Side Effects and Safety
Side Effects
Infusion site pain and reaction are the most common side effects reported among those who chose SC administration. Infusion site reaction includes redness, swelling, rash and skin hardening.1 These symptoms occur in the majority of patients, and are often severe and could lead to treatment with narcotics or discontinuation of Remodulin. Click here for tips on Managing Site Reactions.
Side effects of Remodulin, whether administered subcutaneously or intravenously, may include diarrhea, jaw pain, swelling of feet, ankles and legs, widening of blood vessels and nausea.1
These lists reflect the most common side effects associated with Remodulin, but are not necessarily comprehensive. Consult your healthcare provider with any side effects or concerns.
Safety
There are several things that you need to know in order to minimize issues associated with SC administration:
Administration Site Selection
The most common site to begin SC administration is in the abdominal area. This will allow you to monitor the site and apply topical remedies as needed. Other sites that may be comfortable include the upper buttocks, lower flanks (the fatty areas on the back of the hips), backs of the upper arms and thighs. You should avoid areas with stretch marks, scar tissue, edema, old nodular sites and bruises, and those near waistbands of clothing.
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Infusion Interruptions
It is best that infusion is given continuously—24 hours a day, 7 days a week—without interruption. If your infusion therapy is interrupted for longer than 30 minutes, call your PAH physician/center or emergency medical services, if necessary.
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Care During Bathing or Showering
When bathing or showering, it is best to cover the infusion site with a watertight cover or sport guard/swim kit. Speak with your healthcare provider for specific recommendations.
Should the SC catheter become dislodged while bathing or showering, you should be prepared to rotate to a new infusion site.
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Site Reactions
Patients on SC Remodulin may experience a number of reactions at the infusion site, including tenderness, mild redness (4–5 inches in diameter), warmth, inflammation, mild bleeding and/or a nodule or hardening of the skin.
Consult your healthcare provider if you experience severe inflammation, bleeding or hardening of the skin, or if redness extends more than 6 inches in diameter around the infusion site.
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Site Rotation
Infusion site reactions can vary from one infusion site to another. The discomfort is often the worst 2 to 5 days after you begin a new injection site. If you are experiencing infusion site pain or reactions after this initial time period, you should rotate administration sites. Some sites may simply be more comfortable than others.
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Important Note About Site Pain
Study results have shown that site pain does not necessarily increase with higher dosage levels.16 Be sure to work closely with your healthcare team to manage any site pain while your dosage is increased so you may reach an optimal dose to help improve your PAH symptoms.
Check out Managing Site Reactions for potential solutions.
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).