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SIGNIFOR LAR
Pituitary disorders
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Drug Name:

SIGNIFOR LAR Rx

Generic Name and Formulations:
Pasireotide pamoate 20mg, 40mg, 60mg; pwd for IM inj after reconstitution.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

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:

Initially 40mg by IM inj every 4 weeks into the right or left gluteus; 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:

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 (including 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. Pregnancy (Cat.C). Nursing mothers: not recommended.

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.

Pharmacological Class:

Cyclohexapeptide somatostatin analog.

Adverse Reactions:

Diarrhea, nausea, hyperglycemia, diabetes, cholelithiasis, headache, abdominal pain, fatigue; bradycardia, QT prolongation, pituitary hormone deficiency.

Generic Availability:

NO

How Supplied:

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

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