FDA updates cobicistat and Stribild labels: interactions with systemic, inhaled, nasal and ophthalmic corticosteriods

26 June 2017. Related: Antiretrovirals, PK and drug interactions.

Simon Collins, HIV i-Base

On 5 May 2017, the FDA updated labels for cobicistat and Stribild with information about interactions with most (but not all) corticosteroids.

The direction of the interactions is for ARV levels to be reduced for cobicistat, elvitegravir, atazanavir and darunavir. At the same time, corticosteroid levels have the potential to be increased.

The corticosteroids with this potential for interactions include betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, prednisone and triamcinolone.

However, no clinically significant interactions have been observed with either beclomethasone or prednisolone.

The labels note:

• Coadministration with oral dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to elvitegravir, atazanavir or darunavir. Consider alternative corticosteroids.
• Coadministration with corticosteroids whose exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression.
• Alternative corticosteroids including beclomethasone and prednisolone (whose PK and/or PD are less affected by strong CYP3A inhibitors relative to other studied steroids) should be considered, particularly for long-term use.

Source:

FDA HIV email update. TRIBILD and TYBOST labels have been updated. (5 May 2017)

The US labels will be updated labels will soon be available drugs@fda or DailyMed.

https://www.accessdata.fda.gov/scripts/cder/daf

https://dailymed.nlm.nih.gov/dailymed/index.cfm