H.P. ACTHAR GEL SIDE EFFECTS
- Generic Name: repository corticotropin injection
- Brand Name: H.P. Acthar Gel
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infections.
- Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal.
- Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia.
- Masking Symptoms of Other Diseases.
- Gastrointestinal Perforation and Bleeding.
- Behavioral and Mood Disturbances.
- Ophthalmic Effects.
- Immunogenicity Potential.
- Negative Effects on Growth and Physical Development.
- Decrease in Bone Density.
Clinical Trials 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. 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 Acthar Gel
| 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.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Acthar Gel.
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 Reactions
Allergic responses have presented as dizziness, nausea, and anaphylaxis (anaphylactic shock, hypotension, respiratory compromise, urticaria, edema).
Cardiovascular
Necrotizing angitis (adults only), congestive heart failure, atrial fibrillation, and palpitations.
Dermatologic
Skin thinning (adults only), facial erythema, and increased sweating (adults only).
Endocrine
Decreased carbohydrate tolerance (infants only), hirsutism, and menstrual irregularities.
Gastrointestinal
Pancreatitis (adults only), abdominal distention, and ulcerative esophagitis.
General Disorders And Administration Site Conditions
Injection site reaction and asthenic conditions (including fatigue, malaise, asthenia, and lethargy).
Infections And Infestations
Abscess.
Investigations
Blood glucose increased.
Metabolic
Hypokalemic alkalosis (infants only) and fluid retention (including peripheral swelling).
Musculoskeletal
Muscle weakness and vertebral compression fractures (infants only).
Neurological
Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).
Psychiatric Disorders
Insomnia.
Possible Additional Steroidogenic Effects
Based on steroidogenic effects of 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 Acthar Gel are:
Dermatologic
Impaired wound healing, petechiae and ecchymoses, and suppression of skin test reactions.
Metabolic
Negative nitrogen balance due to protein catabolism and alteration in glucose tolerance.
Musculoskeletal
Loss of muscle mass and aseptic necrosis of femoral and humeral heads.
Neurological
Increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment, and subdural effusion.
Ophthalmic
Exophthalmos.
SRC: NLM .