ARF: acute renal failure
ASP: average sales price
AWP: average wholesale price
Anaphylaxis: (AN-a-fy-LAK-sis): amanifestation of immediate hypersensitivity resulting from exposure of a sensitized individual to a specific antigen (such as to foreign proteins or drugs). Anaphylactic shock is often a severe, and sometimes fatal, systemic reaction in asusceptible individual characterized especially by respiratory symptoms, fainting, itching, and hives. Treatment of anaphylactic shock may require cardiopulmonary resuscitation
Anemia: (uh-NEE-mee-uh): any condition in which the number of red blood cells, the amount of hemoglobin, and the volume of packed red blood cells in the blood are lower than normal levels
Anemia of chronic disease: condition seen in a wide range of chronic disorders in which iron utilization is impaired, resulting in low levels of iron as hemoglobin despite normal or high levels of stored iron
Blood urea nitrogen [BUN]: (yoo-REE-uh NY-truh-jen): a waste product in the blood that comes from the breakdown of food protein and is removed by the kidneys. As kidney function decreases, the blood urea nitrogen level increases
CHr: reticulocyte hemoglobin content
CKD: chronic kidney disease (see Chronic renal failure)
CPT code: current procedural terminology (CPT) code
CRF: Chronic renal failure (see Chronic renal failure)
Chronic renal failure: (or chronic kidney failure, or chronic kidney disease): slow and progressive loss of kidney function over several years, often resulting in end-stage renal disease
Creatinine clearance: (kree-AT-ih-neen): test of renal function based on the rate at which ingested creatinine is filtered through the renal glomeruli
Dextran: (DEX-tran): aglucose polymer, available in various molecular weights
Dialysate: (di-AL-ih-sayt): cleansing solution, containing salts and glucose, used in dialysis therapy
Dialysis: (dy-AL-ih-sis): form of renal replacement therapy in which blood is passed across a semipermeable membrane to remove waste products and excess fluid
ESA: erythropoiesis stimulating agent
ESRD: end-stage renal disease
Epoetin: (ee-POH-eh-tin); also recombinant human erythropoietin (ree-KAHM-bin-ant eh-rith-roh-POY-eh-tin): a glycoprotein manufactured by recombinant DNA technology that stimulates red-blood-cell production. It is produced by mammalian cells into which the human erythropoietin gene has been introduced
Erythema: (er-ih-THEE-mah): redness of the skin due to capillary dilatation; flush
Erythrocytes: (eh-RITH-roh-SITES): mature red blood cells
Erythroid cells: (eh-RITH-royd): cells in the bone marrow that give rise to red blood cells
Erythron: (ER-i-thron): the total mass of circulating red blood cells and the part of the hematopoietic tissue from which they are derived
Erythropoiesis stimulating agent [ESA]: (eh-RITH-roh-poy-EE-sis): formation of new red blood cells
Erythropoietin [EPO]: (eh-rith-roh-POY-eh-tin): a protein produced by the kidney that enhances the formation of red blood cells
FDA: Food and Drug Administration
Ferritin: (FER-uh-tin): an iron-protein complex found in the intestinal mucosa, spleen, bone marrow, reticulocytes, and liver. It regulates iron storage and transport
Functional iron: pool of iron represented by iron that is a constituent of cell components such as hemoglobin
Functional iron deficiency: iron deficiency that develops during treatment with epoetin, a result of the failure of reticuloendothelial cells to release stores of iron fast enough to meet erythroid cell demand for iron during stimulated red-blood-cell production
Glomerular filtration rate [GFR]: (glow-MEHR-yoo-lar): rate at which a given compound passes through the glomerulus in a given time (usually per minute). If a compound is not reabsorbed or excreted, the amount of compound found in the urine in the given time is a measure of the glomerular filtration rate
HDD-CKD: Hemodialysis dependent - chronic kidney disease
Hematinic agents: (hee-mah-TIN-ik): agents that improve the quality of blood by increasing the red-blood-cell count and hemoglobin concentration
Hematocrit [Hct]: (heh-MAH-toe-krit): percentage of the volume of a blood sample occupied by cells
Hemodialysis: (hee-moh-dy-AL-ih-sis): see dialysis
Hemoglobin [Hb]: (hee-moh-GLOH-bin): the oxygen-carrying pigment in red blood cells
Hemolytic: (hee-moh-LIT-ic): associated with the destruction of red blood cells
Hypochromic: (hy-poh-KROH-mik): cells deficient in hemoglobin and iron content
Iron deficiency: depletion of iron stores to the degree that red-blood-cell production is impaired
Iron deficiency anemia: anemia accompanied by indicators of low iron status
KDOQI: Kidney Dialysis Outcomes Quality Initiative
MCV: mean corpuscular volume (see Mean corpuscular volume)
Mean corpuscular volume [MCV]: (kor-PUS-kyoo-lahr): ameasure of the average volume of red blood cells
Microcytic: cells that are reduced in size relative to normal values
Myoglobin: (MY-oh-GLOH-bin): the oxygen-transporting and storage protein of muscle, resembling blood hemoglobin in function
