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Managing Site Reactions

Managing Site Reactions

There are multiple approaches to helping patients deal with site pain and reactions. One thing that might help is to change to a more concentrated Remodulin solution to allow for less volume infused per hour.

This page discusses some additional tips from topical solutions to prescription pain relievers that may help patients.

General Tips to Suggest to Patients

  • Eliminate medication droplets before needle insertion
  • Use alternative needles and/or catheters
  • Apply a thin layer of DuoDERM® dressing prior to inserting the catheter to allow for frequent topical medication application
  • Use ice packs to reduce swelling and numb the infusion site
  • Apply moist heat to increase blood flow
  • Enjoy a warm bath with Epsom salts to ease swelling
  • Apply vitamin E ointment to speed healing of wounds and reduce scar formation
  • Smooth on aloe vera gel to promote wound healing
  • Use hydrocortisone cream to reduce inflammation and itching

Over-the-Counter Pain Relievers

There are several over-the-counter medications that may help with site pain or discomfort, including acetaminophen, ibuprofen or antihistamines. There are also several non-prescription topical solutions that may help ease site pain or discomfort, including topical antihistamines and hydrocortisone cream.

Note: Patients should always consult the package insert for any product to read about possible side effects and important safety information.

Prescription Pain Relievers

If one or more of the solutions above do not ease a patient's site pain, there are several prescription pain relievers and topical solutions that might be helpful.

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).

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