H.P. Acthar Gel
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H.P. Acthar Gel
Please refer to Adverse Reactions in Infants and Children Under 2 Years of Age (Section 6.1.1) for consideration when treating patients with Infantile Spasms. The adverse reactions presented in Section 6.2 are primarily provided for consideration in use in adults and in children over 2 years of age, but these adverse reactions should also be considered when treating infants and children under 2 years of age.
H.P. Acthar Gel causes the release of endogenous cortisol from the adrenal gland. Therefore all the adverse effects known to occur with elevated cortisol may occur with H.P. Acthar Gel administration as well. Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
Clinical Studies Experience
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.
Adverse Reactions in Infants and Children Under 2 Years of Age
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.
TABLE: Incidence (%) of Treatment Emergent Adverse Events
Occurring in ≥ 2% of H.P. Acthar Gel (repository corticotropin
injection) Infants and Children under 2 years of Age
|System Organ Class||Recommended 75 U/m² bid
|150 U/m² qd
|General disorders and administration site conditions|
|Infections and infestations|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|Respiratory, thoracic and mediastinal disorders|
|Skin and subcutaneous tissue disorders|
|1 Specific infections that occurred at ≥ 2% were candidiasis, otitis media, pneumonia and upper respiratory tract infections. 2 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 associated with the use of H.P. Acthar Gel have been identified from postmarketing experience with H.P. Acthar Gel. Only adverse events that are not listed above as adverse events reported from retrospective chart reviews and non-sponsor conducted clinical trials and those not discussed elsewhere in labeling, are listed in this section. Because the adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to use with H.P. Acthar Gel. Events are categorized by system organ class. Unless otherwise noted these adverse events have been reported in infants, children and adults.
Allergic responses have presented as dizziness, nausea and shock (adults only).
Necrotizing angitis (adults only) and congestive heart failure.
Skin thinning (adults only), facial erythema and increased sweating (adults only).
Decreased carbohydrate tolerance (infants only) and hirsutism.
Hypokalemic alkalosis (infants only).
Muscle weakness and vertebral compression fractures (infants only).
Possible Additional Steroidogenic Effects
Based on steroidogenic effects of H.P. Acthar Gel 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 H.P. Acthar Gel are:
Negative nitrogen balance due to protein catabolism.
Read the H.P. Acthar Gel (repository corticotropin injection) Side Effects Center for a complete guide to possible side effects »
Additional H.P. Acthar Gel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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