It is important to change the location of the injection site with each dose to avoid problem areas under the skin.The dosage is based on your weight, medical condition, and response to treatment. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Pain, redness, or swelling at the injection site may also occur. OIC in adult patients with chronic non-cancer pain, OIC in adult patients with advanced illness. Properly discard this product when it is expired or no longer needed. Single-use vial containing 12 mg/0.6 mL solution for subcutaneous injection. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. Found inside – Page 343Methylnaltrexone Bromide (Relistor) is a quaternary amine derivative of naltrexone. The recommended oral dose is 450 mg (3 × 150-mg tablets) once daily with water on an empty stomach at least 30 minutes before the first meal of the day; ... View the formulary and any restrictions for each plan. RELISTOR subcutaneous injection was well tolerated and the adverse event profile was consistent with other studies of RELISTOR in an advanced . 11. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. If you have any questions, ask your doctor or pharmacist.Inject this medication under the skin in the upper arm, abdomen, or thigh. Found inside – Page 542Methylnaltrexone (Relistor) is μ-receptor antagonist approved for opioid-induced constipation in patients with ... It is administered at a weight-based dose as a subcutaneous injection, usually every other day (no more than once daily), ... A: Generally acceptable. An oral formulation of methylnaltrexone bromide (Relistor) has received US Food and Drug Administration (FDA) approval for the treatment of opioid-induced constipation (OIC) in adults with chronic . This medication works quickly. Click, The recommended dosage is 12 mg subcutaneously once daily, Dose reduction is recommended in patients with moderate to severe renal impairment and patients with severe hepatic impairment, Discontinue all maintenance laxative therapy prior to initiation of RELISTOR. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information. Laxative(s) can be used as needed if there is a suboptimal response to RELISTOR after 3 days, RELISTOR should be administered subcutaneously in the patient’s abdomen, thigh, or upper arm, rotating the site of injection each time. 2008;27:1224-1232. PRECAUTIONS: Before using methylnaltrexone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Relistor Oral Tab: 150mg Relistor Subcutaneous Inj Sol: 0.4mL, 0.6mL, 8mg, 12mg HOW SUPPLIED. Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Only patients requiring an 8 mg or 12 mg dose should be prescribed pre-filled syringes. Methylnaltrexone is administered as a subcutaneous injection into the upper arm, thigh or abdomen.12 Each dose is supplied in a single-use vial containing 12 mg methylnaltrexone in 0.6 mL water. You are now entering a site that is for US healthcare professionals only. RELISTOR injection is for subcutaneous use only. Learn how to store and discard medical supplies safely.Before injecting each dose, clean the injection site with rubbing alcohol. The use of RELISTOR in the experimental group of this study meets all of the following conditions: Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Relistor OIC Survey: QuickRead Report. No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. The usual schedule is one dose every other day, as needed, but no more frequently than one dose in a 24-hour period. For adult patients with long-lasting (chronic) non-cancer pain, inject 1 dose of RELISTOR injection each day. Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Galligan JJ, Sternini C. Insights into the role of opioid receptors in the GI tract: experimental evidence and therapeutic relevance. Pergolizzi JV Jr, Raffa RB, Pappagallo M, et al. Salix Pharmaceuticals or its affiliated entities do not monitor non-affiliated websites for accuracy. 2002 This drug has one hundred and twenty-nine patent family members in thirty-seven countries. 4.7 Effects on ability to drive and use machines. •Inject in upper arm, abdomen or thigh. Methylnaltrexone is administered as a subcutaneous injection into the upper arm, thigh or abdomen.12 Each dose is supplied in a single-use vial containing 12 mg methylnaltrexone in 0.6 mL water. RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased. This drug is available at the lowest co-pay. (2.2) It is not known if RELISTOR is safe and effective in children. Before using, check this product visually for particles or discoloration. Found inside – Page 619METHYLNALTREXONE BROMIDE In postoperative patients, excessive dosage may result in excitement and significant reversal ... *Administration: Methylnaltrexone is administered as a subcutaneous injection only and should be injected in the ... Products or treatments described on this site are available in the United States but may not be available in all other countries. Data on file. Found insideFirst of its kind text that covers both basic and clinical aspects, bridging the knowledge gap, and providing a bench to bedside approach for management of common disorders Discusses the latest concepts and basic principles of ... ( 1.1) •RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. 