Cortrophin Gel (corticotropin)

Use the lowest possible dosage of corticotropin to control the condition being treated. When reduction in dosage is necessary, gradually reduce dosage.

Administer repository corticotropin injection by subcutaneous or IM injection. The drug is commercially available in prefilled single-dose SelfJect injectors (Acthar(R) Gel), single-dose prefilled syringes (Purified Cortrophin(R) Gel), or multiple-dose vials (both Acthar(R) Gel and Purified Cortrophin(R) Gel). The prefilled autoinjectors and syringes are for subcutaneous administration only.

No dosing information is available for this tab.

Formal drug interaction studies have not been conducted with repository corticotropin.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Corticosteroids; Corticotropin (Acth)/Amphotericin B

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Corticosteroids and corticotropin may potentiate potassium excretion and overload salt and water retention.(1)

CLINICAL EFFECTS: Concurrent use of amphotericin b with corticosteroids or corticotropin may potentiate amphotericin b-induced hypokalemia, thereby predisposing patients to cardiac dysfunction.(1-2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of amphotericin b states that concurrent use of corticosteroids or corticotropin should be avoided unless absolutely necessary to avoid side effects. If concurrent use is necessary, serum electrolytes and cardiac function must be monitored closely.(1)

DISCUSSION: There are four case reports of cardiac enlargement, hypokalemia, and hypernatremia from concurrent use of amphotericin b and corticosteroids.(2)

Systemic Corticosteroids; Corticotropin (Acth)/Live Vaccines

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system. In severely immunocompromised patients, virus replication after administration of live, attenuated-virus vaccines can be enhanced and/or the immune response to the vaccine may be decreased.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)

PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1)

PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. Live vaccines should be deferred for at least 1 month after discontinuation of high-dose systemic steroids administered for 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 4 weeks after a live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued.(1) The US manufacturer of corticotropin(2) and triamcinolone(3) and the Australian manufacturer of dexamethasone(4) state that administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids or corticotropin. The manufacturer of deflazacort states that live or live-attenuated vaccines should be administered at least 4 to 6 weeks prior to initiation of therapy with deflazacort.(5)

DISCUSSION: Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Systemic Corticosteroids; Acth/Non-Live Or Non-Rep Vaccines

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1)

PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1)

DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)

*IV administration.

*Concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticotropin.

*Patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin.

*Use of Acthar(R) Gel preparation in infants under 2 years of age who have suspected congenital infections.

• Adrenocortical hyperfunction
• Chronic heart failure
• Fungal infection
• Hypercortisolism
• Invasive surgical procedure
• Ocular herpes simplex
• Osteoporosis
• Peptic ulcer
• Primary adrenocortical insufficiency
• Scleroderma

• Cataracts
• Congenital adrenal hyperplasia
• Edema
• Hypertension
• Hypocalcemia
• Hypokalemia
• Infection
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Major traumatic injury
• Ocular infection
• Pulmonary tuberculosis

• Diabetes mellitus
• Disease of liver
• Diverticulitis of gastrointestinal tract
• Esophagitis
• Glaucoma
• Hepatic cirrhosis
• Hypothyroidism
• Inactive tuberculosis
• Myasthenia gravis
• Ocular hypertension
• Psychotic disorder

The most common adverse reactions reported in the postmarketing setting with corticotropin (Acthar(R) Gel) include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and increased blood glucose.

The most common adverse reactions (>=5%) of corticotropin (Acthar(R) Gel) in patients with infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. In the treatment of infantile spasms, other types of seizures/convulsions may occur because some patients with infantile spasms progress to other forms of seizures (e.g., Lennox-Gastaut Syndrome).

More Frequent

• Hypertension
• Infection

Less Frequent

• Hypothalamic-pituitary insufficiency

Rare or Very Rare

• Abscess
• Acute respiratory failure
• Alkalosis
• Anaphylaxis
• Angioedema
• Aseptic necrosis of head of femur
• Aseptic necrosis of head of humerus
• Chronic heart failure
• Compression fracture
• Fracture
• Gastrointestinal hemorrhage
• Gastrointestinal ulcer
• Glaucoma
• Hyperglycemia
• Hypernatremia
• Hypersensitivity drug reaction
• Hypocalcemia
• Hypokalemia
• Hypotension
• Idiopathic intracranial hypertension
• Impaired wound healing
• Intracranial bleeding
• Osteopenia
• Pancreatitis
• Seizure disorder
• Shock
• Subdural intracranial hemorrhage
• Vasculitis

More Frequent

• Acne vulgaris
• Behavioral disorders
• Diarrhea
• Hypercortisolism
• Increased appetite
• Irritability
• Mood changes

Less Frequent

• Constipation
• Nasal congestion
• Skin rash

Rare or Very Rare

• Abdominal distension
• Anorexia
• Body fluid retention
• Cataracts
• Dizziness
• Ecchymosis
• Erythema
• Esophagitis
• Euphoria
• Exophthalmos
• Fatigue
• Fever
• Flushing
• General weakness
• Headache disorder
• Hirsutism
• Hyperhidrosis
• Injection site sequelae
• Insomnia
• Lethargy
• Malaise
• Menstrual disorder
• Muscle weakness
• Myopathy
• Nausea
• Papilledema
• Petechiae
• Skin atrophy
• Skin pigmentation enhancement
• Urticaria
• Vertigo
• Vomiting
• Weight gain

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Efficacy of repository corticotropin (Acthar(R) Gel) as monotherapy has been established for the treatment of infantile spasms in infants and children less than 2 years of age. Evidence supporting this indication is based on a randomized, single-blinded (video EEG interpreter-blinded) clinical trial and an additional active control supportive trial. Safety in the pediatric population was evaluated by retrospective chart reviews and data from other clinical trials.

Both serious and other adverse reactions that occur in adults can also occur in pediatric patients receiving corticotropin. The frequency and severity of adverse effects may be different in the pediatric population due to the young age of the infant, underlying disorder, duration of therapy, and dosage regimen.

Long-term use of corticotropin can impact growth and physical development in pediatric patients. Pediatric patients receiving prolonged therapy should have their growth and physical development carefully monitored.

Relative adrenocortical insufficiency may occur if corticotropin is withdrawn abruptly. Symptoms of adrenal insufficiency in infants treated with corticotropin for infantile spasms are nonspecific and can be difficult to identify (e.g., anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension, abdominal pain). Parents and caregivers should be instructed to monitor for these symptoms.

Based on its pharmacological effect of stimulating an endogenous steroid response, corticotropin may cause fetal harm when administered to a pregnant woman. Published literature on systemic corticosteroid use during pregnancy suggests possible adverse fetal/neonatal effects (e.g., intrauterine growth restriction, decreased birth weight, preterm birth), which may be relevant to use of corticotropin. However, the underlying maternal condition may also contribute to these risks. Hypoadrenalism has been reported in infants after high-dose and/or long-term maternal use of corticosteroids during pregnancy. The potential adverse developmental effects of corticotropin have not been adequately assessed in animal reproductive studies.

Carefully observe infants for signs of hypoadrenalism (e.g., poor feeding, irritability, weakness, vomiting) after maternal use of corticotropin during pregnancy and manage accordingly.

It is not known whether corticotropin is distributed into either human or animal milk, or whether the drug has any effects on the breastfed infant or on milk production. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for corticotropin and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

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