DRUG INTERACTIONS
Strong Inhibitors of CYP3A4/5 Enzymes
Ketoconazole significantly increased saxagliptin
exposure. Similar significant increases in plasma concentrations of saxagliptin
are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin,
indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and
telithromycin). The dose of ONGLYZA should be limited to 2.5 mg when coadministered
with a strong CYP3A4/5 inhibitor. [See
Dosage and
Administration
and
Clinical
Pharmacology
.]
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OVERDOSAGE
In a controlled clinical trial, once-daily,
orally-administered ONGLYZA in healthy subjects at doses up to 400 mg daily
for 2 weeks (80 times the MRHD) had no dose-related clinical adverse reactions
and no clinically meaningful effect on QTc interval or heart rate.
In
the event of an overdose, appropriate supportive treatment should be initiated
as dictated by the patient’s clinical status. Saxagliptin and its active metabolite
are removed by hemodialysis (23% of dose over 4 hours).
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CONTRAINDICATIONS
History of a serious hypersensitivity reaction to ONGLYZA, such as anaphylaxis, angioedema, or exfoliative skin conditions. [See
Warnings and Precautions
and
Adverse Reactions
.]
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