Acthar Gel, H.P.

Name: Acthar Gel, H.P.

What Is Corticotropin (H.P. Acthar Gel)?

Corticotropin is the generic form of the brand-name medicine H.P. Acthar Gel, which is used in a test to evaluate adrenal gland function.

The adrenal glands are small glands located on top of each kidney that produce certain hormones.

Corticotropin is also commonly used to treat symptoms of many other conditions, including:

  • Multiple sclerosis (MS — a disease that causes weakness, numbness, loss of coordination, and other problems)
  • Lupus (an autoimmune disorder characterized by inflammation and a wide variety of symptoms)
  • Infantile spasms (seizures) in children under age 2
  • Bowel inflammation
  • Breathing, blood, or endocrine problems
  • Various forms of arthritis (including psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis)
  • Skin or eye problems
  • Certain allergies
  • Edema (swelling of the body)
  • Symptomatic sarcoidosis (a disease characterized by inflammation in the lungs, skin, or lymph nodes)
  • Certain cancers

Corticotropin is a prescription hormone medicine. It works by making the body produce certain hormones.

The U.S. Food and Drug Administration (FDA) first approved corticotropin in 1952. It's marketed as H.P. Acthar Gel by Mallinckrodt Pharmaceuticals.

Corticotropin Warnings

Before taking corticotropin, tell your doctor about all medical conditions you have or have ever had, especially:

  • Scleroderma (a skin condition)
  • Osteoporosis (thinning of the bones)
  • Heart problems
  • High blood pressure
  • Eye problems, such as ocular herpes simplex or glaucoma
  • Stomach ulcers
  • Any condition of the adrenal glands
  • Diabetes
  • Underactive thyroid
  • Kidney problems
  • Diverticulitis (inflammation of the small pouches in the digestive tract)
  • Myasthenia gravis (a neuromuscular disorder that causes weakness in the skeletal muscles)
  • High blood sodium levels or low blood potassium levels
  • Liver problems
  • Mental illness
  • Allergies to pig-derived proteins

Corticotropin may mask the symptoms of other diseases. It's important to tell your doctor about all medical issues you have.

Also, tell your doctor if you've recently had surgery or suffered any type of trauma before starting on this drug.

Corticotropin may reduce your body's ability to fight infections, especially if you take it for a long time.

Try to avoid being around people who are sick while using this drug.

Tell your doctor if you have an infection while taking corticotropin and for up to one year after your treatment ends.

Signs of infection may include:

  • Fever
  • Chills
  • Sore throat
  • Painful urination
  • Muscle aches
  • Rash

It's especially important to tell your doctor if you have measles, tuberculosis (TB), chickenpox, or shingles before receiving corticotropin.

Also, tell your healthcare provider if you recently received or are scheduled to have any vaccinations (particularly the vaccine for smallpox).

If you use corticotropin for a long period of time, your adrenal gland may produce too much of the hormone cortisol. This can cause symptoms of Cushing's syndrome, which include:

  • Upper body fat
  • A rounded "moon" face
  • Easy bruising
  • Muscle weakness

After you stop taking corticotropin, your body may not produce enough cortisol, which means you could have an adrenal insufficiency.

Your doctor may prescribe a steroid medicine to protect you until your adrenal glands start working properly again.

If you have diabetes, corticotropin may affect your blood sugar levels. Be sure to monitor your condition carefully.

Keep all appointments with your doctor and laboratory while taking this medicine. You'll probably need to undergo frequent tests to see how your body responds to corticotropin.

Corticotropin may affect growth in children and adolescents. Talk to your doctor if this is a concern.

Tell your doctor that you're taking this medicine before having any type of surgery, including a dental procedure.

Your healthcare provider may recommend changes to your diet while you use corticotropin. Be sure to follow these instructions carefully.

Pregnancy and Corticotropin

It's not known whether corticotropin could harm a fetus.

Animal studies have shown that corticotropin has an adverse effect on fetuses, but there's not enough evidence in pregnant humans to show that the drug is dangerous.

Tell your doctor if you become pregnant while using corticotropin. You'll need to discuss the risks and benefits of taking this medicine during pregnancy.

It's also not known whether corticotropin passes into breast milk or could hurt a breastfeeding baby. Don't breastfeed while taking this drug.

Corticotropin Dosage

Corticotropin comes as a gel that's injected beneath the skin or into a muscle.

Your dose of corticotropin will depend on your age, medical condition, and response to treatment.

Corticotropin injections are usually given by a trained professional at a medical facility, but you may be shown how to give yourself this medicine at home.

Follow your doctor's instructions carefully when injecting this medicine. Don't take more or less corticotropin than is recommended.

Never inject corticotropin into a vein.

Ask your healthcare provider if you have any questions about how to properly administer this medicine.

Don't stop using corticotropin without first talking to your doctor.

Corticotropin Overdose

If you suspect an overdose of corticotropin, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Corticotropin

Call your doctor for instructions if you miss a dose of corticotropin.

