How Acthar May Help After a Transplant

If, after your kidney transplant, you are found with proteinuria, you may be at a higher risk of kidney problems due to nephrotic syndrome. Nephrotic syndrome may be caused by a number of conditions, one of which is called focal segmental glomerulosclerosis, or FSGS.

If you have FSGS, your doctor may have told you that one of the goals in treating it is to reduce or eliminate proteinuria.

After your kidney transplant, you may be wondering what treatment is next. Treatment with Acthar may help your new kidney by reducing proteinuria.

Acthar may be able to help achieve remission of your proteinuria. Acthar is FDA-approved to reduce proteinuria levels in people with nephrotic syndrome.

In a recent study of 20 people with post-transplant FSGS,50% had complete or partial proteinuria remission

Four people achieved complete remission and 6 people achieved partial remission.

The study measured 20 people taking Acthar for proteinuria and included patients who had new or recurring post-transplant FSGS. Most people in this study had been previously treated with therapeutic plasma exchange (TPE) and/or rituximab, and, on average, developed FSGS about 3 months after their transplant.

Eight people in the study experienced a failed transplant. Five of those cases were attributed to recurrent or new FSGS. One person died while taking Acthar. Two people died in the post-Acthar treatment follow-up period.

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

If you have any questions about taking Acthar for post-transplant FSGS, write them down in your Acthar Treatment Journal and bring them to your next appointment.

In a recent study of 20 people with post-transplant FSGS,50% had complete or partial proteinuria remission

Four people achieved complete remission and 6 people achieved partial remission.

The study measured 20 people taking Acthar for proteinuria and included patients who had new or recurring post-transplant FSGS. Most people in this study had been previously treated with therapeutic plasma exchange (TPE) and/or rituximab, and, on average, developed FSGS about 3 months after their transplant.

Eight people in the study experienced a failed transplant. Five of those cases were attributed to recurrent or new FSGS. One person died while taking Acthar. Two people died in the post-Acthar treatment follow-up period.

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

If you have any questions about taking Acthar for post-transplant FSGS, write them down in your Acthar Treatment Journal and bring them to your next appointment.

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IMPORTANT SAFETY
INFORMATION

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

  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral
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What is H.P. Acthar® Gel?

Acthar is a prescription medicine for the 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).

IMPORTANT SAFETY INFORMATION

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

  • 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
  • Allergies to pig-derived proteins
  • Have been given or are about to receive a live or live attenuated vaccine
  • Suspected congenital infections (in children under 2 years of age)
  • If you have been told that you have Cushing's syndrome or Addison's disease

What is H.P. Acthar® Gel?

Acthar is a prescription medicine for the 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).

Acthar is injected beneath the skin or into the muscle.

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

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

Acthar and corticosteroids have similar side effects.

  • 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, or retain too much fluid. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt and 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 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
  • 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
  • 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 on becoming pregnant

What are the most common side effects of Acthar?

The most common side effects of Acthar are similar to those of steroids. They include:

  • Fluid retention
  • High blood sugar
  • High blood pressure
  • Behavior and mood changes
  • Changes in appetite and weight

Specific side effects in children under 2 years of age include:

  • Increased risk of infections
  • High blood pressure
  • Irritability
  • Symptoms of Cushing's syndrome
  • Thickening of the heart muscle (cardiac hypertrophy)
  • Weight gain

The above side effects may also be seen in adults and children over 2 years of age.

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-10881-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-78981-800-778-7898.

Please see full Prescribing Information.