RELISTOR safety information

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RELISTOR tablets have a well-established  safety profile1

Most common adverse reactions

Most common adverse reactions

RELISTOR tablets have a well-established  safety profile1

In the 4-week, double-blind, placebo-controlled period of the clinical study in patients with opioid-induced constipation (OIC) and chronic non-cancer pain (CNCP) (n=401) (Study 1)1

ADVERSE REACTIONS*|| RELISTOR TABLETS
(n=200)		 PLACEBO
(n=201)
ABDOMINAL PAIN† 14% 10%
DIARRHEA 5% 2%
HEADACHE 4% 3%
ABDOMINAL DISTENTION 4% 2%
VOMITING 3% 2%
HYPERHIDROSIS 3% 1%
ANXIETY 2% 1%
MUSCLE SPASMS 2% 1%
RHINORRHEA 2% 1%
CHILLS 2% 0%

*Adverse reactions occurring in at least 2% of patients receiving 3 RELISTOR 150-mg tablets (450 mg total) once daily and at an incidence greater than placebo.1

||Adverse reactions occurring in at least 2% of patients receiving 3 RELISTOR 150-mg tablets (450 mg total) 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

  • RELISTOR tablets 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.
  • Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal1

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RELISTOR tablets provide patients with CNCP the convenience of once-daily oral therapy1

RELISTOR tablets provide patients with CNCP the convenience of once-daily oral therapy1

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RELISTOR subcutaneous injection has a well-established safety profile1

Adverse reactions from all doses in double-blind, placebo-controlled clinical studies of RELISTOR injection in adult patients with OIC and advanced illness (Studies 4 and 5)1

Adverse reactions from all doses in double-blind, placebo-controlled clinical studies of RELISTOR injection in adult patients with OIC and advanced illness (Studies 4 and 5)1

ADVERSE REACTIONS‡|| RELISTOR INJECTION
(n=165)		 PLACEBO
(n=123)
ABDOMINAL PAIN§ 29% 10%
FLATULENCE 13% 6%
NAUSEA 12% 5%
DIZZINESS 7% 2%
DIARRHEA 6% 2%
  • RELISTOR injections 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 perforation1

‡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

§Includes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness.1

STUDY DESIGN: IN ADULT PATIENTS WITH ADVANCED ILLNESS

Study 4 was a multicenter, double-blind, randomized, placebo-controlled study; 154 patients with advanced illness and OIC received a single subcutaneous dose of RELISTOR injection or placebo followed by an open-label 4-week dosing period, where RELISTOR injection could be used as needed, no more frequently than one dose in a 24-hour period.1,2

Study 5 was a 2-week, multicenter, double-blind, randomized, placebo-controlled trial comparing RELISTOR injection given every other day vs placebo in 133 patients, followed by a subsequent 3-month open-label extension study.1,3

  • For additional Important Safety Information, please see below

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RELISTOR subcutaneous injection offers OIC treatment for patients with advanced illness and active cancer pain1

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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.

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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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