Infusion Site Management

Managing site pain and reactions

If you are on subcutaneous (SC) Remodulin, it is common to experience infusion site pain and infusion site reaction. Infusion site reaction was defined as symptoms such as abnormal redness of the skin, inflammation, or rash. Site discomfort varies by patient and infusion site, but has been shown in small studies to be most intense around 2 to 5 days after a site change and to lessen about a week after a site change in some patients. Remember to talk with your doctor about any discomfort or reaction you may have.

When you first begin Remodulin SC, it can be helpful to start your therapy on the stomach area so you can more easily monitor the site and apply remedies as necessary. Ask your doctor when and how often he or she recommends you change sites.

Working with your healthcare team, make a plan for how to manage any site pain you may have. This may include simple, over-the-counter remedies, or it may require prescription medicine. Record your experiences with site pain or reactions in your Remodulin Patient Journal, and share this information with your healthcare team. Working together, you can discover the best way to manage any future site pain or reactions before they occur.

Tips for choosing the best sites

In case of continued discomfort, speak to your doctor about moving to a new site.

Good sites include

You should avoid sensitive areas, including

When you are ready to change sites, try these tips:

Potential remedies for site pain and reaction

The following approaches and products are some of the strategies that patients and doctors have reported as helpful in managing infusion site reactions associated with using Remodulin SC. United Therapeutics does not recommend or endorse using healthcare products other than as directed or prescribed.

Over-the-counter remedies

There are several over-the-counter medications that may help you with site pain or reactions. There are also non-prescription topical solutions that may help you ease site pain or discomfort. Be sure to speak with your doctor to determine what might work best for your particular needs. Always consult the prescribing information of the product you choose to read about possible side effects and important safety information.

Prescription remedies

If one or more of the solutions above does not ease your site pain or reaction, there are several prescription pain relievers and topical solutions that might be helpful. Speak with your doctor to determine if you might benefit from a prescription medication to treat your site pain or reaction.

Selected Important Safety Information

What are the serious side effects of Remodulin?

The intravenous infusion option

Remodulin® (treprostinil) Injection

What is Remodulin?

Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. It is not known if Remodulin is safe and effective in children.

In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms.

Important Safety Information for Remodulin

Before you take Remodulin, tell your healthcare provider if you:

What are the serious side effects of Remodulin?

What are the possible side effects of Remodulin?

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

REMISIdtcJUL18

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit http://www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a healthcare professional for treatment advice.

Important Safety Information and Indication

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Remodulin® (treprostinil) Injection

What is Remodulin?

Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. It is not known if Remodulin is safe and effective in children.

In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms.

Important Safety Information for Remodulin

Before you take Remodulin, tell your healthcare provider if you:

  • Have other medical conditions or take other medicines that may affect your use of Remodulin by increasing the risk of side effects or decreasing the drug’s effectiveness.
  • Have liver or kidney problems. Your Remodulin dose may need to be adjusted if you have liver problems.
  • Have low blood pressure or bleeding problems.
  • Are taking gemfibrozil (for high cholesterol), rifampin (for infection) or other drugs that affect liver enzymes. Your doctor may need to adjust your Remodulin dosage.
  • Are pregnant, breastfeeding, or planning to become pregnant. It is not known if Remodulin will harm your unborn baby or if Remodulin passes into your breast milk.

What are the serious side effects of Remodulin?

  • Continuous intravenous (IV) infusions of Remodulin delivered using an external infusion pump, with a tube placed in a central vein within the chest, are associated with the risk of blood stream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion delivered just beneath the skin is the preferred type of delivery.
  • Worsening of PAH symptoms. Do not stop taking or greatly reduce your Remodulin dose without consulting your doctor.
  • Low blood pressure (symptomatic hypotension). If you have low blood pressure or are taking drugs that lower your blood pressure, the risk of low blood pressure is increased.
  • Bleeding problems. Remodulin may increase the risk of bleeding in people who take blood thinners (anticoagulants).

What are the possible side effects of Remodulin?

  • In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin.
  • IV infusion of Remodulin delivered through an external pump has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain.
  • The most common side effects seen with either SC or IV Remodulin were headache, diarrhea, nausea, rash, jaw pain, widening of the blood vessels (vasodilatation), and swelling from fluid retention (edema). These are not all the possible side effects of Remodulin. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

REMISIdtcJUL18

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit http://www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a healthcare professional for treatment advice.