Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache (27% vs. The IV infusion of Remodulin with an external infusion pump has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin. In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness, swelling, and rash).Remodulin inhibits platelet aggregation and increases the risk of bleeding.In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension. Remodulin is a pulmonary and systemic vasodilator.Titrate slowly in patients with hepatic or renal insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration. Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal.The CADD-MS ® 3 ambulatory infusion pump should not be used for premixing.Do not use reservoirs that have been stored for more than 14 days.Reservoir tubing should be capped before storage.Remodulin cannot be stored for 14 days when mixed with sterile water for injection or 0.9% sodium chloride injection (only 4 hours at room temperature or 24 hours refrigerated) 3 14-day premixing should be done only with high-pH glycine diluent.Be sure to share the following information with your patients Remind patients to continue to change the reservoir at least every 2 days. Be sure to inform the SP if you deem a patient appropriate for premixing at home Specialty Pharmacies can answer any questions they may have about premixing and supply the necessary diluent needed for 14-day premixing.

Be sure to contact the Specialty Pharmacy (SP).Carefully consider your patient’s dosing schedule, mixing proficiency, and diluent.SPmix delivers weekly shipments to eligible patientsīefore introducing the topic of premixing with a patient:

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