Ferabright

Ferabright is an iron-based contrast agent (dye) used to enhance magnetic resonance imaging (MRI) scans of the brain in adults who have or are suspected of having brain cancer. This specialized imaging dye helps doctors visualize malignant brain tumors, particularly those that have disrupted the blood-brain barrier—the protective layer surrounding the brain. Ferabright is the first, and currently only, iron-based contrast agent for MRI.

Ferabright contains ferumoxytol, a superparamagnetic iron oxide coated with a carbohydrate shell. When placed in a magnetic field during an MRI scan, it creates enhanced contrast that makes tumors more visible on T1-weighted images, typically about 24 hours after administration.

The safety and effectiveness of Ferabright have not been established in children under 18 years of age.

Serious Allergic Reactions (Black Box Warning)

Ferabright can cause severe, potentially life-threatening allergic reactions, including anaphylaxis, even in patients who have previously tolerated ferumoxytol products without problems.

Risk factors for serious allergic reactions include:

• History of multiple drug allergies
• Previous reactions to intravenous iron medications
• History of drug allergies or immune system disorders.

Seek immediate medical attention if you experience any of these symptoms:

• Rash, hives, or severe itching
• Swelling of the face, lips, tongue, or throat
• Difficulty breathing or wheezing
• Chest tightness
• Dizziness or lightheadedness
• Rapid or weak pulse
• Fainting or feeling faint (syncope)
• Severe drop in blood pressure.

Other Serious Side Effects

Low Blood Pressure (Hypotension)Ferabright can cause significant drops in blood pressure during or after infusion. Your healthcare provider will monitor your blood pressure closely, and you should remain in a reclined or semi-reclined position during administration.

Iron OverloadBecause Ferabright contains iron, it may cause excessive iron accumulation in the body, particularly with repeated doses or in patients with existing iron storage disorders.

MRI InterferenceFerabright can affect MRI scan results for up to 3 months after administration. Inform all healthcare providers about your Ferabright treatment before undergoing any MRI scans other than your brain imaging.

Do Not Use Ferabright If You:

• Are allergic to ferumoxytol or any ingredients in Ferabright
• Have had allergic reactions to any intravenous (IV) iron products
• Have a known hypersensitivity to iron-containing medications.

Tell Your Doctor If You Have:

• Allergies to multiple medications or contrast agents
• Low blood pressure (hypotension) or cardiovascular conditions
• Iron overload conditions (hemochromatosis or hemosiderosis)
• Kidney disease or are on dialysis
• Liver problems
• Immune system disorders.

Pregnancy and Breastfeeding

Pregnancy: Ferabright may harm your unborn baby if you experience a severe allergic reaction. Inform your doctor if you are pregnant or planning to become pregnant.

Breastfeeding: It is unknown whether Ferabright passes into breast milk. Discuss the risks and benefits with your healthcare provider before breastfeeding after receiving this medication.

Common Side Effects

The most frequently reported side effects of Ferabright include:

• Nausea
• Itching (pruritus)
• Constipation
• Headache
• Diarrhea
• High blood pressure (hypertension)
• Bruising or bleeding at the injection site
• Skin darkening (hyperpigmentation)
• Blood vessel injury at the infusion site
• Altered or metallic taste
• Burning or tingling sensation during injection
• Red or bloodshot eyes
• Nasal congestion or a runny nose
• Back pain
• Vomiting
• Elevated liver enzymes.

Contact your doctor immediately if you experience:

• Signs of allergic reaction (see Warnings section above)
• Symptoms of low blood pressure: severe dizziness, fainting, blurred vision, confusion, extreme weakness or fatigue, nausea or vomiting
• Signs of iron overload: persistent fatigue, joint pain, abdominal pain, irregular heartbeat
• Unusual bleeding or bruising
• Severe headache or vision changes
• Chest pain or difficulty breathing

This is not a complete list of side effects. Report side effects to the FDA at 1-800-FDA-1088 or to Azurity Pharmaceuticals at 1-800-461-7449.

Dosing Information

Ferabright is administered as a single intravenous (IV) infusion based on body weight:

• Patients weighing 50 kg (110 lbs) or less: 300 mg of elemental iron infused over at least 15 minutes
• Patients weighing 51 kg (112 lbs) or more: 510 mg of elemental iron infused over at least 15 minutes

Administration Details

• Dilution required: Ferabright must be diluted in either 0.9% sodium chloride (normal saline) or 5% dextrose solution before administration
• Target concentration: 2 mg/mL to 8 mg/mL of elemental iron
• Positioning: You will be positioned partially or fully reclined with back support during the infusion
• Timing: The MRI scan is typically performed approximately 24 hours after Ferabright administration
• Pre-contrast imaging: You may also have an MRI scan before receiving Ferabright for comparison.

Monitoring Requirements

• Continuous monitoring during the 15-minute infusion
• At least 30 minutes of observation after infusion completion
• Blood pressure monitoring before, during, and after administration
• Wait at least 30 minutes after Ferabright before receiving chemotherapy or antibody treatments.

Ferumoxytol is a superparamagnetic iron oxide nanoparticle coated with a carbohydrate (polyglucose sorbitol carboxymethylether) shell. When placed in the magnetic field of an MRI scanner, these nanoparticles develop a magnetic moment that alters the behavior of water protons in surrounding tissues.

This magnetic effect increases signal intensity (brightness) on T1-weighted MRI images. In brain tumors, the blood-brain barrier becomes disrupted, allowing Ferabright to accumulate in cancerous tissue. Because ferumoxytol molecules are relatively large, they extravasate (leak out of blood vessels) slowly, resulting in optimal contrast enhancement approximately 24 hours after administration.

Important Drug Information

Before receiving Ferabright, inform your healthcare provider about all medications you take, including:

• Prescription medications
• Over-the-counter drugs
• Vitamins and supplements
• Herbal products
• Other iron supplements or treatments
• Chemotherapy agents
• Monoclonal antibodies or immunotherapy
• Blood pressure medications

Timing considerations: Wait at least 30 minutes after Ferabright infusion before receiving medications that may cause allergic reactions or affect blood pressure, such as certain chemotherapy drugs or antibody treatments.

Active and Inactive Ingredients

Active ingredient: ferumoxytolInactive ingredient: mannitol

Available Dosage Forms

Ferabright Injection:

• 300 mg elemental iron per 10 mL (30 mg/mL) single-dose vials
• 510 mg elemental iron per 17 mL (30 mg/mL) single-dose vials

Manufactured for:

Azurity Pharmaceuticals, Inc., Woburn, MA 01801 USA.