saxagliptin package insert fosamax

These adverse reactions occurred more commonly on ONGLYZA than on placebo and occurred in at least 5% of patients treated with ONGLYZA.In patients treated with ONGLYZA 2.5 mg, headache (6.5%) was the only adverse reaction reported at a rate ≥5% and more commonly than in patients treated with placebo.In the add-on to TZD trial, the incidence of peripheral edema was higher for ONGLYZA 5 mg versus placebo (8.1% and 4.3%, respectively). - Keep this leaflet. Dresser GK, Spence JD, Bailey DG. No significant difference in the pharmacokinetics of saxagliptin and its active metabolite were detected between these two populations.The metabolism of saxagliptin is primarily mediated by CYP3A4/5.0.25 mg q6h first day followed by q12h second day followed by QD forAluminum hydroxide + magnesium hydroxide + simethiconeND=not determined; QD=once daily; q6h=every 6 hours; q12h=every 12 hours; BID=twice daily; LA=long acting0.25 mg q6h first day followed by q12h second day followed by QD forethinyl estradiol 0.035 mg and norgestimate 0.250 mg for 21 daysND=not determined; QD=once daily; q6h=every 6 hours; q12h=every 12 hours; BID=twice daily; LA=long actingCarcinogenicity was evaluated in 2-year studies conducted in CD-1 mice and Sprague-Dawley rats. No adverse developmental effects were observedin either species at exposures 1503- and 152-times the 5 mg clinical dose in rats and rabbits, respectively, based on AUC. We use cookies to enhance your site experience and for analytics purposes.Although, these are two different chemicals, they belong to the same class of anti-diabetic medications.

The mean change from baseline in daily dose of insulin was 2 units for the ONGLYZA 5 mg group and 5 units for the placebo group.The change in fasting plasma glucose from baseline to Week 24 was also tested, but was not statistically significant. Difference from placebo + metformin (adjusted mean  Difference from placebo + metformin (adjusted mean  Difference from placebo + metformin (adjusted meanIn this 52-week, active-controlled trial, a total of 858 patients with type 2 diabetes and inadequate glycemic control (A1C >6.5% and ≤10%) on metformin alone were randomized to double-blind add-on therapy with ONGLYZA or glipizide. The curves for both ONGLYZA and placebo arms are close together throughout the duration of the trial.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. FOSAMAX® Once Weekly 70 mg Tablets . Saxagliptin crosses the placenta into the fetus following dosing in pregnant rats.In a prenatal and postnatal development study, no adverse developmental effects were observed in maternal rats administered saxagliptin from gestation day 6 through lactation day 21 at exposures up to 470-times the 5 mg clinical dose, based on AUC.There is no information regarding the presence of ONGLYZA in human milk, the effects on the breastfed infant, or the effects on milk production.Saxagliptin is present in the milk of lactating rats [Saxagliptin is secreted in the milk of lactating rats at approximately a 1:1 ratio with plasma drug concentrations.Safety and effectiveness of ONGLYZA in pediatric patients under 18 years of age have not been established. If pancreatitis is suspected, promptly discontinue ONGLYZA and initiate appropriate management. The 10 mg saxagliptin dosage is not an approved dosage. 0310-6100-30, It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using ONGLYZA.In a cardiovascular outcomes trial enrolling participants with established ASCVD or multiple risk factors for ASCVD (SAVOR trial), more patients randomized to ONGLYZA (289/8280, 3.5%) were hospitalized for heart failure compared to patients randomized to placebo (228/8212, 2.8%). Patients entered the trial on intermediate- or long-acting (basal) insulin or premixed insulin. • 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 . 0000005025 00000 n Pre-existing low blood calcium levels should be corrected before Fosamax administration. Patients were required to be treatment-naive to be enrolled in this study. 0000011210 00000 n The proportion of patients who discontinued for lack of glycemic control or who were rescued for meeting prespecified glycemic criteria was 10% in the ONGLYZA 2.5 mg add-on to TZD group, 6% for the ONGLYZA 5 mg add-on to TZD group, and 10% in the placebo add-on to TZD group.A total of 768 patients with type 2 diabetes participated in this 24-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of ONGLYZA in combination with a sulfonylurea (SU) in patients with inadequate glycemic control at enrollment (A1C ≥7.5% to ≤10%) on a submaximal dose of SU alone.

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