Generic Name: Ferric carboxymaltose Brand Name(s): Ferric carboxymaltose.

Uses

What is Ferric carboxymaltose used for?

Ferric carboxymaltose is commonly used to treat “iron-poor” blood (iron deficiency anemia). Low iron levels can occur due to many conditions, including when your body cannot get enough iron from food (because of poor nutrition or poor absorption) or when there is long-term blood loss. Ferric carboxymaltose is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. It is also used by people who have anemia due to long-term kidney disease.

Iron is an important mineral that your body needs to make enough healthy red blood cells to carry oxygen throughout your body.

How should I take Ferric carboxymaltose?

This medication is given by injection into a vein, usually by a health care professional, as directed by your doctor. It is usually given as 2 doses, at least 7 days apart. It is usually given slowly over several minutes. It can also be mixed in a saline solution and given by infusion into a vein over at least 15 minutes.

The dosage is based on your medical condition, weight, and response to treatment. Your doctor will order laboratory tests to monitor your response.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

How do I store Ferric carboxymaltose?

Store intact vials at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F); do not freeze. Solutions diluted in 0.9% sodium chloride at concentrations of 2-4 mg/mL are stable for 72 hours at room temperature.

If you need to store ferric carboxymaltose at home, talk with your doctor, nurse, or pharmacist about how to store it.

Precautions & warnings

What should I know before using Ferric carboxymaltose?

Before using ferric carboxymaltose, tell your doctor or pharmacist if you are allergic to it; or to other iron injection products; 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, especially of: liver disease.

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.

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.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ferric carboxymaltose during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ferric carboxymaltose. Ferric carboxymaltose is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ferric carboxymaltose?

Flushing, nausea, dizziness, or pain/irritation/bruising at the injection site may occur. Brown staining of the skin around the injection site may also occur and can be long lasting. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

An increase in your blood pressure, sometimes along with dizziness, nausea, or flushing of the face, may rarely occur right after a dose of this medication, but these effects usually go away within 30 minutes. Tell your doctor right away if your blood pressure remains high or if these symptoms persist or worsen.

Tell your doctor right away if you have any serious side effects, including: bone pain/problems.

A rare but very serious, possibly fatal, allergic reaction may occur with this medication. You should be monitored during the dose and for at least 30 minutes afterwards. 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, loss of consciousness.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ferric carboxymaltose?

Some products that may interact with this drug include: dimercaprol, other iron-containing products.

Ferric carboxymaltose may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ferric carboxymaltose?

Ferric carboxymaltose may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ferric carboxymaltose?

Ferric carboxymaltose may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ferric carboxymaltose.

What is the dose of Ferric carboxymaltose for an adult?

Usual Adult Dose for Iron Deficiency Anemia

Patients weighing 50 kg or more: Two doses of 750 mg via slow IV push or infusion separated by at least 7 days

Patients weighing less than 50 kg: Two doses of 15 mg/kg via slow IV push or infusion separated by at least 7 days

Maximum dose: Total cumulative dose should not exceed 1500 mg of iron per course

Comments:

-The dosage is expressed in mg of elemental iron.

-Treatment may be repeated if iron deficiency anemia recurs

Use: Treatment of iron deficiency anemia in adults with an intolerance or unsatisfactory response to oral iron and in adults with non-dialysis dependent chronic kidney disease

Other Comments

Administration advice:

-Administer either as an undiluted slow IV push or by infusion over at least 15 minutes

-When administering as a slow IV push give at a rate of 100 mg per minute.

Storage requirements: Solutions diluted in 0.9% sodium chloride to a concentration of 2 to 4 mg/mL of elemental iron are stable for 72 hours when stored at room temperature.

IV compatibility: The manufacturer product information should be consulted; a solution IV infusion should only be made using 0.9% sodium chloride

General monitoring:

-Hypersensitivity: Signs and symptoms of hypersensitivity reactions during and following ferric carboxymaltose administration.

General:

-Each mL of ferric carboxymaltose injection contains 50 mg of elemental iron

What is the dose of Ferric carboxymaltose for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Ferric carboxymaltose available?

Ferric carboxymaltose is available in the following dosage forms and strengths:

  • Intravenous solution

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ferric carboxymaltose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 30, 2018 | Last Modified: January 30, 2018

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