•
`
`-------------------------------CONTRAINDICATIONS------------------------------
`Hypersensitivity to Injectafer or any of its inactive components. (4)
`
`-----------------------WARNINGS AND PRECAUTIONS------------------------
`• Hypersensitivity reactions: Observe for signs and symptoms of
`hypersensitivity during and after Injectafer administration for at least 30
`minutes and until clinically stable following completion of each
`administration. (5.1)
`• Hypertension: Monitor patients closely for signs and symptoms of
`hypertension following each Injectafer administration. (5.2)
`
`
`------------------------------ADVERSE REACTIONS-------------------------------
`The most common adverse reactions (≥2%) are nausea, hypertension,
`flushing, hypophosphatemia, and dizziness. (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.
`
`-------------------------USE IN SPECIFIC POPULATIONS----------------------
`Nursing Mothers: Exercise caution when administered to a nursing
`•
`woman. (8.3)
`
`
`See 17 for PATIENT COUNSELING INFORMATION and FDA-
`approved patient labeling.
`
`
`
`
`
`
`Revised: July 2013
`
`HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to use Injectafer
`safely and effectively. See full prescribing information for Injectafer.
`
`INJECTAFER® (ferric carboxymaltose injection)
`For intravenous use
`Initial U.S. Approval: 2013
`
`----------------------------INDICATIONS AND USAGE---------------------------
`Injectafer is an iron replacement product indicated for the treatment of iron
`deficiency anemia in adult patients:
`who have intolerance to oral iron or have had unsatisfactory
`•
`response to oral iron;
`who have non–dialysis-dependent chronic kidney disease.
`
`----------------------DOSAGE AND ADMINISTRATION-----------------------
`For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses
`separated by at least 7 days. Give each dose as 750 mg for a total cumulative
`dose of 1500 mg of iron per course.
`
`For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses
`separated by at least 7 days and give each dose as 15 mg/kg body weight.
`
`Injectafer treatment may be repeated if iron deficiency anemia reoccurs. (2)
`
`---------------------DOSAGE FORMS AND STRENGTHS----------------------
`750 mg iron / 15 mL single-use vial. (3)
`
`_____________________________________________________________________________________________________________________________________
`
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`8.4 Pediatric Use
`10 OVERDOSAGE
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`12.2 Pharmacodynamics
`12.3 Pharmacokinetics
`13 NONCLINICAL TOXICOLOGY
`
` 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
`14 CLINICAL STUDIES
` 14.1 Trial 1: Iron Deficiency Anemia in Patients Who are Intolerant to
`Oral Iron or Have Had Unsatisfactory Response to Oral Iron
` 14.2 Trial 2: Iron Deficiency Anemia in Patients with Non–Dialysis-
`Dependent Chronic Kidney Disease
`16 HOW SUPPLIED/STORAGE AND HANDLING
`17 PATIENT COUNSELING INFORMATION
`
`* Sections or subsections omitted from the full prescribing information are not
`listed.
`___________________________________________________________________________________________________________________________________
`
`
` 1
`
`INDICATIONS AND USAGE
`
`2 DOSAGE AND ADMINISTRATION
`3 DOSAGE FORMS AND STRENGTHS
`4 CONTRAINDICATIONS
`5 WARNINGS AND PRECAUTIONS
`5.1 Hypersensitivity Reactions
`5.2 Hypertension
`Laboratory Test Alterations
`5.3
`6 ADVERSE REACTIONS
`6.1 Adverse Reactions in Clinical Trials
`6.2
`Post-marketing Experience
`7 DRUG INTERACTIONS
`8 USE IN SPECIFIC POPULATIONS
`Pregnancy
`8.1
`8.3 Nursing Mothers
`8.5 Geriatric Use
`
`
`
`
`
`1
`
`Pharmacosmos, Exh. 1046, p. 1
`
`

