Skip to Content

Relistor Dosage

Generic name: METHYLNALTREXONE BROMIDE 150mg
Dosage form: tablets: injection, solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1 Important Administration Information

Be within close proximity to toilet facilities once RELISTOR is administered.
Discontinue RELISTOR if treatment with the opioid pain medication is also discontinued.
In adult patients with chronic non-cancer pain and OIC:
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.
Re-evaluate the continued need for RELISTOR when the opioid regimen is changed to avoid adverse reactions.
In patients with chronic non-cancer pain and OIC, take RELISTOR tablets with water on an empty stomach at least 30 minutes before the first meal of the day.

Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain

The recommended dosage of RELISTOR tablets is 450 mg taken orally once daily in the morning.
The recommended dosage of RELISTOR injection is 12 mg administered subcutaneously once daily.

Opioid-Induced Constipation in Adult Patients with Advanced Illness

The pre-filled syringe is only for patients who require a RELISTOR injection dose of 8 mg or 12 mg. Use the vial for patients who require other doses of RELISTOR injection.

Table 1 below shows the recommended weight-based dose of RELISTOR injection and the corresponding injection volume. The recommended dosage regimen is one dose administered subcutaneously every other day, as needed. Do not administer more frequently than one dose per 24-hour period.

Table 1: Weight-Based Dosing of RELISTOR Injection and Corresponding Injection Volume for Adult Patients with OIC and Advanced Illness
*
Calculate the injection volume for these patients by multiplying the patient weight in kilograms by 0.0075 and then rounding up the volume to the nearest 0.1 mL.

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*

Dosage in Patients with Renal Impairment

The recommended dosage of RELISTOR in patients with moderate and severe renal impairment (i.e., creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault) [see Use in Specific Populations (8.6)], is shown below by indication:

OIC in Adult Patients with Chronic NonCancer Pain

RELISTOR tablets: 150 mg once daily in the morning.
RELISTOR injection: 6 mg administered subcutaneously once daily

OIC in Adult Patients with Advanced Illness

RELISTOR injection: The recommended dosage regimen is one dose every other day, as needed is shown in Table 2.

Table 2: Weight-Based Dosing in Moderate and Severe Renal Impairment of RELISTOR Injection and Corresponding Injection Volume for Adult Patients with OIC and Advanced Illness
*
Calculate the injection volume for these patients by multiplying the patient weight in kilograms by 0.0075 and then rounding up the volume to the nearest 0.1 mL.

Weight of Adult Patient

Subcutaneous Dose

Injection Volume

Less than 38 kg

0.075 mg/kg

See below*

38 kg to less than 62 kg

4 mg

0.2 mL

62 kg to 114 kg

6 mg

0.3 mL

More than 114 kg

0.075 mg/kg

See below*

Dosage in Patients with Hepatic Impairment

OIC in Adult Patients with Chronic Non-Cancer Pain

RELISTOR tablets: The recommended dosage in adult patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) is 150 mg, once daily in the morning [see Use in Specific Populations (8.7)].
RELISTOR injection: If considering dose adjustment for patients with severe hepatic impairment, follow the recommendations in Table 3 [see Use in Specific Populations (8.7)].
Table 3: Weight-Based Dosing in Severe Hepatic Impairment of RELISTOR Injection and Corresponding Injection Volume for Adult Patients with OIC and Chronic Non-Cancer Pain
*
Calculate the injection volume for these patients by multiplying the patient weight in kilograms by 0.0075 and then rounding up the volume to the nearest 0.1 mL.

Weight of Adult Patient

Subcutaneous

Dose

Injection Volume

Less than 38 kg

0.075 mg/kg

See below*

38 kg to less than 62 kg

4 mg

0.2 mL

62 kg to 114 kg

6 mg

0.3 mL

More than 114 kg

0.075 mg/kg

See below*

Preparation and Administration of RELISTOR Injection

RELISTOR injection is for subcutaneous use only.
Single-dose pre-filled syringes: Do not remove the pre-filled syringe from the tray until ready to administer.
Inspect RELISTOR injection visually for particulate matter and discoloration prior to administration. RELISTOR injection is colorless to pale yellow. Discard the pre-filled syringe or vial if particulate matter or discoloration is present.
Administer RELISTOR injection subcutaneously in the upper arm, abdomen or thigh. Do not inject at the same spot each time (rotate injection sites).
RELISTOR Single-dose vials: Once drawn into the syringe, 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.
For patient or caregiver instructions for preparation and administration of RELISTOR injection (including recommended specifications for the syringe and needle to be used with the single-dose vial), see Instructions for Use.
Hide