CORTROPHIN GEL (corticotropin)

There are 0 contraindications.

Drug contraindication overview.

*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.

Adverse reaction overview.

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).

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 Relative adrenocortical insufficiency may occur if corticotropin is withdrawn abruptly.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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None