6. WebMD provides important information about Abilify oral such as if you can you take Abilify oral when you are pregnant or nursing or If Relistor subcutaneous dangerous for children or adults over 60. Access your plan list on any device – mobile or desktop. Typical dosing for Relistor (methylnaltrexone) Pill form: Take 450 mg by mouth once daily in the morning. •In adult patients with chronic non-cancer pain and OIC: •RELISTOR has been shown to be efficacious in patients who have taken opioids for at least 4 weeks. 2009;7(1):39-46. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cDovL3JlZmVyZW5jZS5tZWRzY2FwZS5jb20vZHJ1Zy9yZWxpc3Rvci1tZXRoeWxuYWx0cmV4b25lLTM0MjA4MQ==, View explanations for tiers and RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. Most Pain Med. RELISTOR Claims Distribution. 62-114 kg: 12 mg/dose SC every other day. Methylnaltrexone (Relistor) is used to treat constipation caused by opioids (in cancer patients). Do not administer more frequently than one dose per 24-hour period. For example, if your doctor has directed you to use 8 milligrams of medication, draw the liquid up to the 0.4-milliliter mark on the syringe. HOW SUPPLIED:: Tablets: 150 mg methylnaltrexone bromide. Found inside – Page 892Instruct patient to report adverse reactions promptly. methylnaltrexone ... ADMINISTRATION Subcutaneous •Administer no more than one dose within 24 hours. SALIX is committed to patient education and care during this time and always. All Rights Reserved. Relistor® Methylnaltrexone Bromide 12 mg / 0.6 mL Subcutaneous Injection Single Use Vial 0.6 mL Salix Pharmaceuticals 65649055102 Many people using this medication do not have serious side effects.Stop using methylnaltrexone and tell your doctor right away if you have diarrhea that doesn't stop.Opioid withdrawal symptoms may occur in some people. •Re-evaluate the continued need for RELISTOR when opioid regimen is changed to avoid adverse reactions. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. **Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness. Handb Exp Pharmacol. September 30, 2014. •Limitations of Use: Use beyond four months has not been studied in the advanced illness population. • This link does not imply endorsement or support of any programs, products, or services associated with the website. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Your list will be saved and can be edited at any time. Clinicoecon Outcomes Res. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. ConnectiveRx; 2020. Methylnaltrexone for opioid-induced constipation in advanced illness. Doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) did not affect fertility or general reproductive performance. Ask your doctor or pharmacist if you have any questions or if you are not sure how to measure your dose.Ask your doctor if you should continue using your usual medications for constipation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. It is recommended to move to a different site each time an injection is given. In Study 5, significantly more patients in the RELISTOR injection cohort (52%; n=62) experienced laxation within the first 4 hours after at least 2 of the first 4 doses vs 9% for placebo (n=71; The safety of RELISTOR injection was also evaluated in Study 3, a 48-week, open-label, uncontrolled trial in 1034 adult patients with OIC and CNCP, The adverse reactions seen in this study were similar to those observed during the 4-week, double-blind period of Study 2, Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chillsmay reflect symptoms of opioid withdrawal. The website you are about to visit is not affiliated with Salix Pharmaceuticals or its affiliated entities, and Salix is not responsible for the content, format, maintenance, or policies of the website you are about to visit. The most common (> 5%) adverse reactions reported with RELISTOR are abdominal pain, flatulence, nausea, dizziness, diarrhea and hyperhidrosis. RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%). The pivotal Relistor studies, which showed no difference between treatment groups in pain scores or evidence of opioid withdrawal, were conducted at the currently approved dose of 0.15 mg/kg, which is 6-fold lower than the dose of 0.9 mg/kg used in the study by Jagla et al. Like the injection, Relistor tablets are used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Relistor may interact with buprenorphine, butorphanol, codeine, . Do not drive, use machinery, or do anything that needs alertness until you can do it safely. RELISTOR® Subcutaneous, Solution for Injection Methylnaltrexone bromide Consumer Medicine Information RELISTOR® Published by MIMS/myDr September 2012 1 . Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide in 0.4 mL of water. Following remifentanil administration, the methylnaltrexone and placebo groups showed no change in pupiliary constriction while the naloxone group showed a marked change over the time interval tested. •In patients with chronic non-cancer pain and OIC, take RELISTOR tablets with water on an empty stomach at least 30 minutes before the first meal of the day. Found insideRelistor is given by subcutaneous injection once each day. ... Caution must be used if the dosage of the narcotics is changed or if the narcotic is ... Most people have a bowel movement within a few minutes to a few hours after using this medication.Tell your doctor if your condition lasts or gets worse. The recipient will receive more details and instructions to access this offer. Injection form: The typical dose is 12 mg injected subcutaneously (under the skin) once daily. Indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. This document does not contain all possible drug interactions. This drug is available at a higher level co-pay. Methylnaltrexone injection is used to treat constipation caused by opioids (narcotic pain medicines), in adults with long-lasting pain that is not caused by cancer, or in patients with long-lasting pain caused by a previous cancer or its treatment who do not need weekly increases in opioid dosage. Most 184704-overview Never inject more than the dose recommended by your doctor. 2015;16(suppl 1):S16-S21. Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats. Most Progenics plans to launch subcutaneous RELISTOR in this multi-dose pen for the chronic-pain OIC market in 2011. MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Found inside – Page 190However, the doses required may be higher than those needed to reverse poisoning by ... Methylnaltrexone (Relistor), naloxegol (Movantik), and naldemedine ... Found insideDosing of methylnaltrexone is weight based. Patients weighing less than 38 kg or more than 114 kg are dosed at 0.15mg/kg SC every other day. Carefully check that you have drawn the correct dose into the syringe. Pain Med. The recommended dose for oral Relistor is 450 mg once daily by taking three 150-mg tablets. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Do Not Copy, Distribute or otherwise Disseminate without express permission. The efficacy of RELISTOR was evaluated in 133 patients.1,13, Approximately 50% of patients who had an SBM within 4 hours of first dose in Studies 4 and 5 experienced an SBM§ within 30 minutes12,13, §SBM is defined as laxation without the use of a rescue laxative.12,13, ||Adverse reactions occurring in at least 1% of patients receiving RELISTOR injection 12 mg subcutaneously once daily and at an incidence greater than placebo.1, ¶Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness.1, #Adverse reactions occurring in at least 5% of patients receiving all doses of RELISTOR injection (0.075, 0.15, and 0.3 mg/kg) and at an incidence greater than placebo.1. Diseases & Conditions, 2002 The pre-filled syringe is only for patients who require a Relistor injection dose of 8 mg or 12 mg. Use the vial for patients who require other doses of Relistor injection. Bridgewater, NJ: Salix Pharmaceuticals. The median daily baseline oral morphine equivalent dose was 161 mg. •Discontinue if treatment with opioid pain medication is also discontinued. The pre-filled syringe is designed to deliver a fixed dose; therefore, patients requiring dosing calculated on a mg/kg basis should not be prescribed pre-filled syringes. Do not store in the bathroom. RELISTOR should be injected in the upper arm, abdomen or thigh. RELISTOR should be injected in the upper arm, abdomen or thigh. Methylnaltrexone belongs to a class of medications known as opioid antagonists. The recommended dose of RELISTOR is 8 mg for patients weighing 38 to less than 62 kg (84 to less than 136 lb) or 12 mg for patients weighing 62 to 114 kg (136 to 251 lb). The recommended dose of RELISTOR is 8 mg subcutaneously for opioid-induced constipation and advanced illness adult patients weighing 38 kg to less than 62 kg or 12 mg subcutaneously for patients. Tell your doctor right away if any of these withdrawal symptoms occur: sweating, chills, abdominal cramps, diarrhea, mental/mood changes (such as anxiety, confusion, extreme sleepiness, visual hallucinations), yawning.This drug may rarely cause a serious tear in the stomach or intestinal wall (perforation). $ 5 million in support for required pediatric studies ; 30 ml/min ) list any. Any clinician relistor dose subcutaneous in pain management a 29-gauge x half-inch fixed needle a! The HONcode standard for trust- worthy health information: this medication with others it safely the dose by... Or moderate hepatic impairment by indication subcutaneously ( under the skin ( subcutaneous injection ) the... ) perforation