Iron Deficiency Anemia Treatments
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Brand Name
Injectafer
Generic Name
Carboxymaltose
View Brand Information FDA approval date: August 12, 2013
Classification: Parenteral Iron Replacement
Form: Injection
What is Injectafer (Carboxymaltose)?
Injectafer is indicated for the treatment of: iron deficiency anemia in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease., iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Injectafer is an iron replacement product indicated for the treatment of:, iron deficiency anemia in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. , iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
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Related Clinical Trials
Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression: a Multicentric Randomized Open-labelled Controlled Trial
Summary: The objectif of the IRON-DEP Study is to assess the efficacy of intravenous (IV) versus oral iron treatment on the prevalence of postpartum depression (PPD) in women with moderate iron deficiency anemia after caesarean delivery.
A Randomized, Open-label, Two-treatment, Two-period, Two-cross-over Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
Summary: The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants under fasting condition. The main questions it aims to answer are: * \[Question 1\] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection 750 mg iron/15 mL provided by Sichuan Huiyu Pharmaceutical ...
Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy
Summary: The main objective of this study is to evaluate the efficacy and safety of IV FCM(ferric carboxymaltose) in patients with AGC receiving palliative chemotherapy. This study will also evaluate the effect of IV FCM on the treatment outcomes of palliative chemotherapy in patients with gastric cancer receiving fluoropyrimidine and platinum-based regimen in the same 1st-line palliative setting.
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Brand Information
Injectafer (Ferric Carboxymaltose Injection)
WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA
• INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention
• Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia [see Warnings and Precautions (5.1)].
• Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Dosage and Administration (2.1, 2.3)]. Correct pre-existing hypophosphatemia prior to administering INJECTAFER [see Warnings and Precautions (5.1)].
• Advise patients receiving INJECTAFER about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) [see Warnings and Precautions (5.1)].
1
Warnings and Precautions, Symptomatic Hypophosphatemia. (5.2) 02/2020
2INDICATIONS AND USAGE
Injectafer is indicated for the treatment of:
• iron deficiency anemia (IDA) in:
adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease.
• iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
3DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/mL, dark brown, non-transparent, sterile, aqueous solution.
- 100 mg iron/2 mL single-dose vial
- 500 mg iron/10 mL single-dose vial
- 750 mg iron/15 mL single-dose vial
- 1,000 mg iron/20 mL single-dose vial
4CONTRAINDICATIONS
Injectafer is contraindicated in patients with a history of hypersensitivity to Injectafer or any of its components
5ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Symptomatic Hypophosphatemia
- Hypersensitivity Reactions
- Hypertension
- Laboratory Test Alterations
5.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
AdultsIn two randomized clinical studies [Studies 1 and 2, see Clinical Studies (], a total of 1,775 patients were exposed to Injectafer 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron.
Adverse reactions reported by ≥1% of treated patients are shown in the following table.
Table 2. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2
a Includes oral iron and all formulations of IV iron other than Injectafer
*Grouped Terms:
Hypertension includes hypertension, blood pressure increased, and hypertensive crisis.
*Grouped Terms:
Hypertension includes hypertension, blood pressure increased, and hypertensive crisis.
Flushing includes flushing and hot flush.
Injection site reactions include injection site extravasation, injection site discoloration, injection site pain, injection site irritation, injection site bruising, injection site reaction, injection site discomfort, injection site erythema, injection site hematoma, injection site hemorrhage, injection site pruritus, injection site rash, and injection site swelling.
Erythema includes erythema and injection site erythema.
Dizziness includes dizziness, balance disorder, and vertigo.
**Injection site discoloration was also included in the injection site local administration reactions grouped term.
Headache includes headache and migraine.
Hepatic enzyme increased includes alanine aminotransferase increased and aspartate aminotransferase increased.
Dysgeusia includes dysgeusia and ageusia.
Rash includes rash, urticaria, skin exfoliation, blister, erythema multiforme, injection site rash, rash maculo-papular, and rash pruritic.
Other adverse reactions reported by ≥0.5% of treated patients include abdominal pain, diarrhea, gamma glutamyl transferase increased, paresthesia, and sneezing. Transient decreases in laboratory blood phosphorus levels (< 2 mg/dL) have been observed in 27% (440/1,638) of patients in clinical trials.
Table 3. Adverse Reactions (≥1% in any Treatment Group) In Patients Receiving Two Doses of 15 mg/kg to a Maximum of 750 mg to a Cumulative Dose of 1,500 mg or a Single Dose of Injectafer 15 mg/kg to a Maximum of 1,000 mg
ab Included studies 1VIT07017, 1VIT07018, 1VIT09030 and 1VIT09031
*Grouped Terms
**Injection site extravasation and injection site discoloration were also included in the injection site reactions grouped term.
*Grouped Terms
Patients with Iron Deficiency and Heart Failure
The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1,016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications.
5.2Post-marketing Experience
The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer:
- Cardiac disorders: Tachycardia
- General disorders and administration site conditions: Chest discomfort, chills, pyrexia
- Metabolism and nutrition disorders: Hypophosphatemia
- Musculoskeletal and connective tissue disorders: Arthralgia, back pain, hypophosphatemic osteomalacia
- Nervous system disorders: Syncope
- Respiratory, thoracic and mediastinal disorders: Dyspnea
- Skin and subcutaneous tissue disorders: Angioedema, erythema, pruritus, urticaria
- Pregnancy: Fetal bradycardia
6OVERDOSAGE
Excessive dosages of Injectafer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received Injectafer 18,000 mg over 6 months developed hemosiderosis with multiple joint disorder, walking disability, and asthenia. In the postmarketing setting, hypophosphatemic osteomalacia has been reported in patients who have received repeated high-cumulative courses of Injectafer.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
7DESCRIPTION
Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-
[FeO
where n ≈ 10
The chemical structure is presented below:
Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Injectafer is available in 2 mL, 10 mL, 15 mL and 20 mL single-dose vials. Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0.
