Signifor

Signifor

pasireotide

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pasireotide
Indications/Uses
Patients w/ Cushing's disease for whom medical therapy is appropriate.
Dosage/Direction for Use
Adult Initially 0.6 mg SC bid. Dose reduction by decrements of 0.3 mg bid.
Contraindications
Hypersensitivity. Severe hepatic impairment (Child Pugh C).
Special Precautions
Severe hepatic impairment. Assess glycemic status prior to initiation of therapy. Weekly self-monitoring of blood glucose for the 1st 2 or 3 mth & periodically thereafter. Discontinue if uncontrolled hyperglycemia persists. Cushing's disease patients w/ poor glycemic control. Monitor for signs & symptoms associated w/ hypocorticolism & liver function. History of clinically significant bradycardia or acute MI, high-grade heart block, CHF (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation. Patients w/ significant risk of developing QT prolongation. Correct hypokalemia or hypomagnesemia prior to & monitored periodically during therapy. Gallbladder ultrasonic exam prior to & 6- to 12-mth intervals during therapy. Monitor pituitary function prior to initiation & periodically during therapy. Elderly >65 yr. Childn <18 yr. Pregnancy & lactation.
Adverse Reactions
Hyperglycemia, DM; diarrhea, nausea, abdominal pain; cholelithiasis; inj site reaction, fatigue; increased glycosylated Hb.
Drug Interactions
Decrease relative bioavailability of cyclosporine. Antiarrhythmic & other drugs that prolong QT interval. Concomitant use w/ quinidine & terfenadine.
MIMS Class
Cancer Hormone Therapy
ATC Classification
H01CB05 - pasireotide ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.
Presentation/Packing
Form
Signifor soln for inj 0.6 mg/mL
Packing/Price
6 × 1's
Form
Signifor soln for inj 0.9 mg/mL
Packing/Price
6 × 1's
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