Corticotropin

Corticotropin is a prescription medication used to treat relapsing multiple sclerosis, infantile spasms, and nephrotic syndrome (a collection of symptoms that indicate kidney damage).

• Corticotropin is also indicated in the following disorders: rheumatic disorders; collagen diseases; dermatologic diseases; allergic states; ophthalmic diseases; respiratory diseases; and edematous states.
• Corticotropin is available under the following different brand names: H.P. Acthar Gel, Purified Cortrophin Gel.

Common side effects of Corticotropin include:

• infections
• stomach ulcers
• changes in mood and behavior such as irritability or depression
• trouble sleeping
• acne
• dry skin
• thinning skin
• bruising or discoloration
• slow wound healing
• increased sweating
• headache
• dizziness
• spinning sensation
• upset stomach
• changes in the shape or location of body fat (especially in the arms, legs, face, neck, breasts, and waist)

Serious side effects of Corticotropin include:

• vision problems
• swelling
• rapid weight gain
• feeling short of breath
• severe depression
• unusual thoughts or behavior
• seizure (convulsions)
• bloody or tarry stools
• coughing up blood
• pancreatitis (severe pain in the upper stomach spreading to the back, nausea and vomiting, fast heart rate)
• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness, or limp feeling)
• dangerously high blood pressure (severe headache, blurred vision, buzzing in the ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, or seizures)

Rare side effects of Corticotropin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 80 units/mL

Verification of Adrenal Responsiveness

Adult dosage

• 40-80 unit IM/SC every 24-72 hours

Acute Exacerbations of Multiple Sclerosis

Adult dosage

• 80-120 unit IM once a day for 2-3 weeks may be administered

Anti-Inflammatory/Immunosuppressant

Pediatric dosage

• 0.8 unit/kg/day IM or 25 units/m²/day divided every 12-24 hours

Infantile Spasms (West Syndrome)

Pediatric dosage

• Children below 2 years: 75 units/m² IM two times a day for 2 weeks, THEN gradually taper over 2 weeks
• Tapering schedule
  • 30 units/m² IM every morning for 3 days, THEN
  • 15 units/m² IM every morning for3 days, THEN
  • 10 units/m² IM every morning for 3 days, THEN
  • 10 units/m² every other morning for 6 days

Nephrotic syndrome

Adult dosage

• 40-80 units IM/SC every 1-3days

Pediatric dosage

• Children below 2 years: Safety and efficacy not established
• Children above or equal to 2 years: 40-80 units IM/SC every 1-3days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Corticotropin has severe interactions with no other drugs
• Corticotropin has severe interactions with the following drugs:
  • amphotericin B deoxycholate
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • lisocabtagene maraleucel
  • macimorelin
  • testosterone intranasal
  • tisagenlecleucel
  • tofacitinib
• Corticotropin has serious interactions with at least 39 other drugs
• Corticotropin has minor interactions with the following drugs:
  • bendroflumethiazide
  • bumetanide
  • chlorothiazide
  • chlorthalidone
  • cyclopenthiazide
  • ethacrynic acid
  • furosemide
  • indapamide
  • methyclothiazide
  • metolazone
  • torsemide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Sensitivity to porcine proteins
• IV administration
• Infants below 2 years suspected of congenital infections
• Coadministration of live or live-attenuated vaccines with immunosuppressive doses of corticotropin
• Scleroderma
• Osteoporosis
• Systemic fungal infections
• Ocular herpes simplex
• Recent surgery
• Active/history of peptic ulcer
• Primary adrenocortical insufficiency, adrenocortical hyperfunction
• Congestive heart failure
• Hypertension

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Corticotropin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Corticotropin?”

