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For people with excess urinary protein

Relief is possible

What is excess urinary protein?

Some kidney conditions cause the protein in your blood to leak into your urine. When you have too much protein in your urine, this is known as proteinuria due to nephrotic syndrome.

About FSGS

Some people get proteinuria due to nephrotic syndrome from a condition called focal segmental glomerulosclerosis (or FSGS). FSGS is a condition where you have scarring in the special areas of the kidney that filter the blood. It can be caused by an infection, certain medications, or other conditions. Sometimes, the cause is unknown.

If you have a more severe case of FSGS, you may have kidney damage or even kidney failure. If you’ve been living with FSGS and haven’t found relief for your proteinuria, you’re not alone. There may be a treatment that can help.

About IgA nephropathy

Some people develop proteinuria due to nephrotic syndrome from immunoglobulin A (IgA) nephropathy. IgA is a protein that helps your body fight infections.

IgA can sometimes collect in the kidneys and cause inflammation that hurts the kidneys. This can result in blood and protein leaking into the urine.

The exact cause of IgA nephropathy is unknown, but you may be at a higher risk if you have family members with the same condition.

If you have a more severe case of IgA nephropathy, you may develop long-term kidney disease or even kidney failure. If you’ve been living with IgA nephropathy, you’re not alone. There may be a treatment that can help.

How you may feel

Signs and symptoms of proteinuria due to nephrotic syndrome

FSGS or IgA nephropathy may lead to:

Foamy-looking urine

Swelling in your face
or ankles

Unexpected
weight gain

Keep in mind that some people may not have any of these symptoms.

Proteinuria due to post-transplant FSGS was lowered for some people taking Acthar Gel

A study based on a review of medical records looked at the effects of taking Acthar Gel in 20 people who developed FSGS after kidney transplant.

In this study,

50%

of people had reduction of proteinuria that met remission criteria* after taking Acthar Gel for an average of 6 months.

Eight people in the study developed a returning case of kidney failure after kidney transplant. Five of those were due to a returning or new case of FSGS. One person died during treatment, and 2 people died after treatment with Acthar Gel.

There were certain limits in this study. Acthar Gel is not a cure. Though Acthar Gel has been shown to help some people, not all people may experience the same results. Keep in mind that people in these clinical settings were on several treatments in addition to Acthar Gel. The results seen in these people may not all be due to Acthar Gel.

*Complete remission was defined as a decrease in proteinuria levels of <1 g/g with stable kidney function. Partial remission was defined as a decrease in proteinuria levels between 1 and 3.5 g/g with stable kidney function.

For most people, proteinuria due to FSGS was lowered after taking Acthar Gel

Another unblinded study looked at whether Acthar Gel as a treatment would help reduce proteinuria in people with FSGS. The study included 13 people taking Acthar Gel for 6 months.

In this study,

68%

of people achieved remission levels of proteinuria reduction

Of the 13 people with FSGS, 1 person achieved complete remission and 8 achieved partial remission.

The study included 22 people with kidney conditions. Thirteen people had FSGS. Some people experienced side effects. Of the 22 people in the study, there were 5 cases of high blood sugar, 3 cases of swelling, and 2 cases of insomnia. No one in the study stopped participating due to side effects.

There were certain limits in this study. Acthar Gel is not a cure. Though Acthar Gel has been shown to help some people, not all people may experience the same results. Keep in mind that people in these clinical settings were on several treatments in addition to Acthar Gel. The results seen in these people may not all be due to Acthar Gel.

Complete remission was defined as a UP/Cr ratio of <300 mg/g Cr. Partial response was defined as a 50% decrease in the UP/Cr ratio to <3500 mg/g.

Acthar Gel patient: Don shares his experience of taking Acthar Gel

MEET DON

"It’s not what happens to you, it’s
how you deal with it."

Individual results may vary. Actual patient compensated for his time.

After taking Acthar Gel, some people with IgA nephropathy had lowered proteinuria

A separate study based on a review of medical records looked at whether Acthar Gel was effective in treating people with IgA nephropathy. In this study, 19 people took Acthar Gel for 6 months and were followed for 6 months after completing the treatment.

42%

of people had reduction of proteinuria that met remission criteria 6 months after completing a round of treatment with Acthar Gel.

No one in the study stopped participating because of side effects. There were 53 side effects reported. These included 6 infections and 7 injection-site reactions. The most common side effects from Acthar Gel were muscle soreness, acne, hot flashes, anxiety, and trouble sleeping. No one reported serious adverse events.

