SALOFALK

What it is

SALOFALK foam is mesalazine 1 g per application presented as a white-greyish to slightly reddish violet, creamy firm foam.

Approved indications

— Treatment of acute ulcerative colitis of mild to moderate severity. — Maintenance treatment of ulcerative colitis.

Dosing overview

A dose of 2 g or 4 g mesalazine as SALOFALK foam once a day is used for the treatment of acute ulcerative colitis or maintenance of remission. A dose of 2 g SALOFALK foam is equivalent to 2 applications. The best results are achieved if the bowels are evacuated prior to instillation of SALOFALK foam.

Key safety warnings

Mesalazine should be used with caution in patients with pulmonary function impairment, particularly asthma, and in patients with known hypersensitivity to sulfasalazine containing preparations, with treatment instituted under careful medical supervision. Serious blood dyscrasias have been reported very rarely with mesalazine, and haematological investigations should be performed if patients suffer from unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain. Cardiac hypersensitivity reactions including myocarditis and pericarditis have been rarely reported with mesalazine, and SALOFALK should be discontinued immediately if any of these reactions occur. Cases of nephrolithiasis have been reported with the use of mesalazine, including stones with mesalazine content; adequate fluid intake during treatment should be ensured. Severe cutaneous adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with mesalazine treatment, and SALOFALK foam should be discontinued at the first appearance of signs and symptoms of severe skin reactions. Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine; patients should be warned for signs and symptoms including severe or recurrent headache, visual disturbances or tinnitus, and discontinuation should be considered if it occurs.

Contraindications

SALOFALK foam is contraindicated in patients with hypersensitivity to salicylic acid, salicylic acid derivatives (including mesalazine/5-ASA and sulfites) or to any of the other ingredients, and in patients with severe impairment of hepatic and renal function.

PBS listing

SALOFALK foam (rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g) is listed on the PBS with streamlined restriction, with an ex-manufacturer price of A$53.00 and 2 PBS items.

Regulatory history

SALOFALK foam (mesalazine 1 g per application aerosol can) was first listed on the Australian Register of Therapeutic Goods (ARTG 95960) on 5 October 2004. In November 2020, the Pharmaceutical Benefits Scheme Advisory Committee recommended SALOFALK for the treatment of ulcerative colitis.