Cautions

• Increases susceptibility to new infection and risk of exacerbation, dissemination, or reactivation of latent infections; signs and symptoms of infection may be masked; may increase risks related to infections with any pathogen, including viral, bacterial fungal, protozoan, or helminthic infections; patients with latent tuberculosis or tuberculin reactivity should be observed closely, and if therapy is prolonged, chemoprophylaxis should be instituted
• May mask symptoms of other diseases/disorders without altering the course of the other disease/disorder; patients should be monitored carefully during and for a period following discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss
• Therapy can cause GI bleeding and gastric ulcer; there is also increased risk for perforation in patients with certain gastrointestinal disorders; signs of gastrointestinal perforation, such as peritoneal irritation, may be masked by therapy; use caution where there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer
• Behavioral and mood disturbances may occur; may include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis; existing conditions may be aggravated; effects are reversible once therapy is stopped
• Symptoms of diabetes and myasthenia gravis may be worsened with treatment
• Prolonged therapy may produce posterior subcapsular cataracts, and glaucoma with possible damage to optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses; monitor for cataracts, infections, and glaucoma;
• In patients with hypothyroidism or liver cirrhosis, it may result in an enhanced effect
• Gel is immunogenic; limited available data suggest that a patient may develop antibodies to the gel after chronic administration and loss of endogenous adrenocorticotropic hormone (ACTH) and gel activity
• Prolonged administration of the gel may increase the risk of hypersensitivity reactions; cases of anaphylaxis have been reported in the postmarketing setting
• Use in patients with sensitivity to porcine protein is contraindicated, and the possibility of sensitivity should be considered during treatment should symptoms arise
• Patients with comorbid disease may have that disease worsened; use caution when prescribing therapy in patients with diabetes and myasthenia gravis
• Long-term use of this medication may have negative effects on growth and physical development in children; changes in appetite are seen with therapy, with the effects becoming more frequent as the dose or treatment period increases; these effects are reversible once therapy is stopped; growth and physical development of pediatric patients on prolonged therapy should be carefully monitored
• Therapy can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium; dietary salt restriction and potassium supplementation may be necessary; caution should be used in the treatment of patients with hypertension, congestive heart failure, or renal insufficiency
• Decrease in bone density
  • Decrease in bone formation and increase in bone resorption both through an effect on calcium regulation (eg, decreasing absorption and increasing excretion) and inhibition of osteoblast function may occur; these, together with a decrease in the protein matrix of bone (secondary to an increase in protein catabolism) and reduced sex hormone production, may lead to inhibition of bone growth in children and adolescents and development of osteoporosis at any age
  • Give special consideration to patients at increased risk of osteoporosis (eg, postmenopausal women) before initiating therapy, and bone density should be monitored in patients on long-term therapy
• Cushing’s syndrome and adrenal insufficiency upon withdrawal
  • Treatment can cause hypothalamic-pituitary-axis (HPA) suppression and Cushing’s syndrome; these conditions should be monitored especially with chronic use
• Suppression of the HPA may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of medication; patients should be monitored for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension, and abdominal pain
• The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify; the symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension, and abdominal pain
• It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing therapy and should be instructed to observe for, and be able to recognize these symptoms
• The recovery of the adrenal gland may take from days to months so patients should be protected from the stress (eg, trauma or surgery) using corticosteroids during periods of stress
• The adrenal insufficiency may be minimized in adults and infants by tapering of dose when discontinuing treatment; signs or symptoms of Cushing’s syndrome may occur during therapy but generally resolve after therapy is stopped
• Patients should be monitored for these signs and symptoms such as deposition of adipose tissue in characteristic sites (eg, moon face, truncal obesity), cutaneous striae, easy disability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, hypertension
• Vaccination
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of this drug; killed or inactivated vaccines may be administered; however, response to such vaccines cannot be predicted
  • Other immunization procedures should be undertaken with caution in patients who are receiving therapy, especially when high doses are administered, because of possible hazards of neurological complications and lack of antibody response

Pregnancy and Lactation

• This drug has been shown to have an embryocidal effect; there are no adequate and well-controlled studies in pregnant women; this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Lactation
  • It is not known whether this drug is excreted in human milk; because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from this drug, when treating a nursing mother, a decision should be made whether to discontinue nursing