OMNISCAN

OMNISCAN- gadodiamide injection
GE Healthcare Inc.

WARNING: NOT FOR INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

NOT FOR INTRATHECAL USE:

Inadvertent intrathecal use of OMNISCAN has caused convulsions, coma, sensory and motor neurologic deficits [ see Warnings and Precautions (5.1)].

NSF:

  • Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • Do not administer OMNISCAN to patients with:
    • chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
    • acute kidney injury [ see Contraindications (4)].
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • Do not exceed the recommended OMNISCAN dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration [ see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

1.1 CNS (Central Nervous System)

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1)].

1.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 CNS (Central Nervous System)

Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

Pediatric Patients (2-16 years): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [see Dosage and Administration (2.3)].

2.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [see Dosage and Administration (2.3)].

2.3 Dosage Chart

BODY WEIGHT PEDIATRIC ADULTS
0.05 0.1 0.05 0.1
kg lb (mmol/kg) (mmol/kg)
VOLUME (mL) VOLUME (mL)
*
The heaviest patient in clinical studies weighed 136 kg.
12 26 1.2 2.4 - -
14 31 1.4 2.8 - -
16 35 1.6 3.2 - -
18 40 1.8 3.6 - -
20 44 2 4 - -
22 48 2.2 4.4 - -
24 53 2.4 4.8 - -
26 57 2.6 5.2 - -
28 62 2.8 5.6 - -
30 66 3 6 - -
40 88 4 8 4 8
50 110 5 10 5 10
60 132 6 12 6 12
70 154 7 14 7 14
80 176 8 16 8 16
90 198 - - 9 18
100 220 - - 10 20
110 242 - - 11 22
120 264 - - 12 24
130* 286 - - 13 26

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