Banner - About IDA- Detecting and diagnosing IDA

Treating and Managing IDA

Overall, the treatment of IDA consists of remedying the underlying etiology and replenishing iron stores.27

IDA treatment goals28

  • Correct the anemia
  • Prevent a further fall in hemoglobin (Hb)
  • Avoid the use of blood transfusions
  • Increase Hb, serum ferritin, and transferrin saturation (TSAT) above the lower threshold of normal

IDA requires ongoing care to ensure iron levels stay where they need to be. Until a patient's iron returns to a sufficient level, which can take time depending on which therapy they are on, they may still experience symptoms like fatigue.

IDA requires ongoing care to ensure iron levels stay where they need to be. Until a patient's iron returns to a sufficient level, which can take time depending on which therapy they are on, they may still experience symptoms like fatigue.

Two common treatment options are oral and intravenous iron.1

IDA management and treatment options

There's more to evaluating IDA than hemoglobin levels

Patients with IDA may fail oral iron for a number of reasons

Patients with IDA may fail oral iron for a number of reasons

Oral iron is poorly absorbed, even in healthy patients29

Less than 10% of oral iron is absorbed

*Less than 10% absorption of oral iron is based on a regimen of 300-mg or 320-mg tablets 3 to 4 times a day.

Oral Iron Therapy Issues Icon Oral Iron Therapy Issues Icon

CLINICAL CONSIDERATION A wide variety of inflammatory conditions can elevate hepcidin, hindering oral iron absorption and reducing serum iron levels.30

Adherence issues

Oral Iron Therapy Adherence Rate Icon

Data show the adherence rate for oral iron therapy is 40% to 60%.31
Adherence may be affected by side effects.29

Side effects

Oral Iron Therapy Side Effects Icon

10% to 40% of patients taking oral iron may experience side effects, which could necessitate reduction of dose or dosing frequency.32

Adverse reactions reported by ≥2% of Injectafer-treated patients were nausea (7.2%); hypertension (3.8%); flushing/hot flush (3.6%); blood phosphorus decrease (2.1%); and dizziness (2.0%).26

Consider testing your patients 14 to 30 days after starting oral iron to see if they are having an adequate response to oral iron therapy33,34

Consider testing your patients 14 to 30 days after starting oral iron to see if they are having an adequate response to oral iron therapy33,34

100% of IV iron is delivered into the patient's bloodstream

100% of Injectafer iron is delivered into the patient’s bloodstream

If your patients do not respond adequately to oral iron,
you may want to consider IV iron

IV Iron Therapy Delivers 100% Iron Into Bloodstream

  • The full dose of IV iron is available to be utilized in hemoglobin production or stored as ferritin for future use as hemoglobin is depleted.35

Routinely test across all 3 key indices
to determine if your patient’s iron therapy is working15,16

When oral iron fails, it may be time to consider an IV iron like Injectafer

When oral iron fails, it may be time to consider an IV iron like Injectafer

CHOOSING INJECTAFER

CHOOSING INJECTAFER

Important Safety Information

INDICATIONS

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the 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, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. 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 Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer 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 Injectafer. 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.

In clinical studies, hypertension was reported in 3.8% (67/1775) of subjects. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration.

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

ADVERSE REACTIONS

In two randomized clinical studies, a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a single maximum dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse reactions reported by ≥2% of Injectafer-treated patients were nausea (7.2%); hypertension (3.8%); flushing/hot flush (3.6%); blood phosphorus decrease (2.1%); and dizziness (2.0%).

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.

CLINICAL CONSIDERATIONS 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 in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.

You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see Full Prescribing Information.

References - About IDA