What is Injectafer?

Injectafer is a prescription iron replacement medicine used for the treatment of iron deficiency anemia (IDA) in adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron or adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease)

Injectafer is also used for the treatment of iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity).

About Iron Deficiency Anemia

What is iron deficiency anemia (IDA)?

Iron deficiency anemia occurs when the level of healthy red blood cells in your body decreases. Red blood cells carry oxygen to the body's tissues. Without enough iron, your body can't produce enough hemoglobin. Hemoglobin is the substance in red blood cells that enables them to carry oxygen.

IDA is the most common type of anemia.

  • There are other kinds of anemia, but IDA is the most common, affecting approximately 10 million people in the US
  • We get iron from the foods we eat, and it is absorbed into our blood in our small intestine. But if you aren't getting enough iron, or you're losing too much iron, or your body isn't able to absorb it, you may become iron deficient
Graphic showing how normal red blood cells look with healthy levels of hemoglobin
Graphic showing how normal red blood cells look with healthy levels of hemoglobin
Normal red blood cell counts with a healthy level of oxygen-carrying hemoglobin
Graphic showing how red blood cells look with IDA, less hemoglobin in each cell
Graphic showing how red blood cells look with IDA, less hemoglobin in each cell
IDA is a condition in which you have fewer healthy red blood cells and less hemoglobin inside each cell

Common causes of IDA

Gastrointestinal icon
Gastrointestinal icon

Gastrointestinal (GI) conditions

Even if you have enough iron in your diet, your body may not be able to absorb it. For example, this can happen if you have a disease of the intestine, such as Crohn's disease or ulcerative colitis.

Woman icon
Woman icon

Women's health conditions

Iron is found in red blood cells in our blood and so when you lose blood, you lose some iron, too. That's why long or abnormal periods, fibroids in the uterus, or blood loss during childbirth may cause low iron levels.

Cancer ribbon icon
Cancer ribbon icon

Certain Cancers

Cancer-related anemia can develop due to many reasons, including chemotherapy, chronic blood loss, lack of a certain hormone in people with kidney disease, and solid tumors or metastases in the bone marrow, among others.

Kidneys icon
Kidneys icon

Chronic Kidney Disease (CKD)

Heart rhythm icon
Heart rhythm icon

Heart Failure

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Blood droplets icon

Chronic Blood loss

These are not all the causes of IDA, and every patient may not experience IDA even if they have one of these underlying conditions. Please speak with your healthcare provider if you are concerned you may have IDA.

What are some of the symptoms of IDA?

Symptoms of IDA can be similar to those of other conditions. That's why it may be helpful to understand what the symptoms of IDA are so you can talk to your healthcare professional about any you may be experiencing.*

Some of the most common symptoms may include:

Dizziness icon

Dizziness

Woman feeling weak icon

Weakness

Ice  icon

Pica

(craving non-food items such as ice or dirt)

Low battery icon

Fatigue

Person with shortness of breath icon

Shortness of Breath

Some people with IDA experience a range of symptoms, while other people experience no symptoms at all. Not all patients feel the same way with IDA. It's possible to confuse the signs of IDA with symptoms of other conditions you may have. That's why it is important to speak with your healthcare professional.

*Injectafer is not indicated to treat symptoms of IDA.

How is IDA diagnosed?

Only your healthcare professional can diagnose IDA and they will use specific blood tests to diagnose it. IDA is determined by testing three different parts of your blood: hemoglobin (Hb), ferritin, and transferrin saturation (TSAT).

If you do have IDA, your healthcare professional will continue to use blood tests to keep an eye on your iron levels and determine which treatment option is right for you. 

Learn more about common blood tests for diagnosing IDA:

HEMOGLOBIN (Hb)

Hb is a protein in red blood cells that carries oxygen throughout the body. You can develop anemia when there are not enough red blood cells, or when the cells are not working properly.

