Acthar Gel (corticotropin): Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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Overview: Acthar Gel is used to relieve symptoms of multiple sclerosis (MS), certain types of arthritis and inflammatory disorders. This medicine is also used to treat infantile spasms. Acthar gel signals your body to make hormones that help control inflammation. Common side effects include tiredness, infections, mood changes, fluid retention, and high blood pressure. Long-term use of Acthar Gel increases your risk of serious side effects, such as problems with your stomach, bones, or hormone glands.

Uses

What is Acthar Gel used for?

Acthar Gel (repository corticotropin) is commonly used for the following conditions.

Multiple sclerosis (MS), which is a condition where your immune system attacks the tissue covering your nerves
Certain types of joint inflammation (arthritis)
Other inflammatory disorders or allergy-related conditions
Infantile spasms, also called West syndrome, which is a seizure disorder

Acthar Gel may also be used for other conditions as determined by your health care provider.

How does Acthar Gel work (mechanism of action)?

Acthar Gel acts like a natural hormone in your body called adrenocorticotropic hormone (ACTH). It works by signaling your adrenal glands to make certain hormones that help control inflammation. This can relieve flare-ups of MS, treat infantile spasms, and reduce symptoms of other inflammatory conditions.

How is Acthar Gel supplied (dosage forms)?

Acthar Gel is available as an intramuscular (IM) injection that is usually given by a health care provider. It is also available as a subcutaneous (under the skin) injection in the following forms that you or a caregiver may administer.

40 units/0.5 mL single-dose SelfJect injector
80 units/mL single-dose SelfJect injector

How should I store Acthar Gel?

Acthar Gel should be stored in the refrigerator, at temperatures between 36 F and 46 F (2 C and 8 C). Do not freeze. Keep the medicine in the carton to protect it from light.

A Selfject injector may be removed from the refrigerator and kept at room temperature, between 68 F and 77 F (20 C and 25 C), for up to 24 hours. Do not heat the medicine, and do not store it in direct sunlight.

Side Effects

What are the most common side effects of Acthar Gel?

The most common side effects of Acthar Gel are listed below. Tell your health care provider if you have any of these side effects that bother you.

Infections (see below)
Muscle contractions, or convulsions
Increased blood pressure (see below)
Mood and behavior changes (see below)
Fever
Pain, itching, swelling, or redness near where the needle went in
Tiredness, weakness, and generally feeling unwell
Swelling of your hands, legs, or feet due to fluid retention
Trouble sleeping
Headache
High blood sugar levels

There may be other side effects of Acthar Gel that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Acthar Gel?

While less common, the most serious side effects of Acthar Gel are described below, along with what to do if they happen.

Severe Allergic Reactions. Acthar Gel may cause allergic reactions, which can be serious. Stop using Acthar Gel and get help right away if you have any of the following symptoms of a serious allergic reaction.

Breathing problems or wheezing
Racing heart
Fever or general ill feeling
Swollen lymph nodes
Swelling of the face, lips, mouth, tongue, or throat
Trouble swallowing or throat tightness
Itching or skin rash
Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
Nausea or vomiting
Dizziness, feeling lightheaded, or fainting
Stomach cramps
Joint pain

Infections. Acthar Gel can increase your risk of infections, including serious infections. Call your health care provider right away if you have an infection or any of the following symptoms.

Burning or stinging when you pee
Cough or coughing up blood
Fever, sweats, chills, or muscle aches
Shortness of breath
Diarrhea or stomach pain
Weight loss

Reactivated Infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from that infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Acthar Gel may increase your risk of a latent microbe becoming active again, causing an infection. Before you start treatment with Acthar Gel, tell your health care provider if you have ever had tuberculosis (TB), hepatitis B, or any other serious infections.

Cushing’s Syndrome. Rarely, using Acthar Gel for a long time may cause Cushing’s syndrome. Cushing’s syndrome is a condition that happens when your body is exposed to too much cortisol (the stress hormone). Tell your health care provider if you have any of the following symptoms of Cushing’s syndrome.

A rounded face
Weight gain, especially in the upper body
A fat buildup in the upper back or base of the neck
Thinning skin that bruises easily
Weak muscles
Depression or anxiety
High blood sugar
High blood pressure

Reduced Adrenal Function. Using Acthar Gel for a long time can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone), which is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of a fever, surgery, or trauma. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.

Nausea and vomiting
Weakness, tiredness, or lack of energy
Low blood pressure

Increased Blood Pressure. Acthar Gel may increase your blood pressure or make it worse if you already have high blood pressure (hypertension). If you check your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

Sudden severe headache
Chest pain
Dizziness or confusion
Trouble breathing
Nausea or vomiting
Blurry vision or other changes to vision
Anxiety
Buzzing in the ears
Nosebleed
Feeling of skipped heartbeats

Low Potassium Levels (Hypokalemia). Acthar Gel can cause a low potassium level, which can be serious and may lead to death. Your health care provider may check your potassium levels, especially if you take certain other medicines. Keep all appointments to have your blood checked. Take any potassium supplement that your health care provider may recommend. Call your health care provider if you have any of the following symptoms of a low potassium level.

Weakness
Unusual tiredness
Muscle cramps or twitching
Constipation

Fluid Retention (Edema). Acthar Gel can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. Tell your health care provider right away if you have any of the following symptoms.

Chest pain
Irregular heartbeat
Shortness of breath
Stretched or shiny skin
Swollen body parts, such as the belly or ankles

Stomach Bleeding. Acthar Gel can increase your risk of bleeding, ulcers, and tears (perforations) in your gut. The risk is higher if you have a history of stomach ulcers or other problems with your stomach or intestines. Get emergency help if you have any of the following symptoms.

