Cortrophin Gel (repository corticotropin injection) is an injectable therapy approved to treat acute relapses — times when symptoms suddenly appear or worsen — in people with multiple sclerosis (MS).
While Cortrophin Gel can help speed the recovery from relapses, it does not alter the overall progression of MS. The therapy is marketed by ANI Pharmaceuticals.
The active ingredient in Cortrophin Gel — called corticotropin or adrenocorticotropic hormone (ACTH) — is a naturally occurring signaling molecule prompting the body to make a hormone called cortisol. This hormone has numerous effects throughout the body; of particular note, cortisol broadly dampens the inflammatory activity of the immune system.
Cortrophin Gel’s mechanism of action is not fully known, but it is thought to work mainly by increasing cortisol levels, which reduces the inflammatory autoimmune attack that drives MS exacerbations. The therapy also is thought to bind to specific cell receptors that play a role in regulating inflammation.
Cortrophin Gel was first approved in the U.S. to treat numerous autoimmune diseases in the 1950s; it was then indicated to treat MS relapses in the 1970s, but the therapy fell out of use in the 1980s. The U.S. Food and Drug Administration (FDA) gave the medicine a new approval for the treatment of MS relapses in 2021, prompting its relaunch for MS.
The therapy is available through a network of specialty pharmacies and distributors in the U.S. To access it, patients and their providers must fill out and submit the Cortrophin Gel Enrollment Form with their prescription. The treatment should be prescribed in cases where patients do not respond to more conventional therapies.
ANI Pharmaceuticals acquired the rights over Cortrophin Gel from Merck (known as MSD outside North America) in 2016.
Besides MS, the FDA has authorized the use of Cortrophin Gel in the management of numerous other autoimmune and inflammatory disorders, including rheumatoid arthritis, sarcoidosis, and systemic lupus erythematosus.
Cortrophin Gel only should be administered once testing confirms administration of the medication prompts an increase in cortisol levels as expected in the body.
Cortrophin Gel should not be used to treat people with:
Cortrophin Gel is given by injection. It may be administered intramuscularly (into the muscle) or subcutaneously (under the skin), but it should never be given intravenously (into the bloodstream) or taken orally.
For the treatment of acute MS relapses, the recommended dosing regimen is 80-120 units, given daily via intramuscular injections for two to three weeks. Dosing is typically tailored based on the situation of the individual patient. Intramuscular administration is usually done in the upper-outer thigh muscle or the upper arm muscle. The injection site must be rotated, keeping at least 1 inch distance between sites when injecting in the same area.
The therapy is supplied in a 5 mL multiple-dose vial containing 80 units of the medication per mL for a total of 400 units in each 5 mL vial. The vials should be stored in a refrigerator at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), and then warmed by rolling between the hands for a few minutes — the microwave or stove should not be used to heat the vial — to a liquid gel before being injected.
Cortrophin Gel may be self-administered or given by a caregiver, although its use requires prior training by a healthcare provider.
Needles of differing sizes might be needed; typically, a 20G needle is used for withdrawal of the Cortrophin Gel from the vial into the syringe and a 23G needle is used for injecting it into the body.
Cortrophin Gel was first approved to treat MS relapses by the FDA in the 1970s. The approval was supported by data from earlier studies showing this type of treatment helped patients recover from relapses more quickly than a placebo.
In 2019, ANI Pharmaceuticals announced results from a small clinical trial that evaluated a relaunched version of Cortrophin gel in 20 healthy volunteers. Results showed the relaunched version was comparable to the original version in terms of safety as well as the effect on cortisol levels.
Common side effects of Cortrophin Gel include:
Since it works to reduce the activity of the immune system, Cortrophin Gel may increase an individual’s susceptibility to infections. Additionally, because many symptoms indicative of infection actually are caused by the immune system’s response (e.g., fever), infection symptoms may not be obvious in patients treated with Cortrophin Gel. The therapy also may hide symptoms of other diseases.
Some patients experience an allergic reaction to long-term treatment with Cortrophin Gel, where the immune system accidentally attacks the medication as if it were an infectious threat by developing antibodies against it. The immune system’s response to Cortrophin Gel may lower the medicine’s effectiveness.
Cortrophin Gel can increase the risk of eye infections and may cause other eye problems such as cataracts, glaucoma, or damage to the nerves that connect the eyeballs to the brain (optic nerves).
Cortrophin Gel can increase blood pressure and cause the body to retain water and certain salts, while excreting excess amounts of calcium and potassium. Dietary changes and/or nutritional supplements may be necessary to manage these effects.
Patients should not be vaccinated for smallpox while being treated with Cortrophin Gel. Other vaccines should be administered with caution. As Cortrophin Gel reduces immune activity, patients are likely to have a reduced response to vaccines aimed at boosting the immune system’s ability to fight off infections, and neurological complications may occur.
Cortrophin Gel can cause the development of a Cushingoid state, a hormonal condition caused by excess cortisol levels that is characterized by symptoms such as a puffy face and weight gain. Long-term treatment with Cortrophin Gel also may result in adrenal insufficiency, where the body is unable to make enough natural cortisol. Gradually tapering off the dosage of Cortrophin Gel may help prevent adrenal insufficiency from developing.
The effects of Cortrophin Gel may be magnified in patients who have an underactive thyroid (hypothyroidism) or cirrhosis (scarring) of the liver. The therapy should be used with caution in people with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and/or myasthenia gravis.
Cortrophin Gel may cause emotional disturbances including euphoria, insomnia, mood swings, personality changes, depression, and psychosis. Existing mental health conditions may be aggravated by Cortrophin Gel use.
Animal data suggests Cortrophin Gel may cause problems with a developing fetus. The medication should be used only in pregnancy if the potential benefits of treatment outweigh the risks.
Cortrophin Gel can slow the growth and development of children; pediatric patients on treatment should be carefully monitored.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Cortrophin Gel was initially approved by the U.S. Food and Drug Administration (FDA) in 1954 to treat a number of inflammatory and autoimmune conditions; then in 1977 it was indicated for the management of acute MS relapses. The therapy fell out of use during the 1980s. The FDA approved the reintroduction of Cortrophin Gel in the U.S. market to treat MS relapses in late 2021.
In animal models, the use of Cortrophin Gel during pregnancy resulted in abnormalities with the developing fetus. A careful evaluation of the potential benefits and risks of treatment should be made when deciding whether or not to use Cortrophin Gel in patients who are pregnant, have the ability to become pregnant, or are breastfeeding. Babies born after being exposed to Cortrophin Gel during pregnancy should be monitored for signs of abnormal adrenal gland function.
The medication’s prescribing information does not report a direct interaction between Cortrophin Gel and alcohol. As alcohol can interfere with some medications and aggravate certain disease symptoms, patients are advised to talk to their healthcare provider about whether and how much it is safe for them to drink.
Everyone responds to medicines differently. Patients are encouraged to talk to their healthcare providers about what they should expect from their treatment given their unique situation.
Cortrophin Gel may result in the development of a hormonal imbalance called Cushingoid state, characterized by excess cortisol levels. Weight gain is a common symptom associated with Cushingoid state. Hair loss has not been reported as a side effect of Cortrophin Gel. Patients are advised to talk to their healthcare providers about any unanticipated effects from the medication.
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