Ferritin

Ferritin is a protein inside your cells that stores iron. It allows your body to use the iron when it needs it. A ferritin test indirectly measures the amount of iron in your blood.

Transferrin saturation (TSAT)

Transferrin is a protein that transports iron in the body. The TSAT test is used to measure how much of your transferrin is available to hold iron.

Normal lab values may vary based on patient characteristics, other medical conditions and by laboratory.

Treatment options for IDA

If your healthcare professional has diagnosed you with iron deficiency anemia (IDA), they may recommend treatment to increase your iron levels. When treating IDA, both oral iron and IV iron are treatment options.

  • Iron supplement icon

    About Oral iron

    Learn more about oral ironExpand content icon

    Many people with iron deficiency anemia (IDA) are first treated with oral iron, which is iron taken by mouth as a pill or tablet. While oral iron works well for some people, it may not be the best choice for everyone. Here are some possible reasons:

    Your Body May Not Absorb Enough Iron

    • Your digestive system can only absorb a small amount of the iron in iron tablets, so your body may not get all the iron it needs.
    • Certain health conditions that cause inflammation such as inflammatory bowl disease (IBD), Crohn's disease and ulcerative colitis can make it even harder for your body to absorb iron.

    *A common dose is one iron tablet taken 3 to 4 times a day. Even then, only about 10% of the iron is typically absorbed.

    It Can Be Hard to Take as Prescribed

    • Studies show that only 40% to 60% of people take oral iron exactly as recommended.
    • One reason may be that side effects can make it uncomfortable to continue treatment.

    Possible Side Effects

    Some people experience side effects from oral iron, such as:

    • Nausea
    • Vomiting
    • Constipation
    • Diarrhea

    Nausea and vomiting are more common with higher doses, but they can sometimes be improved by taking smaller amounts at a time.

  • IV iron icon

    About IV iron

    Learn more about IV ironExpand content icon

    IV iron is iron given directly into a vein. Because it goes straight into the bloodstream, your body receives the full dose right away to help make healthy red blood cells (hemoglobin) or store iron for later use.

    When IV Iron May Be an Option

    IV iron may be recommended if:

    • You cannot tolerate oral iron because of side effects.
    • Oral iron did not work well enough to improve your iron levels.
    • You have certain medical conditions, such as some types of heart failure, where oral iron has not been shown to be very effective, but IV iron has shown to improve the ability to exercise.

    Sticking to the treatment

    Some treatments require more than one dose. It may be challenging for some people to return for all follow up visits, which can affect completing care.

    Possible Side Effects

    Some adults experience side effects from IV iron, such as:

    • Nausea
    • Temporary increase in blood pressure
    • Flushing (a warm or red feeling)
    • Reactions at the injection site
    • Dizziness
    • Skin redness

    Some children experience side effects from IV iron, such as:

    • Low phosphate levels
    • Reactions at the injection site
    • Rash
    • Headache
    • Vomiting

    Your healthcare team will monitor you during and after treatment to help manage any side effects.

    *Side effects listed do not reflect all side effects for each available IV iron

Normal lab values may vary based on patient characteristics, comorbidities, and by laboratory.

The information on this website should not take the place of talking with your healthcare professional. If you have any questions about your condition, or if you want more information about iron deficiency anemia, iron deficiency in heart failure, or Injectafer, talk to your healthcare professional. Only your healthcare professional can decide if Injectafer is right for you.

Injectafer® (ferric carboxymaltose injection) is available by prescription only. Ask your healthcare provider if Injectafer is right for you.

What is Injectafer?

Injectafer is a prescription iron replacement medicine used for the treatment of:

  • iron deficiency anemia (IDA) in:
    • adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron
    • adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease)
  • iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity)

It is not known if Injectafer is safe and effective in children with IDA who are under 1 year of age.

It is not known if Injectafer is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity.

IMPORTANT SAFETY INFORMATION

Who should not receive Injectafer?

You should not receive Injectafer if you are allergic to ferric carboxymaltose or any of the other ingredients in Injectafer. The active ingredient in Injectafer is ferric carboxymaltose, the inactive ingredients are: water for injection, sodium hydroxide or hydrochloric acid.

What should I tell my healthcare provider before receiving Injectafer?

Before you receive Injectafer, tell your healthcare provider about all of your medical conditions, including if you:

  • have had an allergic reaction to iron given into your vein
  • have a history of trouble absorbing certain vitamins or phosphate in your body
  • have inflammatory bowel disease
  • have hyperparathyroidism
  • have low vitamin D levels
  • have high blood pressure
  • have previously received Injectafer
  • are pregnant or plan to become pregnant. Injectafer may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Injectafer
  • are breastfeeding or plan to breastfeed. Injectafer passes into your breast milk. It is not known if Injectafer will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Injectafer

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Injectafer?

Injectafer is given into your vein (intravenously) by your healthcare provider.

Injectafer is usually given in 2 doses at least 7 days apart for iron deficiency anemia or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.

If your healthcare provider decides it is right for you, Injectafer may be given intravenously by your healthcare provider as a single-dose treatment.

Injectafer treatment may be repeated if your healthcare provider decides it is needed.

What are the possible side effects of Injectafer?

Injectafer may cause serious side effects, including:

  • Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive Injectafer and may include the following signs or symptoms:
    • low blood pressure
    • feeling dizzy or lightheaded
    • loss of consciousness
    • trouble breathing
    • swelling
    • fast heartbeat
    • cold or clammy skin
    • feet or hands turn blue
    • itching
    • rash
    • hives
    • wheezing

    Your healthcare provider will watch you during and for at least 30 minutes after you receive Injectafer. Tell your healthcare provider right away if you develop any signs or symptoms of allergic reactions during or after treatment with Injectafer

  • Symptoms of low blood phosphate levels. Injectafer may cause low levels of phosphate in your blood that may be serious and can lead to softening of your bones and broken bones (fractures), especially in people who have received multiple Injectafer treatments. Your healthcare provider may check your blood phosphate levels before a repeat treatment with Injectafer if you are at risk for low blood phosphate levels. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider should check your blood phosphate levels. Tell your healthcare provider if you develop any of the following signs or symptoms of low blood phosphate levels during treatment with Injectafer:
    • feeling very tired
    • muscle weakness or pain
    • bone or joint pain
    • broken bones
  • High blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with Injectafer. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive Injectafer

The most common side effects of Injectafer include:

  • In adults:
    • nausea
    • high blood pressure
    • flushing
    • injection site reactions
    • skin redness
    • low levels of phosphate in your blood
    • dizziness
  • In children:
    • low levels of phosphate in your blood
    • injection site reactions
    • rash
    • headache
    • vomiting

These are not all of the possible side effects of Injectafer.

Call your healthcare provider for medical advice about side effects.

To report side effects, contact American Regent at 1-800-734-9236 or Email: pv@americanregent.com Fax: 1-610-650-0170.

You may also report side effects to the FDA at 1-800-332-1088 or www.fda.gov/medwatch.

The risk information provided here is not comprehensive. To learn more about Injectafer, talk with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.americanregent.com.

Please see Full Prescribing Information for Injectafer.

IMPORTANT SAFETY INFORMATION Expand

Who should not receive Injectafer?

You should not receive Injectafer if you are allergic to ferric carboxymaltose or any of the other ingredients in Injectafer. The active ingredient in Injectafer is ferric carboxymaltose, the inactive ingredients are: water for injection, sodium hydroxide or hydrochloric acid.

Injectafer® (ferric carboxymaltose injection) is available by prescription only. Ask your healthcare provider if Injectafer is right for you.

What is Injectafer?

Injectafer is a prescription iron replacement medicine used for the treatment of:

  • iron deficiency anemia (IDA) in:
    • adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron
    • adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease)
  • iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity)

It is not known if Injectafer is safe and effective in children with IDA who are under 1 year of age.