Vial closure is not made with natural rubber latex.
8HOW SUPPLIED/STORAGE AND HANDLING
Injectafer (ferric carboxymaltose injection) is a dark brown, non-transparent, sterile, aqueous solution.
NDC 0517-0602-01 100 mg iron/2 mL Single-Dose Vial Individually Boxed
NDC 0517-0610-01 500 mg iron/10 mL Single-Dose Vial Individually Boxed
NDC 0517-0650-01 750 mg iron/15 mL Single-Dose Vial Individually Boxed
NDC 0517-0620-01 1,000 mg iron/20 mL Single-Dose Vial Individually Boxed
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See the USP controlled room temperature.] Do not freeze.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information) and discuss with the patient the etiology of the iron deficiency anemia and the patient’s iron deficiency anemia treatment options.
Symptomatic HypophosphatemiaAdvise patients to report any signs or symptoms of hypophosphatemia such as fatigue, muscle weakness or pain, bone and joint pain, or bone fractures [see Warnings and Precautions (.
Prior History of Reactions to Parenteral Iron ProductsQuestion patients regarding any prior history of reactions to parenteral iron products [see Warnings and Precautions (.
Serious Hypersensitivity ReactionsAdvise patients to report any signs and symptoms of hypersensitivity that may develop during and following Injectafer administration, such as rash, itching, dizziness, lightheadedness, swelling, and breathing problems [see Warnings and Precautions (.
PregnancyAdvise pregnant women about the risk of hypersensitivity reactions which may have serious consequences for the fetus. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (
Injectafer is manufactured under license from Vifor (International) Inc, Switzerland.
Manufactured by:
RQ1052-K
10Patient Information
INJECTAFER (in-jekt-a-fer)
(ferric carboxymaltose injection)
What is the most important information I should know about INJECTAFER?Hypophosphatemia has happened after one or more doses of INJECTAFER and can be severe or serious, and lead to hospitalization, softening of your bones (osteomalacia), and broken bones (fractures). Hypophosphatemia can happen even if your blood phosphate levels were normal before treatment and you do not have any risk factors for hypophosphatemia. Your healthcare provider will check your blood phosphate levels before a repeat treatment with INJECTAFER if you are at risk for hypophosphatemia. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider will check your blood phosphate levels.
Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with INJECTAFER:
• tiredness • bone or joint pain
• muscle weakness or pain • broken bones
Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with INJECTAFER:
• tiredness • bone or joint pain
• muscle weakness or pain • broken bones
Your healthcare provider may permanently stop treatment with INJECTAFER if you develop sever hypophosphatemia with symptoms or if your blood phosphate levels remain low during treatment with INJECTAFER.
See
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.
Who should not receive INJECTAFER?
Do not receive INJECTAFER if you are allergic to ferric carboxymaltose or any of the ingredients in INJECTAFER. See the end of this Patient Information leaflet for a complete list of ingredients in INJECTAFER.
Before receiving INJECTAFER, tell your healthcare provider about all of your medical conditions, including if you:
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 hereditary hemorrhagic telangiectasia (HHT) or Osler-Weber-Rendu syndrome have had an allergic reaction to iron given into your vein have previously received INJECTAFER have had high blood pressure (hypertension) 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 medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive INJECTAFER?
INJECTAFER is given into your vein by intravenous (IV) infusion by your healthcare provider. INJECTAFER is usually given in 2 doses at least 7 days apart for IDA, 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. INJECTAFER can cause discoloration or staining of your skin if leaking happens at your infusion site. Tell your healthcare provider if you notice any leaking from the infusion site during your infusion. What are the possible side effects of INJECTAFER? See “What is the most important information I should know about INJECTAFER?”
Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive INJECTAFER. 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 of the following signs or symptoms of allergic reactions during or after treatment with INJECTAFER:
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
• 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 in adults include:
The most common side effects of INJECTAFER in adults include:
nausea high blood pressure flushing injection site reactions skin redness low blood phosphate levels dizziness
The most common side effects of INJECTAFER in children include:
low blood phosphate levels injection site reactions rash headache vomiting
These are not all the possible side effects of INJECTAFER.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of INJECTAFER.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about INJECTAFER that is written for health professionals.
What are the ingredients in INJECTAFER?
Active ingredient: ferric carboxymaltose.
Inactive ingredients: water for injection. Sodium hydroxide or hydrochloric acid may be added to adjust pH to 5.0-7.0.
Inactive ingredients: water for injection. Sodium hydroxide or hydrochloric acid may be added to adjust pH to 5.0-7.0.
Manufactured by:
INJECTAFER is manufactured under license from Vifor (International) Inc, Switzerland.
For more information go to www.injectafer.com or call 1-800-734-9236.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 08/2026
11PRINCIPAL DISPLAY PANEL - 2 ML CONTAINER LABEL
NDC 0517-0602-01
12PRINCIPAL DISPLAY PANEL - 2 ML CARTON LABELING
NDC 0517-0602-01
13PRINCIPAL DISPLAY PANEL - 15 ML CONTAINER LABEL
NDC 0517-0650-01
14PRINCIPAL DISPLAY PANEL - 15 ML CARTON LABELING
NDC 0517-0650-01
15PRINCIPAL DISPLAY PANEL - 20 ML CONTAINER LABEL
NDC 0517-0620-01
16PRINCIPAL DISPLAY PANEL - 20 ML CARTON LABELING
NDC 0517-0620-01
Injectafer
17Serialization Label (2 mL)
18Serialization Label (15 mL)
19Serialization Label (20 mL)
