OMNISCAN Dosage & Rx Info | Uses, Side Effects

Omniscan Generic Name & Formulations

Legal Class

General Description

Gadodiamide 287mg/mL; soln for IV inj; preservative-free.

Pharmacological Class

Gadolinium-based contrast agent.

How Supplied

Vials (10mL, 15mL, 20mL)—10

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Manufacturer

GE Healthcare

Generic Availability

Mechanism of Action

Omniscan is a paramagnetic agent with unpaired electron spins which generate a local magnetic field. As water protons move through this local magnetic field, the changes in magnetic field experienced by the protons reorient them with the main magnetic field more quickly than in the absence of a paramagnetic agent. By increasing the relaxation rate, Omniscan decreases both the T₁ and T₂ relaxation times in tissues where it is distributed. At clinical doses, the effect is primarily on the T₁relaxation time, and produces an increase in signal intensity.

Omniscan Indications

Indications

For 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. For use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.

Omniscan Dosage and Administration

Adults and Children

<2yrs: not established. Give as a bolus IV inj, followed by 5mL normal saline flush to ensure complete injection. ≥2yrs: CNS: 0.2mL/kg (0.1mmol/kg). Kidney: 0.1mL/kg (0.05mmol/kg). Intrathoracic (noncardiac), intra-abdominal, pelvic cavities: 0.2mL/kg (0.1mmol/kg).

Omniscan Contraindications

Contraindications

Chronic, severe kidney disease (GFR <30mL/min/1.73m²). Acute kidney injury.

Omniscan Boxed Warnings

Boxed Warning

Risk associated with intrathecal use. Nephrogenic systemic fibrosis.

Omniscan Warnings/Precautions

Warnings/Precautions

Not approved for intrathecal use. Increased risk of nephrogenic systemic fibrosis in chronic kidney disease or acute kidney injury (see Contraindications). Screen for renal dysfunction. Do not exceed recommended dose and allow sufficient time for drug elimination before re-administration. Have emergency resuscitative equipment available. History of asthma or other allergic disorders. Monitor for hypersensitivity reactions during and up to several hrs after administration. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Renal impairment: use lowest effective dose. Avoid extravasation. Interpreting Omniscan MRI scans without a companion non-contrast MRI. Elderly. Pregnancy. Nursing mothers.

Omniscan Pharmacokinetics

Distribution

Volume of distribution: 200 ± 61 mL/kg.

Elimination

Renal. Half-life: 77.8 ± 16 minutes.

Omniscan Interactions

Interactions

Interferes with serum calcium measurements with some colorimetric methods.

Omniscan Adverse Reactions

Adverse Reactions

Nausea, headache, dizziness; cardiac failure, arrhythmia, MI, hypersensitivity reactions.

Omniscan Clinical Trials

See Literature

Omniscan Note

Not Applicable

Omniscan Patient Counseling