Drugplain

SOMATULINE DEPOT 90 mg/.3mL

lanreotide acetate · INJECTION · Ipsen Biopharmaceuticals, Inc.

No Recall History
Plain English

SOMATULINE DEPOT is a injection containing lanreotide acetate at 90 mg/.3mL, taken subcutaneous. Manufactured by Ipsen Biopharmaceuticals, Inc..

Key Facts

Brand Name
SOMATULINE DEPOT
Generic Name
lanreotide acetate
NDC Code (Product)
15054-1090
Manufacturer
Ipsen Biopharmaceuticals, Inc.
Strength
90 mg/.3mL
Dosage Form
INJECTION
Route
SUBCUTANEOUS
Marketing Status
Application #
NDA022074
Marketing Start
11/14/2007

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use1,409 reports
diarrhoea1,382 reports
death1,163 reports
fatigue930 reports
nausea698 reports
injection site pain577 reports
abdominal pain550 reports
headache485 reports
malaise422 reports
dizziness402 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal. 1.2 Gastroenteropancreatic Neuroendocrine Tumors SOMATULINE DEPOT is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): For deep subcutaneous injection only. Intended for administration by a healthcare provider. Administer in the superior external quadrant of the buttock. Alternate injection sites. Recommended Dosage ( 2.1 ) Acromegaly: 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen. GEP-NETs: 120 mg every 4 weeks. Carcinoid Syndrome: 120 mg every 4 weeks. If patients are already being treated with SOMATULINE DEPOT for GEP-NET, do not administer an additional dose for carcinoid syndrome. Dosage Adjustment: See full prescribing information for dosage adjustment in patients with acromegaly and renal or hepatic impairment. ( 2.3 , 2.4 ) 2.1 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 inject…

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 )

Drug Interactions

7 DRUG INTERACTIONS 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 absorpti…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions to SOMATULINE DEPOT 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 adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions. ( 6.1 ) GEP-NET (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. ( 6.1 ) Carcinoid Syndrome : (≥5% and at least 5% greater than placebo): headache, dizziness and muscle spasm. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observ…

Frequently Asked Questions

What is SOMATULINE DEPOT used for?

SOMATULINE DEPOT contains lanreotide acetate. It is a injection taken subcutaneous. Consult your doctor for specific uses.

Is SOMATULINE DEPOT a controlled substance?

SOMATULINE DEPOT is not classified as a controlled substance by the DEA.

What is the generic name for SOMATULINE DEPOT?

The generic name for SOMATULINE DEPOT is lanreotide acetate. There are 9 other brand versions of lanreotide acetate.

What is the NDC code for SOMATULINE DEPOT 90 mg/.3mL?

The NDC (National Drug Code) for SOMATULINE DEPOT 90 mg/.3mL is 15054-1090, listed by Ipsen Biopharmaceuticals, Inc..

Product NDC

15054-1090

Package NDC

15054-1090-4

Other Lanreotide Brands

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