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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Laboratory Test Alterations [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness. ( 6.1 ) The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. Adults In two randomized clinical studies [Studies 1 and 2, see Clinical Studies ( 14 ) ], a total of 1,775 patients were exposed to Injectafer 15 mg/kg 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 1,500 mg of iron. Adverse reactions reported by ≥1% of treated patients are shown in the following table. Table 2. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2 Injectafer (N=1,775) % Pooled Comparators a (N=1,783) % Oral iron (N=253) % Nausea 7.2 2 1.2 Hypertension* 4 2 0.4 Flushing* 4 0.2 0 Injection site reactions* 3 3.2 0 Erythema* 3 0.6 0 Hypophosphatemia 2.1 0.1 0 Dizziness* 2.1 1.3 0.4 Vomiting 2 1 0.4 Injection Site Discoloration** 1.4 0.3 0 Headache* 1.3 1.2 0.4 Hepatic enzyme increased* 1.2 0.2 0 Dysgeusia* 1.2 2.1 0 Hypotension 1 2 0 Rash* 1 0.3 0 Constipation 0.5 0.9 3.2 a Includes oral iron and all formulations of IV iron other than Injectafer *Grouped Terms: Hypertension includes hypertension, blood pressure increased, and hypertensive crisis. Flushing includes flushing and hot flush. Injection site reactions include injection site extravasation, injection site discoloration, injection site pain, injection site irritation, injection site bruising, injection site reaction, injection site discomfort, injection site erythema, injection site hematoma, injection site hemorrhage, injection site pruritus, injection site rash, and injection site swelling. Erythema includes erythema and injection site erythema. Dizziness includes dizziness, balance disorder, and vertigo. **Injection site discoloration was also included in the injection site local administration reactions grouped term. Headache includes headache and migraine. Hepatic enzyme increased includes alanine aminotransferase increased and aspartate aminotransferase increased. Dysgeusia includes dysgeusia and ageusia. Rash includes rash, urticaria, skin exfoliation, blister, erythema multiforme, injection site rash, rash maculo-papular, and rash pruritic. Other adverse reactions reported by ≥0.5% of treated patients include abdominal pain, diarrhea, gamma glutamyl transferase increased, paresthesia, and sneezing. Transient decreases in laboratory blood phosphorus levels (< 2 mg/dL) have been observed in 27% (440/1,638) of patients in clinical trials. Pooled data from two Phase 3 studies 1VIT09030 (NCT00981045) and 1VIT09031 (NCT00982007) with a dosing regimen of Injectafer 15 mg/kg up to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg of iron were analyzed to compare rates of adverse reactions in two Phase 3 parallel group studies 1VIT07017 (NCT00548860) and 1VIT07018 (NCT00548691) with a dosing regimen of Injectafer 15 mg/kg up to a maximum of 1,000 mg single dose (Table 3). Table 3. Adverse Reactions (≥1% in any Treatment Group) In Patients Receiving Two Doses of 15 mg/kg to a Maximum of 750 mg to a Cumulative Dose of 1,500 mg or a Single Dose of Injectafer 15 mg/kg to a Maximum of 1,000 mg Injectafer 15 mg/kg to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg Injectafer 15 mg/kg to a maximum of 1,000 mg single dose IVIT09030 and IVIT09031 b (N=1,775) % IVIT07017 and IVIT07018 a (N=1,200) % Any Adverse Reaction 24 12 Injection site reactions* 3 4 Injection site extravasation** 0.2 2 Hepatic enzyme increased* 1.2 1.2 Rash* 1 1.2 Headache* 1.3 1 Dizziness* 2.1 1 Dysgeusia* 1.2 1 Nausea 7.2 1 Hypertension* 4 1 Hypophosphatemia 2.1 1 Erythema* 3 0.3 Flushing* 4 0.3 Vomiting 2 0.2 Injection site discoloration** 1.4 <0.1 Hypotension 1 <0.1 ab Included studies 1VIT07017, 1VIT07018, 1VIT09030 and 1VIT09031 *Grouped Terms **Injection site extravasation and injection site discoloration were also included in the injection site reactions grouped term. Pediatric Patients The safety of Injectafer in pediatric patients was evaluated in study 1VIT17044 (NCT03523117; Study 3). Study 1VIT17044 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 1,500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting. Table 4 summarizes the adverse reactions in Study 3. Table 4. Adverse Reactions of any Grade in Pediatric Patients Receiving Injectafer in Study 3 Injectafer (N=40) % Oral Ferrous Sulfate (N=38) % Any Adverse Reactions 35 26 Hypophosphatemia* 13 0 Injection site reactions* 8 0 Rash* 8 0 Headache 5 3 Vomiting 5 3 Nasopharyngitis 3 5 Flushing 3 0 Gastrointestinal infections 3 0 Liver function test increased 3 0 Platelet count decreased 3 0 White blood cell count decreased 3 0 *Grouped Terms Injection site reactions include infusion site hematoma, infusion site hypoesthesia and injection site pain. Hypophosphatemia includes hypophosphatemia and blood phosphorus decreased. Rash includes rash, exanthema and urticaria. Patients with Iron Deficiency and Heart Failure The safety of Injectafer 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 1,016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications. 6.2 Post-marketing Experience 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 Nervous system disorders: Syncope Respiratory, thoracic and mediastinal disorders: Dyspnea Skin and subcutaneous tissue disorders: Angioedema, erythema, pruritus, urticaria Pregnancy: Fetal bradycardia