It is not known if Injectafer is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity.

IMPORTANT SAFETY INFORMATION

Who should not receive Injectafer?

You should not receive Injectafer if you are allergic to ferric carboxymaltose or any of the other ingredients in Injectafer. The active ingredient in Injectafer is ferric carboxymaltose, the inactive ingredients are: water for injection, sodium hydroxide or hydrochloric acid.

What should I tell my healthcare provider before receiving Injectafer?

Before you receive Injectafer, tell your healthcare provider about all of your medical conditions, including if you:

  • have had an allergic reaction to iron given into your vein
  • have a history of trouble absorbing certain vitamins or phosphate in your body
  • have inflammatory bowel disease
  • have hyperparathyroidism
  • have low vitamin D levels
  • have high blood pressure
  • have previously received Injectafer
  • are pregnant or plan to become pregnant. Injectafer may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Injectafer
  • are breastfeeding or plan to breastfeed. Injectafer passes into your breast milk. It is not known if Injectafer will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Injectafer

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Injectafer?

Injectafer is given into your vein (intravenously) by your healthcare provider.

Injectafer is usually given in 2 doses at least 7 days apart for iron deficiency anemia or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.

If your healthcare provider decides it is right for you, Injectafer may be given intravenously by your healthcare provider as a single-dose treatment.

Injectafer treatment may be repeated if your healthcare provider decides it is needed.

What are the possible side effects of Injectafer?

Injectafer may cause serious side effects, including:

  • Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive Injectafer and may include the following signs or symptoms:
    • low blood pressure
    • feeling dizzy or lightheaded
    • loss of consciousness
    • trouble breathing
    • swelling
    • fast heartbeat
    • cold or clammy skin
    • feet or hands turn blue
    • itching
    • rash
    • hives
    • wheezing

    Your healthcare provider will watch you during and for at least 30 minutes after you receive Injectafer. Tell your healthcare provider right away if you develop any signs or symptoms of allergic reactions during or after treatment with Injectafer

  • Symptoms of low blood phosphate levels. Injectafer may cause low levels of phosphate in your blood that may be serious and can lead to softening of your bones and broken bones (fractures), especially in people who have received multiple Injectafer treatments. Your healthcare provider may check your blood phosphate levels before a repeat treatment with Injectafer if you are at risk for low blood phosphate levels. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider should check your blood phosphate levels. Tell your healthcare provider if you develop any of the following signs or symptoms of low blood phosphate levels during treatment with Injectafer:
    • feeling very tired
    • muscle weakness or pain
    • bone or joint pain
    • broken bones
  • High blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with Injectafer. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive Injectafer

The most common side effects of Injectafer include:

  • In adults:
    • nausea
    • high blood pressure
    • flushing
    • injection site reactions
    • skin redness
    • low levels of phosphate in your blood
    • dizziness
  • In children:
    • low levels of phosphate in your blood
    • injection site reactions
    • rash
    • headache
    • vomiting

These are not all of the possible side effects of Injectafer.

Call your healthcare provider for medical advice about side effects.

To report side effects, contact American Regent at 1-800-734-9236 or Email: pv@americanregent.com Fax: 1-610-650-0170.

You may also report side effects to the FDA at 1-800-332-1088 or www.fda.gov/medwatch.

The risk information provided here is not comprehensive. To learn more about Injectafer, talk with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.americanregent.com or call 1-800-645-1706.

Please see Full Prescribing Information for Injectafer.

To contact us with questions or concerns about an American Regent product, please call us: 888-354-4855.

Injectafer® and the Injectafer® logo are trademarks of Vifor (International) Inc., Switzerland. Injectafer® is manufactured under license from Vifor (International) Inc., Switzerland. Trademarks not owned by American Regent, Inc. or Vifor (International) are the property of their respective owners.

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