H.P. Acthar Gel is a highly purified preparation of adrenocorticotropic hormone (ACTH) in a gel that is designed to provide extended release of the ACTH following injection. ACTH, which stimulates the adrenal cortex gland to secrete cortisol, corticosterone, and aldosterone, has been shown in controlled clinical trials to be effective in speeding the resolution of acute MS attacks. ACTH was approved in 1978 by the U.S. Food and Drug Administration (FDA) as a short-term treatment for acute exacerbations of MS. Although there was a period when its availability in the U.S. and elsewhere became very restricted due to limited manufacturing production, the product is once again available. According to its FDA labeling, corticosteroids (such as methylprednisolone or dexamethasone) are considered the treatment of choice for acute exacerbations. ACTH is available for those individuals who cannot tolerate the side effects of high dose corticosteroids; have been treated unsuccessfully with corticosteroids in the past; prefer the convenience of self-injection; or have difficulty receiving intravenous medication because of poor venous access. ACTH does not affect the ultimate outcome or long-term natural history of the disease. ACTH is included in the updated list of medications covered under the Medicare Replacement Drug Demonstration Project.
- ACTH is administered via intramuscular injection for the treatment of MS exacerbations. Varied dosing schedules have been used in the studies of ACTH and in clinical practice, generally starting at 80 units per day for a week followed by a tapering schedule over a second week. The dosing schedule that is given in the package insert is 80-120 units daily for 2-3 weeks.
- The medication should be stored in the refrigerator and allowed to come to room temperature before injecting.
- Do not stop taking this medicine without checking with your physician. Serious side effects can occur if the medication is stopped suddenly.
- If you are taking this medication daily and miss an injection, take it as soon as you remember and then resume your regular dosing schedule.
- ACTH should not be taken by individuals with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, a current or past peptic ulcer, congestive heart failure, or hypertension, or by anyone with reduced function of the adrenal cortex.
- There have been no adequate studies of ACTH in pregnant women. Since it has been shown in animal studies to be harmful to embryos, ACTH should be used during pregnancy only if the potential benefits outweigh the risks.
- It is not known if ACTH passes into breast milk. If you are nursing or plan to nurse, be sure to discuss this with your physician.
- ACTH can stimulate the appetite and increase water retention. It is advisable to follow a low-salt and/or potassium-rich diet and watch your caloric intake. Your physician will make specific dietary recommendations for you.
- ACTH can lower your resistance to infection and make any infection that you get more difficult to treat. Contact your physician if you notice any sign of infection, such as sore throat, fever, coughing, or sneezing. While on this medication, check with your physician before having any immunizations (vaccinations). People in your household should not be given any live vaccines while you are on this medication.
- ACTH may produce mood changes and/or mood swings of varying intensity. These mood alterations can vary from relatively mild to extremely intense, and can vary in a single individual from one course of treatment to another. Neither the patient nor the physician can predict with any certainty whether the ACTH is likely to precipitate these mood alterations. If you have a history of mood disorders (depression or bipolar disorder, for example), be sure to share this information with your physician. If you begin to experience mood changes or swings that feel unmanageable, contact your physician so that a decision can be made about whether or not you need an additional medication to help you until the mood alterations subside.
Possible Side Effects
- Side effects that may go away as your body adjusts to the medication and do not require medical attention unless they continue or are bothersome: vomiting, changed in appetite; diarrhea, constipation, restlessness, difficulty sleeping, sweating
- Less common side effects that should be reported as soon as possible to your physician: severe mood changes or mood swings; decreased or blurred vision*; frequent urination*.
- Additional side effects that can result from the prolonged use of ACTH and should be reported to your physician: acne or other skin problems; swelling of the face; swelling of the feet or lower legs; rapid weight gain; pain in the hips or other joints (caused by bone cell degeneration); stomach pain; elevated blood pressure; markedly increased thirst (with increased urination indicative of diabetes mellitus); menstrual irregularities; unusual bruising of the skin; thin, shiny skin; hair loss; muscle cramps or pain.
- Once you stop this medication after taking it for a long period of time, it may take several months for your body to readjust.