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.
Approved To Treat
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Brand Information
Injectafer (Ferric Carboxymaltose Injection)
1RECENT MAJOR CHANGES
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
- 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:
- Hypersensitivity Reactions
- Hypophosphatemia
- 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.
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, 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 0517-0650-01 750 mg iron/15 mL Single-Dose Vial Individually Boxed
NDC 0517-0620-01 1,000 mg iron/20 mL Single-Dose Vial Individually Boxed
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.
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 (.
Symptomatic Hypophosphatemia
Advise patients to report any signs or symptoms of hypophosphatemia such as fatigue, muscle weakness or pain, bone and joint pain, or bone fractures
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.
Distributed by:
RQ1052-I
10Patient Information
INJECTAFER (in-jekt-a-fer)
(ferric carboxymaltose injection)
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.
Do 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 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 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 (intravenously) 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. What are the possible side effects of INJECTAFER?
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 in adults include:
nausea high blood pressure flushing injection site reactions skin redness low levels of phosphate in your blood dizziness
The most common side effects of INJECTAFER in children include:
low levels of phosphate in your blood 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.
Distributed 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: 05/2023
11PRINCIPAL DISPLAY PANEL - 2 ML CONTAINER LABEL
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12PRINCIPAL DISPLAY PANEL - 2 ML CARTON LABELING
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13PRINCIPAL DISPLAY PANEL - 15 ML CONTAINER LABEL
NDC 0517-0650-01
14PRINCIPAL DISPLAY PANEL - 15 ML CARTON LABELING
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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)
