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INDICATIONS
RELISTOR® (methylnaltrexone bromide) 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 (methylnaltrexone bromide) beyond four months has not been studied.
DOSAGE AND ADMINISTRATION
General Dosing Information
FOR SUBCUTANEOUS INJECTION ONLY
RELISTOR (methylnaltrexone bromide) should be injected in the upper arm, abdomen or thigh.
Dosing
RELISTOR (methylnaltrexone bromide) 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 [see Clinical Studies].
The recommended dose of RELISTOR (methylnaltrexone bromide) is 8 mg for patients weighing 38 to less than 62 kg (84 to less than 136 Ib) or 12 mg for patients weighing 62 to 114 kg (136 to 251 Ib). Patients whose weight falls outside of these ranges should be dosed at 0.15 mg/kg. See the table below to determine the correct injection volume.
| Patient Weight | Injection Volume | Dose | |
| Pounds | Kilograms | ||
| Less than 84 | Less than 38 | See below* | 0.15 mg/kg |
| 84 to less than 136 | 38 to less than 62 | 0.4 mL | 8mg |
| 136 to 251 | 62 to 114 | 0.6 mL | 12 mg |
| More than 251 | More than 114 | See below* | 0.15 mg/kg |
| *The injection volume for these patients should be calculated using one of the following: | |||
- Multiply the patient weight in pounds by 0.0034 and round up the volume to the nearest 0.1 mL.
- Multiply the patient weight in kilograms by 0.0075 and round up the volume to the nearest 0.1 mL.
In patients with severe renal impairment (creatinine clearance less than 30 mL/min), dose reduction of RELISTOR by one-half is recommended [see Use in Specific Populations].
Preparation for Injection
RELISTOR (methylnaltrexone bromide) is a sterile, clear, and colorless to pale yellow aqueous solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these are present, the vial should not be used.
Once drawn into the syringe, if immediate administration is not possible, store at ambient room temperature and administer within 24 hours [see PATIENT INFORMATION].
HOW SUPPLIED
Dosage Forms And Strengths
12 mg/0.6 mL solution for subcutaneous injection in a single-use vial [see DOSAGE AND ADMINISTRATION].
| NDC NUMBER | PACK SIZE | CONTENTS |
| 0008-1218-01 | 1 vial per carton | one 12 mg/0.6 mL single-use vial |
| 0008-2513-02 | 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 %-inch) needle (VanishPoint®), two alcohol swabs |
Storage
RELISTOR® (methylnaltrexone bromide) should be stored at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.
Marketed by: Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Progenics Pharmaceuticals, Under license from: Progenies Pharmaceuticals, Inc. Tarrytown, NY 10591. Revised: 07/2010
Last reviewed on RxList: 8/13/2010
This monograph has been modified to include the generic and brand name in many instances.
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