Magnevist

MAGNEVIST® (brand of gadopentetate dimeglumine) Injection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). MAGNEVIST Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.

MAGNEVIST Injection is a 0.5-mol/L solution of 1-deoxy-1-(methylamino)-D-glucitol dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl] glycinato (5-) ]gadolinate(2-)(2:1) with a molecular weight of 938, an empirical formula of C28H54GdN5O20, and has the following structural formula:

Each mL of MAGNEVIST Injection contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. MAGNEVIST Injection contains no antimicrobial preservative.

MAGNEVIST Injection has a pH of 6.5 to 8.0. Pertinent physicochemical data are noted below:

MAGNEVIST Injection has an osmolality 6.9 times that of plasma which has an osmolality of 285 mOsmol/kg water. MAGNEVIST Injection is hypertonic under conditions of use.

MAGNEVIST Injection is a clear, colorless to slightly yellow solution containing 469.01 mg/ mL of gadopentetate dimeglumine. MAGNEVIST Injection is supplied in the following sizes:

Storage

MAGNEVIST Injection should be stored at controlled room temperature, between 15-30° C (59- 86° F) and protected from light. DO NOT FREEZE. Should freezing occur in the vial MAGNEVIST Injection should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, MAGNEVIST Injection should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard vial.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Manufactured in Germany. March 2012

Gadopentetate dimeglumine 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 gadopentetate dimeglumine. Also tell your doctor if you have recently received any contrast agent similar to gadopentetate dimeglumine

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;
• 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 gadopentetate dimeglumine will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

Gadopentetate dimeglumine can pass into breast milk and may harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Kidney failure has happened with Magnevist in people who already had kidney problems. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Magnevist as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Magnevist is contraindicated in patients with:

Nephrogenic Systemic Fibrosis

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

Instruct the patients to contact their physician if they develop signs or symptoms of NSF following Magnevist 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.

Instruct patients to inform their physician if they:

© 2016, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.

Whippany, NJ 07981

Manufactured in Germany

NDC 50419-188-82

10 x 10 mL

Rx only

sterile solution

Magnevist®

(brand of gadopentetate dimeglumine) injection

For intravenous administration.

Single-dose container.

Discard unused portion.

Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine and 0.40 mg diethylenetriamine pentaacetic acid.

Contains no antimicrobial preservative.

Protect from light.

Store at controlled room temperature, between 15-30°C (59-86°F). DO NOT FREEZE.

Dosage: See package insert.

Get emergency medical help if you have any of these signs of an allergic reaction to Magnevist: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers 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

• swelling, bruising, redness, itching, burning, or skin changes where the injection was given.

Less serious Magnevist side effects may include:

• headache, dizziness;

• nausea;

• feeling unusually hot;

• unusual or unpleasant taste in your mouth;

• flushing (warmth, redness, or tingly feeling);

• numbness; or

• cold feeling, warmth, pain, or burning 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.