What is Ryplazim?
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.
Who should not use Ryplazim?
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.
Ryplazim side effects
- Common side effects are:
- abdominal pain
- extremity pain
- dry mouth
- 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@example.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What other drugs will affect Ryplazim?
How do I store Ryplazim?
- Store Ryplazim vials in the refrigerator or at room temperature (36°F to 77°F, [2°C to 25°C]). Do not freeze.
- Store the other supplies at room temperature (68°F to 77°F [20°C to 25°C]).
- After the vials are opened and mixed with Sterile Water for Injection (SWFI), they must be used within 3 hours.
- Keep the vials in the original package before using.
- Do not use Ryplazim or SWFI after the expiration date on the vials.
- 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.
Instructions for Use
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. The steps listed below are general guidelines for using Ryplazim. If you are unsure about any of the steps, contact your healthcare provider before using.
A. Gathering Supplies
- Your healthcare provider should tell you how many vials of Ryplazim to use based on your weight. If you store Ryplazim in the refrigerator, then let the vials sit at room temperature for at least 15 minutes before you use them.
- Check the expiration date on the vial labels and carton. Do not use Ryplazim or Sterile Water for Injection, USP vials after the expiration date.
- Make sure you work on a clean, flat surface.
- Gather the following supplies and any other materials that you will need, as instructed by your healthcare provider:
- Required number of vials of Ryplazim
- One 20-mL syringe per vial of Ryplazim for mixing the drug
- 18- to 22-gauge needles for reconstitution and administration
- Sterile Water for Injection, USP (SWFI) (10 mL, 20 mL or 50 mL)
- One syringe disc filter per infusion of Ryplazim required (Baxter Supor® 5-micron Syringe Filter or equivalent)
- One (or more) administration syringe(s) (20mL, 30mL or 60 mL)
- Alcohol wipes
- Antiseptic surface wipes
- Medical tape
- Butterfly needle or sterile infusion set
- 10 mL normal saline
- Sterile gauze pad
B. Preparing Ryplazim
- Always work on a clean surface and wash your hands before performing the procedure.
- Once the Ryplazim has been prepared, use it at room temperature within 3 hours. Do not refrigerate after preparation.
- Remove the caps from the Ryplazim vials and the Sterile Water for Injection, USP (SWFI) vials to expose the central portion of the rubber stoppers.
- Clean the surface of the rubber stoppers with alcohol wipes and allow to dry. Do not blow on them. Do not touch the rubber stoppers with your hand after cleaning them.
- Using a syringe with an 18- to 22-gauge needle, draw 12.5 mL of SWFI. Ensure that all air bubbles have been removed.
Note: Depending on the SWFI vial sizes used, more than one SWFI vial(s) may be required.
- If using a 10-mL vial of SWFI, you will need two 10-mL vials of SWFI for each vial. Draw 9.0 mL of SWFI from the first SWFI vial with the 20-mL syringe. Discard the first needle, attach a new 18- to 22-gauge sterile needle and draw 3.5 mL from the second 10-mL vial of SWFI to equal to 12.5 mL.
- Repeat the above process for every vial that will need to be reconstituted.
- If using a 20-mL or 50-mL vial of SWFI, only one vial of SWFI per vial will be needed for reconstitution.
- Do not use the remaining SWFI in the vial with a different Ryplazim vial.
NOTE: A 30-mL syringe cannot hold more than 2 vials of reconstituted Ryplazim and a 60-mL syringe cannot hold more than 4 vials of reconstituted Ryplazim.
- One filter is needed per infusion.
- Only administer Ryplazim by infusing it into a vein through a syringe disc filter.
- Inspect the solution in the syringe. Do not use if you see discoloration or particulate matter.
- Administer Ryplazim by a separate infusion line. Do not administer Ryplazim with other medications.
- Draw 10 mL of normal saline into a different syringe. Push the plunger down to remove any air bubbles.
- Attach a syringe disc filter to the pre-filled syringe of normal saline (from previous step) and the infusion tubing with butterfly needle.
- Inject the normal saline through the syringe disc filter and butterfly needle tubing to remove any air bubbles.
- Remove the normal saline syringe. The syringe disc filter must remain attached to the tubing, as it is required for administration of the Ryplazim. Discard the normal saline syringe.
- Attach the administration syringe containing Ryplazim to the syringe disc filter that is connected to the butterfly needle tubing.
- Choose a peripheral vein (e.g., antecubital or dorsum of hand). Clean the injection site with a sterile alcohol wipe and allow to dry. Do not blow on it.
- Insert the butterfly infusion set needle in the chosen peripheral vein, as taught by your healthcare provider, and tape in place.
- Infuse the amount of Ryplazim you need as instructed by your healthcare provider. Deliver the total dose slowly over 10-30 minutes (approximately 5 mL/min). Using a timer (e.g., watch or clock), push the plunger of the syringe approximately 1 mL every 12 seconds.
- Discard any open vials, unused solution, and administration equipment following administration.
More about Ryplazim (plasminogen, human)
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