Vasovist

Side Effects
Interactions

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

Anaphylaxis and anaphylactoid reactions were the most common serious reactions observed following VASOVIST injection administration [see WARNINGS AND PRECAUTIONS].

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 (%)
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.

Read the Vasovist (gadofosveset trisodium injection for intravenous use) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Following injection, VASOVIST (gadofosveset trisodium injection for intravenous use) binds to blood albumin and has the potential to alter the binding of other drugs that also bind to albumin. No drug interaction reactions were observed in clinical trials. Consider the possibility of VASOVIST (gadofosveset trisodium injection for intravenous use) interaction with concomitantly administered medications that bind to albumin. An interaction may enhance or decrease the activity of the concomitant medication [see CLINICAL PHARMACOLOGY].

Warfarin

In a clinical trial of 10 patients receiving a stable dose of warfarin, a single dose of VASOVIST (gadofosveset trisodium injection for intravenous use) (0.05 mmol/kg) did not alter the anticoagulant activity of warfarin as measured by the International Normalized Ratio (INR).

Last reviewed on RxList: 10/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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