PROLASTIN®-C LIQUID (Alpha 1-Proteinase Inhibitor [Human]) 3045824 (Revised: 9/2017) 2 2 DOSAGE AND ADMINISTRATION For intravenous use only. • United Therapeutics. See full prescribing information for All other brands are trademarks of their respective owners. Remodulin is indicated for subcutaneous (SC) or intravenous (IV) use only as a continuous infusion. New York, NY; Pfizer, Inc.; January 2019. Treprostinil/Remodulin is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. If you are not a US healthcare provider, please click CLOSE to return to the patient section of the site. Click CONTINUE to proceed or CLOSE to return to Remodulin.com. Research Triangle Park, NC. Remodulin [package insert]. Pulmonary Arterial Hypertension in Patients Requiring Transition from Epoprostenol The risk information provided here is not comprehensive. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION . x���1 01ǐʷ\ˢ�A�x�'MF[����. REMODULIN (treprostinil) Injection Package Insert . Call your doctor for medical advice about side effects. Research shows that differences in perspective between healthcare providers and their patients sometimes create barriers to communication. What pump options are available for Remodulin? Please see Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437). Pharmacologic therapy for pulmonary arterial hypertension in adults. 0000000016 00000 n your life and in your pocket. Bleeding problems. Remodulin package insert. Remodulin (treprostinil) Line(s) of Business: HMO; PPO; QUEST Integration Medicare Advantage Original Effective Date: 10/01/2015 Current Effective Date: 10 /01/2019 POLICY A. Simonneau G, Robbins IM, Beghetti M, et al. Remodulin may increase the risk of bleeding in people who take blood thinners (anticoagulants). Princeton, New Jersey, March 25, 2019 – Sandoz today announced the US availability of Treprostinil Injection, the first fully substitutable AP rated generic version of Remodulin ®* (treprostinil) Injection, sold by United Therapeutics Corporation, including 180 days of marketing exclusivity for the product. The lowest GoodRx price for the most common version of generic Remodulin is around $2,512.00, 84% off the average retail price of $16,530.37. It is not known if Remodulin is safe and effective in children. Accessed December 2019. 0000041521 00000 n REMODULIN ® (treprostinil) Injection 1. The infusion rate is initiated at 1.25 ng/kg/min. 0 It is not known if Remodulin is safe and effective in children. Remodulin is supplied in 20-mL multidose vials as sterile solutions in water for injection, individually packaged in cartons. Low blood pressure (symptomatic hypotension). A single vial of Remodulin should be used for no more than 30 days after the initial introduction into the vial. Initiate Remodulin at a recommended dose of 10% of the current Flolan dose Decrease the dose of Flolan while simultaneously increasing the dose of Remodulin, based on … To learn more about Remodulin, talk with your healthcare provider. What are the possible side effects of Remodulin? In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness, swelling, and rash). 0000028732 00000 n 0000032766 00000 n Chest 2007; 131: 1917-1928. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088. Treprostinil, sold under the brand names Remodulin for infusion, Orenitram for oral, and Tyvaso for inhalation, is a vasodilator that is used for the treatment of pulmonary arterial hypertension. Research Triangle Park, NC: United Therapeutic Corp; July 2018. 0000003834 00000 n Updated clinical classification of pulmonary hypertension. Remodulin (treprostinil) Injection is a sterile solution of treprostinil formulated for subcutaneous or intravenous administration. In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms. 0000006591 00000 n Use patience, knowledge, determination, and take one day at a time. Medical uses. 0000023593 00000 n Research Triangle Park, NC: United Therapeutics Corporation; 2018. 0000009911 00000 n 0000028498 00000 n Revatio [package insert]. Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Remodulin is preferably infused subcutaneously, but can be administered by a central intravenous line if the subcutaneous route is not tolerated, because of severe site pain or reaction. endstream endobj 1077 0 obj <>/Size 1031/Type/XRef>>stream Parenteral conversation. Unopened vials of Treprostinil Injection are stable until the date indicated when stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 1.1 Pulmonary Arterial Hypertension . xref Have low blood pressure or bleeding problems. Remodulin is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. 0000014252 00000 n Remodulin is preferably infused subcutaneously, but can be administered by a central intravenous line if the subcutaneous route is not tolerated because of severe site pain or reaction. US/REM/0458. Is cost assistance available for Remodulin? 