Ablavar

Name: Ablavar

Gadofosveset trisodium 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;
  • nausea;
  • flushing (warmth, redness, or tingly feeling);
  • mild itching;
  • numbness; or
  • redness, cold feeling, warmth, pain, burning, or bruising where the medicine was injected.

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.

Uses For Ablavar

Gadofosveset is a contrast agent. It is used in magnetic resonance angiography (MRA) to help create a clear picture of the blood vessels (arteries). The MRA scan is a special kind of diagnostic procedure. It uses magnets and computers to create images or “pictures” of the blood vessels in certain areas of the body. Gadofosveset is a gadolinium-based contrast agent (GBCA).

Gadofosveset is given by injection before MRA to help diagnose problems in the blood vessels (e.g., blockage of the arteries).

This medicine is to be used only by or under the direct supervision of a doctor.

Patient information

Instruct patients receiving ABLAVAR Injection to inform their physician or healthcare provider if they:

  • are pregnant or breast feeding
  • have a history of allergic reaction to contrast media, a history of bronchial asthma or allergic
  • respiratory disorder
  • have a history of kidney and/or liver disease
  • have recently received a gadolinium-based contrast agent
  • have a history of heart rhythm disturbances, or cardiac disease
  • are taking any prescription or over-the counter medications

GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. To counsel patients at risk for NSF:

  • Describe the clinical manifestations of NSF
  • Describe procedures to screen for the detection of renal impairment

Instruct the patients to contact their physician if they develop signs or symptoms of NSF following ABLAVAR administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

Inform patients that they may experience:

  • reactions at the injection site, such as: redness, mild and transient burning or pain or feeling of warmth or coldness
  • side effects of itching or nausea

Dosing & Uses

Dosage Forms & Strengths

injectable solution

  • 244mg/mL

MRI Contrast

MRI contrast agent for visualisation of abdominal or limb vessels

0.12 mL/kg (0.03 mmoL/kg) IV bolus

Administer over period up to 30 sec; follow by 25-30 mL NS flush; infusion rate not to exceed 1.5 mL/seconds

Safety and efficacy not established

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadofosveset in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gadofosveset.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

What is gadofosveset trisodium (ablavar)?

Gadofosveset trisodium 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.

Gadofosveset trisodium is used to help diagnose certain disorders of the heart and blood vessels.

Gadofosveset trisodium may also be used for purposes not listed in this medication guide.

What should i discuss with my health care provider before receiving gadofosveset trisodium (ablavar)?

Gadofosveset trisodium can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

  • burning, itching, swelling, scaling, and tightening or hardening of your skin;
  • muscle weakness;
  • joint stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • trouble moving; or
  • skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadofosveset trisodium. Also tell your doctor if you have recently received any contrast agent similar to gadofosveset trisodium.

To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:

  • diabetes;
  • high blood pressure;
  • liver disease;
  • a heart rhythm disorder;
  • a personal or family history of Long QT Syndrome;
  • asthma, hay fever, or a history of food or drug allergies;
  • if you are over 60 years old;
  • if you have ever had any type of reaction to a contrast agent; or
  • if you have recently had an injury, surgery, or severe infection.

FDA pregnancy category C. It is not known whether gadofosveset trisodium will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

It is not known whether gadofosveset trisodium passes into breast milk or if it could harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby.

What should i avoid after receiving gadofosveset trisodium (ablavar)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Side effects

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

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

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 (%)
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 entire FDA prescribing information for Ablavar (Gadofosveset Trisodium Injection)

Read More »
(web3)