Multihance

— THERAPEUTIC CATEGORIES —
  • Imaging agents

Multihance Generic Name & Formulations

General Description

Gadobenate dimeglumine 529mg/mL; soln for IV inj; preservative-free.

Pharmacological Class

Gadolinium-based contrast agent.

How Supplied

Single dose vials (5mL, 10mL, 15mL, 20mL)—5

Storage

Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).

Do not freeze.

Manufacturer

Generic Availability

NO

Mechanism of Action

Gadobenate dimeglumine is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The large magnetic moment produced by the paramagnetic agent results in a large local magnetic field, which can enhance the relaxation rates of water protons in its vicinity leading to an increase of signal intensity (brightness) of tissue.

Multihance Indications

Indications

For use in MRI of the CNS in adults and children to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues. For use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.

Multihance Dosage and Administration

Adults and Children

MRI: Preterm neonates: not established. Give as a rapid IV bolus inj, followed by a saline flush of ≥5mL to ensure complete injection. <2yrs: 0.1–0.2mL/kg. ≥2yrs: 0.2mL/kg (0.1mmol/kg). MRA: <18yrs: not established. ≥18yrs: 0.2mL/kg (0.1mmol/kg) by rapid IV bolus inj, followed by a saline flush of ≥20mL either manually or using an automatic injector system.

Multihance Contraindications

Not Applicable

Multihance Boxed Warnings

Boxed Warning

Risk associated with intrathecal use. Nephrogenic systemic fibrosis.

Multihance Warnings/Precautions

Warnings/Precautions

Not approved for intrathecal use. Increased risk of nephrogenic systemic fibrosis in chronic kidney disease or acute kidney injury; avoid use. 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 for 2hrs after administration. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Underlying conditions or medications that predispose to cardiac arrhythmias. Dubin Johnson syndrome. Avoid extravasation. Interpreting contrast MR images in the absence of companion non-contrast MR images. Elderly. Pregnancy. Nursing mothers.

Multihance Pharmacokinetics

Distribution

Volume of distribution (by area): ranged from 0.170 ± 0.016 to 0.282 ± 0.079 L/kg.

Elimination

Renal (78–96%), biliary, fecal. Half-life: 1.17±0.26 to 2.02±0.60 hours.

Multihance Interactions

Interactions

May potentiate concomitant drugs that compete for cMOAT sites (eg, cisplatin, anthracyclines, vinca alkaloids, methotrexate, etoposide, tamoxifen, paclitaxel).

Multihance Adverse Reactions

Adverse Reactions

Nausea, headache, inj site reaction, feeling hot; hypersensitivity.

Multihance Clinical Trials

See Literature

Multihance Note

Not Applicable

Multihance Patient Counseling

See Literature