RELISTOR SOLUTION FOR INJECTION 12MG/0.6ML [SIN13783P]

Product Info

RELISTOR SOLUTION FOR INJECTION 12MG/0.6ML

[SIN13783P]

4.1 Therapeutic indications

Treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.

4.2 Posology and method of administration

For adults only.

RELISTOR should be added to induce prompt bowel movements when response to usual laxative therapy has been insufficient.

The recommended dose of methylnaltrexone bromide is 8 mg (0.4 ml RELISTOR) (for patients weighing 38–61 kg) or 12 mg (0.6 ml RELISTOR) (for patients weighing 62–114 kg).

The usual administration schedule is one single dose every other day. Doses may also be given with longer intervals, as per clinical need.

Patients may receive two consecutive doses 24 hours apart, only when there has been no response (bowel movement) to the dose on the preceding day.

Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg. The injection volume for these patients should be calculated:

Dose (ml) = patient weight (kg) x 0.0075

Renal patients
No dose adjustment is required in patients with mild or moderate impairment. In patients with severe renal impairment (creatinine clearance less than 30 ml/min), reduce the dose of methylnaltrexone bromide by one half. There are no data available from patients with end-stage renal impairment on dialysis, and RELISTOR is not recommended in these patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and RELISTOR is not recommended in these patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric patients
There is no experience in children under the age of 18 (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, methylnaltrexone should not be used in the paediatric age group until further data become available.

Elderly patients
No dose adjustment is recommended based on age (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Administration

RELISTOR is given as a subcutaneous injection.

It is recommended to rotate injection sites. It is not recommended to inject into areas where the skin is tender, bruised, red, or hard. Areas with scars or stretch marks should be avoided.

The three areas of the body recommended for injection of RELISTOR are upper legs, abdomen, and upper arms.

RELISTOR can be injected without regard to food.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction or acute surgical abdomen is contraindicated.