PH Product Resource Center

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Resources for PH Therapies

Explore the clinical and patient materials for our PH therapies—Orenitram, TYVASO, and Remodulin—in the Resource Center below.

By selecting “Add to my Request Form,” you can add materials to your Resource Center Request Form and they will be delivered to your practice, as well as get in contact with a United Therapeutics representative.

After you have made your selection, click the REQUEST NOW button below, which will take you to the form with your materials you have chosen.




Orenitram® resources


  • Orenitram Patient Brochure: Considering Orenitram thumbnail

    Orenitram Patient Brochure: Considering Orenitram

    A guide for patients considering Orenitram to learn why treatment may be right for them and more.

    DOWNLOAD
  • Orenitram Patient Brochure: What to Expect thumbnail

    Orenitram Patient Brochure: What to Expect

    A guide for patients to learn what to expect between the time they are prescribed Orenitram and when they receive their first shipment of drug.

    DOWNLOAD
  • Orenitram HCP Brochure: Getting Started thumbnail

    Orenitram HCP Brochure:
    Getting Started

    An informative brochure highlighting 3 key steps to successfully get patients started on Orenitram.

    DOWNLOAD
  • Orenitram HCP and Patient Package: Side Effect Management thumbnail

    Orenitram HCP and Patient Package: Side Effect Management

    Brochures for healthcare providers and patients to learn more about Orenitram side effects and the best strategies to manage them.

    DOWNLOAD
  • Orenitram HCP and Patient Package: 90-Day Trial Program thumbnail

    Orenitram HCP and Patient Package: 90-Day Trial Program

    An informational package for patients who want to try Orenitram at no cost for up to 90 days.

    DOWNLOAD
  • Orenitram HCP Referral Form thumbnail

    Orenitram HCP Referral Form

    A referral form and 3-step process to authorize patients to receive Orenitram from their Specialty Pharmacy.

    DOWNLOAD
  • Orenitram HCP Video: Overview of FREEDOM-EV thumbnail

    Orenitram HCP Video: Overview of FREEDOM-EV

    The principal investigator of FREEDOM-EV, R. James White, MD, PhD, describes the trial, key patient characteristics, and important outcomes.

    WATCH
  • Orenitram HCP Video: Right Heart Function in FREEDOM-EV thumbnail

    Orenitram HCP Video: Right Heart Function in FREEDOM-EV

    Paul Forfia, MD, on the relationship between right heart dysfunction and clinical worsening, and the impact of Orenitram in the FREEDOM-EV trial.

    WATCH
  • Orenitram HCP Video: Measuring Risk and the Impact of Orenitram thumbnail

    Orenitram HCP Video: Measuring Risk and the Impact of Orenitram

    Jean Elwing, MD, on the effect that Orenitram had on several key parameters of risk, as well as overall risk status in the FREEDOM-EV trial.

    WATCH
  • Orenitram HCP Video: Dosing and AE Management as a Team thumbnail

    Orenitram HCP Video: Dosing and AE Management as a Team

    Franck Rahaghi, MD, and Starlet Harrimon, RN, on working with patients, lessons from FREEDOM-EV, and using risk assessments with Orenitram.

    WATCH
  • Orenitram Patient Video: Luisa’s Experience thumbnail

    Orenitram Patient Video:
    Luisa’s Experience

    Learn how Luisa works with her healthcare team to balance titration and side effects.

    WATCH
  • Orenitram Patient Video: Jenny’s Experience thumbnail

    Orenitram Patient Video:
    Jenny’s Experience

    Watch Jenny discuss how she and her doctor developed a dosing plan that aligns with her treatment goals.

    WATCH
  •  Patients Considering Orenitram Canadian French Translation thumbnail

    Patients Considering Orenitram Canadian French Translation

    A guide for patients considering Orenitram to learn why treatment may be right for them and more. Translated in Canadian French.

    DOWNLOAD
  •  Patients Considering Orenitram Vietnamese Translation thumbnail

    Patients Considering Orenitram Vietnamese Translation

    A guide for patients considering Orenitram to learn why treatment may be right for them and more. Translated in Vietnamese.

    DOWNLOAD
  •  Patients Considering Orenitram Chinese (China) Translation thumbnail

    Patients Considering Orenitram Chinese (China) Translation

    A guide for patients considering Orenitram to learn why treatment may be right for them and more. Translated in Chinese.

    DOWNLOAD
  •  Patients Considering Orenitram Brazilian Portuguese Translation thumbnail

    Patients Considering Orenitram Brazilian Portuguese Translation

    A guide for patients considering Orenitram to learn why treatment may be right for them and more. Translated in Brazilian Portuguese.

    DOWNLOAD

TYVASO® for PAH resources


  • TYVASO Patient Brochure thumbnail

    TYVASO PAH Patient Brochure

    Informational booklet for patients that provides details on PAH, treatment, administration tips, and more.

