Patient Support
Patient Support Programs
If you have pulmonary arterial hypertension (PAH), there are ways you can chart your health and stay informed about your condition: taking 6-minute walk tests, having your blood pressure monitored, keeping track of how many nanograms (your dosage) of REMODULIN® (treprostinil sodium) Injection you are using or how many breaths of TYVASO (treprostinil) Inhalation Solution you have inhaled. It is important to be proactive in managing your PAH.
Patients who are on PAH therapies have a wide range of support resources available to them. United Therapeutics encourages all patients to take advantage of these programs whenever they are able, and to seek out as much information and assistance as possible to better cope with the challenges of living with PAH.
For a comprehensive network of patient support, visit www.livingpah.com. We also offer the following patient support programs:
PEER Network (Patients Exchanging Experiences with REMODULIN)
The PEER Network is a unique program that connects people who are considering taking REMODULIN or who have recently started therapy with experienced REMODULIN patients - called PEER Mentors. The PEER Network allows for the exchange of private phone calls and one-to-one e-mails through a secure Web-based system and also offers a supportive group speaker program.
www.peernetwork.net
RTA (REMODULIN Therapy Assistance)
Through RTA, every REMODULIN patient has the opportunity to build a relationship with a dedicated REMODULIN Therapy Assistant whose role is to offer nonmedical assistance in support of REMODULIN therapy. Assistance may include providing additional information about REMODULIN and answering general insurance questions.
For more information, please contact United Therapeutics via e-mail at RTA@unither.com or call 1-877-UNITHER. You can also click here to sign up for RTA.
PAP (Patient Assistance Program)
United Therapeutics created this program to provide access to REMODULIN, TYVASO or ADCIRCA and any related supplies for patients who cannot afford therapy because of their financial situations, those who do not have enough insurance or are between insurance plans, and those who have insurance restrictions.
For more information, please contact United Therapeutics at 1-888-485-8350.
REMODULIN® (treprostinil sodium) Injection
Indication
REMODULIN is indicated for the treatment of pulmonary arterial hypertension 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 pulmonary arterial hypertension 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:
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. 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. 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. Dose 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, vasodilation, and edema.
Please see the REMODULIN full prescribing information for further details.
TYVASO™ (treprostinil) Inhalation Solution
Indication
TYVASO is indicated to increase walk distance in patients with WHO Group I pulmonary arterial hypertension and NYHA Class III symptoms. 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 controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.
Important Safety Information:
TYVASO is intended for oral inhalation only. TYVASO is approved for use only with the TYVASO Inhalation System.
The safety and efficacy of TYVASO have not been established in patients with significant underlying 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.
In patients with low systemic arterial pressure, TYVASO may cause symptomatic hypotension. The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
Hepatic or renal insufficiency may increase exposure to TYVASO and decrease tolerability. TYVASO dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn.
The most common adverse events seen with TYVASO in ³ 4% of PAH patients and more than 3% greater than placebo in the placebo-controlled clinical study 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%).
TYVASO should be used in pregnancy only if clearly needed. Caution should be exercised when TYVASO is administered to nursing women.
For more information, please see the Full Prescribing Information, Patient Package Insert and the TYVASO Inhalation System Instructions for Use manual.
ADCIRCA™ (tadalafil) Tablets
Indication
Adcirca is a phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise ability.
Important Safety Information:
Adcirca should not be used in patients taking medicines that contain nitrates, as the combination could cause a sudden, unsafe drop in blood pressure. If a patient experiences anginal chest pain after taking Adcirca they should seek immediate medical attention.
Adcirca contains the same ingredient (tadalafil) as Cialis, which is used to treat erectile dysfunction (ED). The safety and efficacy of combinations of Adcirca with Cialis or other PDE-5 inhibitors have not been studied. Therefore, the use of such combinations is not recommended.
Patients with a known serious hypersensitivity to tadalafil should not take Adcirca.
PDE-5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing Adcirca, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such actions. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of Adcirca to these patients is not recommended.
The use of Adcirca with alpha blockers, blood pressure medications, and alcohol may lower blood pressure significantly and may lead to symptomatic hypotension (fainting).
Tadalafil is metabolized predominantly by CYP3A in the liver. Use of Adcirca with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on Adcirca therapy that require treatment with ritonavir, Adcirca should be discontinued at least 24 hours prior to starting ritonavir. For patients on ritonavir therapy that require treatment with Adcirca, start Adcirca at 20 mg once a day. Use of Adcirca with potent inducers of CYP3A, such as rifampin, should be avoided.
The use of Adcirca is not recommended for patients with severe renal or hepatic impairment. Please see full prescribing information for dosing recommendations for patients with mild to moderate renal or hepatic impairment
In rare instances, men taking PDE-5 inhibitors (including tadalafil) for ED reported a sudden decrease or loss of vision or hearing, or an erection lasting more than four hours. A patient who experiences any of these symptoms should seek immediate medical attention.
The most common side effects with Adcirca seen in the PHIRST-1 clinical trial were headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, extremity pain, nausea, back pain, dyspepsia and nasal congestion.
For full prescribing information and/or patient information, http://www.ADCIRCA.com or call 1-800-545-5979.