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Limitation of use: Use of RELISTOR beyond four months has not been studied in the advanced illness population.
DOSAGE AND ADMINISTRATION
General Dosing Information
RELISTOR is for subcutaneous use only.
For adult patients with opioid-induced constipation and advanced illness, 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 is 8 mg subcutaneously for opioid-induced constipation and advanced illness adult patients weighing 38 kg to less than 62 kg or 12 mg subcutaneously for patients weighing 62 kg to 114 kg. Adult Patients whose weight falls outside of these ranges should be dosed at 0.15 mg/kg. See Table 1 to determine the correct injection volume. The pre-filled syringe is designed to deliver a fixed dose; therefore, adult patients requiring dosing calculated on a mg/kg basis should not be prescribed pre-filled syringes.
Table 1: Weight of Adult Patient with Opioid-Induced Constipation
and Advanced Illness
|Injection Volume||Subcutaneous Dose|
|Less than 38 kg||See below*||0.15 mg/kg|
|38 kg to less than 62 kg||0.4 mL||8 mg|
|62 kg to 114 kg||0.6 mL||12 mg|
|More than 114 kg||See below*||0.15 mg/kg|
|*The injection volume for these patients should be calculated using the following method: Multiply the patient weight in kilograms by 0.0075 and round up the volume to the nearest 0.1 mL.|
Use in Patients with Severe Renal Impairment
In adult patients with severe renal impairment (creatinine clearance less than 30 mL/min as estimated by Cockcroft-Gault), dose reduction of RELISTOR by one-half is recommended [see Use in Specific Populations]. No dosage adjustment is recommended for adult patients with mild to moderate renal impairment.
The pre-filled syringe is designed to deliver a fixed dose; therefore, adult patients with severe renal impairment should only be prescribed single-use vials to ensure correct dosing.
Administration and Storage
RELISTOR is a sterile, clear, and colorless to pale yellow aqueous solution. Inspect parenteral drug product visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the vial if any of these are present.
Inject RELISTOR subcutaneously in the upper arm, abdomen or thigh. Do not inject at the same spot each time (rotate injection sites).
Once drawn into the 1 mL syringe with a 27-gauge x ½-inch needle, if immediate administration is not possible, store at ambient room temperature and administer within 24 hours. Discard any unused portion that remains in the vial. Advise patients concerning proper training in subcutaneous technique.
Single-use Pre-filled Syringes
Only adult patients requiring an 8 mg or 12 mg dose should be prescribed pre-filled syringes. Do not remove the pre-filled syringe from the tray until ready to administer.
Dosage Forms And Strengths
- Single-use vial containing 12 mg/0.6 mL solution for subcutaneous injection, for use with a 27 gauge x ½-inch needle and 1 mL syringe
- Single-use vial containing 12 mg/0.6 mL solution for subcutaneous injection, with one 1 mL syringe with retractable 27 gauge x ½-inch needle, two alcohol swabs
- Single-use pre-filled syringe containing 8 mg/0.4 mL solution for subcutaneous injection, with a 29-gauge x ½-inch fixed needle and a needle guard
- Single-use pre-filled syringe containing 12 mg/0.6 mL solution for subcutaneous injection, with a 29-gauge x ½-inch fixed needle and a needle guard
Storage And Handling
|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|
|65649-551-07||1 pre-filled syringe per carton||one 12mg/0.6 mL single-use pre-filled syringe with needle guard system|
RELISTOR should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.
Manufactured for: Salix Pharmaceuticals, Inc. Raleigh, NC 27615. Under license from: Progenics Pharmaceuticals, Inc. Tarrytown, NY 10591. Revised Aug 2013.
Last reviewed on RxList: 9/19/2013
This monograph has been modified to include the generic and brand name in many instances.
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