Ablavar

Name: Ablavar

What Is Gadofosveset trisodium?

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.

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.

Also tell your doctor if you have diabetes, high blood pressure, liver disease, a heart rhythm disorder, a personal or family history of Long QT Syndrome, asthma or allergies, if you are over 60 years old, if you have ever had a reaction to a contrast agent, or if you have recently had an injury, surgery, or severe infection.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

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.

Before Using Ablavar

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of gadofosveset in the pediatric population. Safety and efficacy have not been 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or allergies, history of or
  • Heart disease, history of or
  • Heart rhythm problems (e.g., QT prolongation) or
  • Kidney problems, severe (recent or long-term)—Use with caution. May cause side effects to become worse.
  • Diabetes or
  • Hypertension (high blood pressure)—Use with caution. May increase risk for kidney problems.

Uses of Ablavar

  • It is used during an MRA (magnetic resonance angiography) test.

What are some other side effects of Ablavar?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where the shot is given.
  • Itching.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

US Brand Name

  1. Ablavar

Indications

ABLAVAR is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease [see Clinical Studies].

Warnings

Black Box Warnings

Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73 sq.m, hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant

NSF affects internal organs, skin, and muscle and can be fatal

Only use if essential and MRI cannot not provide appropriate diagnostic image

Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses

Contraindications

Hypersensitivity to product or component of the formulation

Cautions

Renal insufficiency

Asthma, allergic disorder, hypersensitivity; trained personnel and emergency resuscitative equipment must be available prior to and during administration

Risk of nephrogenic systemic fibrosis (NSF) with severe renal impairment

Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with use of gadolinium contrast media in patients with kidney disease; do not exceed recommended dose

Mild QT prolongation w/ elevated levels of gadofosveset (repeated use or overdose >0.05 mmoL/kg)

QTc prolongation reported (rare)

Elimination may occur faster in patients with hypoalbuminemia

Use in patients with sickle cell anemia not studied

Use caution in patients that have received iodine containing agents within 24 hr prior to gadofosveset

Brain deposits

  • 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
  • Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
  • It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
  • Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation

Pregnancy & Lactation

Pregnancy Category: C

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

What is the most important information i should know about 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.

Also tell your doctor if you have diabetes, high blood pressure, liver disease, a heart rhythm disorder, a personal or family history of Long QT Syndrome, asthma or allergies, if you are over 60 years old, if you have ever had a reaction to a contrast agent, or if you have recently had an injury, surgery, or severe infection.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

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