Reconstituting Veletri
Prepare a clean work surface.
Remove the caps from the vial of Veletri and from the normal saline (NS) or sterile water (SW).
Clean the rubber stoppers of the vials of Veletri and NS or SW with an alcohol pad.
Important: Veletri is stable only when reconstituted as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. These solutions are readily available from approved specialty pharmacies. Veletri must not be reconstituted or mixed with any other intravenous medications or solutions prior to or during administration, including Sterile Diluent for Flolan®.
Flolan is a registered trademark of GlaxoSmithKline.
Hold the 5-mL or 10-mL syringe with needle and draw back the plunger to the 5-mL mark.
Be careful to avoid touching the plunger shaft.
Confirm that the needle is tightly attached to the syringe before removing the needle cap.
Insert the needle's tip bevel up (as shown) into the NS or SW vial at a 45-degree angle. Push the needle into the core of the vial. Press down on the plunger to inject the air from the syringe into the solution.
With the needle still inserted into the vial, turn the vial upside down.
Position the needle tip below fluid level and draw the prescribed amount of NS or SW into the syringe.
Gently pull the syringe out of the vial.
To add the prescribed amount of NS or SW to the powdered Veletri medication vial, insert the needle's tip bevel up (as shown) at a 45-degree angle into the rubber stopper.
Slowly inject the NS or SW, making sure to prevent turbulence and foaming of the medication.
DO NOT SHAKE. Gently roll the vial of Veletri in your hands until the powder is completely dissolved and the solution is clear.
Turn the vial upside down to trap any undissolved powder near the top of the vial. Cloudiness and particles should not be present in the solution.
Draw back the appropriate amount of medication from the vial into the 5-mL or 10-mL syringe based on the desired concentration.
Recap the syringe and put it down on your clean work surface. You are now ready to fill the medication cassette.
Repeat steps 2 through 11 if more than one vial of Veletri is being used.
Learn about diluting Veletri and filling the medication cassette
*What is Veletri?
Veletri is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. Veletri may improve your ability to exercise as measured by how far you can walk in 6 minutes(6-minute walk test).
Studies showing Veletri is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.
Who should not take Veletri?
Veletri should not be used if you have heart failure due to severe left heart disease, if you develop fluid in the lungs (pulmonary edema) when starting therapy, or if you are allergic to epoprostenol.
Some medications may interact with Veletri. Please talk to your doctor about all of your medications.
What is the most important information I should know about Veletri?
It is important to use Veletri as directed by your doctor. Veletri should be used only with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix Veletri with other intravenous medications. Do not freeze Veletri or expose to direct sunlight.
When you take epoprostenol for the first time, you must be in a setting (hospital or clinic) where you can be monitored for any serious side effects or in case of emergency. Your blood pressure and heart rate should also be monitored with any dose changes. If you are taking Veletri, your doctor may prescribe another kind of medicine used to prevent blood clots. Use of these types of medicines may increase the risk of bleeding.
Sudden and dramatic changes in dose may lead to unstable blood pressure, a return of pulmonary hypertension symptoms, or fatal low blood pressure (hypotension). Do not stop using Veletri without first talking to your doctor. To reduce the risk of infection in the bloodstream, it is important to know how to properly care for the catheter and infusion pump.
What are the possible side effects of Veletri?
The most commonly reported side effects during clinical trials include flushing, jaw pain, headache, low blood pressure, fast heartbeat, nausea, vomiting, flu-like symptoms, anxiety/nervousness, and diarrhea.
Talk to your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Veletri. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see accompanying full prescribing information.