    DOWNLOAD
  • TYVASO Patient Video: How to Use TYVASO thumbnail

    TYVASO Patient Video: How to Use the TYVASO Nebulizer

    Learn more about how to use the TYVASO nebulizer.

    WATCH
  • TYVASO Patient Instructions for Use thumbnail

    TYVASO Patient Instructions for Use

    TYVASO Instructions for Use manual with details on programming, safety, cleaning, and storage.

    DOWNLOAD
  • TYVASO HCP Referral Form thumbnail

    TYVASO HCP Referral Form

    A referral form for HCPs outlining a 5-step process to ensure patients receive TYVASO treatment, including TYVASO DPI.

    DOWNLOAD
  • TYVASO Patient Video: How to use TYVASO DPI thumbnail

    TYVASO Patient Video: How to Use TYVASO DPI

    Learn more about how to use TYVASO DPI for the treatment of PAH.

    WATCH
  • TYVASO HCP Video: About TYVASO DPI thumbnail

    TYVASO HCP Video: About TYVASO DPI

    See an overview of TYVASO DPI, including the benefits and how it works.

    WATCH
  • TYVASO DPI Patient Instructions for Use thumbnail

    TYVASO DPI Patient Instructions for Use

    TYVASO DPI Instructions for Use manual with details on how to use TYVASO DPI.

    DOWNLOAD
  • TYVASO DPI Patient Quick Tips Guide thumbnail

    TYVASO DPI Patient Quick Tips Guide

    Read tips on how to use TYVASO DPI.

    DOWNLOAD
  • TYVASO DPI Patient Titration Guide thumbnail

    TYVASO DPI Patient Titration Guide

    Learn more about titrating to target dose with TYVASO DPI.

    DOWNLOAD
  • TYVASO Nebulizer Patient Quick Tips Guide thumbnail

    TYVASO Nebulizer Patient Quick Tips Guide

    Read tips on how to use the TYVASO nebulizer.

    DOWNLOAD
  • TYVASO PAH Patient Brochure Canadian French Translation thumbnail

    TYVASO PAH Patient Brochure Canadian French Translation

    Informational booklet for patients that provides details on PAH treatment, administration tips, and more. Translated in Canadian French.

    DOWNLOAD
  • TYVASO PAH Patient Brochure Vietnamese Translation thumbnail

    TYVASO PAH Patient Brochure Vietnamese Translation

    Informational booklet for patients that provides details on PAH treatment, administration tips, and more. Translated in Vietnamese.

    DOWNLOAD
  • TYVASO PAH Patient Brochure Chinese (China) Translation thumbnail

    TYVASO PAH Patient Brochure Chinese (China) Translation

    Informational booklet for patients that provides details on PAH treatment, administration tips, and more. Translated in Chinese.

    DOWNLOAD
  • TYVASO PAH Patient Brochure Brazilian Portuguese Translation thumbnail

    TYVASO PAH Patient Brochure Brazilian Portuguese Translation

    Informational booklet for patients that provides details on PAH treatment, administration tips, and more. Translated in Brazilian Portuguese.

    DOWNLOAD

TYVASO® for PH-ILD resources


  • TYVASO PH-ILD Patient Brochure thumbnail

    TYVASO PH-ILD Patient Brochure

    Informational booklet for patients that provides details on PH-ILD treatment, administration tips, and more.

    DOWNLOAD
  • TYVASO PH-ILD Patient Video: Catherine’s Story thumbnail

    TYVASO PH-ILD Patient Video: Catherine’s Story

    Hear from Catherine, a real TYVASO patient, about her experiences with TYVASO and the impact it has had on her.

    WATCH
  • TYVASO PH-ILD Patient Video: Tina’s Story thumbnail

    TYVASO PH-ILD Patient Video: Tina’s Story

    Hear from Tina and her experience with titrating with TYVASO.

    WATCH
  • TYVASO PH-ILD HCP Referral Form thumbnail

    TYVASO PH-ILD HCP Referral Form

    A referral form for HCPs outlining a 5-step process to ensure patients receive TYVASO treatment, including TYVASO DPI.

    DOWNLOAD
  • TYVASO DPI Patient Instructions for Use thumbnail

    TYVASO DPI Patient Instructions for Use

    TYVASO DPI Instructions for Use manual with details on how to use TYVASO DPI.

    DOWNLOAD
  • TYVASO Patient Instructions for Use thumbnail

    TYVASO Patient Instructions for Use

    TYVASO Instructions for Use manual with details on programming, safety, cleaning, and storage.

    DOWNLOAD
  • TYVASO PH-ILD Patient Brochure Canadian French Translation thumbnail

    TYVASO PH-ILD Patient Brochure Canadian French Translation

    Informational booklet for patients that provides details on PH-ILD treatment, administration tips, and more. Translated in Canadian French.

