Acthar® Gel: What you need to know
Acthar Gel was approved by the FDA for treatment of some autoimmune diseases including lupus in 1952. Below are answers to some questions you may have about this drug as you explore it as an option to help you manage your lupus.
Acthar® Gel (repository corticotropin injection) is a prescription medication used to treat flares or as a maintenance therapy for people living with certain chronic inflammatory or autoimmune conditions, such as systemic lupus erythematosus (SLE).
Acthar Gel works with your immune system to help reduce inflammation associated with autoimmune diseases. It is not a steroid but can have similar side effects to what you may experience with steroids.
Acthar Gel was initially developed by Armour Pharmaceuticals and was approved by the US Food and Drug Administration (FDA) in 1952 for many inflammatory diseases, including systemic lupus erythematosus (SLE), psoriatic arthritis and rheumatoid arthritis.
Acthar Gel differs from other lupus treatments in its unique mechanism of action. Unlike traditional corticosteroids, it works by modulating the immune system through melanocortin receptors, rather than directly suppressing it. This may offer a different therapeutic approach for managing lupus symptoms.
Acthar Gel is also available in a pre-filled SelfJect™ injector, allowing for easier at-home administration. While it has been shown to provide symptom relief in lupus patients, its exact mechanism requires further study, and it’s essential to consult a health care provider to determine if it's the right treatment for your condition.
The Acthar® Gel Single-Dose Pre-filled SelfJect™ Injector is a device designed to make treatment easier for adults who use Acthar Gel. It delivers a 40- or 80-unit dose under the skin (subcutaneously) and may be especially helpful for people with vision impairments or grip difficulties. For those who take other doses, Acthar Gel can still be administered with a vial and syringe, either under the skin or into a muscle (intramuscularly). Injections are typically given in the upper thigh, abdomen, or back of the arm, but should not be placed within one inch of the belly button, knee, or groin.
Acthar Gel is prescribed for individuals with certain conditions, including systemic lupus erythematosus (SLE) and other autoimmune disorders, to help manage inflammation. It is typically recommended for those experiencing disease flares or requiring maintenance therapy.
However, Acthar Gel may not work for everyone, as its effectiveness can vary depending on the individual’s response to treatment. Before taking Acthar Gel, tell your doctor if you have received or are planning to receive a live or live attenuated vaccine, or if you have scleroderma (a skin condition), bone density loss or osteoporosis, or any infections, including fungal, bacterial, or viral.
Acthar Gel is approved for use children with lupus. It is generally given as an injection under the skin. The dosage is adjusted based on the severity of the disease and the patient’s response.
Yes. Because researchers don’t fully understand how Acthar Gel works, further studies are being done.
There is limited clinical trial data on Acthar Gel’s effectiveness in treating lupus patients with organ involvement beyond the kidneys. If you're considering Acthar Gel for lupus with multi-organ involvement, it's best to consult with a rheumatologist or specialist to discuss potential benefits, risks and alternative treatment options.
Acthar Gel can cause common side effects like injection site reactions, fatigue, fluid retention, insomnia, headaches, and elevated blood sugar. Serious side effects may include an increased risk of infections, elevated blood pressure, irritability, muscle pain, dehydration, adrenal insufficiency, pneumonia, kidney failure, and even stroke. Prolonged use may also lead to eye issues like cataracts and glaucoma. It’s important to talk to your health care team about potential side effects before starting treatment with Acthar Gel.
Acthar Gel is administered via two primary injection methods: the SelfJect™ injector and the vial and syringe method.
The SelfJect injector is a pre-filled, all-in-one device designed for subcutaneous (under the skin) injection, available in 40 or 80-unit doses. Individuals with grip issues may find it easier to use due to its easy-to-hold design. It is suitable for administration by adults aged 18 and older.
Teens and children (for example, people with Juvenile RA) can be prescribed Acthar Gel, but SelfJect should be given by an adult.
The injector should be stored in the refrigerator and allowed to reach room temperature before use. It is important to inspect the device for contamination and check its expiration date before administration.
The vial and syringe method provides more dosage flexibility, allowing for doses other than 40 or 80 units. This method can be used to inject the medicine under the skin or into the muscle, depending on the doctor’s instructions. A health care professional will guide the patient on how to properly draw the prescribed dose from the vial using a syringe and administer the injection. Both methods require proper preparation, storage and inspection before use to ensure safe and effective treatment.
Acthar Gel may suppress the immune system, potentially increasing the risk of infections. Therefore, it's important to consult your health care provider before receiving any vaccinations during treatment. They can advise you on which vaccines are safe and appropriate for you.
Coat can vary depending on insurance and available assistance programs. The insurance approval process can be more difficult for Acthar Gel than it is for other drugs. However, about two-thirds of patients can access the medication through their insurer, sometimes with a small co-pay, or through the Patient Assistance Program at no cost.
For commercially insured patients, monthly out-of-pocket costs are generally low, often less than $50 and frequently $0 through the Commercial Co-Pay Program.
Many government-insured patients may pay less than $20 per month if they qualify for the Medicare Extra Help Program. For those who do not qualify, the 2025 Medicare Prescription Payment Plan caps total annual out-of-pocket costs for all prescriptions and allows payments to be spread out monthly, potentially as low as around $167 per month.
Financial assistance options, including co-pay programs and a Patient Assistance Program, may be available. While coverage always depends on the patient’s insurance, the best person to speak with is a case manager at Acthar Patient Support, who is assigned once the medication is prescribed and can provide detailed information about available financial assistance options.
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