Recommended Topic Related To:

Relistor

"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...

Relistor

Relistor

INDICATIONS

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.

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.

Dosing

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).

Single-use Vials

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.

HOW SUPPLIED

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

Storage

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.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Chronic Pain/Back Pain

Find tips and advances in treatment.

Related Drugs
Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations