ferric carboxymaltose (Rx)

Brand and Other Names:Injectafer
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50 mg/mL (15-mL and 20-mL single-dose vials)
  • Each mL contains 50 mg of elemental iron

Iron Deficiency Anemia

Indicated for treatment of iron deficiency anemia (IDA) in adults who have intolerance or an unsatisfactory response to oral iron; also indicated for IDA in adults with nondialysis dependent chronic kidney disease

≥50 kg

  • 750 mg IV in 2 doses separated by at least 7 days; not to exceed cumulative dose of 1500 mg per course
  • Alternatively, may administer 15 mg/kg IV as a single dose; not to exceed 1000 mg

<50 kg

  • 15 mg/kg IV in 2 doses separated by at least 7 days

Dosage Forms & Strengths

injectable solution

  • 50 mg/mL (15-mL and 20-mL single-dose vials)
  • Each mL contains 50 mg of elemental iron

Iron Deficiency Anemia

Indicated for treatment of iron deficiency anemia (IDA) in pediatric patients aged ≥1 year who have intolerance or unsatisfactory response to oral iron

<50 kg

  • 15 mg/kg IV in 2 doses separated by at least 7 days

≥50 kg

  • 750 mg IV in 2 doses separated by at least 7 days; not to exceed cumulative dose of 1500 mg per course
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Adverse Effects

>10%

Pediatric patients

  • Hypophosphatemia (13%)

1-10%

Adults

  • Nausea (1-7.2%)
  • Injection site reactions (3-4%)
  • Hypertension (1-4%
  • Flushing (0.3-4%)
  • Erythema (0.3-3%)
  • Dizziness (1-2.1%)
  • Hyperphosphatemia (1-2.1%)
  • Vomiting (0.2-2%
  • Injection site extravasation (0.2-2%)
  • Injection site discoloration (<1.4%)
  • Headache (1-1.3%)
  • Hepatic enzyme increased (1.2%)
  • Rash (1-1.2%)
  • Dysgeusia (1-1.2%)
  • Hypotension (<1%)

Pediatric patients

  • Injection site reactions (8%)
  • Rash (8%)
  • Headache (5%)
  • Vomiting (5%)
  • Nasopharyngitis (3%)
  • Flushing (3%)
  • Gastrointestinal infections (3%)
  • Liver function test increased (3%)
  • Platelet count decreased (3%)
  • White blood cell count decreased (3%)

<1%

Adults

  • Constipation (0.5%)

Postmarketing Reports

Adults

  • 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 (rarely reported event)
  • Nervous system disorders: Syncope
  • Respiratory, thoracic and mediastinal disorders: Dyspnea
  • Skin and subcutaneous tissue disorders: Angioedema, erythema, pruritus, urticaria
  • Pregnancy: Fetal bradycardia
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Warnings

Contraindications

Hypersensitivity

Cautions

Hypertension reported; transient elevations in systolic BP were observed and sometimes occurred with facial flushing, dizziness, or nausea; monitor patients for signs and symptoms of hypertension following the administration of the product

Laboratory assays may overestimate serum iron and transferrin bound iron in the 24 hr following administration

Hypophosphatemia

  • Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in postmarketing setting; these cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment
  • Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition; in most cases, hypophosphatemia resolved within three months
  • Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment

Serious hypersensitivity reactions

  • Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported
  • Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse
  • Monitor for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of the infusion
  • Only administer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions
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Pregnancy & Lactation

Pregnancy

Data are insufficient to assess risk of major birth defects and miscarriage

Animal data

  • Administration of ferric carboxymaltose to rabbits during organogenesis caused adverse developmental outcomes including malformations and increased implantation loss at maternally toxic doses of ~12-23% of the human weekly dose of 750 mg (based on body surface area)

Clinical considerations

  • There are risks to mother and fetus associated with untreated IDA in pregnancy
  • Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight
  • Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur, which may cause fetal bradycardia, especially during second and third trimester

Lactation

Available published data on use in lactating females demonstrate that iron is present in breast milk

Adverse reactions like constipation and diarrhea reported in the breastfed infants but not considered related to drug exposure

There is no information on effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin

Absorption

Peak plasma concentration: 37-333 mcg/mL

Peak plasma time: 0.25-1.21 hr

Distribution

Vd: 3 L

Elimination

Half-life: 7-12 hr

Renal elimination of iron was negligible

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Administration

IV Compatibilities

0.9% NaCl

IV Preparation

Visually inspect vials for particulate matter and discoloration before administration; contains no preservatives

Each vial is intended for single-use only

Discard any unused drug remaining after injection

For IV infusion, dilute in up to 250 mL 0.9% NaCl; resulting concentration should be 2-4 mg/mL

IV Administration

IV infusion: Infuse over at least 15 minutes

IV push

  • 750-mg dose: Infuse over ~100 mg/min
  • 1000-mg dose: Infuse over 15 mg/min
  • Discard any unused portion

Extravasation

  • Avoid extravasation since brown discoloration of site may be long lasting
  • Monitor for extravasation; if extravasation occurs, discontinue administration at that site

Storage

Unopened vials

  • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
  • Do not freeze

Diluted solutions

  • Store at room temperature for 72 hr
  • Do not dilute to concentration less than 2 mg iron/mL to maintain physical and chemical stability
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Injectafer intravenous
-
50 mg iron/mL vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
ferric carboxymaltose intravenous

FERRIC CARBOXYMALTOSE - INJECTION

(FER-ik kar-BOX-ee-MAWL-tose)

COMMON BRAND NAME(S): Injectafer

USES: This medication is used to treat "iron-poor" blood (iron deficiency anemia). Low iron levels can occur due to many conditions, including when your body cannot get enough iron from food (because of poor nutrition or poor absorption) or when there is long-term blood loss. Ferric carboxymaltose is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. It is also used by people who have anemia due to long-term kidney disease.Iron is an important mineral that your body needs to make enough healthy red blood cells to carry oxygen throughout your body.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using ferric carboxymaltose and with each treatment. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein, usually by a health care professional, as directed by your doctor. It is usually given as 2 doses, at least 7 days apart. It is usually given slowly over several minutes. It can also be mixed in a saline solution and given by infusion into a vein over at least 15 minutes.The dosage is based on your medical condition, weight, and response to treatment. Your doctor will order laboratory tests to monitor your response.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

SIDE EFFECTS: Flushing, nausea, dizziness, or pain/irritation/bruising at the injection site may occur. Brown staining of the skin around the injection site may also occur and can be long lasting. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.An increase in your blood pressure, sometimes along with dizziness, nausea, or flushing of the face, may rarely occur right after a dose of this medication, but these effects usually go away within 30 minutes. Tell your doctor right away if your blood pressure remains high or if these symptoms last or get worse.Tell your doctor right away if you have any serious side effects, including: bone pain/problems, symptoms of low phosphate levels (such as muscle weakness, mental/mood changes).A rare but very serious, possibly fatal, allergic reaction may occur with this medication. You should be monitored during the dose and for at least 30 minutes afterwards. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, loss of consciousness.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ferric carboxymaltose, tell your doctor or pharmacist if you are allergic to it; or to other iron injection products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: dimercaprol, other iron-containing products.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Lab and/or medical tests (such as complete blood count, iron/phosphate levels) should be done while you are using this medication. Keep all medical and lab appointments.It is important to eat a well-balanced diet that has enough iron, vitamins, and minerals. Good sources of iron include meats (especially liver), eggs, raisins, figs, broccoli, brussels sprouts, beans, lentils, and iron-fortified or enriched cereals. Follow any diet recommendations given to you by your doctor.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2022. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.