FDA Updates STRIBILD and TYBOST Labels

Source: Midwest AIDS Training + Education Center
Published May 4, 2017

The STRIBILD and TYBOST labels were updated to include revised text regarding corticosteroids as follows:

STRIBILD

Section 7 Drug Interaction, Table 6 was revised for systemic, inhaled, nasal, and ophthalmic corticosteroids as follows:

Table 6: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction

Beclomethasone and prednisolone were added to section 7.6 Drugs Without Clinically Significant Interactions with STRIBILD.

TYBOST

Section 7 Drug Interaction, Table 6 was revised for systemic, inhaled, nasal, and ophthalmic corticosteroids as follows. Additionally, section 7.4 was added as shown below:

Table 6: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction

7.4 Drugs without Clinically Significant Interactions with TYBOST

No clinically significant drug interactions have been either observed or are expected when TYBOST is combined with the following drugs: beclomethasone and prednisolone.

The updated labels will soon be available at Drugs@FDA or DailyMed.