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).

WHY INJECTAFER?

ORAL IRON MAY NOT WORK FOR EVERYONE

ASK YOUR HEALTHCARE PROFESSIONAL TO CHECK YOUR IRON LEVELS AND SEE IF IV IRON IS RIGHT FOR YOU

INJECTAFER, AS AN IV IRON, CAN PROVIDE MORE IRON IN LESS TIME THAN ORAL IRON

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).

IRON OPTIONS

Iron supplement icon

Even in healthy patients, when taking oral iron, less than 10% is absorbed by the body.*

IV iron icon

With Injectafer, 100% of the iron goes directly into the bloodstream.

WHEN ORAL IRON ISN'T RIGHT FOR YOU INJECTAFER CAN GIVE YOU MORE IRON IN LESS TIME VS ORAL IRON*

AND THE MOST IRON OF ANY IV IRON PER COURSE OF TREATMENT

Injectafer is the only IV iron that offers up to 1500 mg of iron in 2 doses of up to 750 mg each at least 7 days apart.

1st dose of INJECTAFER®: a single-dose vial with 750mg

1st administration up to 750 mg of iron

7 days apart
7 days apart
2nd dose of INJECTAFER®: a single-dose vial with 750mg

2nd administrationup to 750 mg of iron

If you weigh less than 110 pounds, you may be given a smaller amount of Injectafer.
Your healthcare professional will decide on the most appropriate way to give you your treatment:
  • By injection, directly into a vein
  • By infusion, diluted in normal saline and given directly into a vein
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).

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

THE WHERE, WHO, AND WHEN OF GETTING INJECTAFER

If your healthcare provider determines Injectafer is right for you, here is some information that may be helpful

The location

Injectafer is given by IV infusion, usually at an infusion center, where a healthcare professional can administer it directly into the bloodstream through a vein.

The providers

Infusion centers are medical facilities equipped and staffed for administering infusions.

The timing

Each Injectafer infusion may take about 15 minutes. Afterward, your healthcare professional will monitor you for about 30 minutes for signs of an allergic reactions or any other side effects.

Tell your healthcare provider right away if you develop any signs or symptoms of allergic reactions during or after treatment with Injectafer.

Your healthcare professional may monitor your serum phosphate levels if you are at risk of low serum phosphate and receive a second course of treatment, or for anyone who receives a second course of treatment within 3 months.

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
  • bone or joint pain
  • muscle weakness or pain
  • broken bones

Possible Injectafer Side Effects

With Injectafer, you may experience side effects. Your healthcare professional will monitor you after your infusion for any signs or symptoms of allergic reactions, usually for 30 minutes.

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

    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.

Tell your healthcare professional if you have ever had any unusual or allergic reactions to IV iron.

Talk to your healthcare professional if you have any signs and symptoms of an allergic reaction to Injectafer.

You may report side effects to FDA at 1-800-FDA-1088.

*Oral iron is typically taken in 300 mg or 320 mg tablets 3-4 times a day. The body is unable to absorb that much iron in the digestive tract at one time, so iron repletion may be possible in smaller oral iron doses over time.

For iron deficiency anemia (IDA), one course of treatment is 2 doses of 750 mg separated by at least 7 days. For patients weighing less than 50 kg (110 lb), the recommended dosage is Injectafer 15 mg/kg body weight intravenously in 2 doses separated by at least 7 days per course.

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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