PubChem compound: 16132265
Based on corticotropin’s pharmacological effect of stimulating an endogenous steroid response, corticotropin may cause fetal harm when administered to a pregnant woman. The published literature on systemic corticosteroid use during pregnancy, which may be relevant, suggests potential concerns. Intrauterine growth restriction, decreased birth weight, and preterm birth have been reported with maternal use of corticosteroids; however, the underlying maternal condition may also contribute to these risks. Hypoadrenalism has also been reported in infants after high-dose and/or long-term use of corticosteroids during pregnancy. The potential adverse developmental effects of corticotropin have not been adequately assessed in animals.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Hypoadrenalism has been reported in infants born to mothers treated with systemic corticosteroids during pregnancy. Infants born to mothers treated with corticotropin should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly.
There are no available data on the presence of corticotropin in either human or animal milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for corticotropin and any potential adverse effects on the breastfed infant from corticotropin or from the underlying maternal condition.
Adequate studies of the carcinogenic potential of corticotropin have not been conducted.
The genotoxic potential of corticotropin has not been adequately evaluated.
The potential effects of corticotropin on fertility have not been adequately assessed in animals.
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
While the types of adverse reactions seen in infants and children under age 2 treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen. Below is a summary of adverse reactions specifically tabulated from source data derived from retrospective chart reviews and clinical trials in children under 2 years of age treated for infantile spasms. The number of patients in controlled trials at the recommended dose was too few to provide meaningful incidence rates or to permit a meaningful comparison to the control groups. The most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia.
TABLE. Incidence (%) of Adverse Reactions Occurring in ≥2% of Infants and Children Under 2 Years of Age Treated with corticotropin:
| Adverse Reactions | Recommended 75 U/m2 twice daily n=122, (%) | 150 U/m2 once daily n=37 (%) |
|---|---|---|
| Cardiac disorders | ||
| Cardiac Hypertrophy | 3 | 0 |
| Endocrine disorders | ||
| Cushingoid | 3 | 22 |
| Gastrointestinal disorders | ||
| Diarrhea | 3 | 14 |
| Vomiting | 3 | 5 |
| Constipation | 0 | 5 |
| General disorders and administration site conditions | ||
| Irritability | 7 | 19 |
| Pyrexia | 5 | 8 |
| Infections and infestations | ||
| Infection* | 20 | 46 |
| Investigations | ||
| Weight gain | 1 | 3 |
| Metabolism and nutrition disorders | ||
| Increased appetite | 0 | 5 |
| Decreased appetite | 3 | 3 |
| Nervous system disorders | ||
| Convulsion† | 12 | 3 |
| Respiratory, thoracic and mediastinal disorders | ||
| Nasal Congestion | 1 | 5 |
| Skin and subcutaneous tissue disorders | ||
| Acne | 0 | 14 |
| Rash | 0 | 8 |
| Vascular disorders | ||
| Hypertension | 11 | 19 |
* Specific infections that occurred at ≥2% were candidiasis, otitis media, pneumonia and upper respiratory tract infections.
† 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 (for example, Lennox-Gastaut Syndrome). Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment, the other seizures may become visible.
These adverse reactions may also be seen in adults and children over 2 years of age when treated for other purposes and with different doses and regimens.
The following adverse reactions have been identified during post approval use of corticotropin.
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Allergic responses have presented as dizziness, nausea, and anaphylaxis (anaphylactic shock, hypotension, respiratory compromise, urticaria, edema).
Necrotizing angitis (adults only), congestive heart failure, atrial fibrillation, and palpitations.
Skin thinning (adults only), facial erythema, and increased sweating (adults only).
Decreased carbohydrate tolerance (infants only), hirsutism, and menstrual irregularities.
Pancreatitis (adults only), abdominal distention, and ulcerative esophagitis.
Injection site reaction and asthenic conditions (including fatigue, malaise, asthenia, and lethargy).
Abscess.
Blood glucose increased.
Hypokalemic alkalosis (infants only) and fluid retention (including peripheral swelling).
Muscle weakness and vertebral compression fractures (infants only).
Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).
Insomnia.
Based on steroidogenic effects of corticotropin certain adverse events may be expected due to the pharmacological effects of corticosteroids. The adverse events that may occur but have not been reported for corticotropin are:
Impaired wound healing, petechiae and ecchymoses, and suppression of skin test reactions.
Negative nitrogen balance due to protein catabolism and alteration in glucose tolerance.
Loss of muscle mass and aseptic necrosis of femoral and humeral heads.
Increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment, and subdural effusion.
Exophthalmos.
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