`

`FULL PRESCRIBING INFORMATION
`
` 1
`
`INDICATIONS AND USAGE
`
`Injectafer is indicated for the treatment of iron deficiency anemia in adult patients:
`
`
`• who have intolerance to oral iron or have had unsatisfactory response to oral iron;
`• who have non–dialysis-dependent chronic kidney disease.
`
` 2
`
`DOSAGE AND ADMINISTRATION
`
`For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses separated by
`at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500
`mg of iron per course.
`
`For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by
`at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not
`to exceed 1500 mg of iron per course.
`
`The dosage of Injectafer is expressed in mg of elemental iron. Each mL of Injectafer
`contains 50 mg of elemental iron. Injectafer treatment may be repeated if iron deficiency
`anemia reoccurs.
`
`Administer Injectafer intravenously, either as an undiluted slow intravenous push or by
`infusion. When administering as a slow intravenous push, give at the rate of
`approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to
`750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP,
`such that the concentration of the infusion is not less than 2 mg of iron per mL and
`administer over at least 15 minutes.
`
`When added to an infusion bag containing 0.9% sodium chloride injection, USP, at
`concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is
`physically and chemically stable for 72 hours when stored at room temperature. To
`maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
`
`Inspect parenteral drug products visually for the absence of particulate matter and
`discoloration prior to administration. The product contains no preservatives. Each vial of
`Injectafer is intended for single-use only. Any unused drug remaining after injection must
`be discarded.
`
`Avoid extravasation of Injectafer since brown discoloration of the extravasation site may
`be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the
`Injectafer administration at that site.
`
` 3
`
`
`
`DOSAGE FORMS AND STRENGTHS
`
`
`750 mg iron / 15 mL single-use vial
`
` 4
`
`CONTRAINDICATIONS
`
`Hypersensitivity to Injectafer or any of its components [see Warnings and Precautions
`(5.1)].
`
`2
`
`
`
`Pharmacosmos, Exh. 1046, p. 2
`
`

`

`
`
`WARNINGS AND PRECAUTIONS
`
`5
`
`5.1 Hypersensitivity Reactions
`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. [see Adverse Reactions (6.1 and 6.2)].
`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 not limited to, pruritus,
`rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these
`subjects.
`
`5.2 Hypertension
`In clinical studies, hypertension was reported in 3.8% (67/1,775) of subjects in clinical
`trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with
`facial flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in these
`two clinical trials. These elevations generally occurred immediately after dosing and
`resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension
`following each Injectafer administration [see Dosage and Administration (2)].
`
`5.3 Laboratory Test Alterations
`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.
`
` 6
`
`
`
`ADVERSE REACTIONS
`
`
`The following adverse reactions are discussed in greater detail in other sections of the
`labeling:
`Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
`•
`Hypertension [see Warnings and Precautions (5.2)]
`•
`Lab Test Alterations [see Warnings and Precautions (5.3)]
`•
`
`6.1 Adverse Reactions in Clinical Trials
`
`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.
`
`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 1500 mg of iron.
`
`3
`
`
`
`Pharmacosmos, Exh. 1046, p. 3
`
`

`

`
`Adverse reactions reported by ≥1% of treated patients are shown in the following table.
`
`Table 1. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2
`
`Injectafer
`Pooled
`Oral
`Comparatorsa
`
`
`iron
`Term
`
`
`
`(N=1775)
`(N=1783)
`(N=253)
`%
`%
`%
`7.2
`1.8
`1.2
`Nausea
`3.8
`1.9
`0.4
`Hypertension
`3.6
`0.2
`0.0
`Flushing/Hot Flush
`2.1
`0.1
`0.0
`Blood Phosphorus Decrease
`2.0
`1.2
`0.0
`Dizziness
`1.7
`0.5
`0.4
`Vomiting
`1.4
`0.3
`0.0
`Injection Site Discoloration
`1.2
`0.9
`0.0
`Headache
`1.1
`0.2
`0.0
`Alanine Aminotransferase Increase
`1.1
`2.1
`0.0
`Dysgeusia
`1.0
`1.9
`0.0
`Hypotension
`0.5
`0.9
`3.2
`Constipation
`a Includes oral iron and all formulations of IV iron other than Injectafer
`
`Other adverse reactions reported by ≥0.5% of treated patients include abdominal pain,
`diarrhea, gamma glutamyl transferase increased, injection site pain/irritation, rash,
`paraesthesia, sneezing. Transient decreases in laboratory blood phosphorus levels (<2
`mg/dL) have been observed in 27% (440/1638) patients in clinical trials.
`
`6.2 Post-marketing Experience
`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 serious adverse reactions have been most commonly
`reported from the post-marketing spontaneous reports with Injectafer: urticaria, dyspnea,
`pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain,
`arthralgia, and syncope. One case of hypophosphatemic osteomalacia was reported in a
`subject who received 500 mg of Injectafer every 2 weeks for a total of 16 weeks. Partial
`recovery followed discontinuation of Injectafer.
`
` 7
`
`DRUG INTERACTIONS
`
`Formal drug interaction studies have not been performed with Injectafer.
`
` 8
`
`
`
`USE IN SPECIFIC POPULATIONS
`
`
`8.1 Pregnancy
`Pregnancy Category C
`
`Risk Summary
`Adequate and well controlled studies in pregnant women have not been conducted.
`However, animal reproduction studies have been conducted with ferric carboxymaltose. In these
`studies, administration of ferric carboxymaltose to rabbits during the period of
`organogenesis caused fetal malformations and increased implantation loss at maternally
`
`4
`
`Pharmacosmos, Exh. 1046, p. 4
`
`

`

`toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on
`body surface area). The incidence of major malformations in human pregnancies has not
`been established for Injectafer. However, all pregnancies, regardless of exposure to any
`drug, has a background rate of 2 to 4% for major malformations, and 15 to 20% for
`pregnancy loss. Injectafer should be used during pregnancy only if the potential benefit
`justifies the potential risk to the fetus.
`
`Animal Data
`Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to
`30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryofetal
`findings. This daily dose in rats is approximately 40% of the human weekly dose of 750
`mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a
`one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18
`mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the
`human weekly dose of 750 mg). Spontaneous abortions occurred starting at the daily iron
`dose of 4.5 mg/kg (12% of the human weekly dose based on body surface area). Pre-
`implantation loss was at the highest dose. Adverse embryofetal effects were observed in
`the presence of maternal toxicity.
`
` A
`
` pre- and post-natal development study was conducted in rats at intravenous doses up to
`18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg on a
`body surface area basis). There were no adverse effects on survival of offspring, their
`behavior, sexual maturation or reproductive parameters.
`
`8.3 Nursing Mothers
`A study to determine iron concentrations in breast milk after administration of Injectafer
`(n=11) or oral ferrous sulfate (n=14) was conducted in 25 lactating women with
`postpartum iron deficiency anemia. Mean breast milk iron levels were higher in lactating
`women receiving Injectafer than in lactating women receiving oral ferrous sulfate.
`
`8.4 Pediatric Use
`Safety and effectiveness have not been established in pediatric patients.
`
`8.5 Geriatric Use
`Of the 1775 subjects in clinical studies of Injectafer, 50% were 65 years and over, while
`25% were 75 years and over. No overall differences in safety or effectiveness were
`observed between these subjects and younger subjects, and other reported clinical
`experience has not identified differences in responses between the elderly and younger
`patients, but greater sensitivity of some older individuals cannot be ruled out.
`
`10 OVERDOSAGE
`Excessive dosages of Injectafer may lead to accumulation of iron in storage sites
`potentially leading to hemosiderosis. A patient who received Injectafer 18,000 mg over 6
`months developed hemosiderosis with multiple joint disorder, walking disability and
`asthenia. Hypophosphatemic osteomalacia was reported in a patient who received
`Injectafer 4000 mg over 4 months. Partial recovery followed discontinuation of Injectafer.
`[see Post-marketing Experience (6.2)].
`
`11
`
`DESCRIPTION
`
`5
`
`
`
`Pharmacosmos, Exh. 1046, p. 5
`
`

