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.
Ryplazim side effects
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.
Before taking Ryplazim
You should not use Ryplazim if you have had a severe reaction to Ryplazim or another product containing plasminogen.
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
Bandage
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.
Gently and slowly add the 12.5 mL of SWFI down the side of the Ryplazim vial to prevent foaming. This should resemble a stream down the side of the vial. Discard used syringe and needle(s).
Gently swirl the vial in slow rotation to ensure it is fully dissolved. Do not shake the vial. The Ryplazim should fully dissolve within 10 minutes. Discard if the product is not fully dissolved after 10 minutes.
After the Ryplazim is dissolved in the SWFI, inspect the solution. It should be colorless and clear to slightly pearly. Discard if discoloration or particulate matter is observed.
Repeat Preparation Steps 3 to 8 above for each vial of Ryplazim needed.
Select an administration syringe of appropriate volume based on the dose required. Depending on the syringe size used, more than one vial of mixed Ryplazim can be drawn into one administration syringe. 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.
Using the selected administration syringe(s) with an 18- to 22-gauge needle, slowly draw the Ryplazim from each reconstituted vial to administer the required dose. Do not mix Ryplazim with other medications.
After drawing the Ryplazim from the last vial, push the plunger down to remove any air bubbles. Dispose of the needle in an appropriate container.
Infusing 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.
What other drugs will affect Ryplazim
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.
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