HEALTHCARE PROFESSIONALS

Mixing (Reconstituting) VELETRI® (epoprostenol) for Injection

Thoroughly wash your hands with soap and warm water for at least one minute, then dry. To help prevent infection, clean your work surface with disinfectant wipes or 70% alcohol.

 

Remove the caps from the vial of VELETRI and from the normal saline (NS) or sterile water (SW).

If you are using the 0.5 mg vial of VELETRI, the cap will be white.

 

Clean the rubber stoppers of the vials of VELETRI and NS or SW with a disinfectant or antiseptic pad, or a pad with 70% alcohol.

Important: VELETRI is stable only when reconstituted as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. VELETRI must not be reconstituted or mixed with any other intravenous medications or solutions prior to or during drug administration. The same solution must be used for both reconstituting and diluting VELETRI. Do not combine sterile water with normal saline when preparing VELETRI.

These solutions are commercially available and can be purchased from either regular or specialty pharmacies.

Hold the 5-mL or 10-mL syringe with needle and draw back the plunger to the 5-mL mark to draw in air.

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 (see inset) 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 the 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 (see inset) 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 that may be present 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.

Note: Please be cautious when re-capping the needle. As there are alternatives to re-capping the needle, please discuss this step with your healthcare professional.

Repeat steps 2 through 11 if more than one vial of VELETRI is being used.

Learn about diluting VELETRI and filling the medication cassette


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. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI 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. It is the use of these medications concomitantly (in combination) with VELETRI that may potentially cause an increase in the risk of bleeding.

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. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI 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. It is the use of these medications concomitantly (in combination) with VELETRI that may potentially cause an increase in 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 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.

What are the possible side effects of VELETRI?

You may have side effects at the start of treatment or with dose increases. The most common side effects seen in at least 1% of patients were flushing, headache, nausea/vomiting, low blood pressure, anxiety/nervousness, chest pain, dizziness, slow heartbeat, abdominal pain, pain in the muscles and/or ligaments and bones, shortness of breath, back pain, sweating, upset stomach, numbness/increased sensitivity, and fast heartbeat.

The most common side effects in patients with PAH due to unidentified or hereditary factors with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were flu-like symptoms, fast heartbeat, flushing, diarrhea, nausea/vomiting, jaw pain, pain in the muscles and/or ligaments and bones, anxiety/nervousness, dizziness, headache, and numbness/increased sensitivity/tingling.

The most common side effects in patients with PAH due to connective tissue disease with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were flushing, low blood pressure, lack of appetite, nausea/vomiting, diarrhea, jaw pain, neck/joint pain, headache, skin ulcer, and rash.

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 or www.fda.gov/medwatch.

Please see full Prescribing Information.