Lanreotide
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Dosage Adjustment in Renal Impairment Acromegaly The recommended starting dosage of SOMATULINE DEPOT in acromegalic patients with moderate or severe renal impairment (creatinine clearance less than 60 mL/min) is 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dosage adjustment [see Dosage and Administration , Use in Specific Populations ].
Dosing in liver impairment
Dosage Adjustment in Hepatic Impairment Acromegaly The recommended starting dosage of SOMATULINE DEPOT in acromegalic patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) is 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dosage adjustment [see Dosage and Administration , Use in Specific Populations ] .
Preparation and administration
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Important Administration Instructions For deep subcutaneous injection only. SOMATULINE DEPOT is intended for administration by a healthcare provider. Refer to the Instructions For Use (IFU) for complete administration instructions with illustrations. Preparation Remove SOMATULINE DEPOT from the refrigerator 30 minutes prior to administration and allow to come to room temperature.
Keep pouch sealed until just prior to injection. Product left in its sealed pouch at room temperature (not to exceed 104°F or 40°C) for up to 72 hours may be returned to the refrigerator for continued storage and use at a later time. Prior to administration, inspect the SOMATULINE DEPOT syringe visually for particulate matter and discoloration.
Do not administer if particulate matter or discoloration is observed. The content of the prefilled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a color varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection.
These differences are normal and do not interfere with the quality of the product. Administration Slowly administer for 20 seconds as a deep subcutaneous injection in the superior external quadrant of the buttock. Alternate the injection site between the right and left sides from one injection to the next.
Drug interactions
Check lanreotide against a medication listLabel text (6 paragraphs)
Cyclosporine : SOMATULINE DEPOT may decrease the absorption of cyclosporine. Dosage adjustment of cyclosporine may be needed. ( 7.2 ) Bromocriptine : SOMATULINE DEPOT may increase the absorption of bromocriptine. ( 7.3 ) Bradycardia-Inducing Drugs (e.g., beta-blockers) : SOMATULINE DEPOT may decrease heart rate. Dosage adjustment of the coadministered drug may be necessary. ( 7.3 )
7.1 Insulin and Oral Hypoglycemic Drugs Lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Therefore, blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated or when the dose is altered, and antidiabetic treatment should be adjusted accordingly [see Warnings and Precautions (5.2) ] .
7.2 Cyclosporine Concomitant administration of cyclosporine with SOMATULINE DEPOT may decrease the absorption of cyclosporine, and therefore, may necessitate adjustment of cyclosporine dose to maintain therapeutic drug concentrations. [see Clinical Pharmacology (12.3) ]
7.3 Bromocriptine Limited published data indicate that concomitant administration of a somatostatin analog and bromocriptine may increase the absorption of bromocriptine [see Clinical Pharmacology (12.3) ] .
7.4 Bradycardia-Inducing Drugs Concomitant administration of bradycardia-inducing drugs (e.g., beta-blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Dosage adjustments of concomitant drugs may be necessary.
7.5 Drug Metabolism Interactions The limited published data available indicate that somatostatin analogs may decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that SOMATULINE DEPOT may have this effect, avoid other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine). Drugs metabolized by the liver may be metabolized more slowly during SOMATULINE DEPOT treatment and dose reductions of the concomitantly administered medications should be considered [see Clinical Pharmacology (12.3) ] .
Contraindications
4 CONTRAINDICATIONS SOMATULINE DEPOT 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 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Limited available data based on postmarketing case reports with SOMATULINE DEPOT use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, decreased embryo/fetal survival was observed in pregnant rats and rabbits at subcutaneous doses 5- and 2-times the maximum recommended human dose (MRHD) of 120 mg, respectively (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data A reproductive study in pregnant rats given 30 mg/kg of lanreotide by subcutaneous injection every 2 weeks (5 times the human dose, based on body surface area comparisons) resulted in decreased embryo/fetal survival. A study in pregnant rabbits given subcutaneous injections of 0.45 mg/kg/day (2 times the human therapeutic exposures at the maximum recommended dose of 120 mg, based on comparisons of relative body surface area) shows decreased fetal survival and increased fetal skeletal/soft tissue abnormalities.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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Recalls (last 24 months)
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