NDC: National drug code
NDD-CKD: Non-dialysis dependent - chronic kidney disease
NKF-KDOQI: National Kidney Foundation-Kidney Dialysis Outcomes Quality Initiative
RBC: red blood cell
Recombinant: (ree-KAHM-bin-ant): manufactured by inserting the DNA of a desired gene into the DNA of a bacterium, which then reproduces itself, yielding more of the desired gene
Respiratory enzymes:(EN-zimes): enzymes within cells that convert complex substances to carbon dioxide and water, transferring the removed electrons to oxygen
Reticulocytes: (reh-TIK-you-low-SITES): immature red blood cells; first red blood cells to enter the circulation during erythropoiesis
Reticuloendothelial cells: (reh-TIK-you-low-EN-dough-THEE-lee-al): specialized cells in liver, spleen, and bone marrow that take up and store inert particles
Reticuloendothelial system: (reh-TIK-you-low-EN-dough-THEE-lee-al): acollection of cells arising from stem cells in the bone marrow as well as specialized cells in the spleen, liver, and lymph nodes
Serum ferritin: (FER-I-tin): soluble form of iron-protein complex, containing up to 23% of iron, in circulation
Sickle cell anemia: inherited disorder leading to production of crescent (sickle)-shaped erythrocytes and accelerated red-blood-cell destruction
Sideroblastic anemia: (SID-er-oh-BLAS-tik): enzyme disorder in which the body is unable to incorporate iron into hemoglobin regardless of iron supply
TIBC: total iron-binding capacity
TSAT: transferrin saturation (see Transferrin saturation)
Total dose infusion of iron: a full therapeutic dose of iron given by single IV infusion. Dosage amount is calculated according to a specific formula, taking into account patient body weight and hemoglobin levels
Transferrin: (trans-FER-in): iron-transporting protein that circulates in the blood
Transferrin saturation [TSAT]: (trans-FER-in satch-uh-RAY-shun): the amount of protein-bound iron in circulation
Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.
In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥5% of Venofer® exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).
In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to Venofer® administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).
ASP: average sales price
AWP: average wholesale price
Anaphylaxis: (AN-a-fy-LAK-sis): amanifestation of immediate hypersensitivity resulting from exposure of a sensitized individual to a specific antigen (such as to foreign proteins or drugs). Anaphylactic shock is often a severe, and sometimes fatal, systemic reaction in asusceptible individual characterized especially by respiratory symptoms, fainting, itching, and hives. Treatment of anaphylactic shock may require cardiopulmonary resuscitation
Anemia: (uh-NEE-mee-uh): any condition in which the number of red blood cells, the amount of hemoglobin, and the volume of packed red blood cells in the blood are lower than normal levels
Anemia of chronic disease: condition seen in a wide range of chronic disorders in which iron utilization is impaired, resulting in low levels of iron as hemoglobin despite normal or high levels of stored iron
Blood urea nitrogen [BUN]: (yoo-REE-uh NY-truh-jen): a waste product in the blood that comes from the breakdown of food protein and is removed by the kidneys. As kidney function decreases, the blood urea nitrogen level increases
CHr: reticulocyte hemoglobin content
CKD: chronic kidney disease (see Chronic renal failure)
CPT code: current procedural terminology (CPT) code
CRF: Chronic renal failure (see Chronic renal failure)
Chronic renal failure: (or chronic kidney failure, or chronic kidney disease): slow and progressive loss of kidney function over several years, often resulting in end-stage renal disease
Creatinine clearance: (kree-AT-ih-neen): test of renal function based on the rate at which ingested creatinine is filtered through the renal glomeruli
Dextran: (DEX-tran): aglucose polymer, available in various molecular weights
Dialysate: (di-AL-ih-sayt): cleansing solution, containing salts and glucose, used in dialysis therapy
Dialysis: (dy-AL-ih-sis): form of renal replacement therapy in which blood is passed across a semipermeable membrane to remove waste products and excess fluid
ESA: erythropoiesis stimulating agent
ESRD: end-stage renal disease
Epoetin: (ee-POH-eh-tin); also recombinant human erythropoietin (ree-KAHM-bin-ant eh-rith-roh-POY-eh-tin): a glycoprotein manufactured by recombinant DNA technology that stimulates red-blood-cell production. It is produced by mammalian cells into which the human erythropoietin gene has been introduced
Erythema: (er-ih-THEE-mah): redness of the skin due to capillary dilatation; flush
Erythrocytes: (eh-RITH-roh-SITES): mature red blood cells
Erythroid cells: (eh-RITH-royd): cells in the bone marrow that give rise to red blood cells
Erythron: (ER-i-thron): the total mass of circulating red blood cells and the part of the hematopoietic tissue from which they are derived
