WHIPPANY, N.J., June 29, 2018 /PRNewswire/ -- Bayer announced today the launch of myMentor, a U.S. peer-to-peer support program for adult patients with pulmonary arterial hypertension (PAH, WHO Group 1) or chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4). The program was announced today during the Pulmonary Hypertension Association International PH Conference and Scientific Sessions in Orlando.
"Being diagnosed with a rare, progressive and debilitating disease can be confusing and even frightening for some patients despite guidance from their healthcare provider," said Aleksandra Vlajnic, M.D., Vice President of Medical Affairs, Bayer. "Our hope is that myMentor will provide an additional layer of support and emotional reassurance that only patients who have had similar experiences can provide one another, especially during the start of treatment and lifestyle adjustment."
Patients with PAH and CTEPH would welcome more information for themselves and caregivers about these rare diseases when first diagnosed.1 myMentor is designed to help patients who have not yet been prescribed a treatment or have started treatment but still have questions about living with these diseases or conditions, and who may benefit from conversations with peers who can offer support and insights along the treatment journey. Patients can go to mymentorprogram.com to speak privately and confidentially with a mentor who lives with either PAH or CTEPH. Patients undergoing treatment should always speak with their healthcare provider.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension (PAH, WHO Group 1) is defined by elevated pressure in the arteries going from the right side of the heart to the lungs.2 Typical symptoms of PAH include shortness of breath on exertion, fatigue, weakness, chest pain and syncope.3 PAH is caused by abnormalities in the walls of the pulmonary arteries.2,4
About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Chronic Thromboembolic Pulmonary Hypertension (CTEPH, WHO Group 4) is a progressive type of pulmonary hypertension, in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually lead to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart. CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard and potentially curative treatment for CTEPH is pulmonary thromboendarterectomy (PTE), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material. However, a considerable number of patients with CTEPH (20%-40%) are not operable and in up to 35 percent of patients, the disease persists or reoccurs after PTE.
About Adempas® (riociguat)
Riociguat, licensed in the U.S. as Adempas, is a stimulator of soluable guanylate cyclase (sGC) and is the only treatment approved in the U.S. for use in two types of pulmonary hypertension (WHO Groups 1 and 4).
Adempas® (riociguat) is a stimulator of soluble guanylate cyclase (sGC) and the only treatment approved in the U.S. for use in two types of pulmonary hypertension (WHO Groups 1 and 4). Adempas was the first sGC stimulator developed as part of a worldwide strategic collaboration between Bayer and Merck (known as MSD outside the United States and Canada). Adempas has received marketing authorization in the U.S., Canada, the EU, Japan, China and other countries around the world.
- Adempas (riociguat) tablets is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class.
- Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening.*
Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominantly patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).
*Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD, and persistent worsening of WHO functional class.
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
Do not administer Adempas (riociguat) tablets to a pregnant female because it may cause fetal harm.
Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and one month after stopping treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.
For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.
Adempas is contraindicated in:
- Pregnancy. Based on data from animal reproduction studies, Adempas may cause fetal harm when administered to a pregnant woman and is contraindicated in females who are pregnant. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
- Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form.
- Concomitant administration with specific phosphodiesterase (PDE)-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil.
- Patients with Pulmonary Hypertension associated with Idiopathic Interstitial Pneumonias (PH-IIP).
Warnings and Precautions
Embryo-Fetal Toxicity. Based on data from animal reproduction studies, Adempas may cause embryo-fetal toxicity when administered to a pregnant female and is contraindicated in females who are pregnant. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment, monthly during treatment, and for one month after stopping treatment. Advise females of reproductive potential to use effective contraception during treatment with Adempas and for at least one month after the last dose.
For females, Adempas is only available through a restricted program under the Adempas REMS Program.
Adempas REMS Program. Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program.
Important requirements of the Adempas REMS Program include the following:
- Prescribers must be certified with the program by enrolling and completing training.
- All females, regardless of reproductive potential, must enroll in the Adempas REMS Program prior to initiating Adempas. Male patients are not enrolled in the Adempas REMS Program.
- Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements.
- Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Adempas.
Further information, including a list of certified pharmacies, is available at www.AdempasREMS.com or 1-855-4ADEMPAS.
Hypotension. Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a dose reduction if patient develops signs or symptoms of hypotension.
Bleeding. In the placebo-controlled clinical trials, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients. Serious hemoptysis occurred in 5 (1%) patients taking Adempas compared to 0 placebo patients, including one event with fatal outcome. Serious hemorrhagic events also included 2 patients with vaginal hemorrhage, 2 with catheter-site hemorrhage, and 1 each with subdural hematoma, hematemesis, and intra-abdominal hemorrhage.
Pulmonary Veno-Occlusive Disease. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Therefore, administration of Adempas to such patients is not recommended. Should signs of pulmonary edema occur, the possibility of associated PVOD should be considered and if confirmed, discontinue treatment with Adempas.
Most Common Adverse Reactions
The most common adverse reactions occurring more frequently (≥3%) on Adempas than placebo were headache (27% vs 18%), dyspepsia/gastritis (21% vs 8%), dizziness (20% vs 13%), nausea (14% vs 11%), diarrhea (12% vs 8%), hypotension (10% vs 4%), vomiting (10% vs 7%), anemia (7% vs 2%), gastroesophageal reflux disease (5% vs 2%), and constipation (5% vs 1%).
Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension, and peripheral edema.
For important risk and use information, please see the full Prescribing Information, including Boxed Warning.
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David Patti, +1-973-452-6793
Bayer, Product Communications
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1 Ivarsson, B et al. Information Experiences and Needs in Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension. Nursing Research and Practice. 2014;Article 704094;1-8.
2 Rosenkranz S. Pulmonary hypertension: current diagnosis and treatment. Clin Res Cardiol. 2007;96(8):527-541.
3 McKenna SP et al. The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Qual Life Res 2006;15(1):103-115.
4 Galiè, N et al. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension. Eur Heart J 2009;30:394-403.