Acthar Gel
Acthar Gel (corticotropin) is a mixture of adrenocorticotropic hormone (ACTH) analogs, similar to ACTH that's naturally made in the body. It's used in adults and children to treat different conditions, including infantile spasms, multiple sclerosis, and rheumatoid arthritis. Acthar Gel (corticotropin) is available as a vial and prefilled SelfJect injector. The medication is given as an injection under the skin or into the muscle once or twice per day for a few days to few weeks, depending on your age and your condition. Common side effects include injection site reactions, tiredness, and weakness.
What is Acthar Gel (corticotropin)?
What is Acthar Gel (corticotropin) used for?
- Infantile spasms
- Multiple sclerosis flare up
- Rheumatic condition flare-up (e.g., psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis)
- Systemic lupus erythematosus (SLE)
- Systemic dermatomyositis
- Skin conditions (e.g., severe erythema multiforme, Stevens-Johnson syndrome)
- Serum sickness
- Eye inflammation
- Breathing conditions (e.g., sarcoidosis)
- Fluid build-up from kidney damage due to lupus or unknown cause
How Acthar Gel (corticotropin) works
Acthar Gel (corticotropin) is made up of a mixture of proteins and adrenocorticotropic hormone (ACTH) analogs, similar to those found in your body.
The exact way it treats various FDA-approved conditions isn't well-understood, but it works similarly to ACTH. Acthar Gel (corticotropin) is thought to lower inflammation and the activity of the immune system by triggering the release of steroid hormones (e.g., cortisol) and binding to certain proteins.
Drug facts
Side effects of Acthar Gel (corticotropin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Infantile spasms (children under 2 years old):
- Infection (20%)
- Seizures (12%)
- High blood pressure (11%)
- Irritability (7%)
- Fever (5%)
Conditions other than infantile spasms (adults and children):
- Injection site reactions
- Tiredness
- Weakness
- Low energy
- Swelling
- Trouble sleeping
- Headache
- Higher blood sugar levels
Less Common Side Effects
- Vomiting
- Diarrhea
- Changes in appetite
- Cushingoid (e.g., face swelling, weight gain)
Acthar Gel (corticotropin) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infections: fever, difficulty breathing, headache, weakness, confusion, sweating, chills, stiff neck, fast heart rate, muscle aches, diarrhea
- Severe allergic reaction: hives; swelling of the lips, tongue, or face; difficulty breathing; chest pain
The following Acthar Gel (corticotropin) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Backache
blurred vision
body aches or pain
chest pain or tightness
chills
difficulty with breathing
dizziness
ear congestion
facial hair growth in females
fractures
full or round face, neck, or trunk
headache
increased thirst or urination
irritability
loss of sexual desire or ability
loss of voice
menstrual irregularities
muscle wasting
nervousness
pounding in the ears
redness or swelling in the ear
runny or stuffy nose
seizures
slow or fast heartbeat
unusual tiredness or weakness
white patches in the mouth or throat or on the tongue
white patches with diaper rash
Incidence not known
Accumulation of pus
bruising
bulging soft spot on the head of an infant
change in the ability to see colors, especially blue or yellow
decreased range of motion
decreased urine output
dilated neck veins
extreme tiredness or weakness
eyeballs bulge out of the eye sockets
fast, weak pulse
full or bloated feeling
irregular breathing
irregular heartbeat
joint pain
large, flat, blue, or purplish patches in the skin
lightheadedness
limp
loss of appetite
noisy, rattling breathing
pressure in the stomach
severe headache
slow healing
small red or purple spots on the skin
swelling of the stomach area
swelling of the face, fingers, feet, or lower legs
swollen, red, or tender area of infection
trouble sleeping
vomiting
Incidence not known-For adults only
cold clammy skin
confusion
coughing up blood
dark urine
feeling of constant movement of self or surroundings
headache, sudden and severe
increased sweating
indigestion
loss of appetite
pain in the muscles
pains in the stomach, side, or abdomen, possibly radiating to the back
redness of the face
sensation of spinning
skin rash
sweating
thinning of the skin
unusual weight loss
weakness
yellow eyes or skin
Incidence not known-For infants only
excess air or gas in the stomach or bowels
mood changes
muscle pain or cramps
numbness or tingling in the hands, feet, or lips
passing gas
problems with speech or speaking
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Changes in appetite
Incidence not known
Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
general feeling of discomfort or illness
increased hair growth, especially on the face
muscle weakness
unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Acthar Gel (corticotropin)
Pros
- Can help treat many different inflammatory conditions
- Available as prefilled SelfJect injector, which makes under-the-skin injections easier
- Can be used in children under 2 years old for certain conditions
Cons
- Brand-name medication only
- Can raise your risk of infections
- Can cause withdrawal symptoms if stopped too suddenly
Pharmacist tips for Acthar Gel (corticotropin)
- Acthar Gel (corticotropin) can raise your risk of getting a serious or life-threatening infection. Get medical help right away if you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) while you're taking Acthar Gel (corticotropin). You might have to stop taking Acthar Gel (corticotropin) so your body can fight and fully recover from the infection.
