H.P. ACTHAR(repository corticotropin)injection(七)
ing 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.
6.1 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.
6.1.1 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
n=122, (%)
150 U/m2 qd
n=37 (%)
1Specific 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.
Cardiac disorders
Cardiac Hypertrophy
3 0
Endocrine disorders
Cushingoid
3 22
Gastrointestinal disorders
Constipation
0 5
Diarrhea
3 14
Vomiting
3 5
General disorders and administration site conditions
Irritability
7 19
Pyrexia
5 8
Infections and infestations
Infection1
20 46
Investigations
Weight gain
1 3
Metabolism and nutrition disorders
Increased appetite
0 5
Decreased appetite
3 3
Nervous system disorders
Convulsion2
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
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.
6.2 Postmarketing Experience
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