    DOWNLOAD
  • TYVASO PH-ILD Patient Brochure Vietnamese Translation thumbnail

    TYVASO PH-ILD Patient Brochure Vietnamese Translation

    Informational booklet for patients that provides details on PH-ILD treatment, administration tips, and more. Translated in Vietnamese.

    DOWNLOAD
  • TYVASO PH-ILD Patient Brochure Chinese (China) Translation thumbnail

    TYVASO PH-ILD Patient Brochure Chinese (China) Translation

    Informational booklet for patients that provides details on PH-ILD treatment, administration tips, and more. Translated in Chinese.

    DOWNLOAD
  • TYVASO PH-ILD Patient Brochure Brazilian Portuguese Translation thumbnail

    TYVASO PH-ILD Patient Brochure Brazilian Portuguese Translation

    Informational booklet for patients that provides details on PH-ILD treatment, administration tips, and more. Translated in Brazilian Portuguese.

    DOWNLOAD

Remodulin® resources


  • Remodulin HCP DAW State Language thumbnail

    Remodulin HCP DAW State Language

    Outlines state-specific requirements for “Dispense as Written” (DAW) to prescribe brand name Remodulin.

    DOWNLOAD
  • Remodulin HCP Referral Form thumbnail

    Remodulin HCP Referral Form

    A referral form to fill out for patients to receive Remodulin through Specialty Pharmacies.

    DOWNLOAD
  • Remodulin Patient Video: How Blood Flows in the Vessels in the Lungs thumbnail

    Remodulin Patient Video: How Blood Flows in the Vessels in the Lungs

    See what happens to the flow of blood in your lungs with PAH.

    WATCH
  • Remodulin Patient Video: Carey’s Story thumbnail

    Remodulin Patient Video: Carey’s Story

    PAH patient Carey shares her story about how she persevered and didn’t let her disease define her.

    WATCH
  • Remodulin Patient Video: Helpful Information About Remodulin thumbnail

    Remodulin Patient Video: Helpful Information About Remodulin

    Dr. Sean Studer and nurse Glenna Traiger review Remodulin benefits, risks, administration, and side effects.

    WATCH
  • Remodulin Patient Video: PAH Life Hacks—Showering With Your Pump thumbnail

    Remodulin Patient Video: PAH Life Hacks—Showering With Your Pump

    PAH patient Carey shares her tips on how to protect a pump in the shower.

    WATCH
  • Remodulin Patient Video: PAH Life Hacks—Traveling With Your Pump thumbnail

    Remodulin Patient Video: PAH Life Hacks—Traveling With Your Pump

    PAH patient Wendy shares her advice that made traveling with a Remodulin pump more manageable for her.

    WATCH
  • Remunity HCP and Patient Video: Remunity User Guide—First-Time Setup thumbnail

    Remunity HCP and Patient Video: Remunity® User Guide—First-Time Setup

    A video on setting up the Remunity pump, including pairing pump to remote and setting a delivery rate.

    WATCH
  • Remunity HCP and Patient Video: Remunity User Guide—Connecting Your First Cassette thumbnail

    Remunity HCP and Patient Video: Remunity® User Guide—Connecting Your First Cassette

    A video on how to prime a Remodulin cassette, connect it to the pump, and connect the pump to the catheter.

    WATCH
  • Remunity HCP and Patient Video: Remunity User Guide—Cassette Change thumbnail

    Remunity HCP and Patient Video: Remunity® User Guide—Cassette Change

    A video on how to disconnect infusion sets before changing a cassette, replace the pump battery, and reconnect devices.

    WATCH
  • Remunity HCP and Patient Video: Remunity User Guide—Pump Alerts and Alarms thumbnail

    Remunity HCP and Patient Video: Remunity® User Guide—Pump Alerts and Alarms

    A video showing what Remunity pump notifications, alerts, and alarms mean and what to do when they occur.

    WATCH
  • Remunity HCP and Patient Video: Remunity User Guide—Troubleshooting and FAQs thumbnail

    Remunity HCP and Patient Video: Remunity® User Guide—Troubleshooting and FAQs

    A video about how to troubleshoot if the pump isn’t functioning properly, including answers to frequently asked questions.

    WATCH
  • Remodulin HCP and Patient Video: Remodulin SC Site Pain thumbnail

    Remodulin HCP and Patient Video: Remodulin SC Site Pain

    Patients and HCPs talk about injection site pain with Remodulin SC and ways to help manage it.

    WATCH
  • Remodulin Patient Brochure Canadian Translation thumbnail

    Remodulin Patient Brochure Canadian French Translation

    This brochure helps patients understand treatment with Remodulin and the resources available to them through United Therapeutics. Translated in Canadian French.

