Ferric Carboxymaltose

Carboxymaltose is a prescription medication used to treat Iron Deficiency Anemia. 

• Carboxymaltose is available under the following different brand names: Injectafer

Adult and pediatric dosage

Injectable solution

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

Iron Deficiency Anemia

Adult and pediatric dosage

• Weighing 50 kg or less: 
  • 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
• Weighing over 50 kg: 
  • 15 mg/kg IV in 2 doses separated by at least 7 days
  • Not to exceed cumulative dose 1500 mg per course

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Carboxymaltose include:

• nausea, 
• dizziness, 
• high blood pressure, 
• flushing (warmth, redness, or tingly feeling), and
• low phosphorus levels

Serious side effects of Carboxymaltose include:

• hives, 
• difficult breathing, 
• swelling in the face or throat, 
• lightheadedness, 
• severe headache, 
• pounding in the neck or ears, 
• dizziness, 
• nausea, 
• confusion, 
• bone pain, 
• muscle weakness, 
• metallic taste in the mouth, 
• bloody or tarry stools, 
• vomiting blood, 
• severe shortness of breath, 
• chest pain, 
• pale skin, 
• blue lips or fingernails, 
• loss of consciousness, and 
• seizures

Rare side effects of Carboxymaltose include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Carboxymaltose has no noted severe interactions with any other drugs.
• Carboxymaltose has no noted serious interactions with any other drugs. 
• Carboxymaltose has no noted moderate interactions with any other drugs.
• Carboxymaltose has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Carboxymaltose?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Carboxymaltose?”

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 hours 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
• 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

Pregnancy and Lactation

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