Pancrezyme

Pancrezyme

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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)].

History

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
SOMATULINE DEPOT
90 mg/0.3 mL
SOMATULINE DEPOT
120 mg/0.5 mL
Lanreotide acetate77.9 mg113.6 mg149.4 mg
Acetic Acidq.s.q.s.q.s.
Water for injection186. 6 mg272. 3 mg357.8 mg
Total Weight266 mg388 mg510 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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