    DOWNLOAD
  • Remodulin Patient Brochure Vietnamese Translation thumbnail

    Remodulin Patient Brochure Vietnamese Translation

    This brochure helps patients understand treatment with Remodulin and the resources available to them through United Therapeutics. Translated in Vietnamese.

    DOWNLOAD
  • Remodulin Patient Brochure Chinese (China) Translation thumbnail

    Remodulin Patient Brochure Chinese (China) Translation

    This brochure helps patients understand treatment with Remodulin and the resources available to them through United Therapeutics. Translated in Chinese.

    DOWNLOAD
  • Remodulin Patient Brochure Brazilian Portuguese Translation thumbnail

    Remodulin Patient Brochure Brazilian Portuguese Translation

    This brochure helps patients understand treatment with Remodulin and the resources available to them through United Therapeutics. Translated in Brazilian Portuguese.

    DOWNLOAD

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PH management resources

To access and download clinical materials for general PH management, visit the PH Management Resource Center.

VIEW RESOURCES

AE=adverse event; DPI=dry powder inhaler; MOA=mechanism of action; PAH=pulmonary arterial hypertension; PH=pulmonary hypertension; PH-ILD=pulmonary hypertension associated with interstitial lung disease; SC=subcutaneous.

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SELECT IMPORTANT SAFETY INFORMATION

  • Orenitram is Contraindicated in patients with severe hepatic impairment (Child Pugh Class C).
  • TYVASO and TYVASO DPI have a Warning and Precaution for patients with low systemic arterial pressure, as either product may produce symptomatic hypotension.
  • Remodulin has a Warning and Precaution for chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter, as they are associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.

Please see below for Indication, additional Important Safety Information, and links to the Full Prescribing Information for Orenitram, TYVASO, TYVASO DPI, and Remodulin.

SELECT IMPORTANT SAFETY INFORMATION

  • Orenitram is Contraindicated in patients with severe hepatic impairment (Child Pugh Class C).
  • TYVASO and TYVASO DPI have a Warning and Precaution for patients with low systemic arterial pressure, as either product may produce symptomatic hypotension.
  • Remodulin has a Warning and Precaution for chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter, as they are associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.

Please see below for Indication, Important Safety Information, and links to the Full Prescribing Information for Orenitram, TYVASO, TYVASO DPI, and Remodulin.

Orenitram® (treprostinil) Extended-Release Tablets

INDICATION

Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%).

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

CONTRAINDICATIONS

  • Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.

WARNINGS AND PRECAUTIONS

  • Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
  • The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.

ADVERSE REACTIONS

  • In the 12-week, placebo-controlled, monotherapy study, and an event-driven placebo-controlled, combination therapy study, adverse reactions that occurred at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea, nausea, vomiting, flushing, pain in jaw, pain in extremity, hypokalemia, abdominal discomfort, and upper abdominal pain.

DRUG INTERACTIONS

  • Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.

SPECIFIC POPULATIONS

  • Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies with Orenitram in pregnant women.
  • It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.
  • Safety and effectiveness of Orenitram in pediatric patients have not been established.
  • Use of Orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients.

Please see Full Prescribing Information and Patient Information at www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).

OREISIhcpOCT19

TYVASO® (treprostinil) Inhalation Solution and TYVASO DPI™ (treprostinil) Inhalation Powder

INDICATION

TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics indicated for the treatment of:

  • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with TYVASO establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

    The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

    While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with TYVASO was limited to 12 weeks in duration.
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with TYVASO establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).

IMPORTANT SAFETY INFORMATION FOR TYVASO AND TYVASO DPI

WARNINGS AND PRECAUTIONS

  • TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension.
  • Both products inhibit platelet aggregation and increase the risk of bleeding.
  • Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.
  • Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO and TYVASO DPI.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

  • The concomitant use of either product with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
  • Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.
  • Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Safety and effectiveness in pediatric patients have not been established.
  • Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH-ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

ADVERSE REACTIONS

  • Pulmonary Arterial Hypertension (WHO Group 1)
    In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.

    In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of TYVASO who switched to a corresponding dose of TYVASO DPI, the most commonly reported adverse events seen with TYVASO DPI in ≥4% of PAH patients during the 3-week treatment phase included cough (35.3%), headache (15.7%), dyspnea (7.8%), and nausea (5.9%).
  • Pulmonary Hypertension Associated with ILD (WHO Group 3)
    In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions with TYVASO were similar to the experience in studies of PAH.

Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.TYVASOhcp.com or call 1-877-UNITHER (1-877-864-8437).

TYVISIhcpMAY2022

Remodulin® (treprostinil) Injection

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.

IMPORTANT SAFETY INFORMATION FOR REMODULIN

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.

Please see accompanying Full Prescribing Information for Remodulin.

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

REMISIhcpMAY2021