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Somatuline Depot

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Overview

What is Somatuline Depot?

Somatuline Depot (lanreotide) Injection 60, 90 and 120 mg is a prolonged-release formulation for deep subcutaneous injection containing the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, and water for injection.

Somatuline Depot is available as sterile, ready-to-use, pre-filled syringes containing lanreotide supersaturated bulk solution of 24.6% w/w lanreotide base.

Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is:

For appearance of the formulation, see



What does Somatuline Depot look like?



What are the available doses of Somatuline Depot?

Single use syringe: 60, 90 and 120 mg ()

What should I talk to my health care provider before I take Somatuline Depot?

How should I use Somatuline Depot?

Somatuline Depot (lanreotide) Injection 60 mg, 90 mg and 120 mg 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.

Patients should begin treatment with Somatuline Depot 90 mg given via the deep subcutaneous route, at 4 week intervals for 3 months.

After 3 months dosage may be adjusted as follows:

Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in serum GH and /or IGF-1 levels; and/or changes in symptoms of acromegaly.

Somatuline Depot should be injected via the deep subcutaneous route in the superior external quadrant of the buttock. The skin should not be folded and the needle should be inserted perpendicular to the skin, rapidly and to its full length. The injection site should alternate between the right and left side.

The starting dose in patients with moderate and severe renal or moderate and severe hepatic impairment should be 60 mg via the deep subcutaneous route, at 4 week intervals for 3 months followed by dose adjustment as described above [].


What interacts with Somatuline Depot?

Sorry No Records found


What are the warnings of Somatuline Depot?

Sorry No Records found


What are the precautions of Somatuline Depot?

Sorry No Records found


What are the side effects of Somatuline Depot?

Sorry No records found


What should I look out for while using Somatuline Depot?

None


What might happen if I take too much Somatuline Depot?

If overdose occurs, symptomatic management is indicated.

There are no confirmed postmarketing cases of overdose with lanreotide that were serious or led to an adverse reaction.

Up-to-date information about the treatment of overdose can often be obtained from the National Poison Control Center at phone number 1-800-222-1222.


How should I store and handle Somatuline Depot?

Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArraySomatuline Depot is supplied in strengths of 60 mg, 90 mg and 120 mg in a single, sterile, pre-filled, ready-to-use, polypropylene syringe fitted with a 20 mm needle covered by a dry natural rubber sheath. Each pre-filled syringe is sealed in a laminated pouch and packed in a carton.NDC 15054-060-01 60-mg, sterile, pre-filled syringeNDC 15054-090-01 90-mg, sterile, pre-filled syringeNDC 15054-120-02 120-mg, sterile,pre-filled syringeSomatuline Depot is supplied in strengths of 60 mg, 90 mg and 120 mg in a single, sterile, pre-filled, ready-to-use, polypropylene syringe fitted with a 20 mm needle covered by a dry natural rubber sheath. Each pre-filled syringe is sealed in a laminated pouch and packed in a carton.NDC 15054-060-01 60-mg, sterile, pre-filled syringeNDC 15054-090-01 90-mg, sterile, pre-filled syringeNDC 15054-120-02 120-mg, sterile,pre-filled syringeSomatuline Depot is supplied in strengths of 60 mg, 90 mg and 120 mg in a single, sterile, pre-filled, ready-to-use, polypropylene syringe fitted with a 20 mm needle covered by a dry natural rubber sheath. Each pre-filled syringe is sealed in a laminated pouch and packed in a carton.NDC 15054-060-01 60-mg, sterile, pre-filled syringeNDC 15054-090-01 90-mg, sterile, pre-filled syringeNDC 15054-120-02 120-mg, sterile,pre-filled syringeSomatuline Depot is supplied in strengths of 60 mg, 90 mg and 120 mg in a single, sterile, pre-filled, ready-to-use, polypropylene syringe fitted with a 20 mm needle covered by a dry natural rubber sheath. Each pre-filled syringe is sealed in a laminated pouch and packed in a carton.NDC 15054-060-01 60-mg, sterile, pre-filled syringeNDC 15054-090-01 90-mg, sterile, pre-filled syringeNDC 15054-120-02 120-mg, sterile,pre-filled syringe


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Lanreotide, the active component of Somatuline Depot is an octapeptide analog of natural somatostatin. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin.

Non-Clinical Toxicology
None

The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal absorption of concomitant drugs.

Lanreotide may decrease the relative bioavailability of cyclosporine. Concomitant administration of Somatuline Depot and cyclosporine may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels [].

Lanreotide may reduce gallbladder motility and lead to gallstone formation therefore, patients may need to be monitored periodically [].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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