Frequently asked questions about Acthar Gel

• Acthar Gel is an FDA-approved prescription medicine for people living with certain chronic or acute inflammatory or autoimmune conditions. Please see the full Prescribing Information for a complete list of approved uses
• Acthar Gel is not a steroid medication. It contains a mix of proteins and natural hormones similar to ones your body already makes. It is thought to work with your body's immune system to help reduce inflammation. Acthar Gel can have similar side effects to steroids. Ask your doctor what you should expect from treatment with Acthar Gel. The way Acthar Gel works is not fully understood. Further studies are being done. The information above is based on studies done in labs and with healthy volunteers. How the information relates to patient benefits is still uncertain. Learn more about how it is believed to work

Acthar Gel is approved for specific uses, including:

• Treatment for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM)
• Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus)
• 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
• Treatment for people with symptomatic sarcoidosis
• 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
• 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 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 infantile spasms in infants and children under 2 years of age

Ask your doctor if Acthar Gel may help with your or your loved one's condition.

Acthar Gel is thought to work with your body’s immune system to help reduce inflammation. It is not a steroid, but it can have some similar side effects. Ask your doctor about what to expect from treatment with Acthar Gel. The way Acthar Gel works is not fully understood. Further studies are being done. The information above is based on lab and clinical data, and how it relates to patient benefits is unknown.

Acthar Gel is given as an injection, either under the skin (subcutaneously) or into a muscle (intramuscularly).

People can take Acthar Gel using a vial and syringe or with the Acthar® Gel Single-Dose Pre-filled SelfJect™ Injector. Your doctor will help you decide which option is best for you.

The SelfJect injector is a device designed to help people take a 40- or 80-unit dose of Acthar Gel under the skin (subcutaneously). Its design may be helpful for people who have vision impairment or issues with grip. SelfJect should only be given by people 18 years of age and older.

If you miss a dose, call your doctor or pharmacist for advice. Do not take extra doses unless your doctor and/or pharmacist tells you to.

How soon your symptoms might improve depends on your condition and treatment plan. Ask your doctor about what to expect.

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.

Always talk to your doctor about what to expect with Acthar Gel treatment.

• Never inject Acthar Gel directly into a vein
• Acthar Gel is injected beneath the skin or into the muscle. Always inject Acthar Gel with SelfJect beneath the skin
• Follow your doctor’s instructions for injecting Acthar Gel
• 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 Gel
• 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 Gel 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 Gel 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 Gel. Talk to your doctor about which vaccines are safe to use when you are taking Acthar Gel
• Acthar Gel 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 Gel 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 Gel can make you feel irritable or depressed. You may also have mood swings or trouble sleeping. These effects are reversible once Acthar Gel 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 Gel; these allergies may be severe. Signs of allergic reaction include:
  • Skin rash and itching
  • Swelling of the face, tongue, lips, or throat
  • Trouble breathing
• The effects of Acthar Gel may be intensified if you have an underactive thyroid or cirrhosis of the liver
• Long-term Acthar Gel use can affect growth and physical development in children. This can be reversed when Acthar Gel is no longer needed
• Acthar Gel may cause osteoporosis (weak bones)
• Acthar Gel might harm an unborn baby. Therefore, tell your doctor if you are pregnant or plan to become pregnant

• Increased risk of infections
• 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 Gel.

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 1-800-844-2830. Please see full Prescribing Information for additional Important Safety Information.

Yes. Acthar Patient Support offers free injection training in person, online, or by phone, based on your needs.

Keep Acthar Gel vials or SelfJect injectors in the refrigerator between 36 and 46 °F (2 and 8 °C) until you are ready to use them. Always check the expiration date before use.

The length of time you use Acthar Gel depends on your condition and how you respond to treatment. You should ask your doctor how long you will need to continue treatment with Acthar Gel. You should also let your doctor know how you are feeling or if you notice any changes while using the treatment. Never stop or change your treatment plan without talking to your doctor first. If you have any questions or concerns about your treatment, be sure to discuss them with your doctor.

Only you and your doctor can decide if Acthar Gel is right for your child. Talk with their doctor to learn if this medicine is an option for their condition. Discuss any questions or concerns you may have with your child’s doctor. Always follow your doctor's instructions when giving Acthar Gel to your child.

To get Acthar Gel, you’ll need a prescription from your doctor. Here’s an overview of the process:

Talk with your doctor

• You and your doctor will discuss whether Acthar Gel is right for you, including the potential benefits and risks

Insurance or other approval is requested

• After your doctor prescribes Acthar Gel, insurance approval or other approval is needed. The Acthar Patient Support Team can provide information about this step
• It’s normal to be denied. Your doctor may need to appeal or provide more information

Delivery from a Specialty Pharmacy

• If approved, a Specialty Pharmacy will schedule delivery to your home. Someone will need to be there to receive it

This process can take time, and your healthcare team and the Acthar Patient Support Team can help along the way.

Prior authorization is when your insurance company reviews a prescription to make sure it’s medically necessary before they agree to cover it. Your doctor’s office usually starts this process, and you may be asked to provide information if needed. You can contact your Case Manager for guidance. Please check with your doctor's office for additional support.

The cost of Acthar Gel depends on your health insurance and your personal situation.

• If you have private insurance: Your out-of-pocket cost will depend on your specific plan. Some or all of the cost may be covered. You may also qualify for financial support programs
• If you do not have insurance, or if your insurance has denied coverage: There may be financial assistance programs that can help lower the cost of Acthar Gel or provide the medicine at no charge
• If you have Medicare: The cost of Acthar Gel may be covered, but coverage rules vary by state. There may be options to spread out your payments to as low as $175 per month. Learn more at Medicare.gov

A Case Manager can help you understand your options and find financial support programs if you're eligible. If you have questions about cost, talk to your Case Manager for help.

For information and resources to guide patients through the approval process, visit our Office Staff Resources page.