RELISTOR Letter of Medical Necessity 

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

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RELISTOR Letter of Medical Exception

File exceptions or prior authorization requests for Medicare Part D coverage.  

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RELISTOR Appeal Letter

Appeal a denied claim for RELISTOR.

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RELISTOR TIERED 
EXCEPTION LETTER

Request a formulary exception to allow coverage for RELISTOR.

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RELISTOR Medical Exceptions & Patient Support Services Guide

A guide to steps required, requested documentation, and correct forms.

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RELISTOR Navigating Access Brochure

Being proactive with PAs may lead to higher approval rates.1 Follow this helpful guide to request coverage of RELISTOR.

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download ADDITIONAL resources

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COMMON REASONS FOR PA DENIAL and how to avoid them

Double-check PA, fill in missing information, and resubmit.

Confirm dosing

  • RELISTOR tablets: RELISTOR 450 mg, three 150 mg tablets once daily (90 tablets/prescription) 
  • RELISTOR Subcutaneous Injection: RELISTOR 12 mg subcutaneously, once daily, as directed (28 prefilled syringes)
  • Please refer to full Prescribing Information for dose adjustments in patients with renal or hepatic impairment

Confirm ICD-10-CM code and resubmit




The following ICD-10 codes can be considered for OIC:‡

  • K59.03: Drug-induced constipation

‡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.

Include information on why RELISTOR is necessary and appropriate for the patient. 

Ensure documentation of OTC laxative trial and failure or trial and failure of any other appropriate step therapies, if applicable.

Confirm coverage; Medicare excludes certain drugs

  • RELISTOR is not in a Medicare excluded category

Be sure the below information is included and accurate on RELISTOR PAs

Age
Check Check

18 years or older2

Suggested ICD-10-CM 
CODE FOR OIC*
check check

K59.033:
Drug-induced constipation

prEVIOUS 
THERAPIES TRIED 
AND FAILED
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duration of therapy
(eg, OTC laxatives
and other relevant prescription therapies)

APPROVED
DOSING
FOR OIC
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RELISTOR Tablets:
450 mg, three 150 mg tablets once daily (90 tablets/prescription)2

Please refer to full Prescribing Information for dose adjustments in patients with renal or hepatic impairment
check check

RELISTOR Subcutaneous Injection: 12 mg subcutaneously, once daily, as directed
(28 prefilled syringes)2

ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification; OIC, opioid-induced constipation.

*The ICD-10 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. 

Understand your local state laws regarding patient access

Access Step Therapy Laws by State

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REFERENCES: 1. Data on File. PA Approval. Salix Pharmaceuticals, Bridgwater, NJ. 2. RELISTOR [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 3. ICD-10. Centers for Medicare & Medicaid Services: https://www.cms.gov/medicare/coding-billing/icd-10-codes.Updated February 26, 2025. Accessed March 20, 2025.

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INDICATIONS

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.
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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.
    • 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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