- If you or your child experience mood changes, swelling in the body, symptoms of an infection, or symptoms of Cushing's syndrome (e.g., more fat in the face or middle of the body, easier bruising, weight gain, muscle weakness, high blood pressure), let your or your child's prescriber know. These are Acthar Gel (corticotropin) side effects that might need more medical attention.
- Avoid getting live vaccines while you're taking Acthar Gel (corticotropin) since it's not known how your body will respond to it during treatment. Before getting any vaccines, let your prescriber or pharmacist know that you're taking Acthar Gel (corticotropin). Talk to them if you're not sure whether you can receive the vaccine.
- Don't stop taking Acthar Gel (corticotropin) suddenly, since this can lead to withdrawal symptoms (e.g., weakness, skin color changes, weight loss, low blood pressure, or abdominal pain). Work with your or your child's prescriber to stop Acthar Gel (corticotropin) slowly.
- Make sure your care team knows your entire medical history, since certain conditions (e.g., thyroid problems, liver problems) can cause this medication to have a stronger effect. Other conditions (e.g., diabetes, myasthenia gravis) can get worse while taking Acthar Gel (corticotropin).
How to use Acthar Gel (corticotropin):
- Acthar Gel (corticotropin) comes as a multiple-dose vial and single-dose prefilled SelfJect injector. Make sure you the strength of your product and how to prepare and administer the dose properly to avoid accidentally wasting the medication or injuring yourself.
- Keep Acthar Gel (corticotropin) in the original carton to protect it from light. Place the cartons in the refrigerator. Once out of the refrigerator, you can keep the medication at room temperature for up to 24 hours. Once it's been out at room temperature, don't place the medication back in the refrigerator.
- Before it's time for your dose, take Acthar Gel (corticotropin) out of the refrigerator, and lay it on a flat surface to warm up. This will take about 45 minutes. Don't try to warm up the medication any other way.
- Look at the Acthar Gel (corticotropin) liquid to make sure it's clear light yellow or orange color. It also might have some air bubbles in it, which is normal. But it shouldn't have any particles (solid chunks) floating around in it. Don't use the medication if the liquid is cloudy, discolored, or has particles. Instead, call your care team for a replacement.
- For injections under the skin (vial or SelfJect Injector): Inject Acthar Gel (corticotropin) into the fatty part of the skin either on top of your thigh or at your stomach (at least 1 inch away from the belly button). You can also ask someone to help inject the medication into the fatty part of the skin at the back of your upper arm.
- For injections into a muscle (vial only): You can inject Acthar Gel (corticotropin) from the vial into the front of your upper thigh or your upper arm. Never inject into your vein or belly button.
- Don't inject Acthar Gel (corticotropin) into skin that's irritated, has tattoos, warts, scars, birthmarks, has stretch marks, or within 1 inch of the knee or groin area. Also, don't inject through clothing.
- Choose a different injection site each time you inject Acthar Gel (corticotropin). Don't use the same injection site more than 1 time per week. Use the calendar in the Acthar Gel treatment journal to record the details of your Acthar Gel (corticotropin) injections.
- After injecting the medication, throw away the Acthar Gel (corticotropin) pen in a sharps container or something made of heavy-duty plastic, such as an empty milk carton or laundry detergent bottle. This helps lower the risk of needle-stick injuries. Don't throw away needles or syringes in your trash can. For guidance on how to throw away your sharps container safely for your specific state, visit the FDA's website.