0000041772 00000 n Available at: Remodulin is supplied in 20-mL multidose vials as sterile solutions in water for injection, individually packaged in cartons. Most eligible patients may pay as little as $5 per prescription. Taichman DB, Ornelas J, Chung L, et al. Remodulin [package insert]. 2.1 Dose • The recommended dose of PROLASTIN-C LIQUID is 60 mg/kg body weight administered intravenously once weekly. 0000032224 00000 n For PAH (WHO Group 1) to diminish symptoms associated with exercise and to diminish the rate of clinical deterioration in patients transitioning from Flolan® Continuous intravenous (IV) infusions of Remodulin delivered using an external infusion pump, with a tube placed in a central vein within the chest, are associated with the risk of blood stream infections and sepsis, which may be fatal. The infusion rate is initiated at 1.25 ng/kg/min. Advice from a cardiologist should be sought to determine the most appropriate monitoring strategy (which may include overnight monitoring) during treatment initiation, if treatment with MAYZENT is considered in patients: Remodulin is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. 3. 0000015888 00000 n 0000008752 00000 n Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. • Badesch D, Abman S, Simonneau G, Rubin L, and McLaughlin V. American College of Chest Physicians Evidence Based Clinical Practice Guidelines: Medical Therapy for Pulmonary Arterial Hypertension. 0000041979 00000 n 0000006018 00000 n What cost assistance is available for Remodulin? Do not stop taking or greatly reduce your Remodulin dose without consulting your doctor. This link will take you to a site maintained by a third party who is solely responsible for the site’s content. 2. 2013; 62:034-841. See full prescribing information for x�b```b``�b`c`�(a`@ V�(� 0000005788 00000 n J Am Coll Cardiol. The Implantable System for Remodulin is an infusion system that is fully implanted into a patient to deliver Remodulin through a patient's veins. Your Remodulin dose may need to be adjusted if you have liver problems. If this initial dose cannot be tolerated because of systemic effects, reduce the infusion rate to 0.625 ng/kg/min. 0000002726 00000 n Treprostinil was approved for use in the United States in May 2002. Approaching the parenteral therapy conversation and increasing patient understanding. Important Safety Information for Remodulin. 0000010048 00000 n 0000022259 00000 n ; Have liver or kidney problems. %PDF-1.5 %���� 0000020784 00000 n INDICATIONS AND USAGE . 0000015849 00000 n Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which … Call your doctor for medical advice about side effects. Remodulin ® (treprostinil) Injection. 0000003349 00000 n (epoprostenol sodium). All rights reserved. 1031 48 Page 6 of 8 This HNE clinical criteria is only a screening tool. Treprostinil is a synthetic analog of prostacyclin (PGI 2). 0000020977 00000 n The information contained in this section of Remodulin.com is clinical in nature and was specifically created for healthcare providers. Remodulin was administered as a subcutaneous Infusion as per the package insert dosing instructions, and the dose averaged 9.3 ng/kg/min at Week 12. 1078 0 obj <>stream CHEST guideline and expert panel report. 0000011877 00000 n Have other medical conditions or take other medicines that may affect your use of Remodulin by increasing the risk of side effects or decreasing the. trailer 0000031920 00000 n © 2020 United Therapeutics Corporation. Before you take Remodulin, tell your healthcare provider if you: What are the serious side effects of Remodulin? Read the latest study data. 0000012515 00000 n Remodulin (treprostinil) Injection is a sterile solution of treprostinil formulated for subcutaneous or intravenous administration. FULL PRESCRIBING INFORMATION . 0000005293 00000 n Remodulin is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. 0000012647 00000 n Remodulin (treprostinil) Injection is a sterile solution of treprostinil formulated for subcutaneous or intravenous administration. 0000002304 00000 n 0000020148 00000 n The most common side effects seen with either SC or IV Remodulin were headache, diarrhea, nausea, rash, jaw pain, widening of the blood vessels (vasodilatation), and swelling from fluid retention (edema). %%EOF TREPROSTINIL is used to treat pulmonary arterial hypertension.This medicine helps to improve symptoms and quality of life. 0000006512 00000 n �� D���v����6y�'�՜�Y�������WӮ9�_f�~�Y�~o�L�x�cR�����e���4tj]�]v'��b��a�H�ϳم�sw)��l�� ����Iea�C=�g�����]A�Kd�JK�Q��6�TzC�PY讠�� �2}50���H����Q�ta���A�&��P�Ѹ@���b�6�=���䖖��椥%�(�0�X�Q0- *Ȥ�lg����h C@����2�&�A Remodulin is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. 2. 