Medical Editor: John P. Cunha, DO, FACOEP
Ablavar (gadofosveset trisodium) Injection is a contrast agent 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. Ablavar is used to help diagnose certain disorders of the heart and blood vessels. Common side effects of Ablavar include:
- unusual or unpleasant taste in your mouth
- flushing (warmth, redness, burning, or tingly feeling under your skin)
- injection site reactions (cold feeling, warmth, pain, bruising, redness, or burning)
- numbness or tingling in your hands or feet
Tell your doctor if you have serious side effects of Ablavar including:
- urinating less than usual or not at all,
- mood changes,
- increased thirst,
- loss of appetite,
- weight gain,
- shortness of breath or
- fast or uneven heart rate.
Ablavar is given 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. Ablavar may interact with other drugs that can harm the kidneys. Tell your doctor all medications and supplements you use. It is unknown if Ablavar 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 Ablavar (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.
The following adverse reactions are discussed in greater detail in other sections of the label:
- Nephrogenic systemic fibrosis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
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 ABLAVAR with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses ABLAVAR. The mean age of the 1379 patients who received ABLAVAR 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 ABLAVAR at a dose of 0.03 mmol/kg.
Table 2 : Common Adverse Reactions in 802 Subjects
Receiving Ablavar 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 Ablavar (Gadofosveset Trisodium Injection)