When speed is clinically useful1
RELISTOR is also available as a subcutaneous injection for adult patients with opioid-induced constipation (OIC) and chronic non-cancer pain (CNCP) and advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.1
RELISTOR subcutaneous injection
When speed is clinically useful1
RELISTOR is also available as a subcutaneous injection for adult patients with opioid-induced constipation (OIC) and chronic non-cancer pain (CNCP) and advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.1
Efficacy: RELISTOR subcutaneous injection
Significant increases in weekly spontaneous bowel movements (SBMs) in adults with OIC and CNCP1
P<0.001
Percentage of responders during the double-blind treatment period (defined as a patient with 3 or more SBMs per week for each of the 4 weeks in the double-blind period)1,*,†,‡
P<0.001
Percentage of responders during the double-blind treatment period (defined as a patient with 3 or more SBMs per week for each of the 4 weeks
in the double-blind period)1,*,†,‡
Percentage of responders during the double-blind treatment period (defined as a patient with 3 or more SBMs per week for each of the 4 weeks in the double-blind period)1,*,†,‡
@lchValue>
*Data from the modified intent-to-treat (mITT) population (all randomized patients who received ≥1 dose of double-blind study medication) are shown.1
†A responder was defined as a patient with 3 or more SBMs per week for each of the 4 weeks in the double-blind period.1
‡A SBM was defined as a bowel movement that occurred without laxative use during the previous 24 hours.1
When speed is clinically useful in adults with OIC and CNCP1,2
Following the first dose, more patients experienced a SBM§ within
4
subcutaneous injection1,2
compared with placebo
of patients receiving RELISTOR 12 mg subcutaneous injection once daily (n=150)1,2
VS
of patients in the placebo group (n=162)1,2
Percentages indicative of the number of patients who met the primary endpoint (P<.001)1,2
Percentages indicative of the number of patients who met the primary
endpoint (P<.001)1,2
§SBM defined as occurring without laxative use during the previous 24 hours.1
Once-daily dosing options for patients with CNCP1
- Administer 12 mg subcutaneously once daily||
- Dose reduction to 6 mg once daily is recommended in patients with moderate to severe renal impairment
- Dose reduction is recommended in patients with severe hepatic impairment¶
- 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 3 days
@lchValue>
||The pre-filled syringe is only for patients who require a RELISTOR subcutaneous injection dose of 8 mg or 12 mg. Do not use the pre-filled syringe and attached needle more than 1 time, even if there is medicine left in the syringe. Use the vial for patients who require other doses of RELISTOR subcutaneous injection. Do not use a RELISTOR vial more than 1 time, even if there is medicine left in the vial.1
¶Refer to the Prescribing Information for more information on weight-based dosing in patients with severe hepatic impairment and CNCP, advanced illness, and dosing in patients with renal impairment and advanced illness.1
Not actual size.
@lchValue>
RELISTOR subcutaneous injection: Most common adverse reactions
Adverse reactions occurring in ≥1% of patients at an incidence greater than placebo1
4-week, double-blind, placebo-controlled clinical study in adults with OIC and CNCPADVERSE REACTIONS# | RELISTOR INJECTION 12 MG (n=150) |
PLACEBO (n=162) |
---|---|---|
ABDOMINAL PAIN** | 21% | 7% |
NAUSEA | 9% | 6% |
DIARRHEA | 6% | 4% |
HYPERHIDROSIS | 6% | 1% |
HOT FLUSH | 3% | 2% |
TREMOR | 1% | <1% |
CHILLS | 1% | 0% |
ADVERSE REACTIONS# | |
---|---|
ABDOMINAL PAIN** | |
RELISTOR INJECTION 12 MG (n=150) |
21% |
Placebo (n=162) | 7% |
NAUSEA | |
RELISTOR INJECTION 12 MG (n=150) |
9% |
Placebo (n=162) | 6% |
DIARRHEA | |
RELISTOR INJECTION 12 MG (n=150) |
6% |
Placebo (n=162) | 4% |
HYPERHIDROSIS | |
RELISTOR INJECTION 12 MG (n=150) |
6% |
Placebo (n=162) | 1% |
HOT FLUSH | |
RELISTOR INJECTION 12 MG (n=150) |
3% |
Placebo (n=162) | 2% |
TREMOR | |
RELISTOR INJECTION 12 MG (n=150) |
1% |
Placebo (n=162) | <1% |
CHILLS | |
RELISTOR INJECTION 12 MG (n=150) |
1% |
Placebo (n=162) | 0% |
#Adverse reactions occurring in at least 1% of patients receiving RELISTOR injection 12 mg subcutaneously once daily and at an incidence greater than placebo.1
**Includes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness.1
- For additional Important Safety Information, please see the sidebar to the right
- For additional Important Safety
Information, please see bottom of page
REFERENCES: 1. RELISTOR [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Michna E, Blonsky ER, Schulman S, et al. Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. J Pain. 2011;12(5):554-562.