Trade Names:Somatuline Depot- Injection, solution, extended-release 60 mg- Injection, solution, extended-release 90 mg- Injection, solution, extended-release 120 mg
Similar to the natural hormone somatostatin. Suppresses secretion of serotonin and gastroenteropancreatic peptides (eg, gastrin, glucagon, insulin, motilin, secretin). Also suppresses growth hormone (GH).
After subcutaneous administration, bioavailability ranges from approximately 69% to 78%, depending on the dose. C max ranges from 4.3 to 8.4 ng/mL during the first day. At steady state, C max ranges from 3.8 to 7.7 ng/mL, increasing linearly with the dose. The steady-state trough serum concentration ranges from 1.8 to 3.8 ng/mL, depending on the dose. Mean serum concentration is greater than 1 ng/mL throughout 28 days with the 90 mg dose and greater than 0.9 ng/mL with 60 mg.
The t ½ is 23 to 30 days.
Less than 5% is excreted in urine and less than 0.5% is recovered unchanged in feces, indicating some biliary excretion.
In patients with moderate to severe renal function impairment, reduce the starting dose to 60 mg. In patients with end-stage renal disease, there is approximately a 2-fold decrease in total serum Cl of lanreotide, with a consequent 2-fold increase in t ½ and AUC.Hepatic Function Impairment
A 30% reduction in Cl is observed in patients with moderate to severe hepatic function impairment.Elderly
Compared with healthy young subjects, elderly subjects showed an 85% increase in t ½ and a 65% increase in mean residence time.
Long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
Subcutaneous Start with 90 mg deep subcutaneously at 4-wk intervals for 3 months. After 3 months, the dose may be adjusted as follows.GH greater than 1 to 2.5 ng/mL or less with insulin-like growth factor-1 (IGF-1) normal and clinical symptoms controlled
maintain dose at 90 mg every 4 wk.GH greater than 2.5 ng/mL with IGF-1 elevated and/or clinical symptoms uncontrolled
Increase dose to 120 mg every 4 wk. GH 1 ng/mL or less with IGF-1 normal and clinical symptoms controlled: reduce dose to 60 mg every 4 wk.
Thereafter, adjust dose according to response of patient as judged by reduction in serum GH and/or IGF-1 levels, and/or changes in acromegaly symptoms.Hepatic/Renal Function Impairment
Subcutaneous In patients with moderate to severe hepatic or renal function impairment, start with 60 mg at 4 wk intervals for 3 months then adjust dose as described above.
Store under refrigeration at 36° to 46°F. Protect from light.
There may be an additive effect on reduction of heart rate associated with lanreotide, necessitating dosage adjustment of concurrent medication.Bromocriptine
Availability may be increased by lanreotide.Cyclosporine
Cyclosporine bioavailability may be reduced, necessitating cyclosporine dosage adjustments.Drugs metabolized by CYP3A4
Cl may be reduced by lanreotide. Use drugs that have a low therapeutic index (eg, quinidine) with caution.Insulin
Insulin and glucagon secretion may be inhibited, necessitating adjustments in antidiabetic treatment.
None well documented.
Bradycardia (18%); hypertension (5%); sinus bradycardia (3%).
Diarrhea (57%); abdominal pain (37%); nausea (11%); constipation (8%); flatulence, vomiting (7%); loose stools (6%).
Cholelithiasis and gallbladder sledge (20%).
Injection-site induration, inflammation, mass, nodule, pain, or pruritus (9%).
Diabetes/hyperglycemia/hypoglycemia (14%); decreased weight (11%).
Monitor blood glucose levels when treatment is started or when the dose is altered. Serum GH and IGF-1 levels are useful markers of the disease and the effectiveness of treatment.
Category C .
Safety and efficacy not established.
Reduce starting dose in patients with moderate to severe renal function impairment.
Reduce starting dose in patients with moderate to severe hepatic function impairment.
In patients with acromegaly, the most common adverse reactions are bradycardia, sinus bradycardia, and hypertension. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Use with caution in patients with bradycardia.
Gallbladder motility may be reduced, leading to gallstone formation; periodically monitor gallbladder function.
Serum glucose control may be altered because of inhibition of insulin and glucagon secretion.
The prefilled syringe needle cover contains rubber.
Slight decreases in thyroid function have been seen during treatment in patients with acromegaly.
There are no confirmed cases of overdose that were serious or led to an adverse reaction.
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