Pancrezyme
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Questions & Answers
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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.
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 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:
For appearance of the formulation, see Dosage Forms and Strengths (3).
Sources
Pancrezyme Manufacturers
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Virbac Ah, Inc.
![Pancrezyme Tablet [Virbac Ah, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pancrezyme | Ipsen Biopharmaceuticals, Inc.
Somatuline Depot should be administered by healthcare professionals. Please see enclosed Instructions for Use Leaflet for administration of Somatuline Depot. 2.1 AcromegalyPatients 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:
GH greater than 1ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain SOMATULINE DEPOT dose at 90 mg every 4 weeks GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase SOMATULINE DEPOT dose to 120 mg every 4 weeks. GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce SOMATULINE DEPOT dose to 60 mg every 4 weeks.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.
Patients who are controlled on SOMATULINE DEPOT 60 mg or 90 mg may be considered for an extended dosing interval of SOMATULINE DEPOT 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response.
Continued monitoring of patient response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.
The starting dose in patients with moderate or severe renal impairment or moderate or 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 [see Clinical Pharmacology (12.3)].
2.2 Gastroenteropancreatic Neuroendocrine TumorsThe recommended dose of SOMATULINE DEPOT is 120 mg administered every 4 weeks by deep subcutaneous injection. There is no recommended dose adjustment for mild or moderate renal impairment. There is insufficient information to recommend a dose for patients with severe renal impairment or with hepatic impairment of any severity [see Clinical Pharmacology (12.3)].
2.3 AdministrationSOMATULINE DEPOT is provided in a single-dose, prefilled syringe affixed with an automatic needle protection system. Inject SOMATULINE DEPOT via the deep subcutaneous route in the superior external quadrant of the buttock. Alternate the injection site between the right and left sides from one injection to the next. Remove SOMATULINE DEPOT from the refrigerator 30 minutes prior to administration. Keep pouch sealed until just prior to injection.
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Virbac Ah, Inc.
Pancrezyme | Virbac Ah, Inc.
SUGGESTED DOSAGE: DOGS. 3/4-1 teaspoonful for adult dogs with
each meal. CATS. 1/4-3/4 teaspoonful for adult cats with each meal. Mix
well with moistened food (canned or dry) and let stand at room
temperature for 15-20 minutes before feeding. Frequent feeding, at
least 3 times daily is important. See accompanying directions for
complete and detailed information.LOT NO.:
EXP. DATE:
![Pancrezyme Powder [Virbac Ah, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c7e7770d-7fc6-43c5-a67a-a1ff1f449c01&name=PancrezymePowder.jpg)
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