WARNING

Ferumoxytol injection is a medication used to treat iron deficiency anemia in adults with chronic kidney disease. Like any medication, it carries potential risks and side effects. Some of the risks associated with ferumoxytol injection include:

• Allergic reactions: Some individuals may experience allergic reactions, ranging from mild to severe, including difficulty breathing, swelling of the face or throat, rash, or itching.
• Hypotension: Ferumoxytol injection can cause a sudden drop in blood pressure, especially during or shortly after administration, leading to symptoms such as dizziness, fainting, or lightheadedness.
• Iron overload: Excessive iron levels in the body can lead to iron overload, which may cause serious complications such as organ damage, particularly in individuals with certain conditions like hemochromatosis.
• Injection site reactions: Pain, swelling, bruising, or irritation at the injection site are common side effects of ferumoxytol injection.
• Cardiovascular events: In clinical trials, some patients receiving ferumoxytol injection experienced cardiovascular events such as myocardial infarction or stroke. The risk may be higher in patients with pre-existing cardiovascular disease.
• Hypersensitivity reactions: In addition to allergic reactions, some individuals may experience hypersensitivity reactions, which can manifest as fever, chills, nausea, vomiting, or headache.
• Risk of serious adverse events: Rare but serious adverse events such as anaphylaxis, cardiac arrest, or death have been reported following ferumoxytol injection.

It’s essential for patients to discuss their medical history and any potential risks with their healthcare provider before starting treatment with ferumoxytol injection. Healthcare providers should closely monitor patients during and after administration to mitigate the risks associated with this medication.

Why is this medication prescribed?

Ferumoxytol injection is prescribed to treat iron deficiency anemia in adults with chronic kidney disease (CKD). Iron deficiency anemia occurs when the body lacks sufficient iron to produce an adequate amount of red blood cells, leading to symptoms such as fatigue, weakness, and shortness of breath. Individuals with CKD often experience this type of anemia due to decreased production of erythropoietin and impaired iron utilization.

Ferumoxytol injection works by replenishing iron stores in the body, which helps stimulate the production of red blood cells and alleviate the symptoms of anemia. It is particularly useful in CKD patients who are unable to tolerate or do not respond to oral iron supplements.

How should this medicine be used?

The typical dosing regimen for ferumoxytol injection involves administering a series of intravenous injections, usually given as two separate doses spaced a few days apart. The dosage and frequency of administration may vary depending on the patient’s iron deficiency severity and response to treatment. Healthcare providers will determine the appropriate dose and schedule based on individual patient factors.

Ferumoxytol injection is administered by a healthcare professional in a clinical setting, such as a hospital or outpatient infusion center. The medication is typically diluted in saline solution and infused slowly into a vein over a specified period, following established protocols to minimize the risk of adverse reactions.

Patients should follow their healthcare provider’s instructions carefully regarding the administration of ferumoxytol injection. It’s essential to attend all scheduled appointments and undergo regular monitoring to assess treatment effectiveness and monitor for any potential side effects or complications.

Other uses for this medicine

There are some off-label uses for ferumoxytol injection, which means it is sometimes prescribed for conditions other than its approved indication. Some off-label uses may include:

• Iron deficiency anemia in non-CKD patients: Ferumoxytol injection may be used to treat iron deficiency anemia in individuals who cannot tolerate or do not respond adequately to oral iron supplements, regardless of their kidney function.
• Anemia associated with other chronic diseases: In certain cases, ferumoxytol injection may be considered for the treatment of anemia associated with chronic diseases other than CKD, such as inflammatory bowel disease or heart failure, when oral iron therapy is ineffective or not feasible.

What special precautions should I follow?

As for special precautions to follow when using ferumoxytol injection, here are some key considerations:

• Allergy and hypersensitivity: Patients should be screened for allergies to iron compounds or any components of the ferumoxytol injection. Allergic reactions, including anaphylaxis, can occur and may be life-threatening.
• Cardiovascular risk: Patients with a history of cardiovascular disease or risk factors for cardiovascular events should be closely monitored during and after administration of ferumoxytol injection due to the potential risk of cardiovascular events, such as myocardial infarction or stroke.
• Hypotension: Patients may experience a sudden drop in blood pressure during or shortly after receiving ferumoxytol injection. Healthcare providers should monitor patients for signs and symptoms of hypotension and manage accordingly.
• Iron overload: Patients should be assessed for underlying conditions that may predispose them to iron overload, such as hereditary hemochromatosis or repeated blood transfusions. Monitoring of iron parameters and clinical symptoms of iron overload is important to prevent complications.
• Drug interactions: Healthcare providers should review the patient’s medication list to identify any potential drug interactions with ferumoxytol injection, particularly medications that may affect blood pressure or cardiovascular function.

