Diabetes Events
Diabetes research and treatment are addressed through a variety of educational formats.
Here are some meetings and events you may find useful.
This list is provided as a courtesy by the Bristol-Myers Squibb/AstraZeneca collaboration.
Bristol-Myers Squibb/AstraZeneca collaboration does not endorse and is not responsible for the contents of any of the listed Web sites. This is not an exhaustive list of Web sites.
Indication and Important Limitations of Use
ONGLYZA™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
ONGLYZA has not been studied in combination with insulin.
April 21-25, 2010
AACE 19th Annual Meeting and Clinical Congress
Sheraton Boston Hotel and the John B. Hynes Veterans Memorial Convention Center
Contact: AACE Meetings Department
Phone: 904-353-7878
Fax: 904-353-8185
E-mail: ebailey@aace.com
June 25-29, 2010
70th ADA Scientific Sessions
Orlando, FL
IMPORTANT INFORMATION ABOUT ONGLYZA (saxagliptin)
Indication and Important Limitations of Use
ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
ONGLYZA has not been studied in combination with insulin.
Important Safety Information
- Use with Medications Known to Cause Hypoglycemia: Insulin secretagogues, such as sulfonylureas, cause hypoglycemia.
Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with ONGLYZA
- Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug
Most common adverse reactions (regardless of investigator assessment of causality) reported in ≥5% of patients treated with ONGLYZA and more commonly than in patients
treated with control were upper respiratory tract infection (7.7%, 7.6%), headache (7.5%, 5.2%),
nasopharyngitis (6.9%, 4.0%) and urinary tract infection (6.8%, 6.1%). When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral
edema for ONGLYZA 2.5 mg, 5 mg, and placebo was 3.1%, 8.1% and 4.3%, respectively.
Drug Interactions: Because ketoconazole, a strong CYP3A4/5 inhibitor, increased
saxagliptin exposure, the dose of ONGLYZA should be limited to 2.5 mg when
coadministered with a strong CYP3A4/5 inhibitor (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg once daily for
patients with moderate or severe renal impairment, or with end-stage renal disease
requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min). ONGLYZA should be
administered following hemodialysis. ONGLYZA has not been studied in patients
undergoing peritoneal dialysis. Assessment of renal function is recommended prior to
initiation of ONGLYZA and periodically thereafter.
Pregnant and Nursing Women: There are no adequate and well-controlled studies in
pregnant women. ONGLYZA, like other antidiabetic medications, should be used during
pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in
human milk. Because many drugs are secreted in human milk, caution should be
exercised when ONGLYZA is administered to a nursing woman.
Pediatric Patients: Safety and effectiveness of ONGLYZA in pediatric patients have not been established.