Who manufactures Somatuline Depot?
Somatuline Depot FDA Approval History Company: Ipsen Biopharmaceuticals, Inc.
What is Somatuline Depot used for?
This medication is a long-acting form of lanreotide. Lanreotide is used to treat a condition called acromegaly that occurs when the body makes too much of a certain natural substance called growth hormone. It is used when surgery or radiation treatment have not been fully successful or cannot be used.
Is lanreotide FDA approved?
The US Food and Drug Administration (FDA) approved lanreotide (Somatuline Depot Injection, Ipsen) on Tuesday for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
How is somatuline administered?
SOMATULINE 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.
Is Somatuline Depot a chemo drug?
Lanreotide (Somatuline Depot Injection) Chemotherapy Drug Information.
Does octreotide shrink tumors?
Octreotide is helpful in treating the symptoms of carcinoid syndrome. Sometimes octreotide can temporarily shrink carcinoid tumors, but it does not cure them. The original version of octreotide (Sandostatin®) is injected under the skin (subcutaneously) at least twice daily.
Is Somatuline chemo?
How long can you take Somatuline?
The treatment with Somatuline Autogel should be continued for as long as needed for tumour control. The recommended starting dose is 60 to 120 mg administered every 28 days.
What is the difference between lanreotide and octreotide?
There are slight differences in FDA approval: octreotide (Sandostatin) is approved for symptoms of carcinoid/VIPoma syndrome and Lanreotide (Somatuline) is approved for tumor control.
What kind of drug is lanreotide?
Lanreotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of certain natural substances produced by the body.
Is somatuline chemo?
When was Somatuline Depot first approved by the FDA?
Somatuline Depot Approval History. FDA Approved: Yes (First approved August 30, 2007) Brand name: Somatuline Depot. Generic name: lanreotide acetate. Dosage form: Injection. Company: Ipsen Biopharmaceuticals, Inc. Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome.
How to report suspected adverse reactions to Somatuline injection?
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. What is SOMATULINE®DEPOT (lanreotide) Injection?
Can You breastfeed if you take Somatuline Depot?
It is not known if SOMATULINE DEPOT will harm your unborn baby or pass into breast milk. You should not breastfeed if you receive SOMATULINE DEPOT and for 6 months after your last dose. SOMATULINE DEPOT may affect your ability to become pregnant.
When to use Somatuline Depot ( lanreotide ) injection?
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.
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