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Manufacturer Warnings

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FDA Labeling Changes

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1.1 Acromegaly

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.

1.2 Gastroenteropancreatic neuroendocrine tumors

SOMATULINE DEPOT Injection 120 mg is indicated for the treatment of patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival [see Clinical Studies (14.2)].


There is currently no drug history available for this drug.

Other Information

SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment).

SOMATULINE DEPOT is available as sterile, ready-to-use, single-use prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base.

Each syringe contains: SOMATULINE DEPOT
60 mg/0.2 mL
90 mg/0.3 mL
120 mg/0.5 mL
Lanreotide acetate 77.9 mg 113.6 mg 149.4 mg
Acetic Acid q.s. q.s. q.s.
Water for injection 186. 6 mg 272. 3 mg 357.8 mg
Total Weight 266 mg 388 mg 510 mg

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:

Chemical Structure

For appearance of the formulation, see Dosage Forms and Strengths (3).

Pancrezyme Manufacturers

  • Virbac Ah, Inc.
    Pancrezyme Tablet [Virbac Ah, Inc.]
  • Virbac Ah, Inc.
    Pancrezyme Powder [Virbac Ah, Inc.]

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