`

`Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex
`with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(1→4)-O-α-D-
`glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate.
`It
`has
`a
`relative
`molecular weight of approximately 150,000 Da corresponding to the following empirical
`formula:
`
`[FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k,
`
`where n ≈ 103, m ≈ 8, l≈ 11, and k ≈ 4
`(l represents the mean branching degree of the ligand).
`
`The chemical structure is presented below:
`
`
`
`
`
`Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic
`colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric
`carboxymaltose in water for injection. Injectafer is available in 15 mL single-use vials.
`Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-
`7.0.
`
`Vial closure is not made with natural rubber latex.
`
`CLINICAL PHARMACOLOGY
`12
`12.1 Mechanism of Action
`Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose,
`a carbohydrate polymer that releases iron.
`
`12.2 Pharmacodynamics
`Using positron emission tomography (PET) it was demonstrated that red cell uptake
`of 59Fe and 52Fe from Injectafer ranged from 61% to 99%. In patients with iron
`deficiency, red cell uptake of radio-labeled iron ranged from 91% to 99% at 24 days after
`Injectafer dose. In patients with renal anemia red cell uptake of radio-labeled iron ranged
`from 61% to 84% after 24 days Injectafer dose.
`6
`
`
`
`Pharmacosmos, Exh. 1046, p. 6
`
`

`

`
`12.3 Pharmacokinetics
`After administration of a single dose of Injectafer of 100 to 1000 mg of iron in iron
`deficient patients, maximum iron levels of 37 µg/mL to 333 µg/mL were obtained
`respectively after 15 minutes to 1.21 hours post dose. The volume of distribution was
`estimated to be 3 L.
`
`The iron injected or infused was rapidly cleared from the plasma, the terminal half-life
`ranged from 7 to 12 hours. Renal elimination of iron was negligible.
`
`NONCLINICAL TOXICOLOGY
`13
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`Carcinogenicity studies have not been performed with ferric carboxymaltose.
`
`Ferric carboxymaltose was not genotoxic in the following genetic toxicology studies: in
`vitro microbial mutagenesis (Ames) assay, in vitro chromosome aberration test in human
`in vitro mammalian cell mutation assay
`lymphocytes,
`in mouse
`lymphoma
`L5178Y/TK+/- cells, in vivo mouse micronucleus test at single intravenous doses up to
`500 mg/kg.
`
`In a combined male and female fertility study, ferric carboxymaltose was administered
`intravenously over one hour to male and female rats at iron doses of up to 30 mg/kg.
`Animals were dosed 3 times per week (on Days 0, 3, and 7). There was no effect on
`mating function, fertility or early embryonic development. The dose of 30 mg/kg in
`animals is approximately 40% of the human dose of 750 mg based on body surface area.
`
`CLINICAL STUDIES
`14
`The safety and efficacy of Injectafer for treatment of iron deficiency anemia were
`evaluated in two randomized, open-label, controlled clinical trials (Trial 1 and Trial 2). In
`these two trials, Injectafer was administered at a dose of 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 1500 mg of iron.
`
`14.1 Trial 1: Iron Deficiency Anemia in Patients Who Are Intolerant to Oral Iron or
`Have Had Unsatisfactory Response to Oral Iron
`
`Trial 1 was a randomized, open-label, controlled clinical study in patients with iron
`deficiency anemia who had an unsatisfactory response to oral iron (Cohort 1) or who
`were intolerant to oral iron (Cohort 2) during the 14 day oral iron run-in period. Inclusion
`criteria prior to randomization included hemoglobin (Hb) <12 g/dL, ferritin ≤100 ng/mL
`or ferritin ≤300 ng/mL when transferrin saturation (TSAT) ≤30%. Cohort 1 subjects were
`randomized to Injectafer or oral iron for 14 more days. Cohort 2 subjects were
`randomized to Injectafer or another IV iron per standard of care [90% of subjects
`received iron sucrose]. The mean age of study patients was 43 years (range, 18 to 94);
`94% were female; 42% were Caucasian, 32% were African American, 24% were
`Hispanic, and 2% were other races. The primary etiologies of iron deficiency anemia
`were heavy uterine bleeding (47%) and gastrointestinal disorders (17%).
`
`
`7
`
`
`
`Pharmacosmos, Exh. 1046, p. 7
`
`

