Patient stories

Uveitis

Dennis, a real Acthar Gel patient

Dennis shares his experience with Acthar Gel support services including reimbursement assistance, injection training, and personal nurse coaching.

[NARRATOR] In a moment, you’ll hear from Dennis. He’s living with bilateral uveitis. He’ll tell you about his experience using H.P. Acthar Gel (repository corticotropin injection). What is Acthar Gel? Acthar is a prescription medicine for people with 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. Acthar is injected beneath the skin or into the muscle.

SELECTED 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

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.

Please see additional Important Safety Information throughout this video.

Please see full Prescribing Information available at www.Acthar.com.

[DENNIS] My name is Dennis and I’m a very driven, career-oriented person. I work at a university in professional education. It’s a demanding job and I travel a lot, but I love it. I’ve been diagnosed with bilateral uveitis. Finding the right doctor, getting a correct diagnosis, and finding a treatment that worked for me was a long process. It started around 10 years ago when I began experiencing blurry vision.

I’d had 20/20 vision up until that point and I thought maybe I needed glasses, but the eye doctor quickly realized that what I was experiencing was more serious than astigmatism. I was referred to a specialist who helped to manage my symptoms, but I didn’t get a definite diagnosis. It wasn’t until I moved to a different state and made an appointment with a new ophthalmologist that I was finally diagnosed with a specific type of bilateral uveitis. At that time, my vision was getting really bad. I was getting my second Master’s degree and I needed to work and study. In order to have clear vision for my tests, I’d have to time my treatments with my exam dates. It was a lot to balance. Then I started to lose some vision in my left eye and I was worried that I might go blind in that eye. I was very concerned about how that was gonna impact my life and my career.

When I moved again for a job opportunity, I found a uveitis specialist whose experience seemed like a good fit for me. After discussing the other treatments that I had in the past, he recommended that I try Acthar. My doctor told me that some of his other patients with similar cases had tried Acthar and responded to the treatment and that he thought I might be a good candidate. He explained to me that Acthar was an injection that could be taken in the muscle or under the skin. He also mentioned that in addition to the potential benefits, there may be some side effects associated with Acthar. After talking to my doctor, I decided I’d give it a try.

One thing that I noticed right away was that the distributer of Acthar was very service-oriented. They ensured that I got all the support that I needed, every step of the way.

The first step was getting insurance approval. That can be a challenging process. My insurance company initially denied coverage for Acthar, but I didn’t feel stressed because the Acthar Hub worked directly with my doctor’s office to manage appeals. I was kept informed during every step of the process, and I did not need to be directly involved.

Once I was approved for the medication there was a lot of support available to help me get started and stay on track. A nurse from the injection training program came to my home and showed me how to give myself the injection, step-by-step. I felt very confident after that training. I also had access to ongoing phone support from a Registered Nurse through the PACT program. I could call anytime I had questions about staying on track with the treatment.

My doctor tells me there’s less inflammation in my eyes. I did experience weight gain and trouble sleeping while taking Acthar, but I made sure to keep my doctor up-to-date with how I was feeling. I’ve been on Acthar treatment for about 2 years now. I haven’t noticed any further worsening in my vision. Since I travel a lot for work, it can be hard to stick to a medication routine. All the support I had access to helped me create a routine that worked for me—even when I was away from home.

Now remember, this is just my experience and other people may respond differently to Acthar.

I’m relieved that I don’t have to plan my work schedule around my condition and treatment anymore. Not having to worry as much about my vision has allowed me to focus on my career and other things that I’m passionate about and that means a lot to me!

[NARRATOR] What is Acthar Gel? Acthar is a prescription medicine for people with 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. 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:

  • 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

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 weigh

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

Please see full Prescribing Information available atwww.Acthar.com

Uveitis

Brenda's Acthar Gel treatment journey

See how Brenda worked with her healthcare providers on treatment options and her experience with self-injection.

[NARRATOR] In a moment, you'll hear from Brenda. She's living with uveitis. She'll tell you about her experience using Acthar Gel (repository corticotropin injection). What is Acthar Gel? Acthar is a prescription medicine for people with 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. Acthar is injected beneath the skin or into the muscle.

SELECT 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

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.

Please see additional Important Safety Information throughout this video and full Prescribing Information at www.ActharEyeConditions.com.

[BRENDA] I have a granddaughter named Liberty Grace. With Liberty it was just an unspoken love. When I'm hurting or when I'm down, just hearing her voice on the phone makes me feel better. I started having symptoms when I was a teenager, but I didn't realize what they were. I would see these flakes in my eyes, but it would come and go, uhm.. so I didn't think anything of it. Then when I hit my mid-twenties, they- they were staying, and then I had the haze over my eyes. It threw my equilibrium off. I didn't want to go to family functions and have Liberty with me because I didn't want them to know that I was afraid to even hold her. I decided it was time to find out what was going on. I went to my regular eye doctor uhm.. and he said, "I see something back there, but I, like, couldn't tell you what it is." Since that doctor didn't know what was going on, he referred me to someone else. At that point I was hopeless. I was expecting to leave another doctor's office with unanswered questions. But when I met that doctor, he said he will do his best to figure out what's going on. Uhm.. at that point in time he did prescribe me some medication which actually caused other issues and other symptoms. But, my doctor and I never gave up. My doctor ran some tests and he discovered that I had birdshot uveitis. Uveitis is inflammation in the eyes. Uhm.. it's an autoimmune issue. My body is basically attacking itself.

