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