Relistor

Relistor Manufacturers

• Salix Pharmaceuticals, Inc.
  

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  Relistor | Salix Pharmaceuticals, Inc.

  

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  2.1 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 (14.1)]. 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. 2.2 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 (14.1)].

  2.3 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 (14.2)]. 

  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 Adults 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 0.1mL.

  
  2.4 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 (8.6)]. 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. 

  2.5 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.

  2.1 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 (14.1)]. 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. 2.2 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 (14.1)].

  2.3 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 (14.2)]. 

  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 Adults 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 0.1mL.

  
  2.4 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 (8.6)]. 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. 

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