I cried. I cried for like three days. Uhm.. and with me having a beautiful granddaughter I didn't feel it was my time to give up. Fortunately, my doctor kept looking into treatments that might help me. At one of my visits, he told me about Acthar Gel. He said, "We'll give you the pamphlet. You read it. You do your research, and come back and see me if you have questions." So I went home and read about Acthar.

I was desperate. I wanted to find a medication that would help manage my uveitis. I told him, "If you can get my uveitis managed with this medication, I want to try it."

When I first found out that I had to give myself injections, I was scared thinking that I'm fixing to stick this needle in myself. The feeling of me injecting myself wasn't that bad. It was more of the fear that I caused myself. I had bruising uhm.. on my injection site in the beginning, only because I didn't know my own strength. I didn't have any bruising after that. In the beginning with Acthar, I gained a little bit of weight. But, that was just my experience. It is important to talk to your doctor about what is right for you.

My doctor and I worked closely together. To adjust the dosage to stabilize my uveitis. Since then, the floaters in my eyes have decreased. We did a retinal angiography and, a visual field study. And, there was no progression. It's a blessing that I got on medication that seems to be working for me. For years, I had to deal with pain and uncertainty. With taking Acthar, it has helped me with my uveitis. I look forward to spending more time with Liberty, uhm.. watching her grow up, to be a beautiful young lady.

For more information talk to your doctor or visit www.ActharEyeConditions.com.

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

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 weigh

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- 1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-7898. Please see full Prescribing Information at www.ActharEyeConditions.com

Uveitis

Dianna's experience with Acthar Gel and Mallinckrodt support services

Hear about Dianna's experience with her personal nurse coach and other resources from the Acthar Hub.

[NARRATOR] In a moment, you'll hear from Dianna. She's living with uveitis. She'll tell you about her experience using Acthar Gel (repository corticotropin injection). What is Acthar Gel? Acthar is a prescription medicine for people with 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. Acthar is injected beneath the skin or into the muscle.

SELECT 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

SELECT IMPORTANT SAFETY INFORMATION

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

  • Uncontrolled high blood pressure
  • Bone density loss or osteoporosis
  • 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

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.

Please see additional Important Safety Information throughout this video and full Prescribing Information at www.ActharEyeConditions.com.

[DIANNA] As a little girl, I was in a very difficult and fearful situation and I remember standing up with every inch of my body, putting my hands on my hip, planting my feet in the ground, and overcoming that situation. I pull that image back in my mind and realize that if a five-year-old can do that, I can always do that.

When I had the pain where the fire poker felt like it was going through my brain out my eyeball, I was afraid. I was afraid that this was something serious going on and that perhaps I didn't have the ability to control what was going on. I had to fight this thing.

A month later, over a period of three days, my symptoms worsened. My eye hurt too bad to even cry. So, I went to the ER. I was sent home with an appointment with an ophthalmologist for the next day. The ophthalmologist evaluated me. I was tested for every possible cause. I was given a diagnosis of vision loss associated with some type of ocular inflammatory disease. I was told that I would likely have additional episodes because the cause was unknown and the pain was atypical. I understood this to mean they didn't know exactly what was going on. Symptoms continued and eventually both my eyes were so sensitive to light that I had to wear sunglasses in the house with the lights dimmed. I wanted to scratch my eyes out every night. So, I took to wearing socks on my hands while I slept so I couldn't hurt my eyes.

Frustration and fear about what was happening began to fill my days. Over the next two years I continued to have pain and vision loss. I went to many specialists and received several different diagnoses and treatments. My ophthalmologist then ran some tests and discovered that I had uveitis.

She suggested Acthar as a possible treatment. After having a discussion with my doctor where she reviewed all the potential side effects as well as doing my own research I was prepared to make a decision. I felt it could help, but understood there was a chance that I could gain weight amongst other things. At this point, I was ready to try anything that might help.

Since being on Acthar, the pain in my eyes has decreased. I started noticing a difference in the first month. I am now better able to deal with the vision challenges instead of always being consumed by the pain.

I did gain the weight I expected but I worked with my healthcare team to try to manage it and we found ways that helped. But that's just my experience. Others may experience different side effects from Acthar.

I didn't realize until after I had received my prescription that I would receive so much support from Mallinckrodt. They can assist me in working with my insurance company.

I receive calls twice a month, or weekly, if I want from a friendly nurse who remembers what is happening in my life and cares.

They even have a 24-hour nurse helpline. All of the available resources helped me feel comfortable while taking Acthar. Medication is only part of the equation. Each of us has the power to make the decisions about how we work with our healthcare team and about what medications we choose to take. Sometimes that is easy to forget. We have to stay positive, stand up with strength, and always keep moving forward. I feel that the little girl, that image that I carry when times are rough and overwhelming and fearful, would actually be proud of me today and would actually say, "You're doing great."

[NARRATOR] For more information talk to your doctor or visit www.ActharEyeConditions.com.

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

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 weigh

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- 1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-7898. Please see full Prescribing Information at www.ActharEyeConditions.com

See full

INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar
  • Acthar is contraindicated where congenital infections are suspected in infants

INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar
  • Acthar is contraindicated where congenital infections are suspected in infants
  • Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins

Warnings and Precautions

  • The adverse effects of Acthar are related primarily to its steroidogenic effects
  • Acthar may increase susceptibility to new infection or reactivation of latent infections
  • Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment
  • Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
  • Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored
  • Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
  • Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding
  • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravated
  • Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
  • Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms
  • Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity
  • There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
  • Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
  • Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy
  • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain
  • Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information.