What is the dosage of Relistor?

Relistor is available in 4 dosages, including 20 mg/ml Prefilled Syringe 0.6 ml, 20 mg/ml Injection 0.6 ml, 150 mg Tab and 20 mg/ml Prefilled Syringe 0.4 ml

What is Relistor made of?

Relistor contains methylnaltrexone which is a Opioid Antagonist

How is Relistor administered?

Relistor is administered as a Injectable or Oral Pill

What is Relistor mechanism of action?

Relistor mechanism of action is Opioid Antagonists

Relistor

(methylnaltrexone bromide)

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Dosage & Administration

Administration Instructions ( 2.1)

* Be within close proximity to toilet facilities once administered.
* Discontinue if treatment with opioid pain medication is also discontinued.
* In adult patients with chronic non-cancer pain and OIC:
* Patients receiving opioids for less than 4 weeks may be less responsive to RELISTOR.
* Discontinue all maintenance laxative therapy before starting RELISTOR; may resume laxatives if there is a suboptimal response to RELISTOR after 3 days.
* Re-evaluate the continued need for RELISTOR when 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.

Dosing

* For OIC in adult patients with chronic non-cancer pain ( 2.2):
* RELISTOR tablets: The recommended dosage is 450 mg once daily in the morning.
* RELISTOR injection: The recommended dosage is 12 mg subcutaneously once daily.

* For OIC in adult patients with advanced illness ( 2.3):
* 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.
* RELISTOR injection: See Table 1in the full prescribing information for the recommended dosage; administer one dose every other day, as needed, but no more frequently than one dose in a 24-hour period.

Dosage Adjustment

* See full prescribing information dosage adjustment in renal or hepatic impairment by indication. ( 2.4, 2.5)

Preparation and Administration of RELISTOR Injection( 2.6)

* For subcutaneous use only.
* Inject in upper arm, abdomen or thigh. Rotate injection sites.

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Relistor Prescribing Information

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

RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Opioid-Induced Constipation in Adult Patients with Advanced Illness

RELISTOR injection is indicated for the treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

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 Non- Cancer 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
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*

*Calculate the injection volume for these patients by multiplying the patient weight in kilograms by 0.00375 and then rounding up the volume to the nearest 0.1 mL.

Tablets:

150 mg methylnaltrexone bromide supplied as film-coated, white, round, biconvex, debossed with “REL” on one side and plain on the other side.

Injection:

Single-dose Vial:

12 mg/0.6 mL methylnaltrexone bromide supplied as colorless to pale yellow solution.

Single-dose Pre-filled Syringe:

8 mg/0.4 mL methylnaltrexone bromide supplied as colorless to pale yellow solution.
12 mg/0.6 mL methylnaltrexone bromide supplied as colorless to pale yellow solution.

Hepatic Impairment

Tablets

In a study of subjects with varying degrees of hepatic impairment receiving a 450 mg dose of RELISTOR tablets, there was a significant increase in systemic exposure of methylnaltrexone for subjects with moderate (Child-Pugh Class B) and severe (Child-Pugh Class C) hepatic impairment compared to healthy subjects with normal hepatic function [see Clinical Pharmacology ( 12.3)] . Therefore, a dosage reduction of RELISTOR tablets is recommended in patients with moderate or severe hepatic impairment [see Dosage and Administration ( 2.5)]. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A).

Injection

In a study of subjects with mild or moderate hepatic impairment, there was no clinically meaningful change in systemic exposure of methylnaltrexone compared to healthy subjects with normal hepatic function [see Clinical Pharmacology ( 12.3)] . Therefore, no dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment [see Clinical Pharmacology ( 12.3)].

Patients with severe hepatic impairment were not studied. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions. If considering dosage adjustment, follow the recommendations in Table 3[see Dosage and Administration ( 2.5)].

Relistor

Dosage & Administration

Relistor Prescribing Information

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

Opioid-Induced Constipation in Adult Patients with Advanced Illness

Dosage in Patients with Renal Impairment

Hepatic Impairment

Severe or Persistent Diarrhea

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