Remodulin adverse reactions

Adverse reactions with SC Remodulin1

In controlled 12-week pivotal trials in PAH, patients receiving SC Remodulin experienced the following adverse reactions at least 3% more frequently than patients receiving placebo.1*

In clinical studies of SC Remodulin infusion, the most common adverse events reported were1:

  • Infusion site pain
  • Infusion site reaction (redness, swelling, and rash)

These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin.1

7% discontinuation due to infusion site pain1

Incidence of infusion site reactions and site pain1
Site Reaction (%) Site Pain (%)
Remodulin Placebo Remodulin Placebo
Severe 38 1 39 2
Requiring narcotics NA§ NA§ 32 1
Leading to discontinuation 3 0 7 0

NA=not available.

*Reported adverse reactions (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 treated population.1

Infusion site reaction was defined as any local adverse event other than pain or bleeding/bruising at the infusion site and included symptoms such as erythema, induration, or rash.1

Based on prescriptions for narcotics, not actual use.

§Medications used to treat infusion site pain were not distinguished from those used to treat site reactions.

Remodulin additional common adverse events

Other common adverse events (≥3% more than placebo) seen with SC Remodulin or placebo, respectively, were1:

  • Headache (27% vs 23%)
  • Diarrhea (25% vs 16%)
  • Nausea (22% vs 18%)
  • Rash (14% vs 11%)
  • Jaw pain (13% vs 5%)
  • Vasodilatation (11% vs 5%)
  • Edema (9% vs 3%)

Adverse reactions with IV Remodulin

The IV infusion of Remodulin with an external infusion pump has been associated with a risk of1:

  • Bloodstream infections
  • Arm swelling
  • Paresthesias
  • Hematoma
  • Pain

IV=intravenous; PAH=pulmonary arterial hypertension; SC=subcutaneous.

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

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%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

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

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

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%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

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

Reference: 1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2018.