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Indications

IMPORTANT SAFETY INFORMATION

  • RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. 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.
  • RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.
  • RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients

IMPORTANT SAFETY INFORMATION

  • 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.
  • Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). 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). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
  • If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
  • Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
  • The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
  • A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.
  • In the clinical studies, the most common adverse reactions were:

OIC in adult patients with chronic non-cancer pain

  • RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
  • 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%).

OIC in adult patients with advanced illness

  • RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%), flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

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IMPORTANT SAFETY INFORMATION

  • 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.
  • Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). 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). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
  • If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
  • Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
  • The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
  • A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.
  • In the clinical studies, the most common adverse reactions were:

OIC in adult patients with chronic non-cancer pain

  • RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
  • 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%).

OIC in adult patients with advanced illness

  • RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%), flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

Indications

  • RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. 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.
  • RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

Request RELISTOR samples

Get appropriate patients started on RELISTOR tablets in just a few simple steps.

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Get appropriate patients started on RELISTOR tablets in just a few simple steps.

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RELISTOR prescription considerations

When it is time to prescribe RELISTOR for your eligible and commercially insured patients, please refer to the following ICD-10 information:

ICD-10-CM code*

K59.03

Drug-induced constipation

ICD-10-CM code*

K59.03

Drug-induced constipation

ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

*The ICD-10-CM code and all other patient access–related information are provided for informational purposes only. It is the treating physician’s responsibility to determine the proper diagnosis, treatment, and applicable ICD-10-CM code. Salix Pharmaceuticals does not guarantee coverage or reimbursement for the product.

The RELISTOR Patient Savings Program

Copay assistance

Prescription copay assistance is available through the RELISTOR Patient Savings Program.

$0

For RELISTOR tablets and subcutaneous injection, many eligible commercially insured patients may pay as little as $0 with our copay card†

download

†Eligibility Criteria, Terms and Conditions: This offer is only valid for patients with commercial insurance, including commercially insured patients without coverage for RELISTOR. Patients without commercial insurance are not eligible. For eligible patients, Salix Pharmaceuticals will be responsible to pay your copay/out-of-pocket expense for each eligible prescription fill using this copay savings card; maximum benefits apply. Please call 1-855-202-3719 for more information. Patient is responsible for all additional costs and expenses after the maximum limit is reached. This copay savings card can be used once per month. You must activate this copay savings card before using it by visiting www.Relistor.com, calling 1-855-202-3719, or texting SaveNow to 27785. You will receive a link to activate your copay savings card via SMS and opt in to refill reminders. Message and data rates may apply. Message frequency varies. Text HELP for help; STOP to opt out. The Privacy Policy can be viewed at https://www.bauschhealth.com/privacy. Salix Pharmaceuticals is a subsidiary of Bausch Health Companies, Inc. The full terms can be viewed at Relistor.copaysavingsprogram.com/sms-terms. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is only good in the USA at participating retail pharmacies. This offer cannot be redeemed at other locations, including government‐subsidized clinics or facilities. This offer is not valid where otherwise prohibited, taxed, or otherwise restricted. Patient is responsible for reporting receipt of copay assistance to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the copay savings card, as may be required. This offer cannot be combined with other offers. This copay savings card has no cash value. No other purchase is necessary. This offer is nontransferable. No substitutions are permitted. This copay savings card is not health insurance. You understand and agree to comply with the terms and conditions of this offer as set forth above. Salix Pharmaceuticals reserves the right to rescind, revoke, or amend this offer at any time without notice.

Patient Assistance Program

RELISTOR Patient Assistance Program

Patients may face financial obstacles that can keep them from obtaining the prescription products they need. Salix is committed to improving access to medications through our patient assistance program.

LEARN MORE

Request a Rep

Request a Rep

Schedule time to discuss RELISTOR with a sales representative to explore options for your patients and discover tools and resources for your practice.

LEARN MORE

Download helpful resources

Discover educational tools for patients.

Copay Savings Card‡

Copay Savings Card

RELISTOR Dosing Guide

RELISTOR Dosing Guide

OIC Screening Tool

OIC Screening Tool

Injection Guide

Injection Guide

Sample Letter of Medical Necessity

Sample Letter of Medical Necessity

Tier Exemption Request

Tier Exemption Request

RELISTOR Patient Brochure

RELISTOR Patient Brochure

OIC Screening Tool

OIC Screening Tool

Guide to Taking RELISTOR

Guide to Taking RELISTOR

‡Eligibility Criteria, Terms and Conditions: This offer is only valid for patients with commercial insurance, including commercially insured patients without coverage for RELISTOR. Patients without commercial insurance are not eligible. For eligible patients, Salix Pharmaceuticals will be responsible to pay your copay/out-of-pocket expense for each eligible prescription fill using this copay savings card; maximum benefits apply. Please call 1-855-202-3719 for more information. Patient is responsible for all additional costs and expenses after the maximum limit is reached. This copay savings card can be used once per month. You must activate this copay savings card before using it by visiting www.Relistor.com, calling 1-855-202-3719, or texting SaveNow to 27785. You will receive a link to activate your copay savings card via SMS and opt in to refill reminders. Message and data rates may apply. Message frequency varies. Text HELP for help; STOP to opt out. The Privacy Policy can be viewed at https://www.bauschhealth.com/privacy. Salix Pharmaceuticals is a subsidiary of Bausch Health Companies, Inc. The full terms can be viewed at Relistor.copaysavingsprogram.com/sms-terms. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is only good in the USA at participating retail pharmacies. This offer cannot be redeemed at other locations, including government‐subsidized clinics or facilities. This offer is not valid where otherwise prohibited, taxed, or otherwise restricted. Patient is responsible for reporting receipt of copay assistance to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the copay savings card, as may be required. This offer cannot be combined with other offers. This copay savings card has no cash value. No other purchase is necessary. This offer is nontransferable. No substitutions are permitted. This copay savings card is not health insurance. You understand and agree to comply with the terms and conditions of this offer as set forth above. Salix Pharmaceuticals reserves the right to rescind, revoke, or amend this offer at any time without notice.

Videos

Learn more about RELISTOR through video resources.

RELISTOR HCP MOA Video

RELISTOR HCP MOA

Explore the mechanism of action in this video if you are considering RELISTOR for your patients with OIC.

RELISTOR Patient MOA Video

RELISTOR HCP MOA

Help introduce RELISTOR to eligible patients through a video designed to describe how RELISTOR works through patient-friendly language and animation.

RELISTOR Resources Video

RELISTOR HCP MOA

Learn how you can help your patients with opioid-induced constipation (OIC) through resources such as RELISTOR brochures and samples.

RELISTOR Patient TV Commercial

RELISTOR HCP MOA

Watch our latest consumer television spot for RELISTOR.

HCP PAINWeek 2024 Video

RELISTOR HCP MOA

View the presentation Pioneering the OIC Landscape for Over 15 Years: A Multispecialty Discussion About How to Help Ease & Reduce OIC.

Take a proactive approach to OIC with RELISTOR
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REFERENCES: 1. RELISTOR [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Slatkin N, Thomas J, Lipman AG, et al. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009;7(1):39-46. 3. Thomas J, Karver S, Cooney GA, et al. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008;358(22):2332-2343.