Common questions about Acthar (FAQ)
Q: Is Acthar the same kind of medicine as a corticosteroid like prednisone?
Acthar is officially classified as an adrenal cortex stimulant. This means it signals your body's adrenal glands to produce and release its own natural steroid hormones, such as cortisol. It is not an exogenous corticosteroid, which is a synthetic steroid hormone that is taken directly, like prednisone.
Q: Does Acthar cause weight gain or changes in appetite?
Weight gain is a reported side effect, especially when the medicine is used for a prolonged time. This may be associated with the drug's effects on steroid hormones, as documented in official safety information. Official reports also indicate that changes in appetite (either a loss or decrease) have been reported by patients.
Q: Can Acthar cause my body to stop producing its own natural stress hormone, and what does that mean?
Yes, using Acthar for a long time can cause the adrenal glands to stop making enough of the natural stress hormone, cortisol. This condition is called adrenal insufficiency and can occur after the medicine is stopped. Official prescribing information notes that tapering the dose is necessary to help the adrenal glands recover.
Q: Does the medicine come in a pre-filled syringe or a multi-dose vial?
Acthar Gel may be supplied in two forms, depending on the indication: a multi-dose vial with a syringe or a single-dose pre-filled self-injection device. The choice of formulation is determined by the healthcare provider based on the patient's condition and the official prescribing information.
Q: Why do some people experience injection site reactions, and what are they?
Injection site reactions are a commonly reported adverse reaction documented in the official product information. These reactions are typically localized and can include symptoms such as pain, itching, redness, swelling, or inflammation at the area where the injection was given.
Q: Can Acthar treatment be used during pregnancy or while breastfeeding?
Official warnings state that this medicine may cause fetal harm when administered during pregnancy. Therefore, women should be informed of the potential risks to the fetus. Regarding breastfeeding, it is unknown if the drug passes into human milk, so the decision regarding breastfeeding or discontinuing the drug must be made by the healthcare provider after assessing the risks and benefits.
Q: Is Acthar appropriate for elderly patients with multiple health conditions?
The official label does not specifically establish safety and effectiveness data for the geriatric population. However, regulatory documents list several conditions common in the elderly (such as heart failure, high blood pressure, and osteoporosis) as formal reasons not to use the drug (contraindications). The presence of comorbid diseases may require careful consideration by the healthcare provider.
Q: What kind of financial assistance or patient support programs are available for Acthar?
The manufacturer offers support programs to help eligible patients with the costs of the medication. These programs may include a commercial co-pay program for insured patients and a patient assistance program for those who have no insurance and meet income requirements.
Q: Do I need to change my diet while I am taking Acthar?
Because Acthar can cause fluid retention, elevated blood pressure, and low potassium levels (hypokalemia), a healthcare provider may recommend dietary changes. Specifically, salt restrictions or the use of potassium supplements may be recommended to help manage these documented fluid and electrolyte effects.
Q: Why is Acthar considered a 'specialty' medicine that is often difficult to get covered by insurance?
The manufacturer acknowledges that, like other specialty medicines, the process for obtaining coverage can be complex. This often involves steps like prior authorization and appeals with insurance companies to confirm the medical necessity of the treatment for a patient's condition.
Q: Are there different brand names or formulations of the drug that work similarly to Acthar?
Official documentation confirms that another brand name product, Purified Cortrophin Gel, which also contains repository corticotropin injection, is available for some of the same FDA-approved conditions as Acthar Gel.
Q: What is the expected duration of treatment for Acthar in most cases?
The duration of treatment is highly individualized and is determined based on the patient’s condition and response. For acute events like MS flares, the official regimen is typically 2–3 weeks. For other conditions, it is generally administered as adjunctive therapy for short-term periods.
Q: If I am taking Acthar long-term, what kind of monitoring will my doctor need to do?
Official warnings note that prolonged use increases the risk of certain serious conditions. Therefore, long-term monitoring by a healthcare provider is recommended, which includes checking for signs of Cushing’s syndrome, changes in bone density (osteoporosis), and changes in eye health (e.g., cataracts and glaucoma).
Q: What are the signs of a serious side effect that require medical attention?
Official product information notes that patients should watch for signs of severe allergic reaction (such as difficulty breathing or swelling of the face), signs of infection (such as fever or chills), or signs of gastrointestinal bleeding/perforation (such as vomiting blood or severe abdominal pain). New or worsening symptoms are typically reported to a healthcare professional right away.
Q: Is there a risk of Acthar masking the symptoms of another developing illness?
Yes, regulatory documents indicate that Acthar may mask the typical signs and symptoms of other underlying diseases or disorders. This includes serious conditions like infections and gastrointestinal problems. Monitoring by a healthcare provider is necessary to watch for signs of these masked conditions.
Q: Can Acthar be taken at the same time as my other regular medications?
Providing a complete list of all medications, including prescription and nonprescription drugs, vitamins, and herbal supplements, to the healthcare provider is an important step. Specific drug classes that may require caution include diuretics, due to the risk of accentuating electrolyte loss.
Q: What types of over-the-counter pain relievers or supplements should be discussed with a doctor before starting Acthar?
It is important for patients to discuss all nonprescription medicines, including common over-the-counter pain relievers and herbal supplements, with their doctor. This is necessary because the official warnings note risks such as gastrointestinal bleeding and fluid/electrolyte imbalances, which may be affected by certain nonprescription products.
Q: What happens when a person needs to stop taking Acthar?
Official instructions state that treatment is typically discontinued slowly by gradually reducing the dose (tapering), especially after prolonged use. Sudden withdrawal carries the risk of adrenal insufficiency, where the body does not make enough cortisol, or a return of symptoms.
Q: Are patients required to get specialized training on how to use the injection?
While the official prescribing information details the method of injection, patient support programs often provide free injection training. This training helps prepare patients who need to self-inject Acthar Gel at home.
Q: How does the medication Acthar differ from a generic corticotropin injection?
Acthar is supplied as a repository corticotropin injection. This repository (gel) formulation is designed to release the active ingredient slowly after injection, providing a sustained, long-acting effect over an extended period.
Q: What does it mean for Acthar to be effective in 'speeding the resolution' of an MS flare but not affecting the 'ultimate outcome'?
Studies on Acthar for acute MS relapses focus on outcomes related to recovery speed from the acute attack. This indicates the drug can shorten the duration of the relapse, but it is not intended to change the long-term course of the disease or affect the patient's ultimate level of disability (the 'ultimate outcome').
Q: How does Acthar interact with medications that affect the immune system?
Official regulatory documents specifically contraindicate the use of live or live attenuated vaccines while receiving immunosuppressive doses of Acthar. Patients should discuss all immune-modulating drugs, including biologics and other therapies, with their healthcare provider.
Q: Can Acthar cause low potassium levels, and is that dangerous?
Official information lists low potassium (hypokalemia) as a possible adverse reaction related to fluid and electrolyte effects. Because low potassium can be serious, monitoring of the patient’s blood levels is standard during treatment, and potassium supplementation may be recommended to manage this effect.