Signifor Generic Name & Formulations
Pasireotide diaspartate 0.3mg/mL, 0.6mg/mL, 0.9mg/mL; soln for SC inj.
Cyclohexapeptide somatostatin analog.
Treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
Signifor Dosage and Administration
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.
Signifor Boxed Warnings
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. Discontinue and treat if cholelithiasis complications are suspected. 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.
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.
Signifor Adverse Reactions
Diarrhea, nausea, hyperglycemia, cholelithiasis, headache, abdominal pain, fatigue, diabetes, inj site reactions; bradycardia, QT prolongation, pituitary hormone deficiency.
Signifor Clinical Trials
Signifor Patient Counseling