Somatuline Depot (lanreotide acetate)

Dosage of lanreotide acetate is expressed in terms of lanreotide.

Lanreotide acetate is administered by deep subcutaneous injection only by a healthcare provider.

The drug is commercially available as a prefilled syringe for subcutaneous injection.

Lanreotide acetate prefilled syringes must be refrigerated at 2-8degreesC and stored in the original carton to protect the drug from light; the product should not be frozen. Prior to administration, the prefilled syringe (in the sealed pouch) should be allowed to reach room temperature for about 30 minutes; the pouch should remain sealed until just prior to injection. Lanreotide in the sealed pouch, left at room temperature (not to exceed 40degreesC) for up to 72 hours, may be returned to the refrigerator for continued storage and later use.

The drug should be inspected visually for particulate matter and discoloration prior to administration. The solution should be gel-like, and white to pale yellow in color, but may have small air bubbles; the drug should be discarded if the solution contains visible particles or is discolored.

Subcutaneous injection of lanreotide acetate should be administered slowly for 20 seconds into the superior external quadrant of the buttock; injection sites should be alternated every 4 weeks between the right and left buttock. Injections should not be made into moles, scars, or areas where the skin is red or hard. The needle should be inserted rapidly to its full length at an angle perpendicular to the skin; the skin should not be pinched prior to administration.

Lanreotide acetate prefilled syringes are intended for single-use only and should be discarded after use.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of hypersensitivity to lanreotide; angioedema and anaphylaxis have been reported following administration.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in >5% of patients receiving lanreotide for acromegaly include diarrhea, abdominal pain, nausea, and injection site reactions.

Adverse effects reported in >10% of patients receiving lanreotide for GEP-NET include abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.

Adverse effects reported in >=5% of patients and at least 5% greater than placebo in those receiving lanreotide for carcinoid syndrome include headache, dizziness, and muscle spasm.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy not established in children.

There are no adequate and well-controlled studies using lanreotide in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

In animal studies, embryofetal toxicity (decreased embryofetal survival, fetal skeletal/soft tissue abnormalities) was observed in rats and rabbits receiving lanreotide in dosages resulting in exposures 5- and 2- times the systemic exposures, respectively, achieved in humans at the maximum recommended human dose.

It is not known whether lanreotide is distributed into human milk, affects milk production, or has any effects on breast-fed infants.

Because of the potential for serious adverse reactions (e.g., glucose metabolism, bradycardia) to lanreotide in breast-fed infants, women should be advised not to breast-feed while receiving the drug and for 6 months after the last dose.

Dosage in geriatric patients should be selected with caution (usually at the low end of the dosage range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Although no overall differences in safety or efficacy were observed between geriatric and younger patients with acromegaly receiving lanreotide, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.

There were an insufficient number of patients >=65 years of age with neuroendocrine tumors to determine whether they respond differently from younger patients.