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H.P. Acthar Gel

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H.P. Acthar Gel

Side Effects
Interactions

SIDE EFFECTS

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
n=122, (%)
150 U/m² qd
n=37(%)
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
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.

Postmarketing Experience

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 Reactions

Allergic responses have presented as dizziness, nausea and shock (adults only).

Cardiovascular

Necrotizing angitis (adults only) and congestive heart failure.

Dermatologic

Skin thinning (adults only), facial erythema and increased sweating (adults only).

Endocrine

Decreased carbohydrate tolerance (infants only) and hirsutism.

Gastrointestinal

Pancreatitis (adults only), abdominal distention and ulcerative esophagitis.

Metabolic

Hypokalemic alkalosis (infants only).

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).

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:

Dermatologic

Impaired wound healing, abscess, petechiae and ecchymoses, and suppression of skin test reactions.

Endocrine

Menstrual irregularities.

Metabolic

Negative nitrogen balance due to protein catabolism.

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.

Read the H.P. Acthar Gel (repository corticotropin injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Formal drug-drug interaction studies have not been performed.

H.P. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.

Read the H.P. Acthar Gel Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/30/2012
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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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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