Reconstituting Veletri
Have your patients prepare a clean workspace as previously explained.
Instruct patients to remove the caps from the vial of Veletri and from the normal saline (NS) or sterile water (SW).
Have patients 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®.
Instruct patients to hold the 5-mL or 10-mL syringe with needle and draw
back the plunger to the 5-mL mark. Advise them to be careful to avoid
touching the plunger shaft.
Before removing the needle cap, have patients confirm that the needle is tightly attached to the syringe, then remove the needle cap.
Instruct patients to insert the needle's tip bevel up (as shown) into the NS
or SW vial at a 45-degree angle and push the needle into the core of the
vial. Tell patients to press down on the plunger to inject the air from the
syringe into the solution.
With the needle still inserted into the vial, have patients turn the vial
upside down. Next have them position the needle tip below fluid level and
draw the prescribed amount of NS or SW into the syringe.
Advise patients to gently pull the syringe out of the vial.
To add the prescribed amount of NS or SW to the powdered Veletri
medication vial, instruct patients to insert the needle (bevel
up) at a 45-degree angle into the rubber stopper.
Next have patients slowly inject the NS or SW, making sure to prevent
turbulence and foaming of the medication.
Ensure that patients DO NOT SHAKE. Instruct patients to gently roll the vial of Veletri in their hands until the powder is completely dissolved and the solution is clear. Patients should 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.
Instruct patients to draw back the appropriate amount of medication from
the vial into the 5-mL or 10-mL syringe based on the desired
concentration.
Have patients recap the syringe and put it down on their clean work surface. Patients are now ready to fill the medication cassette.
Be sure to instruct patients to repeat steps 2 through 10 if more than one vial of Veletri is being used.
Flolan is a registered trademark of GlaxoSmithKline.
INDICATION
Veletri is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
IMPORTANT SAFETY INFORMATION
Veletri is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction, in patients who develop pulmonary edema during dose initiation, and in patients who have known hypersensitivity to the drug or to structurally related compounds.
Veletri should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension after establishing the diagnosis of idiopathic or heritable PAH or PAH/CTD.
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. Do not abruptly lower the dose or withdraw dosing. All dosing initiation and changes should be closely monitored.
The most common and dose-limiting adverse events during dose initiation and escalation were flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), chest pain (11%), and anxiety (11%).
Adverse events occurring in patients with idiopathic or heritable PAH with =10% difference between epoprostenol and conventional therapy alone were chills/fever/sepsis/flu-like symptoms (25% vs 11%), tachycardia (35% vs 24%), flushing (42% vs 2%), diarrhea (37% vs 6%), nausea/vomiting (67% vs 48%), jaw pain (54% vs 0%), myalgia (44% vs 31%), nonspecific musculoskeletal pain (35% vs 15%), anxiety/nervousness/tremor (21% vs 9%), dizziness (83% vs 70%), headache (83% vs 33%), and hypesthesia/hyperesthesia/paresthesia (12% vs 2%).
Adverse events occurring in patients with PAH/CTD with =10% difference between epoprostenol and conventional therapy alone were flushing (23% vs 0%), hypotension (13% vs 0%), anorexia (66% vs 47%), nausea/vomiting (41% vs 16%), diarrhea (50% vs 5%), jaw pain (75% vs 0%), pain/neck pain/arthralgia (84% vs 65%), headache (46% vs 5%), skin ulcer (39% vs 24%), and eczema/rash/urticaria (25% vs 4%).
Additional reductions in blood pressure may occur when Veletri is administered with diuretics, antihypertensive agents, or other vasodilators. There is the potential for Veletri to increase the risk of bleeding when administered with antiplatelet agents or anticoagulants. Patients on digoxin who receive Veletri may show elevations of digoxin concentration, which may be clinically significant in patients prone to digoxin toxicity.
Please see full Prescribing Information