Patients should communicate any concerns or symptoms they experience during treatment with ferumoxytol injection to their healthcare provider promptly. Additionally, they should adhere to all recommended follow-up appointments and monitoring as directed by their healthcare provider to ensure safe and effective use of the medication.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Ferumoxytol Injection. However, it’s essential to maintain a balanced diet rich in iron-containing foods to support your overall health and maximize the effectiveness of iron therapy. Your healthcare provider may provide dietary recommendations or suggest iron supplements to complement your treatment.

What should I do if I forget a dose?

If you miss a scheduled dose of Ferumoxytol Injection, contact your healthcare provider for guidance. Depending on the timing and your treatment schedule, your healthcare provider may recommend rescheduling the missed dose or adjusting your treatment plan accordingly. It’s essential to adhere to your healthcare provider’s instructions and attend all scheduled appointments to ensure consistent and effective treatment. Avoid doubling doses or making changes to your treatment regimen without consulting your healthcare provider.

What side effects can this medication cause?

Ferumoxytol injection, like any medication, can cause side effects. Some common side effects of Ferumoxytol Injection include:

• Nausea
• Dizziness
• Headache
• Injection site reactions (such as pain, swelling, or bruising)
• Itching
• Rash
• Hypotension (low blood pressure)
• Flushing

In addition to these common side effects, Ferumoxytol Injection can also cause more serious side effects in some individuals. These may include:

• Allergic reactions: Some people may experience allergic reactions to Ferumoxytol Injection, which can range from mild to severe. Symptoms may include difficulty breathing, chest tightness, swelling of the face, lips, or tongue, itching, or rash. Severe allergic reactions, including anaphylaxis, can occur, which require immediate medical attention.
• Hypersensitivity reactions: Ferumoxytol Injection can cause hypersensitivity reactions, which may include symptoms such as fever, chills, nausea, vomiting, or joint pain.
• Cardiovascular events: In some cases, patients receiving Ferumoxytol Injection may experience cardiovascular events such as myocardial infarction (heart attack) or stroke.
• Iron overload: Ferumoxytol Injection contains iron, and excessive administration can lead to iron overload, particularly in patients with conditions such as hereditary hemochromatosis or those who receive multiple blood transfusions.
• Hypertension (high blood pressure): Some individuals may experience an increase in blood pressure after receiving Ferumoxytol Injection.

It’s essential for patients to be aware of the potential side effects of Ferumoxytol Injection and to promptly report any unusual or concerning symptoms to their healthcare provider. Healthcare providers will monitor patients closely during and after administration of Ferumoxytol Injection to minimize the risk of adverse reactions and provide appropriate management if side effects occur.

What should I know about storage and disposal of this medication?

Storage and disposal:

• Storage: Ferumoxytol Injection should be stored at room temperature, typically between 20-25°C (68-77°F). It should be kept in its original packaging and protected from light. Do not freeze Ferumoxytol Injection, and avoid storing it in extreme temperatures or environments.
• Disposal: Proper disposal of unused or expired Ferumoxytol Injection is essential to prevent accidental exposure or harm to others. Follow your healthcare provider’s instructions or local regulations for the safe disposal of medical waste. Do not dispose of Ferumoxytol Injection in household trash or pour it down the drain unless instructed to do so.

In case of emergency/overdose

In case of emergency or overdose of Ferumoxytol Injection, take the following steps:

• Seek immediate medical attention: If you suspect an overdose or experience severe symptoms after receiving Ferumoxytol Injection, contact your healthcare provider or go to the nearest emergency room right away.
• Symptoms of overdose: Symptoms of Ferumoxytol Injection overdose may include severe allergic reactions, cardiovascular events, or symptoms of iron overload such as abdominal pain, joint pain, or dark-colored stools.
• Treatment: Emergency treatment for Ferumoxytol Injection overdose will depend on the specific symptoms and severity of the overdose. Healthcare providers may administer supportive care, such as oxygen therapy, intravenous fluids, or medications to manage symptoms.

What other information should I know?

• Patient education: Patients should receive thorough instructions from their healthcare provider regarding the administration of Ferumoxytol Injection, including dosing, schedule, and potential side effects. It’s essential to adhere to these instructions and attend all scheduled appointments for monitoring and follow-up.
• Monitoring: Healthcare providers will monitor patients closely during and after administration of Ferumoxytol Injection to assess treatment response, monitor for side effects, and manage any complications that may arise.
• Medical history: Inform your healthcare provider about your medical history, including any allergies, underlying health conditions, medications you are taking, and previous experiences with iron therapy. This information will help ensure safe and effective treatment with Ferumoxytol Injection.

By following these guidelines and staying informed about Ferumoxytol Injection, patients can minimize risks and maximize the benefits of this medication for the treatment of iron deficiency anemia.