`

`Table 2 shows the baseline and the change in hemoglobin from baseline to highest value
`between baseline and Day 35 or time of intervention.
`
`Table 2. Mean Change in Hemoglobin From Baseline to the Highest Value
`Between Day 35 or Time of Intervention (Modified Intent-to-Treat Population)
`Hemoglobin (g/dL)
`Cohort 1
`Cohort 2
`Mean (SD)
`Injectafer
`Oral Iron
`Injectafer
`(N=244)
`(N=251)
`(N=245)
`10.6 (1.0)
`10.6 (1.0)
`9.1 (1.6)
`
`
`
`
`
`
`12.2 (1.1)
`11.4 (1.2)
`12.0 (1.2)
`
`
`
`
`
`
`1.6 (1.2)
`0.8 (0.8)
`2.9 (1.6)
`
`
`
`
`
`
`Baseline
`
`
`
`IV SCa
`(N=237)
`9.0 (1.5)
`
`
`11.2 (1.3)
`
`
`2.2 (1.3)
`
`
`
`0.001
`
`
`Highest Value
`
`
`
`Change (from baseline to
`highest value)
`
`0.001
`p-value
`SD=standard deviation; a: Intravenous iron per standard of care
`
`Increases from baseline in mean ferritin (264.2 ± 224.2 ng/mL in Cohort 1 and 218.2 ±
`211.4 ng/mL in Cohort 2), and transferrin saturation (13 ± 16% in Cohort 1 and 20 ±
`15% in Cohort 2) were observed at Day 35 in Injectafer-treated patients.
`
`14.2 Trial 2: Iron Deficiency Anemia in Patients with Non–Dialysis-Dependent
`Chronic Kidney Disease
`
`Trial 2 was a randomized, open-label, controlled clinical study in patients with non–
`dialysis-dependent chronic kidney disease. Inclusion criteria included hemoglobin (Hb)
`≤11.5 g/dL, ferritin ≤100 ng/mL or ferritin ≤300 ng/mL when transferrin saturation
`(TSAT) ≤30%. Study patients were randomized to either Injectafer or Venofer. The mean
`age of study patients was 67 years (range, 19 to 96); 64% were female; 54% were
`Caucasian, 26% were African American, 18% Hispanics, and 2% were other races.
`
`Table 3 shows the baseline and the change in hemoglobin from baseline to highest value
`between baseline and Day 56 or time of intervention.
`
`8
`
`
`
`Pharmacosmos, Exh. 1046, p. 8
`
`

`

`
`Table 3. Mean Change in Hemoglobin From Baseline to the Highest Value
`Between Baseline and Day 56 or Time of Intervention (Modified Intent-to-Treat
`Population)
`Hemoglobin (g/dL)
`Mean (SD)
`
`Baseline
`
`Injectafer
`(N=1249)
`
`10.3 (0.8)
`
`
`11.4 (1.2)
`
`1.1 (1.0)
`
`
`Venofer
`(N=1244)
`
`10.3 (0.8)
`
`
`11.3 (1.1)
`
`0.9 (0.92)
`
`
`0.21 (0.13, 0.28)
`
`
`Highest Value
`
`Change (from baseline to highest
`value)
`Treatment Difference (95% CI)
`
`Increases from baseline in mean f erritin (734.7 ± 337.8 ng/mL), and transferrin
`saturation (30 ± 17%) were observed at Day 56 in Injectafer-treated patients.
`
`16
`
`NDC 0517-0650-01
`NDC 0517-0650-02
`
`Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to
`86°F). [See the USP controlled room temperature]. Do not freeze.
`
`17
`
`HOW SUPPLIED/STORAGE AND HANDLING
`
`750 mg iron/15 mL Single-Use Vial
`750 mg iron/15 mL Single-Use Vial
`
`Individually boxed
`Packages of 2
`
`PATIENT COUNSELING INFORMATION
`• Question patients regarding any prior history of reactions to parenteral iron
`products.
`• Advise patients of the risks associated with Injectafer.
`• Advise patients to report any signs and symptoms of hypersensitivity that may
`develop during and following Injectafer administration, such as rash, itching,
`dizziness, lightheadedness, swelling and breathing problems [see Warnings and
`Precautions (5)].
`
`
`Injectafer is manufactured under license from Vifor (International) Inc, Switzerland.
`
`AMERICAN
`REGENT, INC.
`SHIRLEY, NY 11967
`
`IN0650
`RQ1052
`
`9
`
`
`
`Pharmacosmos, Exh. 1046, p. 9
`
`

