Relistor (Methylnaltrexone Bromide Subcutaneous) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

General Dosing Information

FOR SUBCUTANEOUS INJECTION ONLY

RELISTOR should be injected in the upper arm, abdomen or thigh.

Dosing

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 [ see Clinical Studies (14) ].

The recommended dose of RELISTOR is 8 mg for patients weighing 38 to less than 62 kg (84 to less than 136 lb) or 12 mg for patients weighing 62 to 114 kg (136 to 251 lb). 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.

*The injection volume for these patients should be calculated using one of the following:
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	8 mg
136 to 251	62 to 114	0.6 mL	12 mg
More than 251	More than 114	See below *	0.15 mg/kg

• 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 (8.6) ].

Preparation for Injection

RELISTOR 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 Counseling Information (17) ].

DOSAGE FORMS AND STRENGTHS

12 mg/0.6 mL solution for subcutaneous injection in a single-use vial [ see Dosage and Administration (2.2) ].

HOW SUPPLIED/STORAGE AND HANDLING

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 ½-inch) needle (VanishPoint®), two alcohol swabs

Storage

RELISTOR should be stored at 20-25ºC (68-77ºF); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.

PATIENT COUNSELING INFORMATION

Information for Patients

Instruct patients that the usual schedule is one dose every other day, as needed, but no more frequently than one dose in a 24-hour period.

In approximately 30% of patients in clinical trials, laxation was reported within 30 minutes of a dose of RELISTOR; therefore, advise patients to be within close proximity to toilet facilities once the drug is administered.

Instruct patients not to continue taking RELISTOR if they experience severe or persistent diarrhea. Instruct patients that common side effects of RELISTOR include transient abdominal pain, nausea and vomiting. Advise patients to contact their healthcare provider if any of these symptoms persist or worsen.

Instruct patients to discontinue RELISTOR if they stop taking their opioid pain medication.