Vomit blood
Black or tarry poop
Stomach pain that does not go away
Upset stomach

Mood and Behavior Changes. Your mood or behavior may change while you use Acthar Gel. Tell your health care provider if you have any of the following symptoms, especially if they seem severe or worse than usual.

Crankiness
Unusually high energy
Irregular mood swings
Changes in personality
Depression
Trouble sleeping or sleeping too much
Psychotic-like behaviors, such as sudden aggression, confusion, or seeing, hearing, or otherwise perceiving things that others do not

Eye Problems. Using Acthar Gel for a long time can lead to eye problems. These may include an eye infection, cataracts, and increased pressure inside the eye (glaucoma) with possible nerve damage. Tell your health care provider right away if you have any of the following symptoms.

Eye pain, itchiness, or redness
Eye discharge
Swollen eyelids
Fever
Blurriness or shadows
Sensitivity to light
Worsening vision or loss of vision
Problems with glare or driving at night

Slowed Growth and Bone Problems. Using Acthar Gel for a long time can slow growth and delay development in children. It may also lead to weakened bones (osteoporosis) in people of all ages. Keep all medical appointments, so that your health care provider can check your height, weight, and bone density.

Warnings & Precautions

Who should not use Acthar Gel?

Allergies to Ingredients. People who are allergic to any of the following should not use Acthar Gel.

Acthar Gel
Repository corticotropin
Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Acthar Gel.

Intravenous (IV) Use. Acthar Gel should not be injected into a vein. It should only be given as a shot under the skin or into a muscle.

Born With Infection. Acthar Gel should not be used in children under 2 years old who may have a congenital infection, which is an infection passed from mother to baby during pregnancy or childbirth.

Vaccines. You should not receive certain types of vaccines while using certain doses of Acthar Gel. Tell your health care provider about any vaccines that you or someone in your household has recently received or planned.

Current and Past Health Conditions. People with the following health problems should not use Acthar Gel.

Scleroderma, which is a condition that causes hardening of your skin and other tissues
Weak bones (osteoporosis)
A fungal infection that can affect your whole body
An eye problem called ocular herpes simplex
Recent surgery
Stomach ulcer
Heart failure
High blood pressure that is not controlled with medicines
Adrenal problems, including primary adrenal insufficiency or overactive adrenal glands
Allergy or sensitivity to porcine (pig) proteins

What should I know about Acthar Gel before using it?

Do not use Acthar Gel unless it has been prescribed to you by a health care provider. Use it as prescribed. If you will be injecting this medicine under your skin, read and follow the “Instructions for Use”. If you have any questions, talk to your health care provider.

Do not share Acthar Gel with other people, even if they have the same condition as you. It may harm them.

Keep Acthar Gel out of the reach of children. Since this medicine is kept in a refrigerator, take special care to keep it away from children who also use the refrigerator.

It is important to keep all of your appointments, including ones for bloodwork or other tests, while using Acthar Gel.

Acthar Gel can make your body less able to fight infections. Take special care to protect yourself from getting infections by doing things like washing your hands and limiting contact with people who are sick. Tell your health care provider right away if you think you have an infection.

Do not stop using Acthar Gel without talking to your health care provider. Stopping too quickly may cause serious side effects. Call your health care provider right away if you have any of the following symptoms.

Loss of appetite
Weakness and tiredness
Darkening of skin color
Weight loss
Dizziness
Stomach pain

Acthar Gel can sometimes hide, or mask, the symptoms of a condition or infection that you and your health care provider did not know about. After stopping Acthar Gel, tell your health care provider if you have any new or unusual symptoms. Examples may include seizures, fever, unexpected tiredness, fainting, feeling like your heart is racing or pounding, headaches, increased thirst, weight loss or gain, or blood in your stool (poop).

Follow any diet recommendations from your health care provider. You may be asked to follow a low sodium (salt) diet.

What should I tell my health care provider before using Acthar Gel?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Acthar Gel is right for you.

In particular, make sure that you discuss any of the following.

Infections. Acthar Gel can make your immune system less able to fight infections. Before you start treatment with Acthar Gel, tell your health care provider if you have ever had tuberculosis (TB), hepatitis B, or any other serious infections. Also let them know if you have an infection that keeps coming back or have been recently exposed to TB.

Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Any type of infection
Diabetes
High blood pressure
Problems with your heart or kidneys
Stomach ulcer, diverticulitis, or other problems with your stomach or intestines
Liver scarring (cirrhosis)
Thyroid problems
Myasthenia gravis or other conditions affecting your nerves and muscles
Mental health problems
Electrolyte imbalance

Other Medicines and Supplements. Acthar Gel may interact with other medicines and supplements. Before using Acthar Gel, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Do not use Acthar Gel during pregnancy without talking to your health care provider. Using Acthar Gel during pregnancy may harm an unborn baby, or your baby may have side effects after birth. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Acthar Gel while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Acthar Gel passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Acthar Gel while breastfeeding.

How can I get more information about Acthar Gel?

For more information about Acthar Gel, you can visit the drugmaker’s website at www.acthar.com or call them at 800-844-2830.

Interactions

Does Acthar Gel interact with foods or drinks?

There are no known interactions between Acthar Gel and foods or drinks.

It is unknown if drinking alcohol will affect Acthar Gel.

Does Acthar Gel interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are taking a diuretic, also called a water pill, which is a medicine used for high blood pressure and fluid retention.

This may not be a complete list of medicines that can interact with Acthar Gel. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker