SUMMARY

• UPTRAVI for injection, for intravenous (IV) use, is supplied in a 10 mL type I glass vial closed by a stopper and sealed with an aluminum flip-off button, containing 1800 mcg of selexipag.¹
• The dose of UPTRAVI for injection is determined by the patient’s current dose of UPTRAVI tablets.¹
• UPTRAVI for injection is administered as an IV infusion at a dose of 225 mcg to 1800 mcg twice daily over 80 minutes.¹
• Please refer to the DOSAGE AND ADMINISTRATION section of the full Prescribing Information.¹

PRODUCT LABELING

Recommended Dosage

Use UPTRAVI for injection in patients who are temporarily unable to take oral therapy.¹

Administer UPTRAVI for injection twice daily by IV infusion at a dose that corresponds to the patient’s current dose of UPTRAVI tablets (see Table: Dosing Table for UPTRAVI IV Based on Current UPTRAVI Tablets Dose). Administer UPTRAVI for injection as an 80-minute IV infusion.¹

Preparation Instructions

Reconstitute and further dilute UPTRAVI for injection prior to IV infusion following aseptic procedures.¹

Determine the dose and total volume of reconstituted UPTRAVI solution required.¹

Reconstitution

• Remove the carton of UPTRAVI for injection from the refrigerator and allow to stand for approximately 30 to 60 minutes to reach room temperature (20°C to 25°C [68°F to 77°F]).¹
• The vial needs to be protected from light at all times. Ensure the protective wrap around the label is covering the entire vial.¹
• Peel back the light protective wrap on the vial to inspect the contents in the vial. It should appear as a white to almost white broken cake or powdered material. Immediately close the light protective wrap on the vial.¹
• Reconstitute UPTRAVI for injection using a polypropylene syringe with 8.6 mL of 0.9% Sodium Chloride Injection, USP and slowly inject into the UPTRAVI vial with the stream directed toward the inside wall of the vial to obtain a concentration of 225 mcg/mL of selexipag.¹
• Document the date and time of the first puncture. Complete the infusion within 4 hours of the first puncture.¹
• Gently invert the vial and repeat until the powder is completely dissolved. Do not shake.¹
• Inspect the vial by peeling back the light protective wrap around the label for discoloration. The reconstituted solution should appear clear, colorless, and free from foreign material. Do not use if the reconstituted solution is discolored, cloudy, or contains visible particles.¹

Dilution

• UPTRAVI for injection must be diluted in glass containers only.¹
• Withdraw 100 mL of 0.9% Sodium Chloride Injection, USP and transfer into an empty sterile glass container.¹
• Withdraw the required volume of reconstituted solution from the UPTRAVI vial using a single appropriately sized polypropylene syringe and dilute into the glass container containing 100 mL of 0.9% Sodium Chloride Injection, USP to obtain the desired final dose.¹
• Mix the diluted UPTRAVI infusion solution by gentle inversion of the glass container 5 times. Do not shake.¹
• Protect the diluted UPTRAVI infusion solution from light at all times. Assign a 4-hour expiry from the time of the first vial puncture and wrap the glass container completely with light protective cover.¹
• The UPTRAVI infusion solution should be kept at room temperature (20°C to 25°C [68°F to 77°F]) and must be infused within 4 hours from the first puncture of the vial stopper (including infusion time).¹
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The diluted UPTRAVI infusion solution should be clear and colorless. Discard if particulate matter is observed.¹

UPTRAVI for injection vials are single dose, for single administration. All remaining reconstituted product must be discarded.¹

Administration Instructions

Administer by IV infusion over 80 minutes using an infusion set made of di(2-ethylhexyl) phthalate (DEHP)-free polyvinyl chloride (PVC), natural latex rubber-free microbore tubing protected from light.¹

Do not use a filter for administration.¹

Once the solution for infusion glass container is empty, continue the infusion at the same rate with 0.9% saline to empty the remaining solution for infusion in the IV line to ensure that the entire solution for infusion has been administered.¹

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 16 April 2024.