it may be administered by healthcare providers or trained patients/caregivers at home.
- Preparation: Detailed instructions for preparation and infusion are provided to ensure proper administration. This includes gathering the necessary supplies, reconstituting the medication with sterile water, and using a syringe disc filter for the infusion.
Warnings and Precautions
Allergic Reactions: Patients should not use Ryplazim if they have had severe reactions to it or any other plasminogen-containing products. Allergic reactions can include trouble breathing, chest tightness, swelling, itching, and rash.
Pregnancy and Breastfeeding: It is not known if Ryplazim affects pregnancy or passes into breast milk. Patients should inform their healthcare provider if they are pregnant, planning to become pregnant, or breastfeeding.
Bleeding Risks: Ryplazim may worsen or prolong bleeding. It is crucial to seek emergency care if experiencing significant or persistent bleeding.
Antibody Formation: The body may produce antibodies against Ryplazim, which could reduce its effectiveness. Regular monitoring by healthcare providers is necessary.
Side Effects
Common side effects of Ryplazim include:
- Abdominal pain
- Bloating
- Nausea
- Fatigue
- Pain in extremities
- Hemorrhage
- Constipation
- Dry mouth
- Headache
- Dizziness
- Joint pain
- Back pain
Patients should immediately stop treatment and contact their healthcare provider if they experience symptoms of a severe allergic reaction or significant side effects.
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