RESOTRANS

What it is

RESOTRANS is a film-coated tablet containing prucalopride (as succinate) available in 1 mg and 2 mg strengths.

Approved indications

— Chronic functional constipation in adults in whom laxatives fail to provide adequate relief.

Dosing overview

The standard adult dose is 2 mg once daily. Patients with severe hepatic impairment (Child-Pugh class C) should receive 1 mg once daily. Patients with severe renal impairment (GFR < 30 mL/min/1.73m²) not requiring dialysis should receive 1 mg once daily. Elderly patients should start with 1 mg once daily, with the option to increase to 2 mg once daily if needed. Prucalopride is not recommended in children and adolescents younger than 18 years. Film-coated tablets are for oral use and can be taken with or without food.

Key safety warnings

Prior to receiving RESOTRANS, patients require a thorough history and examination to exclude secondary causes of constipation and to establish failure to respond adequately to at least two different types of laxatives from different classes for at least six months. Efficacy and safety of prucalopride have not been demonstrated in patients with secondary causes of constipation including endocrine disorders, metabolic disorders and neurologic disorders, or in patients with medication-related constipation including constipation due to opioid use; use in these patients is not recommended. RESOTRANS should be used with caution in patients with a history of arrhythmias or ischaemic cardiovascular disease. Patients should be monitored for persistent worsening of depression or the emergence of suicidal thoughts and behaviours, and patients and their caregivers should be aware of any unusual changes in mood or behaviour and alert the healthcare provider immediately if such changes occur. The most frequently reported adverse reactions are headache and gastrointestinal symptoms (abdominal pain, nausea or diarrhoea) occurring in approximately 20% of patients each, predominantly at the start of therapy and usually disappearing within a few days with continued treatment. Prucalopride has been associated with dizziness and fatigue particularly during the first day of treatment which may have an effect on driving and using machines.

Contraindications

RESOTRANS is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, renal impairment requiring dialysis, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, active severe inflammatory conditions of the intestinal tract such as Crohn's disease and ulcerative colitis, toxic megacolon/megarectum, and recent bowel surgery.

PBS listing

In November 2017, the PBAC recommended an amendment to the PBS listing to allow prucalopride to be used for the treatment of chronic idiopathic constipation in adult patients who have had an inadequate response to other laxatives.

Regulatory history

RESOTRANS was first registered on the ARTG on 7 October 2011 in two strengths: 1 mg and 2 mg tablets. In November 2017, the PBAC recommended an amendment to the PBS listing for treatment of chronic idiopathic constipation in adults with inadequate response to other laxatives.