Gadofosveset trisodium

What is Gadofosveset trisodium?

• Gadofosveset trisodium (Vasovist, Ablavar) is a gadolinium-based contrast agent used as a contrast agent in magnetic resonance angiography (MRA).

Gadofosveset skeletal

What are the uses of this medicine?

• Gadofosveset trisodium (Vasovist, Ablavar) used as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

How does this medicine work?

• Following intravenous injection, gadofosveset binds reversibly to endogenous serum albumin resulting in longer vascular residence time than non-protein binding contrast agents.
• The binding to serum albumin also increases the magnetic resonance relaxivity of gadofosveset and decreases the relaxation time (T1)
• of water protons resulting in an increase in signal intensity (brightness) of blood.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• History of a prior allergic reaction to a gadolinium-based contrast agent.

What drug interactions can this medicine cause?

• No drug interaction reactions were observed in clinical trials.
• Consider the possibility of Vasovist, Ablavar interaction with concomitantly administered medications that bind to albumin.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• Administer C Injection by an intravenous bolus, manually or by power injection, at a dose of 0.12 mL/kg body weight (0.03 mmol/kg) over a period of time up to 30 seconds followed by a 25-30 mL normal saline flush.

• Imaging is performed in two stages, the dynamic stage which begins immediately following Vasovist, Ablavar Injection and the steady-state stage, which begins following dynamic imaging; generally 5 to 7 minutes after Vasovist, Ablavar Injection.

Administration:

• Administer Vasovist, Ablavar Injection by an intravenous bolus, manually or by power injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• VASOVIST Injection contains 244 mg gadofosveset trisodium (equivalent to 0.25 mmol/mL) and is available in single-use vials.
• ABLAVAR Injection contains 244 mg gadofosveset trisodium (equivalent to 0.25 mmol/mL) and is available in single-use vials.

This medicine is available in fallowing brand namesː

• Vasovist, Ablavar

What side effects can this medication cause?

The most common side effects of this medicine include:

• pruritis
• headache
• nausea
• vasodilatation
• paresthesia

What special precautions should I follow?

• Nephrogenic Systemic Fibrosis may result from administration of gadolinium-based contrast agents to certain patients. Higher than recommended dosing or repeated dosing appears to increase the risk.
• Hypersensitivity reactions, including anaphylactoid and/or anaphylactic reactions may result from Vasovist, Ablavar administration. Assess patients for a history of allergic reactions to gadolinium-based contrast agents and monitor patients closely for need of emergency cardiorespiratory support.
• Gadolinium-based contrast agents, including Vasovist, Ablavar may increase the risk for acute renal failure in patients with a history of renal insufficiency.
• QTc prolongation has been reported following Vasovist, Ablavar administration. Assess patients for a history of underlying conditions that may predispose to arrhythmias due to QTc prolongation.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No Vasovist, Ablavar overdoses were reported in clinical trials.

Management of overdosage:

• In the event of an overdose, direct treatment toward the support of all vital functions and prompt institution of symptomatic therapy.
• Gadofosveset has been shown to be removed by hemodialysis using a high flux dialysis procedure.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Vasovist, Ablavar in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Vasovist, Ablavar in patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• gadofosveset trisodium

Inactive ingredients:

• fosveset
• water

Who manufactures and distributes this medicine?

Vasovist:

• Distributed by Bayer Healthcare, Inc., Wayne, NJ
• Co-Developed by EPIX Pharmaceuticals, Inc., Lexington, MA

Ablavar:

• Distributed by Lantheus Medical Imaging, Inc., 331 Treble Cove Road, North Billerica, MA , United States

What should I know about storage and disposal of this medication?

• Store Vasovist, Ablavar Injection at 25°C (77°F: excursions permitted to 15 to 30°C [59 to 86°F]).
• Protect from light and freezing.

• Dailymed label info on Gadofosveset trisodium
• FDA Gadofosveset trisodium

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