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Share this information during your virtual visits with patients to help discuss iron deficiency anemia (IDA) and Injectafer® (ferric carboxymaltose injection).

Telehealth resource - IDA TREATMENT OPTIONS

IDA treatment options

 

About IV iron

IDA usually requires IV iron therapy. This kind of
treatment is done in an infusion center.

Some of the reasons your doctor may prescribe
IV iron to treat your IDA could include:

  • Oral iron is not absorbing well in the
    digestive system
  • Blood loss—which can be caused by a number
    of things including, but not limited to, heavy
    periods, major surgery or physical trauma,
    and some gastrointestinal diseases

WITH IV IRON, 100%
Delivered into the bloodstream

Your doctor will most likely prescribe an oral iron treatment for you first.

For some people with IDA, iron pills may not be the right option. There are several reasons why this might be.
The most common reasons are7,8:

  • Iron in oral form can cause hard-to-tolerate
    side effects
  • Oral iron can fail to replenish iron levels
    to where the body needs them because the
    digestive system has trouble absorbing it

EVEN IN HEALTHY PATIENTS, 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.

IDA usually requires IV iron therapy. This kind of treatment is done in an infusion center.

Some of the reasons your doctor may prescribe IV iron to treat your IDA could include:

  • Oral iron is not absorbing well in the
    digestive system
  • Blood loss—which can be caused by a number
    of things including, but not limited to, heavy
    periods, major surgery or physical trauma,
    and some gastrointestinal diseases

WITH IV IRON, 100%
Delivered into the bloodstream

Injectafer: An IV iron

  • Injectafer is used to treat adults with iron deficiency anemia3:
    • When oral iron treatments haven't worked, or side effects from oral iron couldn't be tolerated or
    • For adults with non-dialysis-dependent chronic kidney disease
  • Unlike with pills, 100% of the iron in Injectafer goes directly into the bloodstream3
  • Proven in clinical studies in more than 8800 patients, Injectafer demonstrated greater increases in hemoglobin at follow-up than either oral iron or another intravenous (IV) iron16,17
  • Potential side effects with Injectafer include, but are not limited to, allergic reactions, nausea, temporary hypertension, and flushing3

If you weigh less than 110 pounds, you may be given a smaller amount of Injectafer. Your doctor will decide on the most appropriate way to give you your treatment3:

  • Each Injectafer infusion takes about 15 minutes. After your infusion, your healthcare provider will monitor you for signs and symptoms of an allergic reaction—usually for about 30 minutes
  • If you are at risk for low serum phosphate, your doctor may monitor your serum phosphate levels if you require a second course of treatment of Injectafer (beyond 2 administrations of up to 750 mg each). Your doctor can discuss risk factors for low serum phosphate with you

Download helpful information and track your progress with the Injectafer patient brochure

If you take Injectafer, follow up with your doctor after your infusion(s) to see how Injectafer works for you.

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 - Telehealth Resources