What should I discuss with my healthcare provider before using Acthar Gel, H.P. (corticotropin)?

You should not use corticotropin if you are allergic to it, or if you have:

  • adrenal insufficiency (Addison's disease);

  • scleroderma;

  • a fungal infection anywhere in your body;

  • herpes infection of the eyes;

  • osteoporosis;

  • past or present stomach ulcer;

  • congestive heart failure;

  • untreated or uncontrolled high blood pressure;

  • if you have recently had surgery; or

  • if you are allergic to pork proteins.

This medicine should not be used in a child younger than 2 with an infection that was passed from the mother during pregnancy or childbirth.

Corticotropin can worsen an infection you already have, or reactivate an infection you recently had. Before using this medicine, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure corticotropin is safe for you, tell your doctor if you have:

  • liver disease (such as cirrhosis);

  • kidney disease;

  • a thyroid disorder;

  • diabetes;

  • a history of tuberculosis;

  • a muscle disorder such as myasthenia gravis;

  • glaucoma or cataracts;

  • depression or mental illness;

  • a stomach or intestinal disorder; or

  • if you take a diuretic or "water pill."

FDA pregnancy category C. It is not known whether corticotropin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether corticotropin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Corticotropin can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How is Acthar Gel, H.P. (corticotropin)given?

Corticotropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Corticotropin is sometimes given daily, or every 2 to 3 days. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine comes with patient instructions for safe and effective use in treated infantile spasms. If you are the infant's caregiver, follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your dose needs may change during times of stress, serious illness, surgery or medical emergency. Tell your doctor if any of these situations affect you.

If you use this medication long-term, you may need frequent medical tests, including bone scans to check for osteoporosis.

In some people, corticotropin can trigger an immune response to the medicine, making it less effective. Call your doctor if your condition gets worse or if it seems like this medicine does not work as well.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store in the refrigerator, do not freeze.

Take the medication out of the refrigerator and allow it to reach room temperature before preparing your dose.

Acthar Gel, H.P. (corticotropin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In some people, corticotropin can trigger an immune response to the medicine, making it less effective. Call your doctor if your condition gets worse or if it seems like this medicine does not work as well.

Call your doctor at once if you have:

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • severe depression, mood changes, sleep problems, unusual thoughts or behavior;

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;

  • eye swelling, redness, severe discomfort, crusting or drainage;

  • signs of infection--fever, chills, sore throat, flu symptoms, swelling, redness, unusual discharge, mouth sores, skin sores;

  • low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

  • dangerously high blood pressure--severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure.

Be sure your family, caregivers, and close friends also know how to help you watch for these side effects.

Common side effects of corticotropin may include:

  • fluid retention (swelling in your hands or feet);

  • mood changes, irritability;

  • increased appetite; or

  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For the Consumer

Applies to corticotropin: injection gel/jelly

Along with its needed effects, corticotropin (the active ingredient contained in H.P. Acthar Gel) 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 while taking corticotropin:

More common
  • Backache
  • blurred vision
  • body aches or pain
  • chest pain
  • cough
  • difficulty with breathing
  • dizziness
  • ear congestion
  • earache
  • facial hair growth in females
  • fever or chills
  • 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
  • nasal congestion
  • nervousness
  • pounding in the ears
  • redness or swelling in the ear
  • runny nose
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
  • wheezing
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash
Less common
  • Convulsions (seizures)
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
  • cold, clammy skin
  • confusion
  • decreased range of motion
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • eyeballs bulge out of eye sockets
  • fast, weak pulse
  • full or bloated feeling
  • heartburn
  • insomnia
  • irregular breathing
  • irregular heartbeat
  • joint pain
  • large, flat, blue, or purplish patches in the skin
  • lightheadedness
  • limp
  • loss of appetite
  • nausea and vomiting
  • pressure in the stomach
  • severe headache
  • small red or purple spots on the skin
  • sweating
  • swelling of abdominal or stomach area
  • swelling of the face, fingers, feet, or lower legs
  • swollen, red, or tender area of infection
  • trouble healing
  • weight gain
  • wheezing
Incidence not known-For adults only
  • Bloating
  • chills
  • confusion
  • constipation
  • coughing up blood
  • darkened urine
  • fast heartbeat
  • fever
  • headache
  • 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
  • skin rash
  • unusual weight loss
  • weakness
  • yellow eyes or skin
Incidence not known-For infants only
  • Decreased carbohydrate tolerance
  • hypokalemic alkalosis
  • reversible brain shrinkage

Some side effects of corticotropin 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:

More common
  • Blemishes on the skin
  • diarrhea
  • pimples
Less common
  • Increased or decreased appetite
Incidence not known
  • Increased hair growth, especially on the face
  • menstrual changes
  • muscle weakness
Incidence not known-For adults only
  • Feeling of constant movement of self or surroundings
  • sensation of spinning
  • thinning of the skin

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