Common questions about Acthar Gel (corticotropin)
Adrenocorticotropic hormone (ACTH) is a hormone naturally made in the brain. ACTH triggers the release of cortisol (also known as the stress hormone) which plays many roles in the body, including lower inflammation. Acthar Gel (corticotropin) is made up of a mixture of ACTH and other proteins. While the exact way this medication works isn't well-understood, it's thought to trigger the release of cortisol, as well as bind to certain proteins to dampen inflammation. Based on the way it works, Acthar Gel (corticotropin) can help with different inflammatory conditions, such as rheumatoid arthritis and multiple sclerosis flares.
Acthar Gel (corticotropin) isn't a steroid hormone. But it's thought that Acthar Gel (corticotropin) can trigger the release of cortisol in the body, which is a steroid hormone.
Acthar Gel (corticotropin) is a naturally sourced mixture of ACTH and other proteins from porcine (pigs) that gets modified through lab processes.
Your healthcare team will let you know what to expect once you start using Acthar Gel (corticotropin). Because this medication can treat many conditions, how long it takes to work likely depend on your specific condition. For infantile spasms, the medication started to work within 2 weeks.
Yes, you can experience corticosteroid withdrawal symptoms if you stop Acthar Gel (corticotropin) suddenly. Your risk for withdrawal symptoms is higher if you've been taking it for a longer period of time. This happens because Acthar Gel (corticotropin) tells the body to release more cortisol, a steroid hormone. And if you stop taking this medication too suddenly, it can take a while before the body is able to ramp up making cortisol without the help of Acthar Gel (corticotropin). During this time, you can experience withdrawal symptoms such as weakness, tiredness, and poor appetite. If you need to stop Acthar Gel (corticotropin), your healthcare team can help you do so safely by lowering your dose slowly over time.
No. Acthar Gel (corticotropin) might cause harm to your unborn baby if you take it during pregnancy. If you're currently pregnant, discuss the risks and benefits of taking Acthar Gel (corticotropin) with your healthcare team.
There isn't enough information to know if it's safe to take Acthar Gel (corticotropin) while breastfeeding. Based on how it works in the body, this medication isn't likely to get absorbed by breastfed babies. If you're currently breastfeeding, ask your healthcare team about the risks and benefits of continuing Acthar Gel (corticotropin) while nursing.
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Risks and warnings for Acthar Gel (corticotropin)
Acthar Gel (corticotropin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infections
Acthar Gel (corticotropin) can affect your body's ability to fight off infections. This raises your risk of serious and sometimes life-threatening bacterial, viral, or fungal infections. Treatment with Acthar Gel (corticotropin) can also cause new or old tuberculosis (TB) infections to come back. If you get sick, your HCP might ask you to stop taking Acthar Gel (corticotropin) so your body can fight the infection. Go to the hospital right away if you develop symptoms of an infection, including fever, chills, and tiredness.
Low adrenal gland function and Cushing's syndrome
- Risk factors: High doses | Using this medication for a long period of time | Young children | Stress (such as trauma, injury, or infection)
Acthar Gel (corticotropin) acts like the hormone ACTH that's naturally in your body. Having higher ACTH level causes your body to release more stress hormone (cortisol). When this happens, you're at risk for developing symptoms of Cushing's syndrome, including swelling, weight gain, and muscle weakness.
Taking Acthar Gel (corticotropin) can affect how ACTH is released by your own body. If you suddenly stop taking Acthar Gel (corticotropin) after receiving it regularly, your body might not be able to produce enough of its own ACTH hormone. This can lead to symptoms of withdrawal including low energy, feeling tired, and weakness. If you need to stop Acthar Gel (corticotropin), your healthcare team will instruct you to do so safely by slowly lowering your dose over time. Talk to your care team before making any sudden changes in your medication.
Risk of stomach ulcers or bleeding
- Risk factors: Stomach ulcers or bleeding | Taking other medications that can cause stomach damage at the same time | Drinking alcohol
Taking Acthar Gel (corticotropin) raises the risk of damaging your stomach, including bleeding and ulcers. Depending on the risk of stomach problems, your HCP might ask you to take an additional medication to protect your stomach if you need to take Acthar Gel (corticotropin) for a longer period of time. Tell your healthcare team right away if you have stomach pain that doesn't go away or you get bloody or dark stools.
