Storing Veletri†
Understanding your options
IMMEDIATE USE
You only have to change cassettes every 24 hours when Veletri is prepared as directed and used immediately after reconstitution and dilution at concentrations equal to or greater than 6,000 ng/mL.
‡ If you've stored reconstituted solution in the vial prior to dilution to final concentration, this does not apply. Please see section 2.4 of accompanying full prescribing information for complete information about use after storage of reconstituted solution.
- This option applies only to Veletri concentrations equal to or greater than 6,000 ng/mL.
- For concentrations less than 6,000 ng/mL, the maximum time for use at room temperature is 12 hours. This means you need to change your cassette every 12 hours.
- Even though the table includes information on stability up to 72 hours, the pump is not designed for use beyond 48 hours.
1-DAY STORAGE
You can store cassettes in the refrigerator (36°F to 46°F/2°C to 8°C) for 1 day and then use at room temperature (77°F/25°C) for up to 24 hours when Veletri is reconstituted and immediately diluted at concentrations between 12,000 ng/mL and 30,000 ng/mL.
You can store cassettes in the refrigerator (36°F to 46°F/2°C to 8°C) for 1 day and then use at room temperature (77°F/25°C) for up to 48 hours when Veletri is reconstituted and immediately diluted at concentrations equal to or greater than 30,000 ng/mL.
‡ If you've stored reconstituted solution in the vial prior to dilution to final concentration, this does not apply. Please see section 2.4 of accompanying full prescribing information for complete information about use after storage of reconstituted solution.
- Concentrations equal to or greater than 12,000 ng/mL may be used at room temperature for up to 24 hours.
- Concentrations equal to or greater than 30,000 ng/mL may be used at room temperature for a total of 48 hours.
- Concentrations equal to or greater than 6,000 ng/mL and less than 12,000 ng/mL may be used at room temperature for 12 hours.
- Cassettes at concentrations less than 6,000 ng/mL cannot be used at room temperature after being stored for 1 day.
STORAGE FOR UP TO 7 DAYS
You can prepare up to 7 days' worth of medication in advance and store fully diluted cassettes in the refrigerator (36°F to 46°F/2°C to 8°C) and use at room temperature for up to 24 hours at concentrations equal to or greater than 30,000 ng/mL.
‡ If you've stored reconstituted solution in the vial prior to dilution to final concentration, this does not apply. Please see section 2.4 of accompanying full prescribing information for complete information about use after storage of reconstituted solution.
- This storage option applies only to Veletri concentrations equal to or greater than 30,000 ng/mL.
- For concentrations between 9,000 ng/mL and 30,000 ng/mL, the maximum time of use at room temperature is 12 hours after 7 days of refrigeration.
- Cassettes at concentrations less than 9,000 ng/mL cannot be used at room temperature after being stored for 7 days.
For more information about storing Veletri, please see the full prescribing information.
†Veletri offers some unique preparation, storage, and administration options. Your doctor will choose the one that is right for you.
*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.
