About Remodulin
Remodulin is a type of medication called a prostacyclin analog that is used to treat pulmonary arterial hypertension (PAH). Prostacyclin is one of three important substances in the body that are known to play a role in PAH.6 In a person with PAH, levels of prostacyclin can be lower than normal, causing the pulmonary arteries to constrict or become narrow. This causes the blood pressure in the lungs to rise and puts stress on the heart as it tries to pump blood through the narrow arteries. Remodulin acts similarly to the natural prostacyclin that is found in the body, helping to keep the pulmonary arteries open and working properly so there is less stress on the heart.
Chemically Stable Prostacyclin
The first therapies introduced specifically to treat PAH focused on replacing low levels of prostacyclin in the body. Since its introduction, prostacyclin therapy has been shown to be effective in opening up (dilating) the pulmonary arteries and helping with the symptoms of PAH. The challenge has been that native prostacyclin—the prostacyclin that occurs naturally in the body—and synthetic prostacyclin break down rapidly (it has a short half-life) and need to stay cool because it is sensitive to warm temperatures.6,7
Remodulin is a synthetic analog of prostacyclin, which is an altered form of prostacyclin that stays active longer in the body (4-hour half-life) than synthetic prostacyclin. It also minimizes reservoir changes (patients can go up to 72 hours (SC) or 48 hours (IV) before having to change drug reservoirs), and is stable at temperatures up to 104° F, so there's no need for ice packs.7
Remodulin is also the only prostacyclin analog therapy that is approved for delivery by 2 different routes—either via continuous subcutaneous (SC) infusion or continuous intravenous (IV) infusion.6
Select Important Safety Information
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.
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.
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).