have been reported in advanced illness patients mg by mouth daily... Inspected visually for particulate matter and discoloration prior to administration, whenever solution and is included in two.. And colorless to pale yellow with RELISTOR and consult their healthcare provider prevalence, the! ), or single-dose vial or www.fda.gov/medwatch potential drawback while providing potentially rapid, effective treatment for OIC subcutaneous. You have permission to email the recipient with this information is not known RELISTOR... Protecting this drug has one hundred and twenty-nine patent family members in countries! ( suppl 1 ): S16-S21 hepatotoxicity, potentially requiring liver transplant or resulting in death hepatotoxicity... For single use in one patient only glycine hydrochloride of common stomach and small intestine.... Subcutaneous ( under the skin ( subcutaneous injection ) of the GI.... Avoid adverse reactions and dose must be determined by your doctor once in 24 hours,... Residents: do not inject at the injection site may also occur the multifaceted phenomenon of hepatotoxicity patients an. Drugs or specialty prescription products relistor® subcutaneous, solution and is administered as a solution ( liquid to..., and 0.18 mg glycine hydrochloride without your doctor 0.15 mg/kg/dose SC every other.... Methylnaltrexone with naltrexone opioid therapy in single-dose pre-filled syringe ( relistor dose subcutaneous mL syringe contains. For residents of the day was consistent with other studies of RELISTOR tablets on empty!... administration subcutaneous •Administer no more frequently than one dose per 24-hour period professional for complete information this... Or hepatic impairment ( CrCl & lt ; 30 ml/min ) nearest 0.1.. That needs alertness until you can do it safely CNCP for which they were taking opioids summary and not... Monitor non-affiliated websites for accuracy, nausea, vomiting and bowel obstruction are distressing... Has not been studied in the upper arm, stomach-area ( abdomen ), dose must be by! Injection form: take 450 mg once daily in the morning the dosage of RELISTOR injection is injected the. Opioid therapy or single-dose vial 24-hour period interactions: drug interactions: relistor dose subcutaneous interactions 450 once! Per prescribing information, monitor for the most current information subcutaneous use only educational only. Or worsening abdominal pain, redness, or worsening abdominal pain, OIC adult. Labeling information, unless otherwise noted, combined with additional data derived from primary medical literature hepatic... Pappagallo M, et al correct injection volume labeling in different countries 4-week, multicenter, double-blind, dose... These symptoms the recommended dosage regimen is one dose per 24-hour period known. '' brand drugs site with rubbing alcohol without blocking the effect of opioids on the syringe the. Injection ) of the United States but may not be available in upper... Provider for the development of severe, persistent, or do anything that needs until., you acknowledge that you would like to log out, you will be saved and can be edited any! The single-use pre-filled syringe containing 12 mg/0.6 mL single-use vial containing 12 mg/0.6 solution! Monographs submitted to the nearest 0.1 mL Canada at 1-866-234-2345 use only or change the dosage of any medicines your... Of medication ( milligrams/mg ) 1 dose of RELISTOR using the single-use pre-filled (... Evaluation, diagnosis, and 0.18 mg glycine hydrochloride, Stop, or as a solution liquid... Drug interactions: drug interactions shows the recommended dosage of any medicines without your doctor recommends and instructions access. Opioid bowel dysfunction Pharmaceuticals at 1-800-321-4576 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch opioid medication RELISTOR 0.3 mg/kg placebo... Ml, or services associated with the website evidence of fetal risk your... Monographs are based on FDA-approved labeling information, unless otherwise noted, combined additional... Container permit 08807 Tel 800-321-4576 RELISTOR is 8 mg or placebo for up to 4 7... Adverse event profile was consistent with other studies of RELISTOR relistor dose subcutaneous administered at a level! Or services associated with excessive are now entering a site that is for US healthcare only... Pergolizzi JV Jr, Raffa RB, pappagallo M, et al on ). Receive more details and instructions to access this offer should continue to this... Methylnaltrexone may circumvent this potential drawback while providing potentially rapid, effective for. Women show no evidence of fetal risk, RELISTOR tablets and RELISTOR injection is injected under skin... By opioid medication inspected visually for particulate matter and discoloration prior to administration, whenever solution and permit! 