Choose Celtafer To provide the most iron per course of treatment in IDA1-6*† & for appropriate patients with iron deficiency (ID) and heart failure (HF)1‡

Celtafer is a first-line treatment for adult patients with iron deficiency anemia (IDA) and non-dialysis dependent chronic kidney disease (NDD-CKD) and adult patients with HF and ID and New York Heart Association (NYHA) class II/III to improve exercise capacity1
Over 4000 patients treated 7§

*CSL European Investor Site Tour Presentations (Mar 2023).7

†Compared to the dosing regimens of other intravenous (IV) iron treatments.2-7

‡One course of treatment is 2 doses of 500 mg separated by at least 7 days.

||Source: SHS claims data launch to Jan. 2024. 7

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Celtafer for Internal Medicine—replenish your patients’ iron deficit with Celtafer

When oral iron fails, it may be time to consider an IV iron for your patients with IDA

Choose Celtafer (ferric carboxymaltose injection), IV iron that restores up to 1000 mg in 1 course of therapy. Celtafer is dosed in 2 administrations of 500 mg separated by at least 7 days.1 100% of IV iron is delivered into your patient's bloodstream.

1000 mg in one course of treatment #**

Artist's rendering.
IV infusion icon

IV infusion over at least 15 minutes

IV push icon

Slow IV push over 7.5 minutes

For patients weighing less than 50 kg (110 lb), the recommended dosage is Celtafer 15 mg/kg body weight intravenously in 2 doses separated by at least 7 days per course.1

Celtafer treatment may be repeated if IDA or ID in HF reoccurs. Check serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment or for any patient who receives a repeat course of treatment within three months. Treat hypophosphatemia as medically indicated.1

Celtafer is available as a 500mg/10mL single-dose vial.

#Compared to the dosing regimens of other IV iron treatments.1-6

**When administered via IV infusion, dilute up to 500 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not <2 mg of iron per mL, and administer over at least 15 minutes. When administered as a slow IV push, give at the rate of approximately 100 mg (2 mL) per minute. 1

Recommended weight-based dosing for adult patients with ID in HF1
After determining your adult patients with HF and NYHA class II/III have ID, calculate the total iron needed using the dosing tables below1
Initial dose is based on hemoglobin (Hb) at baseline
DAY 1
Hb (g/dL) Patient body weight
<70 kg or ≥70 kg
≤14 1000 mg
≥14* 500 mg

*There are no data available to guide Celtafer dosing in patients with Hb ≥15.

Patients with lower Hb at baseline may require a week 6 dose
WEEK 6†
Hb (g/dL)
Patient body weight
<70 kg ≥70 kg
<10 500 mg 1000 mg
≥10* — 500 mg

*There are no data available to guide Celtafer dosing in patients with Hb ≥15.

†No week 6 dose is needed for patients with a Hb (g/dL) ≥14.

Reassess iron parameters at week 12. Maintenance dosing is recommended if ID is still present
WEEK 12, 24, AND 36‡
Administer a maintenance dose of 500 mg, if serum ferritin <100 ng/mL or serum ferritin 100 ng/mL to 300 ng/mL with Transferrin Saturation (TSAT) <20%

‡There are no data available to guide Celtafer dosing past 36 weeks.

A majority of patients with HF received 1000mg or more of Celtafer 1,8

In the Celtafer pivotal trials for the treatment of IDA, a fixed-dose regimen of 1000 mg was used.1 In CONFIRM-HF (a trial specific to ID treatment in certain HF patients), the mean and median total dose was 1000 mg (with a dosing range of 500 mg-3500 mg iron).8

§For patients weighing less than 50 kg (110 lb), the recommended dosage is Celtafer 15 mg/kg body weight intravenously in 2 doses separated by at least 7 days per course.1

||When administered via infusion, dilute up to 500 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not <2 mg of iron per mL, and administer over at least 15 minutes. When administering Celtafer 500 mg as a slow IV push, give at the rate of approximately 100 mg (2 mL) per minute.1,7

Celtafer is a first-line treatment for adult patients with IDA who have Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD).1

Internal Medicine:

A wide variety of patient types should be tested for IDA

Approximately 6.5 million adults in the United States have IDA7

Learn more about diagnosing and managing IDA

Review the efficacy and safety data from head-to-head pivotal trials

See the data

Patient Resource:

Download the Celtafer IDA Patient Brochure Download the Celtafer ID in HF Patient Brochure
IDA and cancer

There is a 44% to 50% prevalence of IDA across tumor types, including hematological malignancies.9

IDA in women ††

In the United States, 1 in 5 women of childbearing age has IDA.10

IDA and gastrointestinal (GI) conditions

There is a 36% to 76% prevalence of IDA in patients with inflammatory bowel disease (IBD).11

IDA and ID in HF

~50% of all patients with HF have ID.12
17% of patients with chronic HF have ID and anemia13

IDA and cancer

57.88%–58.8% (of men) and 69.9%–72.8% (of women) with NDD-CKD have low iron tests (NHANES III).14‡‡
Celtafer may be used as first-line treatment in adult patients with NDD-CKD.1

††Published studies and available data from postmarketing reports with IV Celtafer are insufficient to assess the risk for pregnant women of major birth defects and miscarriage.1

‡‡Defined in reference as serum ferritin <100 ng/mL or TSAT <20%. Authors concluded this remarkably high prevalence might indicate these indices may not be specific enough and may falsely identify too many patients as iron deficient.12

IMPORTANT SAFETY INFORMATION

INDICATIONS

Celtafer® (ferric carboxymaltose injection) 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, and in adult patients who have non-dialysis dependent chronic kidney disease. Celtafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

CONTRAINDICATIONS

Celtafer is contraindicated in patients with hypersensitivity to Celtafer or any of its inactive components.

WARNINGS AND PRECAUTIONS
Symptomatic Hypophosphatemia

Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Celtafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Celtafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). In most cases, hypophosphatemia resolved within three months.

Correct pre-existing hypophosphatemia prior to initiating therapy with Celtafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Celtafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Celtafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Celtafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Celtafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.

Hypertension

In clinical studies, hypertension was reported in 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Celtafer administration.

Laboratory Test Alterations

In the 24 hours following administration of Celtafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Celtafer.

ADVERSE REACTIONS
Adults

In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Celtafer, 15 mg/kg of body weight, up to a maximum single dose of 500 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1000 mg of iron. Adverse reactions reported by >2% of Celtafer-treated patients were nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

Patients with Iron Deficiency and Heart Failure

The safety of Celtafer 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 1016 patients received Celtafer versus 857 received placebo. The overall safety profile of Celtafer was consistent across the studied indications.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of Celtafer. 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 Celtafer: 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.