Signifor LAR

Signifor LAR

pasireotide

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Pasireotide
Indications/Uses
Acromegaly in adult patients for whom surgery is not an option or has not been curative & who are inadequately controlled on treatment w/ another somatostatin analogue. Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed.
Dosage/Direction for Use
IM Acromegaly Initially 40 mg every 4 wk, may be increased to a max of 60 mg, or decreased if required. Moderate hepatic impairment (Child Pugh B) Initially 20 mg every 4 wk. Max: 40 mg every 4 wk. Cushing's disease Initially 10 mg by deep IM inj every 4 wk. Max: 40 mg every 4 wk. Moderate hepatic impairment (Child Pugh B) Initially 10 mg every 4 wk. Max: 20 mg every 4 wk.
Contraindications
Hypersensitivity. Severe hepatic impairment (Child Pugh C).
Special Precautions
Alterations in blood glucose levels. Assess glycaemic status (fasting plasma glucose/HbA1c [FPG/HbA1c]) prior to starting treatment. Mild transient elevation in aminotransferases. Monitor liver function prior to treatment & after the 1st 2-3 wk, then mthly for 3 mth on treatment. Careful monitoring is recommended in patients w/ cardiac disease &/or risk factors for bradycardia; patients at significant risk of developing QT prolongation. Hypocortisolism. Ultrasonic exam of the gallbladder before & at 6-12 mth intervals during treatment is recommended. Consider monitoring of pituitary function before & periodically during therapy. Patients w/ significantly increased prothrombin time & partial thromboplastin time (PTT) values or patients receiving coumarin-derivative or heparin-derivative anticoagulants. Minor influence on the ability to drive & use machines. Severe renal impairment or end stage renal disease. Female patients of childbearing potential should use adequate contraception if necessary during treatment. Pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Hyperglycaemia, DM; diarrhoea, nausea, abdominal pain; cholelithiasis; fatigue. Anaemia; adrenal insufficiency; type 2 DM, impaired glucose tolerance, decreased appetite; headache, dizziness; sinus bradycardia, QT prolongation; abdominal distension, vomiting; cholecystitis, cholestasis; alopecia, pruritus; inj site reaction; increased glycosylated Hb, ALT, AST, γ-glutamyltransferase, blood glucose, blood creatine phosphokinase, & lipase.
Drug Interactions
Decreased relative bioavailability of ciclosporin. Use w/ caution when co-administered w/ medicinal products known to prolong QT interval eg, class Ia antiarrhythmics (eg, quinidine, procainamide, disopyramide), class III antiarrhythmics (eg, amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (IV erythromycin, pentamidine inj, clarithromycin, moxifloxacin), certain antipsychotics (eg, chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (eg, terfenadine, astemizole, mizolastine), antimalarials (eg, chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo). Clinical monitoring of heart rate is recommended when concomitantly receiving bradycardic medicinal products eg, β-blockers (eg, metoprolol, carteolol, propranolol, sotalol), acetylcholinesterase inhibitors (eg, rivastigmine, physostigmine), certain Ca channel blockers (eg, verapamil, diltiazem, bepridil), certain antiarrhythmics. Dose adjustments of insulin & antidiabetic medicinal products (eg, metformin, liraglutide, vildagliptin, nateglinide) may be required.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01CB05 - pasireotide ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.
Presentation/Packing
Form
Signifor LAR powd & solvent for susp for inj 20 mg
Packing/Price
(+ pre-filled syringe w/ solvent) 1's
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