LANREOTIDE ACETATE

Lanreotide Injection is thought to form a drug depot at the injection site due to the interaction of the formulation with physiological fluids. The most likely mechanism of drug release is a passive diffusion of the precipitated drug from the depot towards the surrounding tissues, followed by the absorption to the bloodstream. After a single, deep subcutaneous administration, the mean absolute bioavailability of lanreotide in healthy subjects was 73.4, 69.0, and 78.4% for the 60 mg, 90 mg, and 1...

The safety and efficacy of Lanreotide Injection have been established based on adequate and well-controlled studies of another lanreotide injection product. Below is a description of the results of these adequate and well-controlled studies of lanreotide injection in these conditions. 14.1 Acromegaly The effect of lanreotide on reducing GH and IGF-levels and control of symptoms in patients with acromegaly was studied in 2 long-term, multiple-dose, randomized, multicenter studies.

Study 1This 1-year study included a 4-week, double-blind, placebo-controlled phase; a 16-week single-blind, fixed-...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [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 ( 5.6 )] Most common advers...

Lanreotide Injection is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [see Adverse Reactions ( 6.3 )] . Hypersensitivity to lanreotide. ( 4 )

Cholelithiasis and Complications of Cholelithiasis : Monitor periodically. Discontinue if complications of cholthiasis are suspected. Gallstones may occur; consider periodic monitoring. ( 5.1 ) Hyperglycemia and Hypoglycemia : Glucose monitoring is recommended and antidiabetic treatment adjusted accordingly. ( 5.2 , 7.1 ) Cardiovascular Abnormalities : Decrease in heart rate may occur. Use with caution in at-risk patients. ( 5.3 ) Thyroid Function Abnormalities : Decreases in thyroid function ma...

7 DRUG INTERACTIONS Cyclosporine : Lanreotide Injection may decrease the absorption of cyclosporine. Dosage adjustment of cyclosporine may be needed. ( 7.2 ) Bromocriptine : Lanreotide Injection may increase the absorption of bromocriptine. ( 7.3 ) Bradycardia-Inducing Drugs (e.g., beta-blockers) : Lanreotide Injection may decrease heart rate. Dosage adjustment of the coadministered drug may be ne...