Details for: MAGNEVIST

BEFORE you are given MAGNEVIST talk to your doctor if any of the following situations apply to you. The doctor will decide whether the intended examination is possible or not:

• You have or have had a previous reaction to contrast media
• You suffer or have suffered from an allergy (eg, hay fever, hives) or asthma.
• You have very poor kidney function.
• You have recently had, or soon expect to have, a liver transplant.
• You have epilepsy or suffer from brain conditions with seizures.
• You are pregnant or could be pregnant (even if you are not sure), since MAGNEVIST should not be used under such circumstances unless it is considered absolutely necessary.
• You suffer from heart or blood circulation problems. This is because in the rare event that you do have an allergic reaction, it is more likely to be serious or fatal.
• You have sickle cell anemia, hemolytic conditions (destruction of red blood cells), or related blood disorders of hemoglobin in the blood (hemoglobinopathies).
• Heart problems, breathing difficulties, or skin reactions may occur with the use of MAGNEVIST. Severe reactions may occur. Most of these reactions occur within half an hour of administration. Therefore, your attending healthcare professional may observe you in this period. Delayed reactions may occur hours or even days later.

MAGNEVIST may increase or decrease blood pressure, so caution must be used when driving or operating machinery.

Accumulation of Gadolinium in the Brain
Recent information shows that gadolinium (as in MAGNEVIST) may build up in the brain after multiple uses and:

• The effect on the brain is unknown right now.
• Your doctor will:
  • Carefully consider whether to use repeated doses
  • Use the lowest dose

Kidney Impairment
Before you receive MAGNEVIST, your healthcare professional will check how well your kidneys are working. Patients with severe kidney disease should not be given MAGNEVIST (See WARNINGS AND PRECAUTIONS – Serious Warnings and Precautions). Patients with mild to moderate kidney disease should only be given MAGNEVIST after a careful assessment by your physician. Your doctor may decide to take a blood test to check this before making the decision to use MAGNEVIST.

If you have poor kidney function, your healthcare professional will make sure that MAGNEVIST has been eliminated from your body before you receive a second injection of MAGNEVIST.

MAGNEVIST can be removed from the body by dialysis. If you are already undergoing regular dialysis, your healthcare professional will decide if you should receive dialysis after you have been given MAGNEVIST.

Breastfeeding
MAGNEVIST is excreted in human breast milk. Discuss with your doctor.

Nephrogenic Systemic Fibrosis

There have been postmarket reports of a rare disease called Nephrogenic Systemic Fibrosis (NSF) following gadolinium-based contrast agent (GBCA) use.

NSF is a rare condition which has only been observed so far in patients with severe kidney disease. At present, there is no evidence that other patient groups are at risk of developing the condition. Due to NSF, the skin becomes thickened, coarse, and hard, which sometimes makes bending of the joints difficult. NSF may spread to other organs and even cause death.

Patients with severe kidney disease should avoid the use of MAGNEVIST unless the health care professional believes the possible benefits outweigh the potential risks. Those who have already had an MR imaging procedure and who have any of the following symptoms should seek medical attention as soon as possible:

• Swelling, hardening, and tightening of the skin
• Reddened or darkened patches on the skin
• Burning or itching of the skin
• Yellow spots on the whites of the eyes
• Stiffness in the joints, problems moving or straightening arms, hands, legs, or feet
• Pain deep in the hip bone or ribs
• Weakness of the muscles

Your healthcare professional will monitor your health after administering MAGNEVIST, if you are considered to be at risk for developing NSF.