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:
` (cid:129) who have intolerance to oral iron or have had unsatisfactory response to oral iron;
` (cid:129) 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 ____________________
`Injection: 750 mg iron / 15 mL single-dose vial. (3)
`
`___________________________ CONTRAINDICATIONS __________________________
`Hypersensitivity to Injectafer or any of its inactive components. (4)
`_______________________ WARNINGS AND PRECAUTIONS ______________________
`(cid:129) 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)
`(cid:129) 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______________________
`Lactation: Monitor breastfed infants for gastrointestinal toxicity. (8.2)
`See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
`Revised: 04/2018
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`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
` 5.3 Laboratory Test Alterations
`6 ADVERSE REACTIONS
` 6.1 Adverse Reactions in Clinical Trials
` 6.2 Post-marketing Experience
`8 USE IN SPECIFIC POPULATIONS
` 8.1 Pregnancy
` 8.2 Lactation
` 8.4 Pediatric Use
` 8.5 Geriatric 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.
`
`FULL PRESCRIBING INFORMATION
`1
`INDICATIONS AND USAGE
`Injectafer is indicated for the treatment of iron deficiency anemia in adult patients:
`(cid:129) who have intolerance to oral iron or have had unsatisfactory response to oral
`iron;
`(cid:129) 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-dose 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
`Injection: 750 mg iron / 15 mL single-dose vial
`4 CONTRAINDICATIONS
`Hypersensitivity to Injectafer or any of its components [see Warnings and
`Precautions (5.1)].
`5 WARNINGS AND PRECAUTIONS
`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, 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)].
`
`PGR2020-00009
`Pharmacosmos A/S v. American Regent, Inc.
`Petitioner Ex. 1027 - Page 1
`
`

`

`Term
`
`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:
`(cid:129) Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
`(cid:129) Hypertension [see Warnings and Precautions (5.2)]
`(cid:129) Laboratory 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.
`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
`(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
`Alanine Aminotransferase Increase 1.1
`0.2
`0.0
`Dysgeusia
`1.1
`2.1
`0.0
`Hypotension
`1.0
`1.9
`0.0
`Constipation
`0.5
`0.9
`3.2
`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.
`8 USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`Risk Summary
`Published studies on the use of ferric carboxymaltose in pregnant women have not
`reported an association with ferric carboxymaltose and adverse developmental
`outcomes. However, these studies cannot establish or exclude the absence of any
`drug-related risk during pregnancy because the studies were not designed to
`assess for the risk of major birth defects (see Data). There are risks to the mother
`and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy (see
`Clinical Considerations).
`In animal reproduction studies, administration of ferric carboxymaltose to rabbits
`during the period of organogenesis caused adverse developmental outcomes
`including fetal malformations and increased implantation loss at maternally toxic
`doses of approximately 12% to 23% of the human weekly dose of 750 mg (based
`on body surface area).
`The estimated background risk of major birth defects and miscarriage for the
`indicated populations is unknown. Adverse outcomes in pregnancy occur
`regardless of the health of the mother or the use of medications. In the U.S. general
`population, the estimated background risk of major birth defects and miscarriage in
`clinically recognized pregnancies is 2-4% and 15-20%, respectively.
`
`Clinical Considerations
`Disease-Associated Maternal and/or Embryo/Fetal Risk
`Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse
`maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes
`associated with IDA include increased risk for preterm delivery and low birth
`weight.
`Data
`Human Data
`Published data from randomized controlled studies, prospective observational
`studies and retrospective studies on the use of ferric carboxymaltose in pregnant
`women have not reported an association with ferric carboxymaltose and adverse
`developmental outcomes. However, these studies cannot establish or exclude the
`absence of any drug-related risk during pregnancy because of methodological
`limitations, including that the studies were not primarily designed to capture safety
`data nor designed to assess the risk of major birth defects. Maternal adverse events
`reported in these studies are similar to those reported during clinical trials in adult
`males and non-pregnant females [see Adverse Reactions (6.1)].
`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
`embryonic or fetal 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 embryonic or fetal 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.
`8.2 Lactation
`Risk Summary
`The available published data on the use of ferric carboxymaltose in lactating women
`demonstrate that iron is present in breast milk. However, the data do not inform the
`full potential exposure of iron for the breastfed infant. Among the breastfed infants,
`there were no adverse events reported that were considered related to ferric
`carboxymaltose exposure through breastmilk. There is no information on the effects
`of ferric carboxymaltose on milk production. The developmental and health benefits
`of breastfeeding should be considered along with the mother’s clinical need for
`Injectafer in addition to any potential adverse effects on the breastfed child from the
`drug or from the underlying maternal condition.
`Clinical Considerations
`Monitor breastfed infants for gastrointestinal toxicity (constipation, diarrhea).
`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 Adverse Reactions (6.2)].
`11 DESCRIPTION
`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
`(lrepresents the mean branching degree of the ligand).
`
`PGR2020-00009
`Pharmacosmos A/S v. American Regent, Inc.
`Petitioner Ex. 1027 - Page 2
`
`

