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Nephrotic Syndrome

What Is Nephrotic Syndrome?

Nephrotic syndrome is a group of symptoms that includes the following:

Low levels of protein in the blood
Swelling of tissue (edema), especially around the eyes, and in the feet, and hands
High levels of cholesterol in the blood

Nephrotic syndrome is caused by a variety of diseases and underlying disorders that damage the kidneys, resulting in excessive excretion of protein in the urine. Some kidney diseases that cause too much protein in your urine are called:

These diseases damage the glomeruli, which are small blood vessels that filter wastes and excess water from the blood and pass them into the bladder as urine.

As a result of protein loss in the urine, the blood is deficient in protein. Normal amounts of blood protein are needed to help regulate fluid pressure throughout the body. Protein in the blood normally draws water from the tissues into the bloodstream. When blood protein levels are low, the normal movement of water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic syndrome.

Nephrotic Syndrome Symptoms

You should be evaluated by a doctor if you experience any of the following signs or symptoms of nephrotic syndrome:

Foam in the toilet water when you urinate. This may be caused by excess protein in your urine, a sign of nephrotic syndrome.
Swelling (edema), particularly around your eyes or in the ankles and feet. This can result from kidney damage that results in leakage of protein into the urine. The resulting loss of protein from the blood can result in fluid retention in the tissues.
Weight gain. The retention of excess fluid in your body due to nephrotic syndrome can lead to weight gain. If your stomach and intestines are affected, edema also can cause loss of appetite and vomiting.

How Is Nephrotic Syndrome Diagnosed?

Diagnosis of nephrotic syndrome requires blood and urine samples. A high level of protein in a single urine sample may indicate nephrotic syndrome. The doctor may order a 24-hour collection of urine in order to get a more precise measurement of how much protein is being passed by the kidneys.

Blood tests may show low levels of protein. If kidney damage is advanced, waste products such as creatinine and urea that are normally filtered from the blood into the urine by the kidney may accumulate in the blood.

Once nephrotic syndrome is diagnosed, the doctor may recommend a kidney biopsy, a procedure in which tiny pieces of the kidney are removed for examination. The biopsy may reveal the underlying disease so that the doctor can determine a course of treatment. Nephrotic syndrome is frequently seen in patients with diabetes. If a person has had diabetes for some time, and the patient history and laboratory tests are consistent with diabetes as the cause of nephrotic syndrome, a biopsy is normally not taken.

Questcor

Uses

H.P. Acthar^® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

Monotherapy treatment of infantile spasms (IS) in infants and children under 2 years of age.
The treatment of exacerbations of multiple sclerosis in adults.
For inducing a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
The following: rheumatic disorders; collagen diseases; dermatologic diseases; allergic states; ophthalmic diseases and respiratory diseases.

Important Safety Information

Patients, parents, and caregivers should be aware of the important information about H.P. Acthar^® Gel.

Acthar should never be given intravenously (into a vein). Acthar should not be used in patients with a skin condition called scleroderma, bone density loss (osteoporosis), infection throughout the body, eye infection called ocular herpes simplex, recent surgery, history of or a current stomach ulcer, heart problems, high blood pressure, or allergy to pig‐derived proteins. Tell your doctor about any health problems or medicines.

Acthar may cause side effects similar to side effects that happen due to treatment with steroid medicines. Not all of these side effects have occurred with Acthar but they may occur. Acthar is a medicine that affects a patient’s immune system, and therefore patients may be more likely to get new infections, or inactive infections may become active. Acthar has effects on the adrenal gland. When a patient is taking Acthar, their adrenal gland may produce too much of a hormone called cortisol. This can cause symptoms of Cushing’s syndrome (upper body fat, rounded face, thin skin), which is more common in patients who take this medicine for a long time. When a patient stops taking Acthar after a long time, the body may not produce enough cortisol on its own (adrenal insufficiency). The doctor may prescribe a steroid medicine to protect the body until the adrenal gland recovers. Do not stop administering Acthar without talking to your doctor first. Your doctor may check your blood pressure during treatment and may instruct you to make some dietary changes. Patients should not receive certain vaccines during treatment with Acthar. Talk to your doctor about which vaccines are safe for use. Acthar may hide (or mask) symptoms of other conditions or diseases and it may be more difficult for your doctor to diagnose other conditions or diseases in you or your child during treatment. The person receiving Acthar has an increased risk for bleeding from the stomach or having a stomach ulcer. Inform your doctor about any pain in the stomach area, bloody vomit, or bloody or black stools. While on Acthar changes in mood and behavior such as irritability, depression, or trouble sleeping, may occur.

Other side effects are possible. Acthar may make certain other medical conditions worse, such as diabetes (may increase blood sugar); cause eye problems, such as cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve; and cause allergic reactions to Acthar (seen as skin rash, swelling of the face, tongue, lips, or throat, and trouble breathing). Acthar may affect growth and physical development after long term use. Long term use of Acthar may cause an increase in the size of the heart, but this condition usually goes away after Acthar is stopped.

The most common side effects of Acthar in infants include: infections, increased blood pressure, irritability and changes in behavior, changes in appetite and weight, diarrhea, and vomiting. Other adverse reactions reported in adults and children over 2 years of age included: abdominal bloating, anxiety, asthma, chest discomfort, congestive heart failure, dizziness, shortness of breath, redness of the face, fluid retention, flushing, headache, injection site pain, tiredness, muscle weakness, nervousness, rapid heart rate and lack of energy. Tell your doctor if there is any side effect that bothers you or your child or that does not go away.

These are not all of the possible side effects of Acthar. For more information, ask your doctor, nurse, or pharmacist, or call 1‐800‐465‐9217. You may report side effects to the FDA at 1‐800‐FDA‐1088.

This is a summary only. For a full list of warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information.

H.P. Acthar^® Gel and Questcor^® are registered trademarks of Questcor Pharmaceuticals, Inc.