New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2... (p to drug exposure. Hypersensitivity...)

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New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2 Diabetes

Date:11/21/2008

p to drug exposure.
Hypersensitivity reactions include anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome [see Warnings and Precautions (5.3); hepatic enzyme elevations.

DRUG INTERACTIONS

Digoxin

There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100mg sitagliptin for 10 days. Patients receiving digoxin should be monitored appropriately. No dosage adjustment of digoxin or JANUVIA is recommended.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy CategoryB:

Reproduction studies have been performed in rats and rabbits. Doses of sitagliptin up to 125mg/kg (approximately 12 times the human exposure at the maximum recommended human dose) did not impair fertility or harm the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Merck & Co., Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to JANUVIA while pregnant. Health care providers are encouraged to report any prenatal exposure to JANUVIA by calling the Pregnancy Registry at (800) 986-8999.

Sitagliptin administered to pregnant female rats and rabbits from gestation day 6 to 20 (organogenesis) wa
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New Study Data: JANUVIA&#8482; (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2...(p to drug exposure. Hypersensitivity...),Health

New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2...(p to drug exposure. Hypersensitivity...),Health