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Information about FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
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
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Concomitant Drug Class: Drug Name
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Potential Effectb
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Clinical Comment
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Systemic/Inhaled/Nasal/Ophthalmic Corticosteriods:
e.g.
betamethasone
budesonide
ciclesonide
dexamethasone
fluticasone
methylprednisolone
mometasone
prednisone
triamcinolone
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↓elvitegravir
↓cobicistat ↑corticosteroids
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Coadministration with oral dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to elvitegravir. 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 [see Drug Interactions (7.6)].
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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
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Concomitant Drug Class: Drug Name
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Potential Effectb
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Clinical Comment
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Systemic/Inhaled/Nasal/Ophthalmic Corticosteriods:
e.g.
betamethasone
budesonide
ciclesonide
dexamethasone
fluticasone
methylprednisolone
mometasone
prednisone
triamcinolone
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↓cobicistat
↓atazanavir
↓darunavir
↑corticosteroids
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Coadministration with oral dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to 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 [see Drug Interactions (7.4)].
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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 drugs@fda or DailyMed
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
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