2. The most common side effects of Tyvaso are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea. Hier sollte eine Beschreibung angezeigt werden, diese Seite lässt dies jedoch nicht zu. Remodulin is a registered trademark and Remunity is a trademark of United Therapeutics Corporation. 0000005069 00000 n • Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. What are the side effects of Remodulin and how can they be managed? Reference ID: 4274798 . 0000017317 00000 n Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. If you have low blood pressure or are taking drugs that lower your blood pressure, the risk of low blood pressure is increased. Therefore, continuous subcutaneous (SC) infusion delivered just beneath the skin is the preferred type of delivery. Are taking gemfibrozil (for high cholesterol), rifampin (for infection) or other drugs that affect liver enzymes. 0000007760 00000 n J Am Coll Cardiol. Research Triangle Park, NC; United Therapeutics Corp; July 2018. Taichman DB, Ornelas J, Chung L, et al. Remodulin has a Warning and Precaution for chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. 0000004933 00000 n The makers of these brands are not affiliated with and do not endorse United Therapeutics or its products. To understand and improve upon the … HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VENTAVIS safely and effectively. Remember that even though you have PAH, PAH doesn’t have to have you. Accessed December 2019. 0000012560 00000 n Your doctor may need to adjust your, Are pregnant, breastfeeding, or planning to become pregnant. Remodulin [package insert]. 0000001284 00000 n Unopened vials of Remodulin are stable until the date indicated when stored at 25°C (77°F), with excursions permitted to 2-30°C (36-86°F). Yes, I am a US healthcare provider and would like to continue. Pharmacologic therapy for pulmonary arterial hypertension in adults. 0000001835 00000 n A single vial of Remodulin should be used for no more than 30 days after the initial introduction into the vial. These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation. Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Simonneau G, Robbins IM, Beghetti M, et al. Remodulin [package insert]. 0000031669 00000 n It is not known if Remodulin will harm your unborn baby or if Remodulin passes into your. 0000018987 00000 n Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. 3. 0000028974 00000 n These highlights do not include all the information needed to use FLOLAN safely and effectively. Remunity™—a small, simple subcutaneous pump that fits in It is not for final clinical or payment decisions. ©2016 Health New England, Inc. startxref 0000004331 00000 n Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which … Important Safety Information for Remodulin. Few subjects received doses > 40 ng/kg/min. WARNING: EMBRYO-FETAL TOXICITY • Do not administer OPSUMIT to a pregnant female because it may cause fetal harm [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1)]. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRACLEER® safely and effectively. 0000002038 00000 n 0000002177 00000 n Worsening of PAH symptoms. Updated clinical classification of pulmonary hypertension. ��,a����P� �c��*~ i 6��0�1�H,�r�${��i�#�>J���8JȕQQS`q��X�$�t�Rr�ۅ@Mo�-[�|Lx�ve3�:�9�v��~�9v����A �e�$ D���)H3��5b`j������E�nD�B�� �k�n Research Triangle Park, NC: United Therapeutic Corp; December 2014. B. Remodulin can reduce symptoms associated with exercise. 2.3. Where can I find tips and advice from other Remodulin patients? Remodulin can reduce symptoms associated with exercise. Have liver or kidney problems. 0000032469 00000 n 2013; 62:034-841. <<85B6BF7021A2CD4AB6B70FBB21DB477B>]>> Treprostinil Injection is supplied in 20-mL multi-dose vials as sterile solutions in water for injection, individually packaged in cartons. Before you take Remodulin, tell your healthcare provider if you: Have other medical conditions or take other medicines that may affect your use of Remodulin by increasing the risk of side effects or decreasing the drug’s effectiveness. 0000020899 00000 n These are not all the possible side effects of Tyvaso. Few subjects received doses > 40 ng/kg/min. Unopened vials of Remodulin are stable until the date indicated when stored at 25°C (77°F), with excursions permitted to 2-30°C (36-86°F). PAH=pulmonary arterial hypertension; WHO=World Health Organization. Healthcare professional site for Orenitram (oral treprostinil), an oral prostacyclin class therapy. IV infusion of Remodulin delivered through an external pump has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain. 1031 0 obj <> endobj January 2010. 0000020812 00000 n These are not all the possible side effects of Remodulin. See full prescribing information for

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