United Therapeutics Launches Living PAH Program for Patients with Pulmonary Arterial Hypertension

SILVER SPRING, Md.--(BUSINESS WIRE)-- United Therapeutics Corporation and Lung Rx, LLC announced today the launch of a nationwide support program for patients who are currently prescribed a United Therapeutics therapy, which includes Remodulin (treprostinil) Injection, Adcirca (tadalafil) tablets or Tyvaso (treprostinil) Inhalation Solution.

Living PAH is a community made up of physicians, nurses, therapists and patients designed to provide disease education, emotional support and reimbursement assistance to those living with pulmonary arterial hypertension (PAH) and their caregivers. As part of Living PAH, patients have access to disease education, healthy lifestyle tips, news and support including help with access to therapies. A national call center (877-948-9137) is staffed Monday through Friday with registered nurses and operators available for patients to find answers to their questions about PAH, United Therapeutics products, additional support services and educational events designed to connect and empower patients and caregivers across the country.

To learn more about Living PAH, or to enroll, please contact the Living PAH Call Center at 877-948-9137 or visit livingpah.com. The Adcirca Reimbursement Hotline, 877-948-9136, will also continue to be a resource for patients and health care providers to provide insurance benefits investigation, reimbursement assistance and other support.

About Pulmonary Arterial Hypertension (PAH)

PAH is a life-threatening disease that affects the blood vessels in the lungs and is characterized by increased blood pressure from the heart to the lungs. The elevated pressure in the pulmonary arteries strains the right side of the heart as it pumps blood to the lungs, which eventually leads to right heart failure and, ultimately, death. It is estimated that PAH affects between 100,000 and 200,000 individuals worldwide.

About United Therapeutics Corporation

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of products to address the medical needs of patients with chronic and life-threatening conditions.

About Lung Rx, LLC

Lung Rx, LLC, a wholly-owned subsidiary of United Therapeutics Corporation, is a biotechnology company focused on addressing medical needs in pulmonary medicine through delivery of innovative pulmonary therapeutic products.

Remodulin® (treprostinil) Injection

Remodulin is indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.

In patients with PAH requiring transition from Flolan® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

Important Safety Information for Remodulin

Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion is the preferred mode of administration. Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH. Remodulin is a potent pulmonary and systemic vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. Remodulin inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants. Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care. Therapy with Remodulin may be used for prolonged periods, and the patient’s ability to administer Remodulin and care for an infusion system should be carefully considered. Remodulin dosage should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic effects or for unacceptable infusion site symptoms. Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided. Caution should be used in patients with hepatic or renal insufficiency.

The most common side effects of Remodulin included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of Remodulin. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilatation, and edema. Click here to see the Full Prescribing Information for Remodulin.

Adcirca® (tadalafil) Tablets

Adcirca is a prescription medication used to treat pulmonary arterial hypertension (WHO Group 1) to improve exercise ability.

Important Safety Information for Adcirca

Patients should discuss all their medical conditions and medications with their doctor before starting Adcirca. Adcirca should not be used in patients taking medicines that contain nitrates (often used for chest pain), as the combination could cause a sudden, unsafe drop in blood pressure. Patients should not take Adcirca if they have a known allergy to tadalafil, or any other ingredient of Adcirca.

If a patient experiences chest pain after taking Adcirca they should seek immediate medical attention. Adcirca is a type of medication called a phosphodiesterase type 5 (PDE5) inhibitor. PDE5 inhibitors can cause blood vessels to widen, which may result in a decrease in blood pressure. Patients with heart-disease or any problems with low blood pressure should inform their doctor before taking Adcirca, as these conditions may be affected by the action of Adcirca. Adcirca is not recommended for patients that have ever had blockage in the veins of their lungs, known as pulmonary veno-occlusive disease (PVOD).

Taking Adcirca with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (fainting). Patients taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole, should not take Adcirca. Patients that require treatment with both Adcirca and ritonavir (Norvir) at the same time will need their Adcirca dose adjusted. Patients with kidney or liver problems should inform their doctor before taking Adcirca. Adcirca contains the same ingredient (tadalafil) as Cialis, which is used to treat erectile dysfunction (impotence). Patients taking Adcirca should not take Cialis or other PDE5 inhibitors. In rare cases, men taking PDE5 inhibitors (including tadalafil) for erectile dysfunction reported side effects such as a sudden decrease or loss of vision or hearing, or an erection lasting more than four hours. Patients that experience any of these side effects should seek medical attention right away. The most common side effects of Adcirca are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, stuffy or congested nose. Click here to see the Full Prescribing Information and Patient Information for Adcirca.

Tyvaso® (treprostinil) Inhalation Solution

Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH, WHO Group I and NYHA Class III symptoms), which is high blood pressure in the arteries of your lungs. Tyvaso can increase walk distance in people who also take bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor). The effects decrease over 4 hours; treatment timing can be adjusted for planned activities.

Important Safety Information for Tyvaso

Tyvaso is intended for oral inhalation (breathed in through the mouth into the lungs) only. Tyvaso is approved for use only with the Tyvaso Inhalation System. The effects of Tyvaso are unknown in patients with lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age. Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect.

Tyvaso may increase the risk of bleeding, particularly in patients receiving anticoagulants (blood thinners). In patients with low systemic arterial pressure (low blood pressure), Tyvaso may cause symptomatic hypotension. The use of Tyvaso with diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure) may increase the risk of symptomatic hypotension.

Other medical conditions and medicines may affect Tyvaso usage by increasing the risk of side effects or decreasing effectiveness. It is important for patients to tell their doctor about any medical conditions and medicines they are taking, including: patients taking gemfibrozil (for high cholesterol) or rifampin (for infection) may require Tyvaso dosage adjustment, patients with liver or kidney problems may find their ability to tolerate Tyvaso affected, patients pregnant, breast-feeding, or planning to become pregnant should talk with their doctor about whether they should take Tyvaso.

The most common side effects of TYVASO are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of TYVASO. Click here to see the Full Prescribing Information, Patient Package Insert, and the Instructions for Use manual for Tyvaso.

Remodulin and Tyvaso are registered trademarks of United Therapeutics Corporation.

Adcirca is a registered trademark of Eli Lilly and Company.



CONTACT:

Media Contact:
United Therapeutics Corporation
Andrew Fisher, 202-483-7000
[email protected]

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