Applies to corticotropin: parenteral solution for injection.
Side effects include:
Associated with long-term therapy: Bone loss, cataracts, indigestion, muscle weakness, back pain, bruising, acne, hyperpigmentation, menstrual irregularities, oral candidiasis. (See Warnings/Precautions under Cautions.)
For Healthcare Professionals
Applies to corticotropin: injectable powder for injection, injectable solution.
General
The more commonly reported adverse effects have included fluid retention, changes in glycemic control, increased appetite and weight gain; for children less than 2 years, increased risk of infections, hypertension, irritability, Cushingoid symptoms, cardiac hypertrophy, and weight gain have been reported.[Ref]
Cardiovascular
The incidence of cardiac hypertrophy in patients less than 2 years treated for infantile spasm was 3% for patients receiving 75 units/m2 twice a day and 0% for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials. For hypertension, the incidence of was 11% for patients receiving 75 units/m2 twice a day and 19% for those receiving 150 units/m2/day.
Very Common (10% or more): Hypertension
Common (1% to 10%): Cardiac hypertrophy
Frequency not reported: Fluid retention
Postmarketing reports: Necrotizing angitis (adults only), congestive heart failure
Nervous system
In the treatment of infantile spasms, other types of seizures/convulsions may occur because some patients progress to other forms of seizures such as Lennox-Gastaut syndrome and because spasms may be masking other seizures. The incidence of seizure was 12% for patients receiving 75 units/m2 twice a day and 3% for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials.
Very Common (10% to more): Convulsions
Postmarketing reports: Headache (adults only), subdural hematoma, intracranial hemorrhage (adults only), reversible brain shrinkage (secondary to hypertension; infants only)
Psychiatric
Common (1% to 10%): Irritability
Frequency not reported: Behavioral and mood changes
Metabolic
Common (1% to 10%): Increased appetite, decreased appetite, weight gain
Frequency not reported: Alteration in glucose tolerance
Postmarketing reports: Hypokalemic alkalosis (infants only), decreased carbohydrate tolerance (infants only)
Dermatologic
The incidence of acne and rash in patients less than 2 years treated for infantile spasm was 0% for patients receiving 75 units/m2 twice a day and 12% and 8%, respectively for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials.
Very common (10% or more): Acne
Common (1% to 10%): Rash
Postmarketing reports: Skin thinning (adults only), facial erythema, increased sweating (adults only), hirsutism
Local
Postmarketing reports: Injection site reactions
Musculoskeletal
Postmarketing reports: Muscle weakness and vertebral compression fractures (infants only)
Endocrine
The incidence of Cushingoid in patients less than 2 years treated for infantile spasm was 3% for patients receiving 75 units/m2 twice a day and 22% for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials.
Common (1% to 10%): Cushingoid
Gastrointestinal
Very common (10% or more): Diarrhea
Common (1% to 10%): Constipation, diarrhea, vomiting
Postmarketing reports: Pancreatitis (adults only), abdominal distention, ulcerative esophagitis
Hypersensitivity
Postmarketing reports: Allergic responses presenting as dizziness, nausea, and shock (adults only)
Other
Very Common (10% or more): Infection
Common (1% or 10%): Pyrexia, candidiasis, otitis media, vertigo (adults only)
Respiratory
Common (1% or 10%): Nasal congestion, pneumonia, upper respiratory infections.
