Special Considerations in Transitioning Patients from Flolan® to Remodulin
Symptoms During Transition
During the transition from Flolan to Remodulin, patients may experience the following symptoms:
- Increased symptoms of PAH, including breathlessness, fatigue, presyncope, chest pressure and edema
Note: These symptoms should initially be treated by increasing the dose of Remodulin
- Increased symptoms of prostacyclin excess, including severe flushing, headache, nausea, diarrhea, hypotension and jaw pain
Note: These symptoms should be treated first by decreasing the dose of Flolan
Transition Support
The specialty pharmacy nurse and/or representative can play a helpful role in transitioning patients from Flolan to Remodulin, including pre-planning, implementation and follow-up. The services they can offer are listed below:
Pre-planning
- Insurance approval
- Patient evaluation (PAH status, prostacyclin side effects, frequency of Flolan titration)
- Dosing charts for Flolan and Remodulin
Implementation
- Assistance during transition with medication mixing, repriming of CVC, patient symptom evaluation, dose adjustment plan, IV access establishment, etc.
- Patient/family/nursing/pharmacy education
Follow-up
- Assistance with monitoring uptitration of Remodulin per the physician’s orders
- Evaluation of PAH symptoms and prostacyclin side effects
- Thorough and timely communication with PAH center/office on at least a weekly basis
- Patient contact assistance for at least the first 12 weeks following transition
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).