BYNFEZIA PEN

AbsorptionAfter subcutaneous injection, octreotide is absorbed rapidly and co mpletely from the injection site. Peak concentrations of 5.2 ng/ mL (100 mcg dose) were reached 0.4 hours after dosing. Peak concentrations and area under the curve (AUC) values were dose proportional after subcutaneous single doses up to 500 mcg and after subcutaneous multiple doses up to 500 mcg 3 times a day (1,500 mcg/day). In patients with acromegaly, a mean peak concentration of 2.8 ng/mL (100 mcg dose) was reac...

The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Conduction Abnormalities [Warnings and Precautions (5.1)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.2)] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.3)] Thyroid Function Abnormalities [see Warnings and Precautions (5.4)] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.5)] Changes in Vitamin B 12 Levels ...

Sensitivity to this drug or any of its co mponents. Sensitivity to this drug or any of the components (4)

• Cardiac Conduction Abnormalities: Bradycardia, arrhythmias, or conduction abnormalities may occur. Use with caution in at-risk patients. Dosage adjustment of cardiac medications may be necessary. (5.1)
• Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected. (5.2)
• Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and anti-diabetic treatment may need adjustment. (5.3) ...

7 DRUG INTERACTIONS The following drugs require monitoring and possible dose adjustment when used with BYNFEZIA PEN : cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. (7) Lutetium Lu 177 Dotatate Injection : Discontinue BYNFEZIA PEN at least 24 hours prior to each lutetium Lu 177 dotatate dose. (7.6) 7.1 Cyclosporine Octreotide has been associated with alterations...