Recommended Topic Related To:

Relistor

"Nov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.

The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of th"...

Relistor

Indications
Dosage
How Supplied

INDICATIONS

Opioid-Induced Constipation In Adult Patients With Chronic Non-Cancer Pain

RELISTOR is indicated for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.

Opioid-Induced Constipation In Adult Patients With Advanced Illness

RELISTOR is indicated for the treatment of opioid-induced constipation in adult 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

Important Administration Information

  • RELISTOR is for subcutaneous use only.
  • Inject RELISTOR subcutaneously in the upper arm, abdomen or thigh. Do not inject at the same spot each time (rotate injection sites).
  • Be within close proximity to toilet facilities once RELISTOR is administered.
  • Discontinue RELISTOR if treatment with the opioid pain medication is also discontinued.
  • In patients with chronic non-cancer pain and opioid-induced constipation:
    • RELISTOR has been shown to be efficacious in patients who have taken opioids for at least 4 weeks. Sustained exposure to opioids prior to starting RELISTOR may increase the patient's sensitivity to the effects of RELISTOR [see Clinical Studies].
    • Discontinue all maintenance laxative therapy prior to initiation of RELISTOR. Laxative(s) can be used as needed if there is a suboptimal response to RELISTOR after three days.
    • Inject one dose every day.
    • Re-evaluate the continued need for RELISTOR when the opioid regimen is changed to avoid adverse reactions.
  • In patients with advanced illness and opioid-induced constipation:
    • Inject one dose every other day, as needed, but no more frequently than one dose in a 24-hour period.

Opioid-Induced Constipation In Adult Patients With Chronic Non-Cancer Pain

The recommended dosage of RELISTOR is 12 mg subcutaneously once daily [see Clinical Studies].

Opioid-Induced Constipation In Adult Patients With Advanced Illness

The recommended dose of RELISTOR administered subcutaneously is 8 mg for adult patients weighing 38 kg to less than 62 kg and 12 mg 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. The recommended dosage regimen is one dose every other day, as needed [see Clinical Studies].

See Table 1 to determine the correct dose by patient weight and injection volume to be administered. 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-Based Dosing of RELISTOR and Corresponding Injection Volume for Adult Patients with Opioid-Induced Constipation and Advanced Illness

Weight of Adult Patient Subcutaneous Dose Injection Volume
Less than 38 kg 0.15 mg/kg See below*
38 kg to less than 62 kg 8 mg 0.4 mL
62 kg to 114 kg 12 mg 0.6 mL
More than 114 kg 0.15 mg/kg See below*
*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 products 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.

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
  • 12 mg/0.6 mL solution for subcutaneous injection, for use with a 27 gauge x ½- inch needle and 1 mL syringe
  • 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
  • 8 mg/0.4 mL solution for subcutaneous injection, with a 29-gauge x ½-inch fixed needle and a needle guard
  • 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 '/-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: September 2014

Last reviewed on RxList: 10/20/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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.


NIH talks about Ebola on WebMD