United Therapeutics is a company on a mission to continuously advance the care for pulmonary arterial hypertension (PAH). Remodulin® has been a trusted method of PAH pump therapy for nearly 20 years, but patients have experienced challenges with fitting a pump into their daily lives. With Remunity®, the latest delivery system for Remodulin, patients can now take advantage of modern innovations designed to make pump therapy simpler and more manageable.
Please see Important Safety Information for Remunity and Remodulin at the end of this article.
“[Remunity is] small, easy to work with, safe, and compatible with a patient staying active. It empowers the patient. It’s an evolution.”
– Remodulin doctor
Understanding PAH
PAH is a narrowing of the arteries that carry blood from the heart to the lungs. This causes the heart to work harder to push blood to the lungs, leading to symptoms like shortness of breath and fatigue during daily activities. As PAH worsens, these symptoms can make it difficult to carry out everyday tasks such as getting dressed, climbing stairs, or walking to the mailbox.
About pump therapy
Pump therapy is a type of infused, or parenteral, treatment. Using a pump provides a steady flow of the necessary medicine used to treat PAH and manage its symptoms around the clock.
Remodulin (treprostinil) from United Therapeutics is the #1 prescribed pump therapy for PAH in the US and has been relied on for nearly 2 decades. It works to keep the blood vessels in the lungs open, making it easier for the heart to pump blood through the lungs, which can help reduce symptoms of PAH.
However, parenteral therapy has been met with some resistance due to the lifestyle challenges it has presented to patients. Historically, this has included large device size and the need to mix a treatment solution for refills.
Remunity: The pump that fits in your life and in your pocket
United Therapeutics has introduced a state-of-the-art delivery system called Remunity. The first pump designed specially for patients with PAH, the Remunity Pump for Remodulin eases some of the challenges that people face on parenteral therapy—and fits more seamlessly into their daily lives.
“My [current] pump weighs 3 lbs … If I want to carry it in my purse, I have to cut holes in my clothes or fish the tube through a sleeve. I’m constantly dealing with this pump. With something smaller, it would be easier to manage and hide. [Remunity] looks smart and modern. This shows me that United Therapeutics is listening to patients on PAH therapy.”
– Remodulin patient
Find out more about what therapy could look like with Remunity. Watch the video >
With Remunity, United Therapeutics has made a number of advancements with the patient experience in mind
SMALL
Remunity easily fits onto a belt or into a pocket and is lighter than most smartphones. People on this type of therapy keep their pump on them at all times. This intentional and portable design can make a difference in patients’ lives.
Remunity also features water-resistant* casing. Patients can now feel more confident about their device when taking a shower or when on the go.
*The Remunity pump can tolerate immersion in water to depths of up to 8 feet for 30 minutes and up to 12 feet for 3 minutes.
SIMPLE
While patients thus far have had to carefully mix medication and refill their pumps, Remunity comes with prefilled cassettes that eliminate the need for syringes and manual refilling. Each one helps ensure accurate dose delivery for up to 3 days (72 hours)—and changing the cassette is simple. Just prime, twist, and go.
SAFE
Security is often a top-of-mind concern for the modern world, and a therapeutic device is no exception. Remunity includes enhancements from passcode protection to airplane mode to a “walkaway attention alarm” that can help patients keep track of their remote.
To learn more about the Remunity Pump for Remodulin, talk to your doctor or visit Remodulin.com/Remunity.
Helpful links from United Therapeutics:
- Therapy with Remunity video
- Free Remunity app for iPad® and iPhone®
- Current and upcoming pump options for Remodulin
Remunity
Pump for Remodulin® (treprostinil) Injection
Indication
The Remunity Pump for Remodulin® (treprostinil) Injection is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years of age).
Important Safety Information for Remunity
Warnings and Cautions
Do not use the system outside the conditions listed in the User Guide. Retain the User Guide for future reference. Refer to the User Guide for all warnings and cautions. Failure to comply with the following warnings and cautions may result in harm.
Limited to use with Remodulin. Only Remunity cassettes may be used with the Remunity pump. Remunity pump is for use only with FDA-cleared infusion sets: Medtronic Quick-set Infusion Set (MMT-392, MMT-393), Medtronic Silhouette Infusion Set (MMT-373), and Smiths Medical Cleo 90 Infusion Set (21-7230-24, 21-7220-24).
Do not use disposables from previously opened or damaged sterile packaging, damaged disposable components, or expired sterile components. Discontinue use of the remote and switch to the spare remote in the event the remote fails to operate. The use of cables, batteries, and battery chargers other than those provided or specified may result in increased emission or decreased immunity of the Remunity pump infusion system. Do not disconnect the pump from the cassette while the cassette is connected to the catheter. Avoid exposure of your pump and cassette to temperatures below 41°F (5°C) or above 104°F (40°C). The pump may affect nearby electrical and electronic devices, including medical devices, cell phones, Bluetooth devices, RFID readers, Wi-Fi equipment, and strong magnetic fields causing these devices to operate abnormally or to stop functioning. Do not open, crush, heat above 140°F (60°C), or incinerate the pump battery or remote, as doing so can lead to fire or rapid spreading of fire resulting in harm. This system supports flow rates between 16 μL/h and 225 μL/h. If your flow rate is outside this range, discuss with your healthcare practitioner.
Prescription Information
Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. Use of this device without the training and supervision of a healthcare practitioner may lead to errors that result in harm.
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See the Remunity Pump for Remodulin (treprostinil) Injection Pharmacy-Filled User Guide for further detailed important safety information including warnings, cautions, and instructions on how to properly use the system.
For further information, please call United Therapeutics Corp. at 1-877-864-8437.
The Remunity Pump for Remodulin (treprostinil) Injection is manufactured for United Therapeutics Corp.
You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.
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.
The risk information provided here is not comprehensive. To learn more about Remodulin, talk with your healthcare provider. Please see Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
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References:
1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2021. 2. Del Pozo R, Hernandez Gonzalez I, Escribano-Subias P. The prostacyclin pathway in pulmonary arterial hypertension: a clinical review. Expert Rev Respir Med. 2017;11(6):491-503. 3. Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med. 2004;351(14):1425-1436. 4. Humbert M, Guignabert C, Bonnet S, et al. Pathology and pathobiology of pulmonary hypertension: state of the art and research perspectives. Eur Respir J. 2019;53(1):1801887. doi: 10.1183/13993003.01887-2018 5. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. 6. Skoro-Sajer N, Lang IM, Harja E, et al. A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary hypertension. Clin Pharmacokinet. 2008; 47(9):611-618. 7. Morland K, Nails A, Classi P, et al. Reasons for refusing parenteral therapy: a qualitative study of patients with pulmonary arterial hypertension. Presented at: CHEST Annual Meeting; October 18-21, 2020; Virtual. Poster P1879.
Remodulin and Remunity are registered trademarks of United Therapeutics Corporation.
All other brands are trademarks of their respective owners. The makers of these brands are not affiliated with and do not endorse United Therapeutics or its products.
© 2021 United Therapeutics Corporation. All rights reserved. US/REM/0562
The post You’ve got more to do: Discover Remunity<sup>®</sup>, the latest pump for Remodulin<sup>®</sup> (treprostinil) Injection appeared first on Pulmonary Hypertension News.
