Injectafer Side Effects Center

Last updated on RxList: 12/2/2021
Injectafer Side Effects Center

What Is Injectafer?

Injectafer (ferric carboxymaltose) injection is an iron carbohydrate complex used to treat iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease.

What Are Side Effects of Injectafer?

Common side effects of Injectafer include:

Dosage for Injectafer

For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course. For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

What Drugs, Substances, or Supplements Interact with Injectafer?

Injectafer may interact with other drugs. Tell your doctor all medications and supplements you use.

Injectafer During Pregnancy and Breastfeeding

During pregnancy, Injectafer should be used only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Injectafer (ferric carboxymaltose) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Sickle cell disease is named after a farming tool. See Answer
Injectafer Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; feeling like you might pass out; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • increased blood pressure--dizziness, nausea, sudden warmth or redness in your face, severe headache, pounding in your neck or ears;
  • low levels of phosphorus in your blood--confusion, bone pain, muscle weakness; or
  • high levels of iron stored in your body--feeling weak or tired, joint pain, finger pain, stomach pain, weight loss, irregular heartbeats, fluttering in your chest.

Common side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Understanding Cancer: Metastasis, Stages of Cancer, and More See Slideshow
Injectafer Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypophosphatemia [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Laboratory Test Alterations [see WARNINGS AND PRECAUTIONS]

Clinical 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.

Adults

In 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 1. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2

Injectafer (N=1,775)
%
Pooled Comparatorsa (N=1,783)
%
Oral iron (N=253)
%
Nausea 7.2 2 1.2
Hypertension* 4 2 0.4
Flushing* 4 0.2 0
Injection site reactions* 3 3.2 0
Erythema* 3 0.6 0
Hypophosphatemia 2.1 0.1 0
Dizziness* 2.1 1.3 0.4
Vomiting 2 1 0.4
Injection Site Discoloration** 1.4 0.3 0
Headache* 1.3 1.2 0.4
Hepatic enzyme increased* 1.2 0.2 0
Dysgeusia* 1.2 1.2 0
Hypotension 1 2 0
Rash* 1 0.3 0
Constipation 0.5 0.9 3.2
a Includes oral iron and all formulations of IV iron other than Injectafer
*Grouped Terms:
Hypertension includes hypertension, blood pressure increased, and hypertensive crisis. 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.

Pooled data from two Phase 3 studies 1VIT09030 (NCT00981045) and 1VIT09031 (NCT00982007) with a dosing regimen of Injectafer 15 mg/kg up to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg of iron were analyzed to compare rates of adverse reactions in two Phase 3 parallel group studies 1VIT07017 (NCT00548860) and 1VIT07018 (NCT00548691) with a dosing regimen of Injectafer 15 mg/kg up to a maximum of 1,000 mg single dose (Table 2).

Table 2. 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.

Injectafer 15 mg/kg to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg Injectafer 15 mg/kg to a maximum of 1,000 mg
single dose
IVIT09030 and IVIT09031b (n=1,775)
%
IVIT07017 and IVIT07018a(n=1,200)
%
Any Adverse Reaction 24 12
Injection site reactions* 3 4
Injection site extravasation** 0.2 2
Hepatic enzyme increased* 1.2 1.2
Rash* 1 1.2
Headache* 1.3 1
Dizziness* 2.1 1
Dysgeusia* 1.2 1
Nausea 7.2 1
Hypertension* 4 1
Hypophosphatemia 2.1 1
Erythema* 3 0.3
Flushing* 4 0.3
Vomiting 2 0.2
Injection site discoloration** 1.4 <0.1
Hypotension 1 <0.1
abIncluded 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.

Pediatric Patients

The safety of Injectafer in pediatric patients was evaluated in study 1VIT17044 (NCT03523117; Study 3). Study 1VIT17044 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1,500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

Table 3 summarizes the adverse reactions in Study 3.

Table 3. Adverse Reactions of any Grade in Pediatric Patients Receiving Injectafer in Study 3

Injectafer
(n=40)
%
Oral Ferrous
Sulfate
(n=38)
%
Any Adverse Reactions 35 26
Hypophosphatemia* 13 0
Injection site reactions* 8 0
Rash* 8 0
Headache 5 3
Vomiting 5 3
Nasopharyngitis 3 5
Flushing 3 0
Gastrointestinal infections 3 0
Liver function test increased 3 0
Platelet count decreased 3 0
White blood cell count decreased 3 0
*Grouped Terms
Injection site reactions include infusion site hematoma, infusion site hypoesthesia and injection site pain.
Hypophosphatemia includes hypophosphatemia and blood phosphorus decreased.
Rash includes rash, exanthema and urticaria.

Post-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 (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

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Injectafer (Ferric carboxymaltose Injection)

© Injectafer Patient Information is supplied by Cerner Multum, Inc. and Injectafer Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors