Signifor Lar

Signifor Lar

Signifor Lar Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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.

Uses

1.1     Acromegaly

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.

History

There is currently no drug history available for this drug.

Other Information

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:

structural formula

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:

*
Corresponds to 20 mg, 40 mg and 60 mg of pasireotide base, respectively.
20 mg40 mg60 mg
Pasireotide pamoate27.42 mg*54.84 mg*82.26 mg*
Poly(D,L-lactide-co-glycolide) [50-60:40-50]26.29 mg52.58 mg78.87 mg
Poly(D,L-lactide-co-glycolide) [50:50]26.29 mg52.58 mg78.87 mg

Each diluent prefilled syringe contains:

Mannitol90 mg
Carboxymethylcellulose sodium14 mg
Poloxamer 1884 mg
Water for injectionsadd to 2 mL

Signifor Lar Manufacturers


  • Novartis Pharmaceuticals Corporation
    Signifor Lar (Pasireotide) Kit [Novartis Pharmaceuticals Corporation]

Login To Your Free Account