IV Administration Side Effects and Safety
Continuous intravenous infusion of diluted Remodulin solution is delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion (undiluted Remodulin solution) is the preferred mode of administration.
In an open-label study of IV treprostinil (n=47), there were 7 catheter-related line infections during approximately 35 patient years, or about 1 BSI event per 5 years of use. A CDC survey of 7 sites that used IV treprostinil for the treatment of PAH found approximately 1 BSI (defined as any positive blood culture) event per 3 years of use.
Other adverse events included diarrhea, jaw pain, edema, vasodilatation and nausea. These side effects are generally considered to be related to the pharmacological effects of Remodulin, whether administered subcutaneously or intravenously.
Tips for IV Administration
Patients should be advised of the risks associated with IV administration. They should be instructed to keep the catheter area clean and dry. Antibacterial patches can also be used with IV administration to help avoid infection.
Continuous subcutaneous infusion (undiluted) of Remodulin is the preferred mode of administration. Intravenous
infusion (dilution required) should only be considered if subcutaneous infusion is not tolerated or if the risks of
BSI (associated with the IV route of delivery) are warranted.
Indication
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms
associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic
or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic
indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who
are intolerant of the subcutaneous route, or in whom these risks are considered warranted.
In patients with PAH requiring transition from Flolan® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical
deterioration. The risks and benefits of each drug should be carefully considered prior to transition.
Important Safety Information for Remodulin
- Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk
of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion is the preferred mode of administration.
- Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH. Remodulin is a potent pulmonary and systemic
vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. Remodulin inhibits platelet
aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants. Remodulin dosage adjustment may be
necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.
- Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care.
Therapy with Remodulin may be used for prolonged periods, and the patient’s ability to administer Remodulin and care for an infusion system should
be carefully considered.
- Remodulin dosage should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic
effects or for unacceptable infusion site symptoms.
- Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided. Caution
should be used in patients with hepatic or renal insufficiency.
- The most common side effects of Remodulin included those related to the method of infusion. For subcutaneous infusion, infusion site pain and
infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment
with narcotics or discontinuation of Remodulin. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising,
and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilatation, and edema.
For more information about REMODULIN, please see the Full Prescribing Information.
Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).