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Feraheme Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Feraheme safely and effectively. Before taking Feraheme please consult with your doctor. See full prescribing information for Feraheme.

Warning

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [ see Warnings and Precautions (5.1) ]. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration [ see Warnings and Precautions (5.1) ]. Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated [ see Warnings and Precautions (5.1) ]. WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS See full prescribing information for complete boxed warning. Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. (5.1) Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration. (5.1) Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. (5.1)

Indications And Usage

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). Feraheme is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). (1)

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Dosage Forms And Strengths

Feraheme Injection is available in single use vials. Each vial contains 510 mg of elemental iron in 17 mL (30 mg per mL). Injection: 510 mg iron per17 mL (30 mg per mL) in single use vials. (3)

Contraindications

Feraheme is contraindicated in patients with: Known hypersensitivity to Feraheme or any of its components History of allergic reaction to any intravenous iron product Known hypersensitivity to Feraheme or any of its components. History of allergic reaction to any intravenous iron product

Warning and Cautions

Greater risk of anaphylaxis in patients with multiple drug allergies. (5.1). Hypotension: Feraheme may cause hypotension. Monitor for signs and symptoms of hypotension following each administration of Feraheme. (5.2) Iron Overload: Regularly monitor hematologic responses during Feraheme therapy. Do not administer Feraheme to patients with iron overload. (5.3) Magnetic Resonance Imaging: Feraheme can alter magnetic resonance imaging (MRI) studies. (5.4) 5.1 Serious Hypersensitivity Reactions Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving Feraheme [ see Boxed Warning ]. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous Feraheme dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each infusion [ see Adverse Reactions (6.2) ]. In clinical studies predominantly in patients with CKD, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects. In other trials excluding patients with Stages 4 and 5 CKD, moderate to severe hypersensitivity reactions were reported in 2.6% (26/1014) of patients treated with Feraheme. In the post-marketing experience, fatal and serious anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes [ see Boxed Warning, Adverse Reactions (6.2) and Use in Specific Populations (8.5) ]. 5.2 Hypotension Severe adverse reactions of clinically significant hypotension have been reported. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Hypotension has also been reported in the post-marketing experience [ see Adverse Reactions from Post-marketing Spontaneous Reports (6.2) ]. Monitor patients for signs and symptoms of hypotension following each Feraheme administration [ see Dosage and Administration (2) and Warnings and Precautions (5.1) ]. 5.3 Iron Overload Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy [ see Dosage and Administration (2) ]. Do not administer Feraheme to patients with iron overload. In the 24 hours following administration of Feraheme, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in the Feraheme complex. 5.4 Magnetic Resonance (MR) Imaging Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Anticipated MR imaging studies should be conducted prior to the administration of Feraheme. Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. If MR imaging is required within 3 months after Feraheme administration, use T1- or proton density-weighted MR pulse sequences to minimize the Feraheme effects; MR imaging using T2-weighted pulse sequences should not be performed earlier than 4 weeks after the administration of Feraheme. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration [ see Clinical Pharmacology (12.3) ]. Feraheme will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.

Adverse Reactions

Feraheme administration may cause serious hypersensitivity reactions and hypotension [ see Warnings and Precautions (5.1),(5.2) ]. In clinical studies, 1,726 subjects were exposed to Feraheme; 1,562 of these had CKD and 164 did not have CKD. Of these subjects 46% were male and the median age was 63 years (range of 18 to 96 years). Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice. The most common adverse reactions (≥ 2%) following the administration of Feraheme are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema. (6.1) To report SUSPECTEDwith Feraheme, contact AMAG Pharmaceuticals, Inc. at 1-877-411-2510, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Reactions in Clinical Studies Across the three randomized clinical trials [Trial 1, 2, and 3, see Clinical Studies (14) ], a total of 605 patients were exposed to two injections of 510 mg of Feraheme and a total of 280 patients were exposed to 200 mg/day of oral iron for 21 days. Most patients received their second Feraheme injection 3 to 8 days after the first injection. Adverse reactions related to Feraheme and reported by ≥ 1% of Feraheme-treated patients in the randomized clinical trials are listed in Table 1. Diarrhea (4.0%), constipation (2.1%) and hypertension (1.0%) have also been reported in Feraheme-treated patients. Table 1: Adverse Reactions to Feraheme Reported in ≥1% of Patients with CKD Adverse Reactions Feraheme 2 x 510 mg (n = 605) Oral Iron (n = 280) Nausea 3.1% 7.5% Dizziness 2.6% 1.8% Hypotension 2.5% 0.4% Peripheral Edema 2.0% 3.2% Headache 1.8% 2.1% Edema 1.5% 1.4% Vomiting 1.5% 5.0% Abdominal Pain 1.3% 1.4% Chest Pain 1.3% 0.7% Cough 1.3% 1.4% Pruritus 1.2% 0.4% Pyrexia 1.0% 0.7% Back Pain 1.0% 0% Muscle Spasms 1.0% 1.4% Dyspnea 1.0% 1.1% Rash 1.0% 0.4% In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria. Following completion of the controlled phase of the trials, 69 patients received two additional 510 mg intravenous injections of Feraheme (for a total cumulative dose of 2.04 g). Adverse reactions following this repeat Feraheme dosing were similar in character and frequency to those observed following the first two intravenous injections. In a placebo-controlled, cross-over trial, 713 patients with CKD received a single 510 mg dose of Feraheme. Adverse reactions reported by these patients were similar in character and frequency to those observed in other clinical trials. 6.2 Postmarketing Experience Because adverse 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 serious adverse reactions have been reported from the post-marketing experience with Feraheme: fatal, life-threatening, and serious anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme.

Drug Interactions

Drug-drug interaction studies with Feraheme were not conducted. Feraheme may reduce the absorption of concomitantly administered oral iron preparations.

Use In Specific Populations

8.1 Pregnancy Pregnancy Category C There are no studies of Feraheme in pregnant women. In animal studies, ferumoxytol caused fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose. Use Feraheme during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects. These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxytol during organogenesis at a maternally toxic dose of 100 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, caused a decrease in fetal weights. In rabbits, administration of ferumoxytol during organogenesis at a maternally toxic dose of 45 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, was associated with external and/or soft tissue fetal malformations and decreased fetal weights. 8.3 Nursing Mothers It is not known whether Feraheme is present in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to avoid Feraheme, taking into account the importance of Feraheme to the mother and the known benefits of nursing. 8.4 Pediatric Use The safety and effectiveness of Feraheme in pediatric patients (less than 18 years old) have not been established. 8.5 Geriatric Use In controlled clinical trials, 330 patients ≥ 65 years of age were treated with Feraheme. No overall differences in safety and efficacy were observed between older and younger patients in these trials, but greater sensitivity of older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes. The potential risks and benefits of Feraheme administration should be carefully considered in these patients [ see Dosage and Administration (2) Serious Hypersensitivity Reactions (5.1) and Clinical Studies (14) ].

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