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Setting patient expectations about adverse reactions

Patients on Remodulin may experience some challenging adverse reactions. For most patients, an adverse reaction management plan can help manage adverse events and maximize the benefit of Remodulin.1

Managing adverse reactions

According to a review article published in 2017 in Pulmonary Circulation, managing adverse reactions can include both pharmacologic and nonpharmacologic interventions, such as1:

Adverse Reactions Management
Pain management1
  • Heating pad
  • Massage
  • Acetaminophen
  • Ibuprofen
  • Gabapentin
Severe headache1
  • Hydrocodone
  • Oxycodone
Nausea1
  • Ondansetron
  • Slow titration
  • Small, frequent meals
Diarrhea1
  • Diphenoxylate/Atropine
  • Loperamide
  • Dietary changes
Managing infusion
site pain and
reactions1-4
For subcutaneous (SC) administration, infusion site pain and reactions are common.
With appropriate site management, most patients are able to stay on Remodulin therapy as prescribed.
Please see below for more information about site management.

United Therapeutics does not provide medical advice.

Set expectations for site pain

Explain that site pain is a common occurrence2,3

  • During clinical trials, infusion site pain (85% vs placebo 27%) and infusion site reaction (83% vs placebo 27%) were the most common adverse events reported

Explain the general course of site pain after starting at a new site3,5

  • Site pain generally reaches an apex approximately 2 to 5 days after a site change and starts to lessen about a week after a site change

Discuss starting a site and when to change sites6

  • In a yearlong prospective study of 26 SC Remodulin patients, 52% of infusion sites lasted >4 weeks
  • While SC patients can maintain infusion sites for long periods of time, sites should be changed when there is ongoing site pain, itching, erythema, drainage, or bleeding

Considerations for choosing the best administration sites3

Best administration sites for Remodulin IV and SC
  • Start therapy on the abdomen—it is a relatively accessible location to administer medication, monitor, and apply topical remedies as needed
    • Create a dry site (one that is not connected to the pump) if the site will need changing in the next couple of days. You can do this by inserting a new cannula in a different location from the current site and waiting at least 24 hours before switching the pump to the new site
    • Avoid sensitive areas, including:
      • Stretch marks
      • Scar tissue
      • Bruises
      • Skin under the waistbands of clothes
      • Folds of the belly
    • In case of continued discomfort, relocate to a new infusion site
      • Good relocation sites include:
        • Upper buttocks
        • Lower flanks
        • Backs of upper arms
        • Thighs

This information has been adapted from The Journal of Heart and Lung Transplantation. United Therapeutics does not provide medical advice.3

Helpful video to share with your patients

What to Expect: Remodulin (treprostinil) Injection SC Site Pain

SC Site Pain

Patients and healthcare professionals talk about site pain with Remodulin SC and ways to help manage it.

Important Safety Information

Warnings and Precautions

  • Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
  • Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.
  • Titrate slowly in patients with hepatic or renal insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
  • Remodulin is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension.
  • Remodulin inhibits platelet aggregation and increases the risk of bleeding.

Adverse Reactions

  • In clinical studies of SC Remodulin infusion, the most common adverse events reported were 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. The IV infusion of Remodulin with an external infusion pump has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were 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%), and hypotension (4% vs. 2%).

Drug Interactions

  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

Specific Populations

  • In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min of ideal body weight, and monitor closely. Remodulin has not been studied in patients with severe hepatic insufficiency.
  • Safety and effectiveness of Remodulin in pediatric patients have not been established.
  • It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.

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

  • Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
  • Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.
  • Titrate slowly in patients with hepatic or renal insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
  • Remodulin is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension.
  • Remodulin inhibits platelet aggregation and increases the risk of bleeding.

Adverse Reactions

  • In clinical studies of SC Remodulin infusion, the most common adverse events reported were 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. The IV infusion of Remodulin with an external infusion pump has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were 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%), and hypotension (4% vs. 2%).

Drug Interactions

  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

Specific Populations

  • In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min of ideal body weight, and monitor closely. Remodulin has not been studied in patients with severe hepatic insufficiency.
  • Safety and effectiveness of Remodulin in pediatric patients have not been established.
  • It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.

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).

References: 1. Kingman M, Archer-Chicko C, Bartlett M, et al. Management of prostacyclin side effects in adult patients with pulmonary arterial hypertension. Pulm Circ. 2017;7(3):598-608. 2. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2018. 3. Mathier MA, McDevitt S, Saggar R. Subcutaneous treprostinil in pulmonary arterial hypertension: practical considerations. J Heart Lung Transplant. 2010;29(11):1210-1217. 4. Sadushi-Koliçi R, Skoro-Sajer N, Zimmer D, et al. Long-term treatment, tolerability, and survival with sub-cutaneous treprostinil for severe pulmonary hypertension. J Heart Lung Transplant. 2012;31(7):735-743. 5. Lang I, Gomez-Sanchez M, Kneussl M, et al. Efficacy of long-term subcutaneous treprostinil sodium therapy in pulmonary hypertension. Chest. 2006;129(6):1636-1643. 6. White RJ, Levin Y, Wessman K, et al. Subcutaneous treprostinil is well tolerated with infrequent site changes and analgesics. Pulm Circ. 2013;3(3):611-621.