Erythropoiesis stimulating agent [ESA]: (eh-RITH-roh-poy-EE-sis): formation of new red blood cells
Erythropoietin [EPO]: (eh-rith-roh-POY-eh-tin): a protein produced by the kidney that enhances the formation of red blood cells
FDA: Food and Drug Administration
Ferritin: (FER-uh-tin): an iron-protein complex found in the intestinal mucosa, spleen, bone marrow, reticulocytes, and liver. It regulates iron storage and transport
Functional iron: pool of iron represented by iron that is a constituent of cell components such as hemoglobin
Functional iron deficiency: iron deficiency that develops during treatment with epoetin, a result of the failure of reticuloendothelial cells to release stores of iron fast enough to meet erythroid cell demand for iron during stimulated red-blood-cell production
Glomerular filtration rate [GFR]: (glow-MEHR-yoo-lar): rate at which a given compound passes through the glomerulus in a given time (usually per minute). If a compound is not reabsorbed or excreted, the amount of compound found in the urine in the given time is a measure of the glomerular filtration rate
HDD-CKD: Hemodialysis dependent - chronic kidney disease
Hematinic agents: (hee-mah-TIN-ik): agents that improve the quality of blood by increasing the red-blood-cell count and hemoglobin concentration
Hematocrit [Hct]: (heh-MAH-toe-krit): percentage of the volume of a blood sample occupied by cells
Hemodialysis: (hee-moh-dy-AL-ih-sis): see dialysis
Hemoglobin [Hb]: (hee-moh-GLOH-bin): the oxygen-carrying pigment in red blood cells
Hemolytic: (hee-moh-LIT-ic): associated with the destruction of red blood cells
Hypochromic: (hy-poh-KROH-mik): cells deficient in hemoglobin and iron content
Iron deficiency: depletion of iron stores to the degree that red-blood-cell production is impaired
Iron deficiency anemia: anemia accompanied by indicators of low iron status
KDOQI: Kidney Dialysis Outcomes Quality Initiative
MCV: mean corpuscular volume (see Mean corpuscular volume)
Mean corpuscular volume [MCV]: (kor-PUS-kyoo-lahr): ameasure of the average volume of red blood cells
Microcytic: cells that are reduced in size relative to normal values
Myoglobin: (MY-oh-GLOH-bin): the oxygen-transporting and storage protein of muscle, resembling blood hemoglobin in function
NDC: National drug code
NDD-CKD: Non-dialysis dependent - chronic kidney disease
NKF-KDOQI: National Kidney Foundation-Kidney Dialysis Outcomes Quality Initiative
RBC: red blood cell
Recombinant: (ree-KAHM-bin-ant): manufactured by inserting the DNA of a desired gene into the DNA of a bacterium, which then reproduces itself, yielding more of the desired gene
Respiratory enzymes:(EN-zimes): enzymes within cells that convert complex substances to carbon dioxide and water, transferring the removed electrons to oxygen
Reticulocytes: (reh-TIK-you-low-SITES): immature red blood cells; first red blood cells to enter the circulation during erythropoiesis
Reticuloendothelial cells: (reh-TIK-you-low-EN-dough-THEE-lee-al): specialized cells in liver, spleen, and bone marrow that take up and store inert particles
Reticuloendothelial system: (reh-TIK-you-low-EN-dough-THEE-lee-al): acollection of cells arising from stem cells in the bone marrow as well as specialized cells in the spleen, liver, and lymph nodes
Serum ferritin: (FER-I-tin): soluble form of iron-protein complex, containing up to 23% of iron, in circulation
Sickle cell anemia: inherited disorder leading to production of crescent (sickle)-shaped erythrocytes and accelerated red-blood-cell destruction
Sideroblastic anemia: (SID-er-oh-BLAS-tik): enzyme disorder in which the body is unable to incorporate iron into hemoglobin regardless of iron supply
TIBC: total iron-binding capacity
TSAT: transferrin saturation (see Transferrin saturation)
Total dose infusion of iron: a full therapeutic dose of iron given by single IV infusion. Dosage amount is calculated according to a specific formula, taking into account patient body weight and hemoglobin levels
Transferrin: (trans-FER-in): iron-transporting protein that circulates in the blood
Transferrin saturation [TSAT]: (trans-FER-in satch-uh-RAY-shun): the amount of protein-bound iron in circulation
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Venofer iron sucrose injection, USP. Reinvigorating anemia management
American Regent. Enriching the lives of anemia patients. ™
IMPORTANT SAFETY INFORMATION: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to Venofer® or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving Venofer®. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Venofer® administration.Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.
In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥5% of Venofer® exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).
In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to Venofer® administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).
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