Vasovist Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Vasovist (gadofosveset trisodium) Injection is a contrast agent that produces magnetic effects. It is used in combination with magnetic resonance angiography (MRA) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRA. It is used to help diagnose certain disorders of the heart and blood vessels. Common side effects include itching; headache, dizziness; nausea, unusual or unpleasant taste in your mouth; warmth, redness, burning, or tingly feeling under your skin; cold feeling, warmth, pain, bruising, or burning where the injection was given; or numbness or tingling in your hands or feet.
Vasovist is administered as an intravenous bolus injection, 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. Vasovist may interact with other medicines harmful to the kidneys. Tell your doctor all medications and supplements you use. It is unknown if Vasovist will harm a fetus. Before you receive this medication, tell your doctor if you are pregnant. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Vasovist (gadofosveset trisodium) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Vasovist in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst, loss of appetite;
- swelling, weight gain, feeling short of breath; or
- fast, uneven heart rate.
Less serious side effects may include:
- headache, dizziness;
- flushing (warmth, redness, or tingly feeling);
- mild itching;
- numbness; or
- redness, cold feeling, warmth, pain, burning, or bruising where the medicine was injected.
Read the entire detailed patient monograph for Vasovist (Gadofosveset Trisodium Injection for Intravenous Use)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vasovist FDA Prescribing Information: Side Effects
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
In all clinical trials evaluating VASOVIST (gadofosveset trisodium injection for intravenous use) with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses VASOVIST (gadofosveset trisodium injection for intravenous use) . The mean age of the 1379 patients who received VASOVIST (gadofosveset trisodium injection for intravenous use) 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 (gadofosveset trisodium injection for intravenous use) at a dose of 0.03 mmol/kg.
Table 2 Common Adverse Reactions in 802 Subjects Receiving
VASOVIST (gadofosveset trisodium injection for intravenous use) at 0.03 mmol/kg
|Preferred Term||n (%)|
|Injection site bruising||19 (2)|
|Burning sensation||17 (2)|
|Venipuncture site bruise||17 (2)|
|Dizziness (excluding vertigo)||8 (1)|
|Feeling cold||7 (1)|
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.
Read the entire FDA prescribing information for Vasovist (Gadofosveset Trisodium Injection for Intravenous Use)
Additional Vasovist Information
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