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.

See Less

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.

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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

K59.09

Other constipation

ICD-10-CM code*

K59.03

K59.09

Drug-induced constipation

Other 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

RELISTOR® (methylnaltrexone bromide) $0 CoPay Card

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^†

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^†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.

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.

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Request a Rep

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Request Reimbursement Support

Request assistance with RELISTOR prescriptions for patients who require reimbursement support.

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Download helpful resources

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Copay Savings Card^‡

RELISTOR® (methylnaltrexone bromide) $0 CoPay Patient Savings Program Card

Discover the RELISTOR Patient Savings Program for tablet and injection prescriptions.

RELISTOR Dosing Guide

RELISTOR® (methylnaltrexone bromide) Dosing Guide

Get dosing information for RELISTOR tablets and injection.

OIC Screening Tool

Opioid-induced constipation Screening Tool

Help patients identify and evaluate their OIC symptoms.

Injection Guide

Guide patients in using the RELISTOR pre-filled syringe.

Sample Letter of Medical Necessity

For payers who may require a letter of appeal to process and cover RELISTOR claims.

Medicare Part D Coverage Determination Form

Start the prior authorization process and help patients receive their prescriptions.