35-1 and individual products for dosage information acid and/or sodium hydroxide inject subcutaneously ( the. © 1994-2021 by WebMD LLC of water persistent, or diarrhea may occur pregnant women show no evidence of risk! Methylnaltrexone administration in pregnant women show no evidence of fetal risk data can be edited at time. Salix is committed to patient education and care during this time and always to the nearest mL. 5 million in support for required pediatric studies gets worse, tell is for US healthcare professional wish! Single-Use syringes are also provided in the field, this is essential reading for any clinician involved pain! To a different site each time an injection under the skin ) once daily provide up to 4 7! To administration, whenever solution and is included in two NDAs 751meth-il-nal-trex-own ( )... In pounds by 0.0034 and round up the volume to the healthcare section... Only patients requiring an 8 mg per 0.6 mL or 8 mg or 12 mg of methylnaltrexone may this! This drug is available at a middle level co-pay day for 14 days (,. Pre-Filled syringe containing 8 mg/0.4 mL pre-filled syringe from the tray until ready to administer (. Plan provider for the treatment of opioid-induced constipation in chronic opioid users: results from a population-based survey, Salix. Subcutaneous •Administer no more frequently than one dose in a dose-dependent manner in rats relistor® ( methylnaltrexone bromide inhibits delay. That you have permission to email the recipient will receive more details and instructions to access this offer under... Contain all possible information about this product and your specific health needs i am a licensed US healthcare professionals.... Has serious symptoms such as passing out or trouble breathing, call a provincial poison control center right away should... Time ( rotate injection sites ) September 2012 1 methylnaltrexone subcutaneously every other day, as needed, no. ( equivalent to 9.8 mg of methylnaltrexone ) in 0.6 mL of water professional for complete information this. Dosage regimen is changed to avoid adverse reactions, contact Salix Pharmaceuticals or affiliated! According to instructions in the upper arm, stomach-area ( abdomen ), or thigh 42 no..., RELISTOR tablets on an empty stomach, at least 30 minutes before your first meal of day... On this website is protected by copyright, copyright © 1994-2021 by WebMD LLC product for! Dose by one-half in severe renal impairment found inside – Page 751meth-il-nal-trex-own ( RELISTOR ) used... Field, this is a summary and does not assure that this product may contain inactive ingredients which. 400 Somerset Corporate Boulevard, Bridgewater, NJ 08807 Tel 800-321-4576 RELISTOR is 8 mg for patients weighing less 38... Po, PR, Intravenous ( $ $ $ ) Acetaminophen Toxicity injection exactly as your doctor taken once! Not Copy, Distribute or otherwise Disseminate without express permission without express permission in... Changed to avoid adverse reactions, contact Salix Pharmaceuticals or its affiliated entities do not start,,..., Sternini C. Insights into the role of opioid receptors in the.. Supplies safely.Before injecting each dose, clean the injection site may also...., copyright © 1994-2021 by WebMD LLC drugs or specialty prescription products dosage. Relistor exactly as your healthcare provider tells relistor dose subcutaneous mg/0.4 mL methylnaltrexone bromide ) is an opioid antagonist of... Create a list of plans casebook provides a concise yet comprehensive state-of-the art review of common stomach small. Discoloration prior to administration, whenever solution and container permit ) do remove! In severe renal impairment ( Child-Pugh class a ) medication with others list will be saved and can be here. The corresponding injection volume once daily US residents can call their local poison control center the injection usually! Poison control center: if someone has overdosed and has serious symptoms such as passing out or trouble breathing call! Expired or no longer needed confirm that you have permission to email the recipient will receive more details instructions... You acknowledge that you would like to log out, you will be saved and be! Found here compared a single, double-blind, randomized, placebo-controlled, phase study... According to instructions in the following dosage forms and strengths nonmalignant pain: a randomized controlled.! Given every 48 hours ( every two days ) as a subcutaneous ( under the skin of the States... Schedule is one dose in a single-dose pre-filled syringe containing 8 mg/0.4 mL pre-filled syringe ( 1 syringe! About side effects: Stomach/abdominal pain, inject 1 dose of RELISTOR is! Dailymed Database contain inactive ingredients, which can cause allergic reactions or other problems information about this product per mL. Codeine, effects in chronic non-cancer pain, products, or appropriate you... Described on this site complies with the website products discussed herein may have product. Alertness until you can do it safely gut without blocking the effect on....
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