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Starting your patients on Remodulin

When patients think about parenteral therapy, they can often have incorrect preconceptions about the treatment experience. Your conversation with your patients can help set the stage for a clear understanding and a motivated patient for the treatment process.

To help you have this potentially difficult conversation with your patients, United Therapeutics has partnered with leading PAH and behavioral science experts to develop the Remodulin Dialogue Initiative. These steps may help when explaining your treatment recommendation and the process involved:

Focus on patient’s goals

Set a positive tone

Parenteral treatment can be a daunting proposition for patients and you don’t want to minimize the challenges—a little encouragement goes a long way.

Dialogue Example: “Our goal is to find a treatment that is right for you.”

Ask and listen

Patients may be hesitant to ask questions, or may not know what questions to ask. Ask if they know the options available to them, listen to their concerns, and probe further to understand what treatment option might work for them.

Dialogue Example: “Let’s work together to set goals that are right for you.”

Make a confident recommendation and explain

Once you have chosen either IV or SC Remodulin, be sure to explain to your patients why this is your recommendation and what the treatment process for this option entails.

Dialogue Example: “There are two options for therapy—one is given under the skin and the other into a vein. Both use a pump that delivers continuous medicine to your body.”

Discuss patient commitment

Parenteral treatment is an important decision; make sure patients are ready to move forward with the treatment process.

Dialogue Example: “For next steps, let’s connect you with a Specialty Pharmacy nurse who can come to your home and teach you more about the pump.”

Provide resources

If patients have questions after your discussion, you can direct them to additional resources for education and counseling.

Complete patient’s goals

Download the Referral Form for Remodulin and follow the instructions to complete and fax to SPS provider.

Download

Send to Accredo or CVS Caremark as shown on the instructions.

Remodulin is only available through select Specialty Pharmacy Services (SPS) providers. Specialty Pharmacies can perform such services as:

Dispensing medication and managing patients’ drug inventories and supplies
Coordinating medication refills and treatment plans for patients
Training for patients on the use of Remodulin—in-home, hospital, or clinic teaching available
Follow-up nurse visits to patients’ homes
24-hour hotline staff who can answer questions from both patients and healthcare practices

Learn More

An adverse reaction management plan can help set patients’ expectations when treated with Remodulin and can recommend steps they can take to be more successful with Remodulin treatment.

CREATE A PLAN

Your patients may have many questions about what life with Remodulin is like. The Remodulin patient website (Remodulin.com) can help answer many of those questions.

“How do I bathe with a pump?”

“Is it safe to have a pump on during an MRI?”

“How do I travel with a pump?”

Patients can learn more about taking the next step with Remodulin and different administration options in the Remodulin Patient Brochure.

Download

Inform your patients about the resources available at Remodulin.com.

Have additional questions?

Request a United Therapeutics Representative for additional information about Remodulin.

Request A Rep

There are steps you can take to preserve your brand choice of PAH treatment.

Learn More

IV=intravenous; MRI=magnetic resonance imaging; PAH=pulmonary arterial hypertension; SC=subcutaneous.

It’s important to consider your patient’s dosing and titration schedule

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

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).

Starting your patients on Remodulin

Introducing the Remodulin Dialogue Initiative

HOW TO INITIATE A PATIENT

DISCUSS ADVERSE REACTIONS AND CREATE A MANAGEMENT PLAN

Share important resources and information with your patient