Diluting Veletri and Filling the Medication Cassette
Instruct patients to attach an 18-gauge needle to the 60-mL syringe and
pull back the plunger to the 50-mL mark.
Tell patients to inject air into the NS or SW bottle until they feel resistance.
Instruct your patients to place the needle tip below the fluid surface; the air injected into the bottle will draw fluid into the syringe. Tell your patient that they may need to inject air into the bottle 2 or 3 times to draw the desired amount* of NS or SW. Once they have the desired amount of fluid drawn, have them to 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 above.
Next, have patients remove the cap from the end of the medication
cassette and place it onto the clean work surface. Tell patients to make
sure they do not drop the cap because it could become contaminated.
Advise patients to be careful not to touch the end of the exposed tubing.
Have patients add the NS or SW to the cassette by screwing the syringe
onto the end of the tubing.
Note: Make sure to tell patients to close the side clamp on the reservoir tubing after filling it with solution; otherwise the medication will flow out.
Next, instruct patients to remove the needle from the syringe containing the 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 side clamp of the cassette tubing.
Have patients repeat 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, instruct patients to tilt the cassette so that large air
bubbles rise to the corner of the cassette where the tubing is attached.
Have patients unclamp the tubing to remove air from the cassette. Advise
them to pull back the plunger until ALL the air is removed from the
cassette and tubing.
Instruct patients to change the tubing and remove the syringe from the
cassette tubing; then have them attach the new sterile cap that was
provided in the package.
Advise patients to discard all used needles and any other sharp materials
in a sharps container.
Instruct patients to connect the cassette by fitting the hooks onto the pivot
pins at the base of the pump. Have them push the cassette up against the
pump. Next, have them place the joined pump and cassette in an upright
position on a steady surface. Make sure they secure the cassette by using
the provided key to turn the lock knob 90° counterclockwise until they feel
it stop.
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.
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