Signifor Lar Recall
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
SIGNIFOR LAR is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
There is currently no drug history available for this drug.
SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR is a somatostatin analog. Pasireotide pamoate, chemically known as (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester pamoic acid salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.
The molecular formula of pasireotide pamoate is C58H66N10O9 • C23H16O6 and the molecular weight is 1435.58.
The structural formula is:
The drug product consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D,L-lactide-co-glycolide) acids (PLGA).
SIGNIFOR LAR is available in a vial containing the sterile pasireotide pamoate, PLGA microspheres powder, 20 mg, 40 mg and 60 mg to be reconstituted with the provided 2 mL sterile diluent. The product should be prepared immediately prior to use for intramuscular injection given once every 4 weeks.
Each vial contains:
|20 mg||40 mg||60 mg|
|Pasireotide pamoate||27.42 mg*||54.84 mg*||82.26 mg*|
|Poly(D,L-lactide-co-glycolide) [50-60:40-50]||26.29 mg||52.58 mg||78.87 mg|
|Poly(D,L-lactide-co-glycolide) [50:50]||26.29 mg||52.58 mg||78.87 mg|
Each diluent prefilled syringe contains:
|Carboxymethylcellulose sodium||14 mg|
|Poloxamer 188||4 mg|
|Water for injections||add to 2 mL|