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reaction to ONGLYZA, such as anaphylaxis, angioedema, or exfoliative skin … 0000000016 00000 n
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The package insert is to be edited for South Africa. 0000024147 00000 n
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A saxagliptin 10 mg treatment arm was included in one of the monotherapy trials and in the add-on combination trial with metformin. 0000014757 00000 n
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Table 1: Adverse Reactions (Regardless of Investigator Assessment of Causality) in Placebo-Controlled Trials* Reported in ≥ 5% of Patients Treated with ONGLYZA (saxagliptin tablets) 5 mg and More Commonly than in Patients Treated with Placebo.In February 2012, Bristol-Myers/Astra Zeneca distributed additional safety information on saxagliptin use in South Africa. 0000019461 00000 n
In April 2016, the U.S. FDA added a warning about increased risk of Saxagliptin is used as monotherapy or in combination with other drugs for the treatment of type 2 diabetes. 0000016916 00000 n
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It does not appear to decrease the risk of 3 adverse reactions were seen higher in saxagliptin vs placebo. 0000005025 00000 n
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It was based on a drug development program with 8 randomized trials: 1 phase 2 dose-ranging (2.5–100 mg/d) study; 6 phase 3, 24-week controlled trials with additional controlled follow-up from 12 to 42 months, double-blinded throughout; and one 12-week mechanism-of-action trial with a 2-year follow-up period.O=C(N1[C@H](C#N)C[C@@H]2C[C@H]12)[C@@H](N)C35CC4CC(C3)CC(O)(C4)C5InChI=1S/C18H25N3O2/c19-8-13-2-12-3-14(12)21(13)16(22)15(20)17-4-10-1-11(5-17)7-18(23,6-10)9-17/h10-15,23H,1-7,9,20H2/t10?,11?,12-,13+,14+,15-,17?,18?/m1/s1EMA publication Contraindications will now include a history of sensitivity to saxagliptin (or another DPP4 inhibitor) as well as pancreatitis. 0000018222 00000 n
Contraindications will now include a history of sensitivity to saxagliptin (or another DPP4 inhibitor) as well as pancreatitis. 0000005266 00000 n
Spontaneously-reported adverse events in South Africa have included anaphylaxis, angioedema and acute pancreatitis. Aristocort inj intralesional - 25mg/ml is shutting a buccal film productions which provides delivery of triamcinolone, a special partial opioid agonist and sch The package insert is to be edited for South Africa. 0000009871 00000 n
4 CONTRAINDICATIONS ONGLYZA is contraindicated in patients with a history of a serious hypersensitivity . trailer
INDICATIONS AND USAGE Monotherapy and Combination Therapy: ONGLYZA is indicated as an … In this study, 565 patients taking pioglitazone or rosiglitazone were randomised to add saxagliptin 2.5 mg, 5 mg or a placebo. A New Drug Application for saxagliptin in the treatment of type 2 diabetes was submitted to the FDA in June 2008. 0000002855 00000 n
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Spontaneously-reported adverse events in South Africa have included anaphylaxis, angioedema and acute pancreatitis. Saxagliptin has also been added to the treatment of patients whose diabetes has not been controlled by a thiazolidinedione. 0000006367 00000 n
After 24 weeks the HbA1c concentration had fallen by 0.66% with 2.5 mg, 0.94% with 5 mg and 0.3% with placebo. 0000005995 00000 n
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• ONGLYZA (saxagliptin) 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets with “2.5” printed on one side and “4214” printed on . 0000016961 00000 n
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the reverse side, in blue ink. 0000007109 00000 n
| www.ema.europa.eu/docs/en_GB/document.../WC500044316.pdf In a cardiovascular outcomes trial, saxagliptin treatment let to a small increase in the risk of being hospitalized for heart failure.Both monotherapy and combination therapy with other agents was generally well tolerated in clinical trials.An association of the DPP-IV inhibitor class with pancreatic problems has been proposed, mainly based on case reports associated with the DPP-IV inhibitor sitagliptin and several incretin mimetics including Lawsuits have been filed in which plaintiffs who developed pancreatic cancer claim that DPP-IV inhibitors or incretins had a causative role in the development of their cancers.The synthesis of saxagliptin by Bristol-Myers Squibb by the amide coupling of N-Boc-3-hydroxyadamantylglycine (Saxagliptin is part of a class of diabetes medications called Because incretin hormones are more active in response to higher blood sugar levels (and are less active in response to low blood sugar), the risk of dangerously low blood sugar (hypoglycemia) is low with saxagliptin monotherapy.