`

`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 IV SCa
` (N=244) (N=251) (N=245) (N=237)
`Baseline 10.6 (1.0) 10.6 (1.0) 9.1 (1.6) 9.0 (1.5)
`Highest Value 12.2 (1.1) 11.4 (1.2) 12.0 (1.2) 11.2 (1.3)
`Change (from
`baseline to 1.6 (1.2) 0.8 (0.8) 2.9 (1.6) 2.2 (1.3)
`highest value)
`p-value 0.001 0.001
`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: REPAIR-IDA, Randomized Evaluation of efficacy and safety of Ferric
`carboxymaltose in Patients with iron deficiency Anemia and Impaired Renal
`function, (NCT00981045) 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 101); 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.
`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) Injectafer Venofer
`Mean (SD) (N=1249) (N=1244)
`Baseline 10.3 (0.8) 10.3 (0.8)
`Highest Value 11.4 (1.2) 11.3 (1.1)
`Change (from baseline to highest value) 1.1 (1.0) 0.9 (0.92)
`Treatment Difference (95% CI) 0.21 (0.13, 0.28)
`
`Increases from baseline in mean ferritin (734.7 ± 337.8 ng/mL), and transferrin
`saturation (30 ± 17%) were observed prior to Day 56 in Injectafer-treated patients.
`16 HOW SUPPLIED/STORAGE AND HANDLING
`NDC 0517-0650-01 750 mg iron/15 mL Single-Dose Vial Individually boxed
`NDC 0517-0650-02 750 mg iron/15 mL Single-Dose Vial Packages of 2
`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 PATIENT COUNSELING INFORMATION
`(cid:129) Question patients regarding any prior history of reactions to parenteral iron
`products.
`(cid:129) Advise patients of the risks associated with Injectafer.
`(cid:129) 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-P
`
`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-dose 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.
`12 CLINICAL PHARMACOLOGY
`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% at 24 days after Injectafer dose.
`12.3 Pharmacokinetics
`After administration of a single dose of Injectafer of 100 to 1000 mg of iron in iron
`deficient patients, maximum iron concentration 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.
`13 NONCLINICAL TOXICOLOGY
`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 lymphocytes, in vitromammalian cell mutation assay 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.
`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
`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.
`Trial 1: A Multi-center, Randomized, Active Controlled Study to Investigate the
`Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients with
`Iron Deficiency Anemia (IDA), (NCT00982007) 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%).
`
`PGR2020-00009
`Pharmacosmos A/S v. American Regent, Inc.
`Petitioner Ex. 1027 - Page 3
`
`

`

`Patient Information
`INJECTAFER (in-jekt-a-fer)
`(ferric carboxymaltose injection)
`
`What is INJECTAFER?
`INJECTAFER is a prescription iron replacement medicine used to treat iron deficiency anemia in adults who have:
`(cid:129) intolerance to oral iron or who have not responded well to treatment with oral iron
`(cid:129) non-dialysis dependent chronic kidney disease
`It is not known if INJECTAFER is safe and effective for use in children.
`Who should not receive INJECTAFER?
`Do not receive INJECTAFER if you are allergic to ferric carboxymaltose or any of the ingredients in INJECTAFER. See the end
`of this leaflet for a complete list of ingredients in INJECTAFER.
`Before receiving INJECTAFER, tell your healthcare provider about all of your medical conditions, including if you:
`(cid:129) have had an allergic reaction to iron given into your vein
`(cid:129) have high blood pressure
`(cid:129) are pregnant or plan to become pregnant. It is not known if INJECTAFER will harm your unborn baby.
`(cid:129) are breastfeeding or plan to breastfeed. INJECTAFER passes into your breast milk. It is unknown whether INJECTAFER
`would pose a risk to your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with
`INJECTAFER.
`Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
`vitamins, and herbal supplements.
`How will I receive INJECTAFER?
`INJECTAFER is given intravenously (into your vein) by your healthcare provider in 2 doses at least 7 days apart.
`What are the possible side effects of INJECTAFER?
`INJECTAFER may cause serious side effects, including:
`(cid:129) Allergic (hypersensitivity) reactions. Serious life-threatening allergic reactions have happened in people who receive
`INJECTAFER. Other serious reactions including itching, hives, wheezing, and low blood pressure also have happened during
`treatment with INJECTAFER. Tell your healthcare provider if you have ever had any unusual or allergic reaction to any iron
`given by vein.
`(cid:129) High blood pressure (hypertension). High blood pressure, sometimes with face flushing, dizziness, or nausea, has
`happened during treatment with INJECTAFER. Your healthcare provider will check your blood pressure and check for any
`signs and symptoms of high blood pressure after you receive INJECTAFER.
`The most common side effects of INJECTAFER include:
`(cid:129) nausea
`(cid:129) dizziness
`(cid:129) flushing (cid:129) high blood pressure
`These are not all the possible side effects of INJECTAFER.
`Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
`General information about INJECTAFER
`Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your
`pharmacist or healthcare provider for information about INJECTAFER that is written for health professionals.
`What are the ingredients in INJECTAFER?
`Active ingredient: ferric carboxymaltose
`Inactive ingredients: water for injection. Sodium hydroxide and/or hydrochloric acid may have been added to adjust
`pH to 5.0-7.0.
`
`(cid:129) low levels of phosphorous in your blood
`
`AMERICAN
`REGENT, INC.
`SHIRLEY, NY 11967
`For more information go to www.injectafer.com or call 1-800-734-9236.
`
`This Patient Information has been approved by the U.S. Food and Drug Administration.
`
`Revised: 04/2018
`
`PGR2020-00009
`Pharmacosmos A/S v. American Regent, Inc.
`Petitioner Ex. 1027 - Page 4
`
`