Pituitary disorders:

Indications for SIGNIFOR LAR:

Treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Adult:

Give by IM inj into the right or left gluteus. Initially 40mg every 4 weeks (28 days); may increase dose to max 60mg after 3 months if GH and/or IGF-1 levels not normalized. If over-response to treatment, may decrease in 20mg decrements. Hepatic impairment: moderate (Child-Pugh B): initially 20mg every 4 weeks; max: 40mg every 4 weeks; severe (Child-Pugh C): avoid.

Children:

<18yrs: not established.

Warnings/Precautions:

Monitor for adrenal insufficiency; give steroid replacement therapy if confirmed. Risk of hyperglycemia; initiate or adjust antidiabetic treatment if occurs; reduce dose or discontinue if remains uncontrolled. Monitor HbA1c and FPG prior to initiation, weekly for first 3 months, 4–6 weeks after dose increase, and thereafter as indicated. Congenital long QT prolongation. Cardiac disease (eg, recent MI, CHF, unstable angina, significant bradycardia); monitor QT interval at 21 days. High-grade heart block. Hypokalemia and/or hypomagnesemia; correct and monitor electrolytes prior to starting and during therapy. Monitor liver tests prior to initiation, 2–3 weeks after, then monthly for 3 months, then as indicated. Discontinue if significant hepatic impairment develops. Monitor baseline ECG, pituitary function prior to initiation and periodically during treatment. Discontinue and treat if cholelithiasis complications are suspected. Renal impairment: not studied. Premenopausal women: potential for unintended pregnancy due to improved fertility. Pregnancy. Nursing mothers.

Pharmacologic Class:

Cyclohexapeptide somatostatin analog.

Interactions:

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.

Adverse Reactions:

Diarrhea, hyperglycemia, diabetes, cholelithiasis (monitor); bradycardia, QT prolongation, pituitary hormone deficiency.

Generic Availability:

NO

How Supplied:

Single-use kit—1 (w. diluents, supplies)