Vasovist Side Effects
Generic Name: gadofosveset trisodium
Please note - some side effects for Vasovist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Vasovist Side Effects - for the Professional
Vasovist
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
Anaphylaxis and anaphylactoid reactions were the most common serious reactions observed following Vasovist injection administration [see Warnings and Precautions (5.2)].
In all clinical trials evaluating Vasovist with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses Vasovist. The mean age of the 1379 patients who received Vasovist was 63 years (range 18 to 91 years); 66% (903) were men and 34% (476) were women. In this population, there were 80% (1100) Caucasian, 8% (107) Black, 12% (159) Hispanic, 1% (7) Asian, and < 1% (6) patients of other racial or ethnic groups. Table 2 shows the most common adverse reactions (≥1%) experienced by subjects receiving Vasovist at a dose of 0.03 mmol/kg.
| Preferred Term | n (%) |
|---|---|
| Pruritis | 42 (5) |
| Headache | 33 (4) |
| Nausea | 33 (4) |
| Vasodilatation | 26 (3) |
| Paresthesia | 25 (3) |
| Injection site bruising | 19 (2) |
| Dysgeusia | 18 (2) |
| Burning sensation | 17 (2) |
| Venipuncture site bruise | 17 (2) |
| Hypertension | 11 (1) |
| Dizziness (excluding vertigo) | 8 (1) |
| Feeling cold | 7 (1) |
Post-marketing Experience
Because post-marketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The profile of adverse reactions identified during the post-marketing experience outside the United States was similar to that observed during the clinical studies experience.
TopSide Effects by Body System - for Healthcare Professionals
Hypersensitivity
Hypersensitivity side effects have included anaphylaxis and anaphylactoid reactions.
Dermatologic
Dermatologic side effects have included pruritus.
Local
Local side effects have included injection site bruising, burning sensation, and venipuncture site bruise.
Nervous system
Nervous system side effects have included headache, paresthesia, and dizziness (excluding vertigo).
Cardiovascular
Cardiovascular side effects have included vasodilatation and hypertension.
Gastrointestinal
Gastrointestinal side effects have included nausea and dysgeusia.
General
General side effects have included feeling cold.
TopMore Vasovist resources
- Vasovist Prescribing Information (FDA)
- Vasovist Consumer Overview
- Gadofosveset Trisodium Professional Patient Advice (Wolters Kluwer)
- Ablavar Advanced Consumer (Micromedex) - Includes Dosage Information
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