Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting. The median age of patients who received Injectafer was 14.5 years (range, 1-17) 83% were female 88% White and 13% Black. Study 3 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 1500 mg 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The safety of Injectafer in pediatric patients was evaluated in Study 3.
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. 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 identified during post approval use of Injectafer. Adverse reactions reported by >2% of Injectafer-treated patients were nausea (7.2%) hypertension (4%) flushing (4%) injection site reactions (3%) erythema (3%) hypophosphatemia (2.1%) and dizziness (2.1%). In two randomized clinical studies, a total of 1775 patients were exposed to Injectafer, 15 mg/kg of 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 1500 mg of iron. 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. Monitor patients for signs and symptoms of hypertension following each Injectafer administration.
These elevations generally occurred immediately after dosing and resolved within 30 minutes. 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. In clinical studies, hypertension was reported in 4% (67/1775) of subjects in clinical trials 1 and 2. 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 trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. 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. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life- threatening and fatal, have been reported in patients receiving Injectafer. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment. In most cases, hypophosphatemia resolved within three months. 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. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting.
Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.