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Drug overview for INJECTAFER (ferric carboxymaltose):
Generic name: FERRIC CARBOXYMALTOSE (FER-ik kar-BOX-ee-MAWL-tose)
Drug class: Iron, Injectable
Therapeutic class: Electrolyte Balance-Nutritional Products
Ferric carboxymaltose, a polynuclear iron (III)-hydroxide carbohydrate complex, is a stable non-dextran iron formulation used to replenish and maintain the total body content of iron; the drug has pharmacologic actions similar to those of other parenteral iron preparations.
No enhanced Uses information available for this drug.
Generic name: FERRIC CARBOXYMALTOSE (FER-ik kar-BOX-ee-MAWL-tose)
Drug class: Iron, Injectable
Therapeutic class: Electrolyte Balance-Nutritional Products
Ferric carboxymaltose, a polynuclear iron (III)-hydroxide carbohydrate complex, is a stable non-dextran iron formulation used to replenish and maintain the total body content of iron; the drug has pharmacologic actions similar to those of other parenteral iron preparations.
No enhanced Uses information available for this drug.
DRUG IMAGES
INJECTAFER 750 MG/15 ML VIAL
INJECTAFER 100 MG/2 ML VIAL
The following indications for INJECTAFER (ferric carboxymaltose) have been approved by the FDA:
Indications:
Anemia in non-dialysis-dependent chronic kidney disease
Iron deficiency anemia
Professional Synonyms:
Anemia in CKD-ND
Anemia in NDD-CKD
Anemia in non-hemodialysis-dependent chronic kidney disease
Hypochromic microcytic anemia
Indications:
Anemia in non-dialysis-dependent chronic kidney disease
Iron deficiency anemia
Professional Synonyms:
Anemia in CKD-ND
Anemia in NDD-CKD
Anemia in non-hemodialysis-dependent chronic kidney disease
Hypochromic microcytic anemia
The following dosing information is available for INJECTAFER (ferric carboxymaltose):
Dosage of ferric carboxymaltose is expressed in terms of elemental iron. Each mL of ferric carboxymaltose injection contains the equivalent of 50 mg of elemental iron.
Ferric carboxymaltose is administered by slow IV injection or IV infusion only. When given by slow IV injection, the drug is administered undiluted at a rate of approximately 100 mg (2 mL)/minute. When given by IV infusion, up to 750 mg of iron should be diluted in no more than 250 mL of 0.9%
sodium chloride injection, providing a concentration of no less than 2 mg/mL of iron; the diluted solution should be administered over at least 15 minutes. When added to an infusion bag containing 0.9% sodium chloride injection, ferric carboxymaltose solutions containing 2-4 mg/mL of iron are physically and chemically stable for 72 hours when stored at room temperature.
Any unused portion of the diluted or undiluted ferric carboxymaltose solution should be discarded. Ferric carboxymaltose injection and diluted solutions of the drug should be inspected visually for particulate matter and discoloration prior to administration. Extravasation of ferric carboxymaltose should be avoided.
Extravasation of the drug may cause brown discoloration of the extravasation site, which may be long lasting. The injection site should be monitored for extravasation during administration of ferric carboxymaltose. If extravasation occurs, ferric carboxymaltose administration at the affected site should be discontinued.
Patients should be monitored for hypersensitivity reactions during and for at least 30 minutes after administration of ferric carboxymaltose until clinically stable. Ferric carboxymaltose should be administered only when appropriate agents and personnel for the treatment of serious hypersensitivity reactions are readily available.
sodium chloride injection, providing a concentration of no less than 2 mg/mL of iron; the diluted solution should be administered over at least 15 minutes. When added to an infusion bag containing 0.9% sodium chloride injection, ferric carboxymaltose solutions containing 2-4 mg/mL of iron are physically and chemically stable for 72 hours when stored at room temperature.
Any unused portion of the diluted or undiluted ferric carboxymaltose solution should be discarded. Ferric carboxymaltose injection and diluted solutions of the drug should be inspected visually for particulate matter and discoloration prior to administration. Extravasation of ferric carboxymaltose should be avoided.
Extravasation of the drug may cause brown discoloration of the extravasation site, which may be long lasting. The injection site should be monitored for extravasation during administration of ferric carboxymaltose. If extravasation occurs, ferric carboxymaltose administration at the affected site should be discontinued.
Patients should be monitored for hypersensitivity reactions during and for at least 30 minutes after administration of ferric carboxymaltose until clinically stable. Ferric carboxymaltose should be administered only when appropriate agents and personnel for the treatment of serious hypersensitivity reactions are readily available.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for INJECTAFER (ferric carboxymaltose):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for INJECTAFER (ferric carboxymaltose):
Drug contraindication overview.
Known hypersensitivity to ferric carboxymaltose or any ingredient in the formulation.
Known hypersensitivity to ferric carboxymaltose or any ingredient in the formulation.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypophosphatemia |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypertension |
The following adverse reaction information is available for INJECTAFER (ferric carboxymaltose):
Adverse reaction overview.
Adverse effects reported in at least 1% of patients receiving ferric carboxymaltose in 2 randomized clinical trials include nausea, hypertension, flushing/hot flush, hypophosphatemia, dizziness, vomiting, injection site discoloration, headache, increased serum ALT concentration, dysgeusia, and hypotension.
Adverse effects reported in at least 1% of patients receiving ferric carboxymaltose in 2 randomized clinical trials include nausea, hypertension, flushing/hot flush, hypophosphatemia, dizziness, vomiting, injection site discoloration, headache, increased serum ALT concentration, dysgeusia, and hypotension.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypertension Hypophosphatemia |
Abnormal hepatic function tests Hypotension Increased alanine transaminase |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Dyspnea Hypersensitivity drug reaction |
There are 27 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dizziness Flushing Nausea Urticaria |
Acute abdominal pain Arthralgia Chest pain Diarrhea Dyschromia Dysgeusia Edema Headache disorder Injection site sequelae Muscle spasm Pharyngitis Vomiting |
| Rare/Very Rare |
|---|
|
Back pain Chills Constipation Erythema Fever Paresthesia Pruritus of skin Skin rash Sneezing Syncope Tachycardia |
The following precautions are available for INJECTAFER (ferric carboxymaltose):
Safety and efficacy of ferric carboxymaltose have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
In lactating women with postpartum iron deficiency anemia, mean breast milk iron concentrations were higher in women receiving IV ferric carboxymaltose than in those receiving oral ferrous sulfate. Ferric carboxymaltose should be used with caution in nursing women.
In overall clinical trials of ferric carboxymaltose, 50% of patients were 65 years of age or older, while 25% were 75 years of age and older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience has revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.
The following prioritized warning is available for INJECTAFER (ferric carboxymaltose):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for INJECTAFER (ferric carboxymaltose)'s list of indications:
| Anemia in non-dialysis-dependent chronic kidney disease | |
| D63.1 | Anemia in chronic kidney disease |
| Iron deficiency anemia | |
| D50 | Iron deficiency anemia |
| D50.0 | Iron deficiency anemia secondary to blood loss (chronic) |
| D50.8 | Other iron deficiency anemias |
| D50.9 | Iron deficiency anemia, unspecified |
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