#
Signifor LAR Injection
  • Professionals
  • FDA PI

Signifor LAR Injection

Generic name:pasireotide
Dosage form: injection
Drug class:Somatostatin and somatostatin analogs

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

INDICATIONS AND USAGE

Acromegaly

SIGNIFOR LAR is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Cushing's Disease

SIGNIFOR LAR is indicated for the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Signifor LAR Injection Dosage and Administration

Recommended Baseline Evaluations Prior to Initiation of SIGNIFOR LAR

Prior to the initiation of SIGNIFOR LAR, it is recommended that patients have the following baseline evaluations:

  • Fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) [see Warnings and Precautions (5.1)]
  • Liver tests [see Warnings and Precautions (5.3)]
  • Electrocardiogram (ECG), serum potassium and serum magnesium levels [see Warnings and Precautions (5.2)]

Patients with poorly controlled diabetes mellitus, who have inadequate glucose control, should have anti-diabetic therapy optimized prior to starting SIGNIFOR LAR [see Warnings and Precautions (5.1)].

Important Administration Instructions

SIGNIFOR LAR must be reconstituted by a trained healthcare professional immediately before use. Illustrations on reconstitution are found in Instructions for Use [see Dosage and Administration (2.6)].

SIGNIFOR LAR must be inspected visually before use. The suspension should appear free of foreign particulates and should be homogeneous after mixing.

SIGNIFOR LAR must be administered by a trained healthcare professional only by intramuscular injection in the right or left gluteus immediately after reconstitution....