PAH Links
Living PAH
Through the Living PAH program, United Therapeutics Corporation offers a number of support services that complement the efforts of your healthcare providers and pharmacists and are provided at no cost to you. These include educational programs, emotional support services and more. The Living PAH network of service options is designed to help patients manage the challenges of living with PAH.
www.LivingPAH.com
In addition to Living PAH, the following websites offer additional information and support for people who are living with PAH. These websites are not affiliated with United Therapeutics Corporation:
Pulmonary Hypertension Association (PHA)
Established in 1997 by three PAH patients, the Pulmonary Hypertension Association has grown to become the mainstay organization for this disorder. The mission of the PHA is to find ways to prevent and cure PAH and to provide hope for the PAH community through support, education, advocacy and awareness. It includes a network of more than 230 patient support groups.
www.phassociation.org
National Heart, Lung and Blood Institute (NHLBI)
The National Heart, Lung and Blood Institute provides information for professionals and the general public about heart and vascular diseases, lung diseases, blood diseases and resources, and sleep disorders.
www.nhlbi.nih.gov
The American Heart Association (AHA)
Founded in 1924, the American Heart Association is the nation’s oldest and largest voluntary health organization dedicated to building healthier lives, free of heart disease and stroke. To help prevent, treat and defeat these diseases—America’s No. 1 and No. 3 killers—the AHA funds cutting-edge research, conducts lifesaving public and professional educational programs, and advocates for public health. To learn more, or to join the AHA in helping all Americans, call 1-800-AHA-USA1.
www.americanheart.org.
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%).
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.
For more information about REMODULIN, please see the Full Prescribing Information.
Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).