What is Acthar Gel?
Not everyone may be familiar with the prescription medication, Acthar Gel. Although it sounds like something one might use externally, it is actually an injected medication that is used to treat several types of conditions, including infantile spasms as well as disorders of the joints, skin, eyes, and respiratory system, to name a few. Acthar Gel is also used to treat MS exacerbations as an alternative to intravenous (IV) steroids.
When an individual with MS is experiencing a flare-up of symptoms (also known as an exacerbation or relapse) a physician will often prescribe several days of IV steroids (corticosteroids) to reduce the severity and duration of an MS exacerbation. This type of treatment can be very helpful for many patients.
However, some individuals may not be able to tolerate the side effects of IV steroids. Additionally, some individuals may have found that previous treatments with steroids were not effective, while others may have difficulty getting timely medical support for IV infusions. Some patients may even have trouble receiving medication through their veins. According to Questcor Pharmaceuticals, Inc., makers of Acthar Gel, this medication may be an option for individuals who experience these types of problems with IV steroids.
How does Acthar Gel work?
Acthar Gel works by stimulating the outer layer of cells of the adrenal gland, promoting the production of natural hormones that reduce inflammation. When someone experiences an exacerbation, inflammation typically occurs along the protective covering of the nerves (myelin) and an increase of lesions is usually seen within the brain and spinal cord. By reducing inflammation, disease flare-ups can often be reduced in terms of severity and duration.
Acthar contains a highly purified preparation of the hormone adrenocorticotropin (also referred to as ACTH) in gelatin. This preparation is injected either into the muscle (intramuscularly) or under the skin (subcutaneously). Acthar Gel injections are usually given once daily for two to three weeks to treat a severe exacerbation, although the dose and frequency should be determined specifically for each patient by the treating physician. Once injected, Acthar Gel is absorbed slowly into the bloodstream. Upon reaching the adrenal gland, steroid hormones (largely cortisol) are produced. Cortisol is involved with the control of several processes within the body, including immune responses.
According to Questcor®, multiple head-to-head clinical studies have shown no difference between the effectiveness of IV steroids and ACTH. Similar to steroids, Acthar speeds up the recovery from acute MS exacerbations. (Please note that while reducing the severity and duration of an exacerbation is vital to the comfort and return of function for an individual with MS, studies have not indicated that such treatment affects the progression or long-term outcome of the disease.)
Who should not take Acthar Gel and what are the side effects?
Patients with any of the following conditions should not use Acthar Gel: scleroderma (a skin condition); osteoporosis (the loss of bone density); infection in the body; infection in the eye (ocular herpes simplex); recent surgery; stomach ulcer (at present or previously); heart problems; high blood pressure; or an allergy to pig-derived proteins. Individuals with any of these conditions should discuss them with their doctor before starting treatment with Acthar Gel.
In studies, the most common side effects of Acthar Gel were: infections; increased blood pressure; irritability and changes in behavior; changes in appetite and weight; diarrhea; and vomiting. Other adverse reactions were also reported but were not as common. These included reactions such as: abdominal bloating and fluid retention; anxiety and nervousness; asthma; chest discomfort; heart problems and rapid heart rate; dizziness; shortness of breath; flushing; headache; injection-site pain; fatigue; and muscle weakness.
No adequate and well-controlled studies have been done with Acthar and women who are pregnant. Regarding women who are nursing, it has not yet been determined if Acthar is excreted in human milk. The makers of Acthar Gel note that this medication could potentially have a harmful effect on a fetus. They also advise not using this drug while nursing.
For More Information
Acthar Gel is only available through Specialty Pharmacy Distribution. Questcor offers a comprehensive patient-support program to assist individuals in affording and receiving the medication (through a doctor’s prescription). The “Acthar Support & Access Program,” or “A.S.A.P.” for short, is a free resource staffed by reimbursement experts. They may be reached by calling (888) 435-2284.
Individuals interested in learning more about the drug and if it might be appropriate for them should contact their physician. Additional information may be found by visiting www.actharmsrelapse.com Individuals may also call MSAA’s Helpline at (800) 532-7667 to speak with a Helpline specialist.
Written by Susan Wells Courtney
Reviewed by Jack Burks, MD