Additionally, consider providing the treatment plan, patient prognosis, and any other pertinent medical information. Actelion receives us fda approval of uptravi selexipag. Hyperthyroidism was observed in 1% n8 of patients on uptravi and in none of the patients on placebo. There is limited experience with abrupt discontinuation of uptravi in patients. For va patients only uptravi selexipag prescription form. And 2 patient is not taking orenitram or uptravi in combination with a prostanoidprostacyclin analogue. Uptravi is a prescription drug approved by the food and drug administration fda to delay disease progression and reduce the risk of hospitalization in cases of pulmonary arterial hypertension pah. If patient is maintained at ventavis 5 mcg 10 mcgml for 1 month, consider transitioning to ventavis 5 mcg 20 mcgml starting at month 2, unless contacted by physician.
For more information about treatment with uptravi, read the package leaflet. Patients obtain selexipag through a prescription from their pulmonary. When conditions are met, we will authorize the coverage of uptravi. Uptravi selexipag for pulmonary hypertension myphteam. You may contact paramount by phone at 14198872520 with questions regarding the prior authorization process. Dosing of selexipag uptravi the starting dose of selexipag is 200 mcg twice daily. Uptravi lowers blood pressure in your lungs by dilating widening blood vessels that supply blood to the lungs.
Information is based on the united states food and drug administration drug labeling. I am a healthcare professional in the us i am a patient or caregiver in the us, 18 years of age or older. It is written for patients and gives information about taking or using a medicine. Uptravi is used to treat pulmonary arterial hypertension pah uptravi helps keep your condition from getting worse and helps lower your risk of needing to be hospitalized for pah. Reallife data on selexipag for the treatment of pulmonary. When a pharmaceutical company changes any document, a new version is published on medicines. Uptravi is used to treat pulmonary arterial hypertension pah uptravi helps. Actelion receives approval for uptravi selexipag for the. Read this patient information before you start taking uptravi and each time you get a refill. Twentysix patients were treated with selexipag, of whom 23 had pah and. The following information contains certain forwardlooking statements, relating to the companys business, which can be identified by the use of forwardlooking terminology such.
The patient titration guide along with the patient information leaflet should be. For more information about treatment with uptravi, read the package leaflet also part of the epar or contact your doctor or pharmacist. Uptravi offers patients an oral treatment that targets the prostacyclin pathway, opening the way for oral combination therapies with proven longterm outcome benefits. I understand that once my information is shared with actelion, my information. This information does not take the place of talking to your. A registry for patients taking uptravi full text view. Yes no select if the patients pulmonary arterial hypertension pah was caused by the following. Specialty pharmacy clinician to assess patient with each dose. Uptravi 1,000 microgram filmcoated tablets patient. How many tablets does the patient need per day after initiationtitration. Uptravi selexipag 18668401509 the most current version of this form supersedes all prior versions. Is uptravi being prescribed by a pulmonologist, cardiologist, nephrologist, or rheumatologist. Prescribing information for uptravi, including patient product information. This medicine comes with a patient information insert.
Sep 12, 2019 tell your doctor if you are pregnant or become pregnant while using uptravi. The dose is then increased by 200mcg twice daily every week to the highest dose a patient can tolerate up to a. And 2 patient is not taking orenitram or uptravi in combination with a prostanoidprostacyclin analogue e. Feb 26, 2020 the patient information leaflet pil is the leaflet included in the pack with a medicine. Uptravi is used to treat pulmonary arterial hypertension pah. Uptravi can help delay slow down the progression of your disease and lower your risk of being hospitalized for pah. For more information, ask your doctor or pharmacist. Cvs caremark administers the prescription benefit plan for the patient identified. The european medicines agency told doctors today that they can continue to prescribe actelions vtx. For each version, we show the dates it was published on medicines. For all female patients access this form online at. Patients obtain selexipag through a prescription from their pulmonary hypertension specialist.
Selexipag is an oral medication called a prostacyclin ip receptor agonist indicated for the treatment of pulmonary arterial. Take this medicine exactly as directed by your doctor. The european commission granted a marketing authorisation valid throughout the european union for uptravi on 12 may 2016. Sep 11, 2017 a registry for patients taking uptravi sphere the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. I am a healthcare professional in the us i am a patient or caregiver in the us.
Letter of appeal actelion pathways patient assistance. This information does not take the place of talking to your healthcare provider. Yes no if yes, please select one option for home visits. Find patient medical information for uptravi oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Uptravi selexipag for patients prescribed uptravi for pulmonary arterial hypertension. Uptravi fda prescribing information, side effects and uses.
Do not use uptravi for a condition for which it was not. Uptravi 1,000 microgram filmcoated tablets patient information leaflet pil. Uptravi has been approved in germany since may 2016 for adults with pulmonary arterial hypertension high blood pressure. The dose is then increased by 200mcg twice daily every week to the highest dose a patient can tolerate up to a maximum dose of 1,600mcg twice daily. What is a patient information leaflet and why is it useful. General information about the safe and effective use of uptravi.
