SIGNIFOR LAR Suspension for injection (2020)
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Περιεχόμενα
Name of the medicinal product
SIGNIFOR LAR Pasireotide for Injectable Suspension. 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg pasireotide (as pasireotide pamoate) per vial.
Summary product information
Route of Administration Dosage Form/Strength Clinically Relevant Nonmedicinal Ingredients Intramuscular (i.m.) Each vial contains:<br>SIGNIFOR LAR 10 mg 10 mg pasireotide (as pamoate)<br>SIGNIFOR LAR ...
Indications and clinical use
SIGNIFOR LAR (pasireotide) is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative. SIGNIFOR LAR (pasireotide) is indicated for the treatment ...
Contraindications
SIGNIFOR LAR is contraindicated in: Patients with moderate or severe hepatic impairment (Child Pugh B or C). Patients with uncontrolled diabetes (≥8% HbA1c while receiving anti-diabetic therapy). Patients ...
Warnings and precautions
Cardiovascular <u>Bradycardia and PR Interval Prolongation:</u> Pasireotide causes a decrease in heart rate and PR interval prolongation (see ACTION AND CLINICAL PHARMACOLOGY – Cardiac Electrophysiology). ...
Adverse reactions
Adverse Drug Reaction Overview The safety profile of SIGNIFOR LAR is largely similar between the acromegaly and Cushings disease indications. Acromegaly A total of 446 acromegaly patients received SIGNIFOR ...
Drug interactions
Overview Caution is required when co-administering SIGNIFOR LAR with drugs that are known to have hepatotoxic potential, or with anti-arrhythmic medicines and other drugs that may prolong the QT interval ...
Dosage and administration
Recommended Dose and Dosage Adjustment Acromegaly The recommended initial dose of SIGNIFOR LAR for the treatment of acromegaly is 40 mg administered by deep intramuscular injection every 4 weeks (q28d). ...
Overdosage
In the event of overdosage, it is recommended that appropriate supportive treatment be initiated, as dictated by the patients clinical status, until resolution of the symptoms. Electrocardiogram monitoring ...
Action and clinical pharmacology
Mechanism of Action Pasireotide is a second generation cyclohexapeptide, injectable somatostatin analogue. Like the natural peptide hormones somatostatin-14 and somatostatin-28 [also known as somatotropin ...
Storage and stability
Store at 2 to 8°C. Do not freeze. Prior to reconstitution, the injection kit should be removed from the fridge and equilibrated to room temperature for a minimum of 30 minutes and maximum of 24 hours. ...
Special handling instructions
SIGNIFOR LAR powder for suspension for injection is supplied in a 6 mL brownish glass vial, consisting of drug loaded poly (D,L-lactide-co-glycolide) microparticles to be suspended in an aqueous vehicle ...
Dosage forms, composition and packaging
SIGNIFOR LAR is a long-acting depot injection form of pasireotide, powder for suspension for injection to be suspended in a solvent immediately prior to intramuscular (i.m.) injection. Powder: Slightly ...
Pharmaceutical information
Drug Substance Proper name: Pasireotide pamoate Chemical name: (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-phenyloctadecahydro3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ...
Detailed pharmacology
Nonclinical Pharmacology In vitro pharmacology Pasireotide is a somatostatin analogue with high binding affinity and high functional activity for somatostatin receptor subtypes sst1, 2, 3 and sst5. In ...
Clinical trials
Acromegaly Study Demographics and Trial Design <b>Table 7. Summary of Patient Demographics for Clinical Trials in Patients With Acromegaly:</b> Study # Trial design Dosage, route of administration and ...
Toxicology
Safety pharmacology The cardiovascular safety of pasireotide was evaluated using in vitro methods (hERG assay, Purkinje fiber assay, effect of pasireotide on potassium channel currents, effect of pasireotide ...
Marketing authorization holder
Recordati Rare Diseases Canada Inc., Toronto, Ontario, Canada, M4N 3N1
Submission control number
237292
Date of approval
February 10, 2015
Date of revision
May 19, 2020
References
Chanson P, Salenave S, Kamenicky P, et al (2009) Acromegaly. Best Practice & Research Clinical Endocrinology & Metabolism; 555-574. Dekkers O M, Biermasz N R, Pereira A M, et al (2008) Mortality in Acromegaly: ...
Serious warnings and precautions box
RISK OF HEPATOTOXICITY Elevations in liver aminotransferases are commonly observed with pasireotide (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS). Cases that met the biochemical ...
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