Feraheme

DRUG DESCRIPTION

Feraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme is Fe5874O8752-C11719H18682O9933Na414 with an apparent molecular weight of 750 kDa.

Feraheme injection is an aqueous colloidal product that is formulated with mannitol. It is a black to reddish brown liquid, and is provided in single use vials containing 510 mg of elemental iron. Each mL of the sterile colloidal solution of Feraheme injection contains 30 mg of elemental iron and 44 mg of mannitol, and has low bleomycin-detectable iron. The formulation is isotonic with an osmolality of 270-330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.

What are the possible side effects of ferumoxytol (Feraheme)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; swelling of your face, lips, tongue, or throat.

Watch for signs of allergic reaction for at least 30 minutes after your injection.

Call your doctor if you have serious side effects such as:

  • feeling like you might pass out;
  • easy bruising;
  • swelling where the medicine was injected; or
  • worsening symptoms of kidney failure (urinating less than usual or not at all,...

Read All Potential Side Effects and See Pictures of Feraheme

What are the precautions when taking ferumoxytol injection (Feraheme)?

Before taking ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI...

Read All Potential Precautions of Feraheme


Feraheme Consumer (continued)

SIDE EFFECTS: Dizziness or fainting (hypotension) may occur. Pain, swelling, or redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness or fainting, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: unusual bruising, skin darkens (bronze tone), swelling of hands/feet/lower legs, chest pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI scan.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Feraheme Patient Information Including Side Effects

Brand Names: Feraheme

Generic Name: ferumoxytol (Pronunciation: FER ue MOX i tol)

  • What is ferumoxytol (Feraheme)?
  • What are the possible side effects of ferumoxytol (Feraheme)?
  • What is the most important information I should know about ferumoxytol (Feraheme)?
  • What should I discuss with my healthcare provider before using ferumoxytol (Feraheme)?
  • How is ferumoxytol given (Feraheme)?
  • What happens if I miss a dose (Feraheme)?
  • What happens if I overdose (Feraheme)?
  • What should I avoid while using ferumoxytol (Feraheme)?
  • What other drugs will affect ferumoxytol (Feraheme)?
  • Where can I get more information?

What is ferumoxytol (Feraheme)?

Ferumoxytol is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Ferumoxytol is used to treat iron deficiency anemia in people with chronic kidney disease. Anemia is a lack of red blood cells caused by having too little iron in the body.

Ferumoxytol may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ferumoxytol (Feraheme)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; swelling of your face, lips, tongue, or throat.

Watch for signs of allergic reaction for at least 30 minutes after your injection.

Call your doctor if you have serious side effects such as:

  • feeling like you might pass out;
  • easy bruising;
  • swelling where the medicine was injected; or
  • worsening symptoms of kidney failure (urinating less than usual or not at all, confusion, mood changes, increased thirst, loss of appetite, swelling, weight gain, feeling short of breath).

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea, constipation;
  • headache, dizziness;
  • swelling in your hands or feet;
  • chest pain; or
  • cough.

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.

What is the most important information I should know about ferumoxytol (Feraheme)?

You should not use this medication if you have ever had an allergic reaction to an injectable form of iron (including ferumoxytol), or if you have iron overload syndrome or any type of anemia that is not caused by iron deficiency.

If you are on hemodialysis, you may need a dose adjustment or special tests to safely use ferumoxytol.

Your blood will need to be tested to help your doctor determine how long to treat you with ferumoxytol. Do not miss any follow-up appointments.

This medication can cause you to have unusual results with magnetic resonance imaging (MRI) tests. Before having an MRI, tell your caregivers if you have received a ferumoxytol injection within the past 3 months.

Ferumoxytol will not affect other types of X-rays, CT scans, ultrasounds, or nuclear radiation imaging.

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