"A US Food and Drug Administration (FDA) advisory committee urged approval â€” though not without some reservations â€” of a new injectable known generically as iGlarLixi that combines fixed doses of insulin glargine (Lantus, Sanofi) with lixis"...
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).
ONGLYZA is contraindicated in patients with a history of a serious hypersensitivity reaction to ONGLYZA, such as anaphylaxis, angioedema, or exfoliative skin conditions [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Last reviewed on RxList: 4/19/2016
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