RELISTOR Solution for injection Ref.[9197] Active ingredients: Methylnaltrexone

Posology

Opioid-induced constipation in adult patients with chronic pain (except palliative care patients with advanced illness)

The recommended dose of methylnaltrexone bromide is 12 mg (0.6 mL of solution) subcutaneously, as needed, given as at least 4 doses weekly, up to once daily (7 doses weekly).

In these patients, the treatment with usual laxatives should be stopped when commencing treatment with Relistor (see section 5.1).

Opioid-induced constipation in adult patients with advanced illness (palliative care patients)

The recommended dose of methylnaltrexone bromide is 8 mg (0.4 mL of solution) (for patients weighing 38-61 kg) or 12 mg (0.6 mL of solution) (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 as follows:

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

In palliative care patients, Relistor is added to usual laxative treatment (see section 5.1).

Special populations

Elderly population

No dose adjustment is recommended based on age (see section 5.2).

Patients with renal impairment

In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 mL of solution) for those weighing 62 to 114 kg. Patients with severe renal impairment whose weight falls outside the 62 to 114 kg range (see section 5.2) need to reduce their mg/kg dose by 50 %. These patients should use Relistor vials and not the pre-filled syringe. There are no data available from patients with end-stage renal impairment on dialysis, and methylnaltrexone bromide is not recommended in these patients (see section 4.4).

Patients with hepatic impairment

No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).

There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and methylnaltrexone bromide is not recommended in these patients (see section 4.4).

Paediatric population

The safety and efficacy of methylnaltrexone bromide in children less than 18 years has not been established. No data are available.

Method of 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.

A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus.

In the event of an overdose, signs and symptoms of orthostatic hypotension should be monitored and reported to a physician. Treatment should be initiated as appropriate.

Shelf life: 4 years.

After withdrawal in the injection syringe: Due to light sensitivity, the solution for injection should be used within 24 hours.

This medicinal product does not require any special temperature storage conditions.

Keep the vial in the outer carton in order to protect from light.

For storage conditions of the medicinal product in the syringe, see section 6.3.

Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flip-off-cap.

Each vial contains 0.6 mL of solution for injection.

Pack sizes of:

• 1 vial,
• 2 vials with 2 sterile 1 mL injection syringes with retractable injection needle and 4 alcohol swabs; or
• 7 vials with 7 sterile 1 mL injection syringes with retractable injection needle and 14 alcohol swabs.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.