VELETRI® (epoprostenol) is a pulmonary arterial hypertension (PAH) treatment that may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).1
| • | VELETRI® should be used only by clinicians experienced in the diagnosis and treatment of pulmonary arterial hypertension |
| • | Stability depends on concentration, temperature, and timing of dilution and administration. Do not expose VELETRI® to direct sunlight |
Storing and Administering VELETRI®
8-day storage and once-weekly preparation
Prepare VELETRI®
for Injection for
immediate use
OR
Prepare up to 8 fully
diluted cassettes
once weekly.
Refrigerate (36°F to 46°F/2°C to
8°C) for up to 8 days, for use at
room temperature
24-hour room temperature stability at all concentrations
| • | Administer VELETRI® for up to 24 hours at room temperature (77°F/25°C) at any concentration without ice packs |
| • | Store a backup cassette for 24 hours at room temperature ◦ or for up to 8 days refrigerated then administer for 24 hours without ice packs |
| • | Do not expose VELETRI® to direct sunlight |
Note: It is not recommended that a single cassette be administered by pump beyond 24 hours.
Short excursions at 104°F/40°C are permitted for up to:
2 hours for concentrations below 15,000 ng/mL
4 hours for concentrations between 15,000 ng/mL and 60,000 ng/mL
8 hours for concentrations above 60,000 ng/mL
Short excursions at 104°F/40°C are permitted for up to:
2 hours for concentrations below 15,000 ng/mL
4 hours for concentrations between 15,000 ng/mL and 60,000 ng/mL
8 hours for concentrations above 60,000 ng/mL
Patients may administer VELETRI® without ice packs and remain on the same 24-hour cassette.
Reconstituting VELETRI®
| • | Reconstitute VELETRI® only as directed using Sterile Water for Injection, USP or Sodium Chloride 0.9% Injection, USP |
| • | Do not mix VELETRI® with any other parenteral medications or solutions prior to or during administration |
| • | Each vial is for single use only; discard any unused solution |
| • | Use after reconstitution and immediate dilution to final concentration |
| • | Use at room temperature (77ºF/25ºC). Do not expose VELETRI® to direct sunlight |
| • | Reconstitute VELETRI® only as directed using Sterile Water for Injection, USP or Sodium Chloride 0.9% Injection, USP |
| • | Do not mix VELETRI® with any other parenteral medications or solutions prior to or during administration |
| • | Each vial is for single use only; discard any unused solution |
| • | Use after reconstitution and immediate dilution to final concentration |
| • | Use at room temperature (77ºF/25ºC). Do not expose VELETRI® to direct sunlight |
| Maximum Duration of Administration (hours) at Room Temperature (77ºF/25ºC) of Fully Diluted Solution in the Drug Delivery Reservoir | |||
|---|---|---|---|
| Final concentration range | Immediate administration | If stored for up to 8 days at 36°F to 46ºF (2°C to 8ºC) | |
 0.5 mg vial | ≥3,000 ng/mL to <15,000 ng/mL | 48 hours | 24 hours |
 1.5 mg vial | ≥15,000 ng/mL to <60,000 ng/mL | 48 hours | 48 hours |
| ≥60,000 ng/mL | 72 hours | 48 hours | |
| Maximum Duration of Administration (hours) at Room Temperature (77ºF/25ºC) of Fully Diluted Solution in the Drug Delivery Reservoir | |
|---|---|
| 0.5 mg vial | |
| Final concentration range | |
| ≥3,000 ng/mL to <15,000 ng/mL | |
| Immediate administration | |
| 48 hours | |
| If stored for up to 8 days at 36°F to 46ºF (2°C to 8ºC) | |
| 24 hours | |
| 1.5 mg vial | |
| Final concentration range | |
| ≥15,000 ng/mL to <60,000 ng/mL | ≥60,000 ng/mL |
| Immediate administration | |
| 48 hours | 72 hours |
| If stored for up to 8 days at 36°F to 46ºF (2°C to 8ºC) | |
| 48 hours | 48 hours |
Note: It is not recommended that a single cassette be administered by pump beyond 24 hours.
The 0.5-mg vial is to be used for patients on concentrations of VELETRI® <15,000 ng/mL.
See step-by-step instructions for your patients for reconstitution, dilution, and storage of VELETRI®.
| • | Prepare continuous chronic infusion of VELETRI® as directed, and administer through a central venous catheter | ||||||||
| • | Temporary peripheral intravenous infusion may be used until central access is established | ||||||||
|
In clinical trials, the most common dose-limiting adverse events were not considered serious and included:
| • | Nausea |
| • | Vomiting |
| • | Hypotension |
| • | Sepsis |
| • | Headache |
| • | Abdominal pain |
| • | Respiratory disorder |
Consider increments in dose if symptoms of pulmonary hypertension persist or recur.
| • | Adjust the infusion by 1 to 2 ng/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be at least 15 minutes |
In clinical trials, incremental increases in dose occurred at intervals of 24 to 48 hours or longer. Following establishment of new chronic infusion rate, perform the following for several hours to ensure that the new dose is tolerated:
| • | Observe the patient |
| • | Monitor standing and supine blood pressure and heart rate |
During chronic infusion, the occurrence of dose-limiting pharmacological events may necessitate a decrease in infusion rate, but the adverse event may occasionally resolve without dosage adjustment.
| • | Make dosage decreases gradually in 2 ng/kg/min decrements every 15 minutes or longer until the dose-limiting effects resolve |
| • | Avoid abrupt withdrawal of VELETRI® or sudden large reductions in infusion rates. Except in life-threatening situations (eg, unconsciousness, collapse, etc), infusion rates of VELETRI® should be adjusted only under the direction of a physician |
Reference: 1. VELETRI® (epoprostenol) for Injection Full Prescribing Information. Actelion Pharmaceuticals US, Inc.