`

`Patient Information
`INJECTAFER (ferric carboxymaltose injection)
`
`Please read this information carefully before taking this medication. This summary does
`not tell you everything about INJECTAFER. Speak with your doctor or healthcare
`professional if there is something you do not understand or if you would like to learn
`more about INJECTAFER. Your doctor or healthcare professional is your best source of
`information about this medicine.
`
`What is INJECTAFER?
`
`Iron is a mineral that the body needs to produce red blood cells. When the body does not
`get enough iron, it cannot produce the number of normal red blood cells needed to keep
`you in good health. This condition is called iron deficiency (iron shortage) or iron
`deficiency anemia.
`
`INJECTAFER is used to treat iron deficiency anemia. Iron deficiency anemia may be
`caused by several medical conditions including heavy menstrual bleeding, pregnancy,
`childbirth, inflammatory bowel disease, other malabsorption diseases, bariatric surgery,
`or chronic kidney disease.
`
`General information about using INJECTAFER safely and effectively
`
`Injectable iron is administered only by or under the supervision of your health care
`professional.
`
`Serious or life threatening allergic reactions have been reported with intravenous iron
`products. Tell your health care professional if you have ever had any unusual or allergic
`reaction to any IV iron.
`
`Patients should report to their healthcare professional any signs and symptoms of an
`allergic reaction to INJECTAFER, in particular rashes, shortness of breath and wheezing.
`
`Iron is not easily eliminated from the body, and its build up may be lead to a condition
`called iron overload which may be harmful. Certain medical conditions such as liver
`disease may also make you more likely to develop iron overload. Ask your doctor or
`healthcare professional.
`
`Who should not take INJECTAFER?
`
`You should not be given INJECTAFER if you have anemia that is not caused by iron
`deficiency, or if you have iron overload.
`
`If you are pregnant or plan to become pregnant please notify your doctor or healthcare
`professional. They will decide whether it is safe for you to receive INJECTAFER.
`
`
`
`
`10
`
`
`
`Pharmacosmos, Exh. 1046, p. 10
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`How should I take INJECTAFER?
`
`INJECTAFER is administered intravenously (into your vein) by your doctor or health
`care professional in two doses.
`
`What should I avoid while taking INJECTAFER?
`
`You should not take iron supplements by mouth if you are receiving iron injections. Tell
`your doctor about all the medicines you take, including prescription and non-prescription
`medicines, vitamins and herbal supplements.
`
`What are the possible side effects of INJECTAFER?
`
`The side effects of INJECTAFER are infrequent, usually mild and generally do not cause
`patients to stop treatment. The most common side effects are nausea, injection site
`reactions (including pain or bruising at the injection site), asymptomatic reductions in
`blood phosphorus, flushing, headache, hypertension, dizziness, and increased alanine
`aminotransferase. Potentially long lasting brown staining of skin near injection site may
`occur.
`
`These are not all the possible side effects of INJECTAFER. For more information ask
`your doctor or healthcare professional.
`
`Talk to your doctor if you think you have side effects from taking INJECTAFER.
`
`
`
`11
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`Pharmacosmos, Exh. 1046, p. 11
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