Ferrlecit
Generic: SODIUM FERRIC GLUCONATE COMPLEX
Basic Information
Manufacturer
sanofi-aventis U.S. LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
b25b34ab-9cf1-4a2b-bdf2-5eaf66625999
Indications & Usage
1 INDICATIONS AND USAGE Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
( 1 )
Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.1) ] Hypotension [see Warnings and Precautions (5.2) ] The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps, and pain.
In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S.
LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (e.g., changes in morphology, color, or number of red blood cells), dyspnea, chest pain, leg cramps and pain.
In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.
Studies A and B In multiple dose Studies A and B (total 126 adult patients), the most frequent treatment emergent adverse reactions following Ferrlecit were: Body as a Whole: injection site reaction (33%), chest pain (10%), pain (10%), asthenia (7%), headache (7%), fatigue (6%), fever (5%), malaise, infection, abscess, chills, rigors, carcinoma, flu-like syndrome, sepsis, lightheadedness, weakness.
Nervous System: cramps (25%), dizziness (13%), paresthesias (6%), agitation, somnolence, decreased level of consciousness.
Respiratory System: dyspnea (11%), coughing (6%), upper respiratory infections (6%), rhinitis, pneumonia.
Cardiovascular System: hypotension (29%), hypertension (13%), syncope (6%), tachycardia (5%), bradycardia, vasodilatation, angina pectoris, myocardial infarction, pulmonary edema.
Gastrointestinal System: nausea, vomiting and/or diarrhea (35%), anorexia, abdominal pain (6%), rectal disorder, dyspepsia, eructation, flatulence, gastrointestinal disorder, melena.
Musculoskeletal System: leg cramps (10%), myalgia, arthralgia, back pain, arm pain.
Skin and Appendages: pruritus (6%), rash, increased sweating.
Genitourinary System: urinary tract infection, and menorrhagia.
Special Senses: conjunctivitis, rolling of the eyes, watery eyes, puffy eye lids, arcus senilis, redness of the eye, diplopia, and deafness.
Metabolic and Nutritional Disorders: hyperkalemia (6%), generalized edema (5%), leg edema, peripheral edema, hypoglycemia, edema, hypervolemia, hypokalemia.
Hematologic System: abnormal erythrocytes (11%) (changes in morphology, color, or number of red blood cells), anemia, leukocytosis, lymphadenopathy.
Study C – Pediatric Pediatric Patients: In a clinical trial of 66 iron-deficient pediatric hemodialysis patients, 6 to 15 years of age, inclusive, who were receiving a stable erythropoietin dosing regimen, the most common adverse reactions, occurring in ≥5%, regardless of treatment dosage, were: hypotension (35%), headache (24%), hypertension (23%), tachycardia (17%), vomiting (11%), fever (9%), nausea (9%), abdominal pain (9%), pharyngitis (9%), diarrhea (8%), infection (8%), rhinitis (6%), and thrombosis (6%).
More patients in the higher dose group (3.0 mg/kg) than in the lower dose group (1.5 mg/kg) experienced the following adverse events: hypotension (41% vs.
28%), tachycardia (21% vs.
13%), fever (15% vs.
3%), headache (29% vs.
19%), abdominal pain (15% vs.
3%), nausea (12% vs.
6%), vomiting (12% vs.
9%), pharyngitis (12% vs.
6%), and rhinitis (9% vs.
3%).
6.2 Postmarketing Experience In the single-dose, postmarketing, safety study, 11% of patients who received Ferrlecit and 9.4% of patients who received placebo reported adverse reactions.
The most frequent adverse reactions following Ferrlecit administration were: hypotension (2%), nausea, vomiting and/or diarrhea (2%), pain (0.7%), hypertension (0.6%), allergic reaction (0.5%), chest pain (0.5%), pruritus (0.5%), and back pain (0.4%).
The following additional events were reported in two or more patients: hypertonia, nervousness, dry mouth, and hemorrhage.
In the multiple-dose, open-label surveillance study, 28% of the patients received concomitant angiotensin-converting enzyme inhibitor (ACEI) therapy.
The incidences of both drug intolerance and suspected allergic events following first dose Ferrlecit administration were 1.6% in patients with concomitant ACEI use compared to 0.7% in patients without concomitant ACEI use.
The patient with a life-threatening event was not on ACEI therapy.
One patient had facial flushing immediately on Ferrlecit exposure.
No hypotension occurred and the event resolved rapidly and spontaneously without intervention other than drug withdrawal.
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 additional adverse reactions have been identified with the use of Ferrlecit from postmarketing spontaneous reports: Cardiovascular System: shock, fetal bradycardia, injection site superficial thrombophlebitis, phlebitis, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction.
Gastrointestinal System: dysgeusia.
Immune System: anaphylactic-type reactions.
Nervous System: loss of consciousness, generalized convulsion, hypoesthesia.
Skin and Appendages: skin discoloration, pallor.
Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events based on information from postmarketing spontaneous reports.
These adverse events included hypotension, nausea, vomiting, abdominal pain, diarrhea, dizziness, dyspnea, urticaria, chest pain, paresthesia, and peripheral swelling.
In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S.
LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (e.g., changes in morphology, color, or number of red blood cells), dyspnea, chest pain, leg cramps and pain.
In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.
Studies A and B In multiple dose Studies A and B (total 126 adult patients), the most frequent treatment emergent adverse reactions following Ferrlecit were: Body as a Whole: injection site reaction (33%), chest pain (10%), pain (10%), asthenia (7%), headache (7%), fatigue (6%), fever (5%), malaise, infection, abscess, chills, rigors, carcinoma, flu-like syndrome, sepsis, lightheadedness, weakness.
Nervous System: cramps (25%), dizziness (13%), paresthesias (6%), agitation, somnolence, decreased level of consciousness.
Respiratory System: dyspnea (11%), coughing (6%), upper respiratory infections (6%), rhinitis, pneumonia.
Cardiovascular System: hypotension (29%), hypertension (13%), syncope (6%), tachycardia (5%), bradycardia, vasodilatation, angina pectoris, myocardial infarction, pulmonary edema.
Gastrointestinal System: nausea, vomiting and/or diarrhea (35%), anorexia, abdominal pain (6%), rectal disorder, dyspepsia, eructation, flatulence, gastrointestinal disorder, melena.
Musculoskeletal System: leg cramps (10%), myalgia, arthralgia, back pain, arm pain.
Skin and Appendages: pruritus (6%), rash, increased sweating.
Genitourinary System: urinary tract infection, and menorrhagia.
Special Senses: conjunctivitis, rolling of the eyes, watery eyes, puffy eye lids, arcus senilis, redness of the eye, diplopia, and deafness.
Metabolic and Nutritional Disorders: hyperkalemia (6%), generalized edema (5%), leg edema, peripheral edema, hypoglycemia, edema, hypervolemia, hypokalemia.
Hematologic System: abnormal erythrocytes (11%) (changes in morphology, color, or number of red blood cells), anemia, leukocytosis, lymphadenopathy.
Study C – Pediatric Pediatric Patients: In a clinical trial of 66 iron-deficient pediatric hemodialysis patients, 6 to 15 years of age, inclusive, who were receiving a stable erythropoietin dosing regimen, the most common adverse reactions, occurring in ≥5%, regardless of treatment dosage, were: hypotension (35%), headache (24%), hypertension (23%), tachycardia (17%), vomiting (11%), fever (9%), nausea (9%), abdominal pain (9%), pharyngitis (9%), diarrhea (8%), infection (8%), rhinitis (6%), and thrombosis (6%).
More patients in the higher dose group (3.0 mg/kg) than in the lower dose group (1.5 mg/kg) experienced the following adverse events: hypotension (41% vs.
28%), tachycardia (21% vs.
13%), fever (15% vs.
3%), headache (29% vs.
19%), abdominal pain (15% vs.
3%), nausea (12% vs.
6%), vomiting (12% vs.
9%), pharyngitis (12% vs.
6%), and rhinitis (9% vs.
3%).
6.2 Postmarketing Experience In the single-dose, postmarketing, safety study, 11% of patients who received Ferrlecit and 9.4% of patients who received placebo reported adverse reactions.
The most frequent adverse reactions following Ferrlecit administration were: hypotension (2%), nausea, vomiting and/or diarrhea (2%), pain (0.7%), hypertension (0.6%), allergic reaction (0.5%), chest pain (0.5%), pruritus (0.5%), and back pain (0.4%).
The following additional events were reported in two or more patients: hypertonia, nervousness, dry mouth, and hemorrhage.
In the multiple-dose, open-label surveillance study, 28% of the patients received concomitant angiotensin-converting enzyme inhibitor (ACEI) therapy.
The incidences of both drug intolerance and suspected allergic events following first dose Ferrlecit administration were 1.6% in patients with concomitant ACEI use compared to 0.7% in patients without concomitant ACEI use.
The patient with a life-threatening event was not on ACEI therapy.
One patient had facial flushing immediately on Ferrlecit exposure.
No hypotension occurred and the event resolved rapidly and spontaneously without intervention other than drug withdrawal.
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 additional adverse reactions have been identified with the use of Ferrlecit from postmarketing spontaneous reports: Cardiovascular System: shock, fetal bradycardia, injection site superficial thrombophlebitis, phlebitis, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction.
Gastrointestinal System: dysgeusia.
Immune System: anaphylactic-type reactions.
Nervous System: loss of consciousness, generalized convulsion, hypoesthesia.
Skin and Appendages: skin discoloration, pallor.
Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events based on information from postmarketing spontaneous reports.
These adverse events included hypotension, nausea, vomiting, abdominal pain, diarrhea, dizziness, dyspnea, urticaria, chest pain, paresthesia, and peripheral swelling.