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    Relistor

    Drug - Relistor® (methylnaltrexone bromide) Subcutaneous Injection [Wyeth]

    October 2012

    Therapeutic Area - Opioid-induced constipation

    FDA approved indication

    Relistor is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of Relistor beyond four months has not been studied.

    Contraindications

    Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

    Criteria

    • Patient has advanced illness and is receiving palliative care AND
    • Has constipation due to long-term opioid treatment after trial and failure of at least two laxatives AND
    • Has concurrent use of any opioid narcotic analgesic prescription filled within the past 30 days prior to each fill of Relistor

    Quantity limits

    • 12 mg/0.6 mL single-use vial = 8.4 mL
    • 12 mg/0.6 mL single-use vial kit = 2 each  
    • 8 mg/0.4 mL single-use prefilled syringe = 5.6 mL
    • 12 mg/0.6 mL single-use prefilled syringe = 8.4 mL

    Dosing

    • Relistor is available as a 12 mg/0.6 mL solution in a single-use vial, and 8 mg/0.4 mL and 12 mg/0.6 mL single-use prefilled syringe
    • Relistor is administered as a subcutaneous injection. The usual schedule is one dose every other day, as needed, but no more frequently than one dose in a 24-hour period
    Patient Weight - Pounds Patient Weight - Kilograms Dose
    84 to < 136 38 to less than 62 8 mg (0.4 mL)
    136 to 251 62 to 114 12 mg (0.6 mL)
    < 84 OR > 251 More than 114 0.15 mg/kg (more than one vial may be needed for patients >251 pounds)

    In patients with severe renal impairment (creatinine clearance less than 30 mL/min), dose reduction by one-half is recommended.

    How Supplied

    NDC NUMBER PACK SIZE CONTENTS
    65649-551-02 1 vial per carton One 12 mg/0.6 mL single-use vial
    65649-553-05 7 trays per kit Each tray contains:
    one 12 mg/0.6 mL single-use vial, one 1 cc (mL) syringe with retractable (27-gauge x ½-inch) needle (VanishPoint®), two alcohol swabs
    65649-552-04 7 pre-filled syringes per carton Seven 8 mg/0.4 mL single-use pre-filled syringes with needle guard system
    65649-551-03 7 pre-filled syringes per carton Seven 12 mg/0.6 mL single-use pre-filled syringes with needle guard system

    QL = quantity limit; QL overrides allowed for dosing > QOD or pt wt > 251 pounds

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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