Generic Name and Formulations:
Pasireotide diaspartate 0.3mg/mL, 0.6mg/mL, 0.9mg/mL; soln for SC inj.
Novartis Pharmaceuticals Corp
Indications for SIGNIFOR:
Treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
Give by SC inj into thigh or abdomen; rotate inj sites. Avoid inflamed or irritated skin. Initially 0.6mg or 0.9mg twice daily; usual range: 0.3mg–0.9mg twice daily. Titrate based on response and tolerability. Hepatic impairment: moderate (Child-Pugh B): initially 0.3mg twice daily; max 0.6mg twice daily; severe (Child-Pugh C): avoid.
<18yrs: not established.
Monitor for hypocortisolism; consider temporary dose reduction, interruption or steroid replacement therapy if occurs. Risk of hyperglycemia; initiate or adjust antidiabetic treatment if occurs; reduce dose or discontinue if remains uncontrolled. Monitor HbA1c or FPG prior to initiation, every week for the first 2–3 months, for 2–4 weeks after dose increase, and thereafter as indicated. Congenital long QT prolongation. Cardiac disease (eg, recent MI, CHF, unstable angina, significant bradycardia). High-grade heart block. Hypokalemia and/or hypomagnesemia; correct and monitor electrolytes prior to starting and during therapy. Monitor liver tests prior to initiation, 1–2 weeks after, monthly for 3 months, then every 6 months thereafter; measure liver enzymes weekly or more frequently as indicated. Transsphenoidal surgery. Pituitary irradiation. Monitor baseline ECG, gallbladder ultrasound, pituitary function prior to initiation and periodically during treatment. Premenopausal women: potential for unintended pregnancy due to improved fertility. Pregnancy. Nursing mothers.
Cyclohexapeptide somatostatin analog.
Caution with antiarrhythmics or other drugs that may prolong the QT interval. May antagonize cyclosporine (adjust dose). May potentiate bromocriptine; dose reduction may be needed.
Diarrhea, nausea, hyperglycemia, diabetes, cholelithiasis, headache, abdominal pain, fatigue; bradycardia, QT prolongation, pituitary hormone deficiency.