High blood pressure, swelling, and electrolyte problems
- Risk factors: Heart failure | High blood pressure | Kidney problems
Acthar Gel (corticotropin) can cause your body to hold on to more salt and water. This can lead to higher blood pressure and swelling, as well as electrolyte problems, like lower potassium and calcium levels. If you have heart failure, high blood pressure, or kidney problems, talk to your prescriber first before starting Acthar Gel (corticotropin). During treatment, it's important to monitor your blood pressure and tell your prescriber about any changes you notice.
Weakening of bones and slowed growth
- Risk factors: Receiving Acthar Gel (corticotropin) for a longer period of time | Infants and young children | Females after menopause
Receiving Acthar Gel (corticotropin) over a longer period of time can lead to weakened bones. This can raise the risk of having bone fractures in older adults or slow growth in children. Discuss any concerns you have with your or your child's prescriber.
Eye problems
- Risk factors: Cataracts or glaucoma | Using Acthar Gel (corticotropin) for a long period of time
Long-term use of Acthar Gel (corticotropin) leads to a higher risk of cataracts, glaucoma, and certain eye infections. Don't take Acthar Gel (corticotropin) if you have herpes simplex of the eye. Let your prescriber know if you experience blurry vision, eye pain, or any vision changes. If you are taking this medication for a long time, you might need to get regular eye exams.
Behavior changes
Acthar Gel (corticotropin) can cause changes in mood or behavior. Tell your prescriber right away if you notice depression, mood swings, trouble sleeping, anxiety, irritability, or hallucinations (hearing or seeing things that aren't there) while taking this medication. These side effects tend to go away after you stop Acthar Gel (corticotropin). But before you make any dose changes, talk to your care team first.
Serious allergic reaction
- Risk factors: Allergy to pork-related products Though rare, people who used Acthar Gel (corticotropin) have developed serious allergic reactions. Don't use Acthar Gel (corticotropin) if you have allergies to pork-related products. Get medical help right away if you notice trouble breathing, rash, and hives after receiving this medication.
Acthar Gel (corticotropin) dosage
Typical dosage for Acthar Gel (corticotropin)
In general, your dose depends on what condition you’re using Acthar Gel (corticotropin) for and how severe it is.
- Infantile spasms (ages 2 years and under): Your child's pediatrician will calculate the dose based on body surface area (BSA), which takes into account your child's weight and height. The typical dose is 75 units/m2 injected into your child's muscle twice daily for 2 weeks.
- Multiple sclerosis: Your prescriber will determine your dose based on your symptoms. The typical dose ranges from 80-120 units injected into the muscle or under your skin, once daily for 2-3 weeks.
- Other conditions: Your prescriber will determine your dose based on your symptoms. The typical dose ranges from 40-80 units injected into the muscle or under your skin every 1 to 3 days.
After your treatment is over, your prescriber might have you slowly lower your dose over the course of a few days before stopping completely to avoid withdrawal symptoms.
Interactions between Acthar Gel (corticotropin) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Rotavirus Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Balofloxacin
- Besifloxacin
- Bupropion
- Ciprofloxacin
- Enoxacin
- Fleroxacin
- Flumequine
- Gatifloxacin
- Gemifloxacin
- Levofloxacin
- Lomefloxacin
- Moxifloxacin
- Nadifloxacin
- Norfloxacin
- Ofloxacin
- Pazufloxacin
- Pefloxacin
- Prulifloxacin
- Rufloxacin
- Sparfloxacin
- Tosufloxacin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Licorice
- Saiboku-To
Acthar Gel (corticotropin) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Acthar Gel (corticotropin) will not be safe for you to take.
- Injections into the veins
- Receiving live vaccines
- Infants under 2 years of age who might have infections present at birth
- Scleroderma (a condition that causes skin to become hardened and tight)
- Osteoporosis (weak bones)
- Certain fungal infections
- Herpes simplex in the eyes
- Recent surgery
- History of or current stomach ulcer
- Congestive heart failure
- Uncontrolled high blood pressure
- Primary adrenocortical insufficiency (a condition where your adrenal glands don't release enough of certain hormones)
- Adrenocortical hyperfunction (a condition where too many substances are produced from a structure in your body called the adrenal cortex)
- Allergy to pig (porcine) proteins
What are alternatives to Acthar Gel (corticotropin)?
This medication is used for many different conditions. Generally, it's used for autoimmune disorders, conditions related to swelling, or cancer. Some examples include: