Feraheme

Feraheme is an iron replacement product that is used to treat iron deficiency anemia secondary to chronic kidney disease. Iron is essential for erythropoiesis.

This drug is to be given only by or under the direct supervision of your healthcare professional.

Before using Feraheme, the risks and benefits for your body should be discussed with your healthcare provider.

Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children below 18 years of age regarding the correlation of age to the effects of Ferumoxytol injection have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of Ferumoxytol injection.

Adverse effects have been reported in animal studies but studies in pregnant women and animals are still inadequate.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects. Inform your healthcare professional if you are taking any other prescription or non-prescription drugs.

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as hypotension, or Iron overload.

To use Feraheme correctly, you must follow all instructions given by your doctor.

A trained health professional will be the only one allowed to give you this drug in a hospital. This drug is administered intravenously through a needle placed in one of your veins. A second dose will be given 3 to 8 days after your first dose.

In using Feraheme, you must be careful and take some precautions as advised by your doctor.

Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness and unwanted effects of the drug. Unwanted effects can be screened using blood tests.

Seek immediate medical attention if you experience symptoms of anaphylaxis such as rash, itching, hoarseness, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this drug.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin using this drug, or when the dose is increased.

Inform your healthcare professional that you are taking this drug before having any medical tests, since the results of some tests may be affected by this drug.

As with many medications, there are several potential side effects associated with Feraheme.

Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chest pain
• confusion
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• rapid weight gain
• sweating
• tightness in the chest
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss
• bluish color of the fingernails, lips, skin, palms, or nail beds
• chest discomfort, cough
• decreased urine output
• difficulty with swallowing
• dilated neck veins
• dizziness, extreme fatigue, fainting, fast, pounding, or irregular heartbeat or pulse
• hives, itching, or skin rash
• irregular breathing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of consciousness
• nausea or vomiting
• no blood pressure or pulse
• pain in the shoulders, arms, jaw, or neck
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stopping of the heart
• swelling of the face, fingers, feet, or lower legs
• unconsciousness, unresponsiveness
• or weight gain

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear.

Ask your healthcare professional about ways to prevent or reduce some of these side effects. If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.