HEALTHCARE PROFESSIONALS

Diluting the Medication and Filling the Medication Cassette

Attach an 18-gauge needle to a 60-mL syringe and pull back the plunger to the 50-mL mark.

Note: The same solution must be used for both mixing (reconstituting) and diluting VELETRI® (epoprostenol) for Injection. Do not combine sterile water (SW) with normal saline (NS) when preparing VELETRI.

 

Inject air into the NS or SW bottle until you feel resistance.

Be careful to avoid touching the plunger shaft.

 

Place the needle tip below the fluid surface; the air you injected into the bottle will draw fluid into the syringe. You may need to inject air into the bottle 2 or 3 times to draw the desired amount* of NS or SW. Once you have the desired amount of fluid drawn, remove the needle.

*Desired amount is 50 mL minus the mL amount of VELETRI drawn earlier in Reconstitution step 11. For example, if 5 mL was used in step 11, then 45 mL should be drawn up for step 3.

 

Next, remove the cap from the end of the medication cassette and place it on your clean work surface. Make sure you do not drop the cap, because it could become contaminated. Be careful not to touch the end of the exposed tubing.

 

Add the NS or SW to the cassette by screwing the syringe onto the end of the tubing.

Note: Close the slide clamp on the reservoir tubing after filling it with solution; otherwise, the medication will flow out.

Remove the empty syringe by unscrewing it.

 

Next, remove the needle from the syringe containing VELETRI. Attach the syringe to the tubing on the medication cassette. Unclamp the tubing and inject the drug into the medication cassette. Recap the end and close the slide clamp of the cassette tubing.

 

Repeat dilution steps 1 through 5 with a second vial of NS or SW, drawing up a total of 50 mL of fluid. The total volume in the medication cassette will then equal 100 mL.

 

To remove excess air, tilt the cassette so that large air bubbles rise to the corner of the cassette where the tubing is attached.

 

Unclamp the tubing to remove air from the cassette. Pull back the plunger until ALL the air is removed from the cassette and tubing.

 

Clamp the tubing and remove the syringe from the cassette tubing; then attach the new sterile cap that was provided in the package.

 

Discard all used needles and any other sharp materials in a sharps container.

Each vial is for single use only. Discard any unused VELETRI solution.

 

Connect the cassette by fitting the hooks onto the pivot pins at the base of the pump. Push the cassette up against the pump. Place the joined pump and cassette in an upright position on a steady surface. Secure the cassette by using a coin to turn the lock knob 90° counterclockwise until you feel it stop.

Learn about storing VELETRI


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.