Gadofosveset trisodium
What is Gadofosveset trisodium?[edit | edit source]
- Gadofosveset trisodium (Vasovist, Ablavar) is a gadolinium-based contrast agent used as a contrast agent in magnetic resonance angiography (MRA).
What are the uses of this medicine?[edit | edit source]
- 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?[edit | edit source]
- 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 ?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- Initial U.S. Approval: 2008
How should this medicine be used?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
The most common side effects of this medicine include:
What special precautions should I follow?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- There are no adequate and well-controlled studies of Vasovist, Ablavar in pregnant women.
Can this medicine be used in children?[edit | edit source]
- 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?[edit | edit source]
Active ingredient:
- gadofosveset trisodium
Inactive ingredients:
- fosveset
- water
Who manufactures and distributes this medicine?[edit | edit source]
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?[edit | edit source]
- 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.
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