There were certain limits in this study. Acthar Gel is not a cure. Though Acthar Gel has been shown to help some people, not all people may experience the same results. Keep in mind that people in these clinical settings were on several treatments in addition to Acthar Gel. The results seen in these people may not all be due to Acthar Gel.

Complete remission was defined as a decrease in proteinuria levels to <300 mg/24 h and a decrease in eGFR levels of ≤10%. Partial remission was defined as a decrease in proteinuria levels of >50% and a decrease in eGFR levels of ≤25%. No one in the study had complete remission. eGFR is short for estimated glomerular filtration rate. It is a way to measure the health of your kidneys.

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What is Acthar Gel?

Acthar® Gel is a prescription medicine used for:

  • Reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus)
  • Treatment of infantile spasms in infants and children under 2 years of age
  • Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar to be effective in speeding recovery from an MS relapse. However, there is no evidence that it affects the ultimate outcome or natural history of the disease

IMPORTANT SAFETY INFORMATION

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

  • Have been given or are about to receive a live or live attenuated vaccine
  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral

What is Acthar Gel?

Acthar® Gel is a prescription medicine used for:

  • Reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus)
  • Treatment of infantile spasms in infants and children under 2 years of age
  • Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar to be effective in speeding recovery from an MS relapse. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
  • Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina
  • Treatment for people with symptoms of sarcoidosis
  • Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus)
  • Treatment for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM)
  • Add-on therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis (RA), including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis

Acthar is injected beneath the skin or into the muscle.

IMPORTANT SAFETY INFORMATION

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

  • Have been given or are about to receive a live or live attenuated vaccine
  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral
  • Eye infections, such as ocular herpes simplex
  • Had recent surgery
  • Stomach ulcers or a history of stomach ulcers
  • Heart failure
  • Uncontrolled high blood pressure
  • Addison’s disease or Cushing’s syndrome
  • Allergies to pig-derived proteins
  • Suspected infections at birth (in infants under 2 years of age)

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking, including all prescription and nonprescription medicines, vitamins, and herbal supplements.

What is the most important information I should know about Acthar?

  • Never inject Acthar directly into a vein
  • Always inject Acthar beneath the skin or into the muscle
  • Follow your doctor’s instructions for injecting Acthar
  • Never stop treatment suddenly unless your doctor tells you to do so
  • Try not to miss any scheduled doctor’s appointments. It is important for the doctor to monitor you while taking Acthar
  • You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores
  • When taking Acthar long-term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing’s syndrome. This may cause increased upper body fat, a rounded “moon” face, bruising easily, or muscle weakness
  • Sometimes when you stop taking Acthar long-term, your body may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers
  • You might develop high blood pressure, retain too much salt and water, or have low blood potassium levels. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt or taking certain supplements
  • Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use when you are taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding and stomach ulcers. Tell your doctor if you have stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping. These effects are reversible once Acthar therapy is stopped
  • If you have other conditions, such as diabetes or muscle weakness, you may find they get worse
  • You might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your body may develop allergies to Acthar. Signs of allergic reaction are:
    • Skin rash and itching
    • Swelling of the face, tongue, lips, or throat
    • Trouble breathing
  • The effects of Acthar may be intensified if you have an underactive thyroid or cirrhosis of the liver
  • Long-term Acthar use can affect growth and physical development in children. This can be reversed when Acthar is no longer needed
  • Acthar may cause osteoporosis (weak bones)
  • Acthar might harm an unborn baby. Therefore, tell your doctor if you are pregnant or plan to become pregnant

What are the most common side effects of Acthar?

Commonly reported side effects of Acthar include:

  • Injection site reaction
  • Fatigue, physical weakness, and lack of energy
  • Fluid retention
  • Insomnia (difficulty sleeping)
  • Headache
  • High blood sugar

The most common side effects for the treatment of infantile spasms (IS) are:

  • Increased risk of infections
  • Convulsions
  • High blood pressure
  • Irritability
  • Fever

The above side effects may also be seen in adults and children over 2 years of age. Some children with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible after treatment for IS has been completed.

These are not all of the possible side effects of Acthar.

Tell your doctor about any side effect that bothers you, or that does not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-2830 1-800-844-2830.

Please see full Prescribing Information for additional Important Safety Information.

For parents and caregivers of patients with Infantile Spasms, please click here for Important Safety Information.