MIRVASO

What it is

MIRVASO is a gel containing brimonidine tartrate 5 mg per gram, equivalent to brimonidine 3.3 mg per gram. MIRVASO gel is a white to light-yellow opaque gel. Brimonidine is a selective α2-adrenergic receptor agonist that is 1000-fold more selective for the α2-adrenergic receptor than the α1-adrenergic receptor. Topical facial application of a highly selective α2-adrenergic receptor agonist is intended to reduce erythema through direct cutaneous vasoconstriction.

Approved indications

— Treatment of facial erythema of rosacea in adult patients.

Dosing overview

MIRVASO is applied once daily. Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week, and the amount of gel can then be increased gradually based on tolerability and patient response. MIRVASO should be applied in five small pea-size amounts, the total estimated to be no more than 1 g, to the main areas of the face (forehead, chin, nose, each cheek) once daily after the usual cleansing routine. No more than 1 g of gel per day should be used, and application to the eyes, eyelids, lips, mouth, and membrane of the inner nose should be avoided.

Key safety warnings

Some subjects in clinical trials discontinued use of MIRVASO because of erythema or flushing. The effect of MIRVASO begins to diminish hours after application. In some patients, erythema and flushing were reported to return with greater severity than was present at baseline, with most cases observed within the first 2 weeks of starting treatment. Intermittent flushing occurred in some patients treated with MIRVASO topical gel, with onset ranging from approximately 30 minutes to several hours. In case worsening of erythema occurs, MIRVASO should be discontinued. Symptomatic measures, such as cooling, non-steroidal anti-inflammatory drugs and antihistamines, may help in alleviating symptoms. MIRVASO contains methyl hydroxybenzoate (E218) which may cause allergic reactions (possibly delayed), and propylene glycol which may cause skin irritation. MIRVASO should not be applied on irritated skin (including following laser therapy) or open wounds.

Contraindications

MIRVASO is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients; children under 18 years of age; and therapy with concomitant monoamine oxidase inhibitor (MAOI), tricyclic or tetracyclic antidepressants, which affect noradrenergic transmission.

PBS listing

No PBS listing information is available in the provided documents.

Regulatory history

The TGA approved MIRVASO gel for the treatment of facial erythema of rosacea in adult patients on 2014-08-01. This decision was made following the sponsor's commitment to address initial quality concerns regarding impurity limits as a condition of registration. The TGA's initial evaluation identified concerns regarding the proposed expiry limits for two potentially genotoxic impurities, which exceeded the threshold of toxicological concern. The sponsor addressed this by proposing a temporary acceptance of the current limits, committing to develop a more sensitive test method and submit a variation to tighten limits within four months. The TGA accepted this proposal as a condition of registration, deeming the short-term exposure risk negligible. MIRVASO brimonidine 3.3 mg/g (as tartrate) gel was first listed on the ARTG on 2014-08-04.