Safety and Side Effects

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?

Subcutaneous infusion

If you are on Remodulin SC, 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. While not everyone experiences these symptoms, they occur in the majority of patients. These symptoms can be severe. Your doctor may prescribe prescription medications to help manage these symptoms.

In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness and swelling). These symptoms were often severe and sometimes required treatment with narcotics or discontinuation of Remodulin. Other common side effects seen with either SC or IV Remodulin were headache, diarrhea, jaw pain, nausea, vasodilatation (widening of the blood vessels), and edema (swelling).

Percentage of patients with PAH receiving Remodulin SC who experienced adverse reactions at least 3% more frequently than patients receiving placebo in controlled, 12-week studies*

Adverse Reaction Remodulin (n=236) Placebo (n=233)
Infusion site pain 85% 27%
Infusion site reaction 83% 27%
Headache 27% 23%
Diarrhea 25% 16%
Nausea 22% 18%
Rash 14% 11%
Jaw pain 13% 5%
Vasodilatation 11% 5%
Edema 9% 3%
*
Reported adverse events (at least 3% more frequent on drug than on placebo) are included, except those too general to be informative and those not plausibly attributable to the use of the drug because they were associated with the condition being treated or are very common in the general population.

Intravenous infusion

The IV infusion of Remodulin has been associated with a risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain.

Long-term IV infusion of Remodulin is delivered via a surgically implanted central venous catheter. The use of central venous catheters may lead to the development of serious blood stream infections and sepsis. Although rare, these events can be fatal. For that reason, SC infusion is the preferred route of administration for Remodulin. Remodulin IV infusion is reserved for patients in whom the SC route is not appropriate.

Talk with your doctor

Before starting therapy with Remodulin, ask your doctor how you may be able to manage side effects if they occur. By knowing what to expect, you may be able to successfully stay on Remodulin.

Connect with a Remodulin PEER Mentor

Remodulin PEER Mentors are Remodulin patients who volunteer their time to help people who are considering, or already taking, Remodulin. Meet the PEER Mentors.

See frequently asked questions

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.