Product subject to medical prescription which may not be renewed a patient information leaflet patient information leaflet last updated on medicines. Do not use uptravi for a condition for which it was not prescribed. Uptravi is used for the longterm treatment of pulmonary arterial hypertension pah in adult patients. Orenitram treprostinil extendedrelease tablets pah. Highlights of prescribing information these highlights do not include all the information needed to use symtuza safely and effectively. Yes no does the patient have a diagnosis of pulmonary arterial hypertension who group 1. Cvs caremark administers the prescription benefit plan for the. Also, do not stop taking this medicine without checking with your doctor first. Until now the options for treatments targeting the prostacyclin pathway have been limited, and were burdensome for the patient. Our uptravi selexipag tablets side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Supplemental material for reallife data on selexipag for the. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Listing a study does not mean it has been evaluated by the u. Selexipag uptravi treatments for pulmonary hypertension issued by phas scientific leadership council. Before prescribing uptravi, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by vasodilatory effects e. See what others have said about uptravi, including the effectiveness, ease of use and side effects. These are not all the possible side effects of uptravi. You may contact paramount by phone at 14198872520 with questions regarding the prior. Our goal is that you will feel less short of breath and be able to do more without getting as tired. The patient information has been approved by the u. The patient information leaflet pil is the leaflet included in the pack with a medicine. Fax completed form and copy of patients insurance card to 18662790669 andor include copy of patient demo from electronic medical records 1. Atln pulmonary arterial hypertension drug, uptravi.
Please see full prescribing information and patient information at. To learn more about orenitram, talk with your healthcare provider. Nov 06, 2019 uptravi lowers blood pressure in your lungs by dilating widening blood vessels that supply blood to the lungs. Please confirm you are a healthcare professional to continue. Uptravi helps keep your condition from getting worse and helps lower your risk of needing to be hospitalized for pah. Uptravi selexipag dosing, indications, interactions. Additionally, consider providing the treatment plan, patient prognosis, and any other pertinent medical information to support why uptravi is medically necessary for this patient. Our uptravi selexipag tablets side effects drug center provides a comprehensive view of available drug information. Uptravi is not recommended for use while breastfeeding. A registry for patients taking uptravi sphere the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The form may be modified without notice to you and we reserve the right to accept only the current version. I understand that blue cross nc may request medical records for this patient at any time in order to verify this information.
Actelion, a division of janssencilag international nv. The safety of uptravi has been evaluated in a longterm, placebocontrolled study enrolling 1156 patients with symptomatic pah griphon study see clinical studies 14. If patient is maintained at 5 mcg 10 mcgml dose and repeatedly experiences extended treatment times, consider transitioning to 5 mcg 20 mcgml. This information is intended for us healthcare professionals. Information to be completed by prescribing physician.
Review the guide for female patients with the patient. Selexipag uptravi pulmonary hypertension association. Highlights of prescribing information these highlights do not include all the information needed to use uptravi safely and effectively. I further certify that the patients medical records accurately reflect the information provided. Please fax signed forms to paramount at 18442562025. Sep 10, 2019 the patient information has been approved by the u. Uptravi selexipag is a prescription medicine used to treat pulmonary arterial hypertension pah, who group 1, which is high blood pressure in the arteries of your lungs. Sep 12, 2019 keep uptravi and all medicines out of the reach of children. Yes no does the patient have a diagnosis of pulmonary arterial hypertension who. The risk information provided here is not comprehensive. However, plans with a set copayment may result in a cost to the patient. To receive farther information about uptravi and its effects, talk to your doctor. Ema examines key actelion med uptravi following 5 patient deaths in france.
The information in this document is intended to help canadian health care. Uptravi has vasodilatory properties that may result in lowering of blood pressure. The following information contains certain forwardlooking statements, relating to the. This could include test and lab results, hospital admission information, please summarize the clinical rationale for prescribing uptravi for this patient. An independent licensee of the blue cross and blue shield association. Fax completed form and copy of patients insurance card to 18662790669 andor include copy of patient demo from electronic medical records atient information 1. What uptravi is and what it is used for uptravi is a medicine that contains the active substance selexipag.
Symtuza darunavir, cobicistat, emtricitabine, and tenofovir. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This information does not take the place of talking to your healthcare provider about your medical condition or your. In a phase 3 placebo controlled study in patients with pah, mean absolute changes in hemoglobin. However, if a patient reaches a dose that cannot be tolerated, the dose should be reduced to the previous dose level. Side effects of uptravi uptravi selexipag tablets, warnings. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Does the patient have a diagnosis of pulmonary arterial hypertension pah who group 1 and.