OPSUMIT is contraindicated in females who are pregnant. Professor Ghofrani presented data showing that the reduction in risk of hospitalization for PAH and death due to PAH associated with macitentan 10mg treatment versus placebo was 50% (p<0.0001) and that all-cause mortality was reduced by 36% (p=ns). 2012 Sep;42(9):901-10. Strong inhibitors of CYP3A4 like ketoconazole approximately double macitentan exposure. The clinical pharmacology program also indicated a low propensity of macitentan for drug-drug interactions [6,7,8] . Absorption, distribution, metabolism, and excretion of macitentan, a dual endothelin receptor antagonist, in humans. 2008;327(3):736-45. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). N Engl J Med 2013;369:809-18. Eur J ClinPharmacol. Xenobiotica. Gatfield J, Mueller Grandjean C, Sasse T, Clozel M, Nayler O (2012). Processed and transmitted by Thomson Reuters ONE. Actelion Pathways and OPSUMIT are registered trademarks of Actelion Pharmaceuticals Ltd. The most common adverse reactions (more frequent than placebo by 3% or more) observed in patients treated with Opsumit® were anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection. You are solely responsible to obtain country specific documentation. SERAPHIN also showed a risk reduction in PAH related hospitalization and death of 50% (p<0.0001) compared to placebo. Initial U.S. Approval: 2013 . ", See "The most important information about OPSUMIT". If you are the parent or caregiver of a female child who started taking OPSUMIT before reaching puberty, check with your child regularly for any signs of puberty. 2012; 55:7849-61. In: Bonow RO, Mann DL, Zipes DP, Libby P, eds. Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Without their contribution, Opsumit® would not have become a reality. 6. Hemoglobin should be measured prior to initiation of treatment and repeat during treatment as clinically indicated. References: 1. At ERS I have highlighted the hospitalization data in more details and shown that macitentan significantly reduced the risk of death due to PAH and hospitalizations for PAH. Patients were randomized 1:1:1 to receive two different doses of macitentan (3 mg and 10 mg once daily) or placebo. stream [1], ABOUT THE SAFETY AND TOLERABILITY PROFILE. Patients were treated with Opsumit® monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. South San Francisco, CA: Actelion Pharmaceuticals US, Inc. References: 1. Humbert M, Lau EM, Montani D, Jaïs X, Sitbon O, Simonneau G. Advances in therapeutic interventions for patients with pulmonary arterial hypertension. {��v`I)߉'a���:,�L4�#\��{����J�&�]Z���I�Nn�����0� O}S��UQF3q R. OPSUMIT for a condition for which it was not prescribed. Actelion Pharmaceuticals UK Ltd Janssen Ltd 50-100 Holmers Farm Way High Wycombe HP12 4DP UK +44 208 987 3333 [email protected] Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Pharmacology of macitentan, an orally active tissue-targeting dual endothelin receptor antagonist. If you are a woman who is able to get pregnant, you must talk to your doctor to learn the benefits and risks of OPSUMIT. South San Francisco, CA: Actelion Pharmaceuticals US, Inc. 3. You are medically able to get pregnant if you are a woman who fits all of the following guidelines: You are not medically able to get pregnant if you are a woman who fits Slow Receptor Dissociation Kinetics Differentiate Macitentan from Other Endothelin Receptor Antagonists in Pulmonary Arterial Smooth Muscle Cells. Initiation of OPSUMIT is not recommended in patients with severe anemia. Last month saw the publication of the SERAPHIN morbidity and mortality data in The New England Journal of Medicine. J Med Chem. Actelion markets Tracleer through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion's over 2,300 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Opsumit is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Just days ago the primary paper of our landmark SERAPHIN study appeared in The New England Journal of Medicine, and in the last 12 months key data have been presented at CHEST, ATS, ESC and ERS. Eur J ClinPharmacol. In PAH, survival rates are unacceptably low and PAH remains incurable. Hoeper MM, Bogaard HJ, Condliffe R, et al. Global enrollment was completed in December 2009 with a total of 742 patients. We will now leverage our existing PAH expertise and infrastructure to bring Opsumit® to patients within the coming weeks.". Females of reproductive potential should be counselled on the use of reliable contraception and have a negative pregnancy test prior to initiating therapy and monthly thereafter. One patient in each treatment group discontinued due to anemia. Eur Respir J. Your message has been sent. Avoid concomitant use of OPSUMIT with strong CYP3A4 inhibitors. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. PLOS ONE 7(10): e47662. Outside of the United States, Actelion continues to work with health authorities to obtain regulatory approval for Opsumit® . South San Francisco, CA: Actelion Pharmaceuticals US, Inc. 3. Do not give OPSUMIT to other people, even if they have the same symptoms that you have. Talk to your doctor about all your medical conditions, as well as all the medicines, vitamins, and supplements you take. Pulido T, Adzerikho I, Channick RN, et al; SERAPHIN Investigators. The SERAPHIN study also demonstrated a significant treatment effect for macitentan 10mg in its secondary outcome measures and compared with placebo, a higher proportion of macitentan- treated patients had nasopharyngitis, headache, and anemia.

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