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Telehealth resource - PREPARING FOR INFUSIONS
Preparing for infusions
Preparing for Injectafer
Injectafer is given by IV infusion, usually at an infusion center, where a healthcare professional can administer it directly into the bloodstream through a vein. Infusion centers are medical facilities equipped and staffed for administering infusions.18
How long do Injectafer infusions take?
- Each Injectafer infusion may take about 15 minutes3
- Afterward, your healthcare provider will monitor you for about 30 minutes for signs of allergic reaction3
Before your first Injectafer infusion+
Before your first Injectafer infusion—
Call ahead to confirm that the infusion center can provide Injectafer IV iron
Ask about Injectafer by name. Injectafer is the only IV iron that can provide up to 1500 mg of iron in just 2 doses of 750 mg separated by at least 7 days3
Dress comfortably and eat as you normally would. There are no special dietary requirements
Bring insurance coverage identification and any other information your doctor has asked you to bring
During your infusion+
During your infusion—
- The usual dosage is 1500 mg, administered in 2 separate doses of 750 mg each separated by at least 7 days. Your dosage may vary based on your weight3
- Your infusion may take about 15 minutes, and your doctor or nurse will monitor your response during and after your infusion3
After each infusion+
After each infusion—
- Your iron stores are replenished over time. So it’s important for you to follow up with your doctor and retest your levels19
- In some patients, an increase in blood pressure with dizziness, nausea, or flushing of the face may occur right after a dose of Injectafer. It usually goes away within 30 minutes. Tell your doctor right away if symptoms persist or worsen3
- Be sure to follow up with your physician to see how Injectafer is working for you
Download helpful information and track your progress with the Injectafer patient brochure
Important Safety Information
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
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.
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.
References - Telehealth Resources