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What is Injectafer (ferric carboxymaltose), and how does it work?
Injectafer is a prescription iron replacement medicine used to treat iron deficiency anemia (IDA) in adults who have:
- intolerance to oral iron or who have not responded well to treatment with oral iron, or
- non-dialysis dependent chronic kidney disease
It is not known if Injectafer is safe and effective for use in children.
What are the side effects of Injectafer?
Injectafer may cause serious side effects, including:
- 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.
- 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:
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.
What is the dosage for Injectafer?
Recommended dosage 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.
Recommended dosage 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.
Each mL of Injectafer contains 50 mg of elemental iron.
Preparation And Administration
Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. 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.
When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. 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.
Discard unused portion.
Repeat Treatment Monitoring Safety Assessment
Injectafer treatment may be repeated if IDA reoccurs. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.
Is Injectafer safe to use while pregnant or breast feeding?
Before receiving Injectafer, tell your healthcare provider about all of your medical conditions, including if you:
Injectafer (ferric carboxymaltose) is a prescription iron supplement injection for people with chronic kidney disease who can't tolerate or absorb oral supplements.
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Kidney (Renal) Failure
Kidney failure can occur from an acute event or a chronic condition or disease. Prerenal kidney failure is caused by blood loss, dehydration, or medication. Some of the renal causes of kidney failure include sepsis, medications, rhabdomyolysis, multiple myeloma, and acute glomerulonephritis. Post renal causes of kidney failure include bladder obstruction, prostate problems, tumors, or kidney stones.Treatment options included diet, medications, or dialysis.
The First Signs of Kidney Stones (Nephrolithiasis)
Kidney stones are solid masses of crystalline material that form in the kidneys. Symptoms of kidney stones can include pain, nausea, vomiting, and even fever and chills. Kidney stones are diagnosed via CT scans and specialized X-rays. Treatment of kidney stones involves drinking lots of fluids and taking over-the-counter pain medications to medical intervention including prescription medications, lithotripsy, and sometimes even surgery.
Kidney Pain: Symptoms, Treatment, and Causes
Kidney pain has a variety of causes and symptoms. Infection, injury, trauma, bleeding disorders, kidney stones, and less common conditions may lead to kidney pain. Symptoms associated with kidney pain may include fever, vomiting, nausea, flank pain, and painful urination. Treatment of kidney pain depends on the cause of the pain.
What Are the Signs That Something Is Wrong With My Kidneys?
Most of the signs of kidney diseases are unnoticed, ignored, or appear very late in the disease. Over 37 million American adults have kidney diseases, and most are not aware of it.
Kidney Infection (Pyelonephritis)
Kidney infection (pyelonephritis) usually is caused by E. coli and other bacteria that have spread from the bladder from a UTI (urinary tract infection), poor hygiene, sexual intercourse, pregnancy, catheter, cystoscope exam, surgery, kidney stones, or prostate enlargement. Symptoms of kidney infection include back pain, frequent urination, pain during urination, fever, and or pus or blood in the urine. Kidney infection can be cured with antibiotic treatment. Cranberry juice may prevent UTIs, but that hasn’t been proven in all research studies.
Kidney Pain vs. Back Pain
The signs and symptoms of kidney pain and back pain depend upon the underlying cause. Doctors may use blood tests, X-rays, CT, and/or MRI to diagnose kidney pain and back pain. Treatment may include rest, ice, stretching, muscle strengthening, and pain-relieving medications.
Kidney Infection in Adults
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Hypertensive Kidney Disease
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Polycystic Kidney Disease (PKD), ARPKD, and ADPKD
Polycystic kidney disease (PKD) is characterized by numerous cysts in the kidneys. Polycystic kidney disease is a genetic disorder. There are two major inherited forms of PKD, autosomal dominant PKD, and autosomal recessive PKD. Symptoms include headaches, urinary tract infections, blood in the urine, liver and pancreatic cysts, abnormal heart valves, high blood pressure, kidney stones, aneurysms, and diverticulosis. Diagnosis of PKD is generally with ultrasound, CT or MRI scan. There is no cure for PKD, so treatment of symptoms is usually the general protocol.
Diabetes and Kidney Disease
In the United States diabetes is the most common cause of kidney failure. High blood pressure and high levels of blood glucose increase the risk that a person with diabetes will eventually progress to kidney failure. Kidney disease in people with diabetes develops over the course of many years. albumin and eGFR are two key markers for kidney disease in people with diabetes. Controlling high blood pressure, blood pressure medications, a moderate protein diet, and compliant management of blood glucose can slow the progression of kidney disease. For those patients who's kidneys eventually fail, dialysis or kidney transplantation is the only option.
Kidney Dysplasia: In Infants and Children
Kidney dysplasia is a condition in which one or both of a baby's kidneys do not develop normally. In kidney dysplasia, cysts replace normal kidney tissue. Signs of kidney dysplasia include enlarged kidneys and, rarely, high blood pressure. A child with kidney dysplasia may not have any symptoms. Genes and maternal exposure to certain drugs may cause kidney dysplasia. Regular checkups should include blood pressure measurements, kidney function tests, and urine testing for protein.
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