Revised SPC: Evotaz (300 mg atazanavir/150 mg cobicistat) film-coated tablets

SPC has been updated following PRAC safety signal to warn of interaction between cobicistat products and corticosteroids primarily metabolised by CYP3A, which could lead to increase in plasma concentrations of the latter, resulting in reduced serum cortisol concentrations.

An MHRA Drug Safety alert on this interaction was issued in Dec 2016 and provided following advice:

 

• All clinicians who may prescribe or administer steroids to patients with HIV should be aware that concomitant use of a corticosteroid metabolised by cytochrome P450 3A (CYP3A) and a HIV-treatment-boosting agent may increase the risk of systemic corticosteroid-related adverse effects.

 

• Although these reactions are rarely reported, there is potential for this interaction to occur even with non-systemically administered steroid formulations, including intranasal, inhaled, and intra-articular routes.

 

• Coadministration of a HIV-treatment-boosting agent with a CYP3A-metabolised corticosteroid is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid-related reactions.

 

• If coadministration is necessary, use of beclomethasone should be considered where possible—particularly for long-term use. Beclomethasone is less dependent on CYP3A metabolism and, although the risk of an interaction leading to adverse corticosteroid effects may not be completely removed, it may be lower.