H.P. ACTHAR(repository corticotropin)injection(八)
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.
6.2.1 Allergic Reactions
Allergic responses have presented as dizziness, nausea and shock (adults only).
6.2.2 Cardiovascular
Necrotizing angitis (adults only) and congestive heart failure.
6.2.3 Dermatologic
Skin thinning (adults only), facial erythema and increased sweating (adults only).
6.2.4 Endocrine
Decreased carbohydrate tolerance (infants only) and hirsutism.
6.2.5 Gastrointestinal
Pancreatitis (adults only), abdominal distention and ulcerative esophagitis.
6.2.6 Metabolic
Hypokalemic alkalosis (infants only).
6.2.7 Musculoskeletal
Muscle weakness and vertebral compression fractures (infants only).
6.2.8 Neurological
Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).
6.3 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:
6.3.1 Dermatologic
Impaired wound healing, abscess, petechiae and ecchymoses, and suppression of skin test reactions.
6.3.2 Endocrine
Menstrual irregularities.
6.3.3 Metabolic
Negative nitrogen balance due to protein catabolism.
6.3.4 Musculoskeletal
Loss of muscle mass and aseptic necrosis of femoral and humeral heads.
6.3.5 Neurological
Increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment, and subdural effusion.
6.3.6 Ophthalmic
Exophthalmos.
7 DRUG INTERACTIONS
Formal drug-drug interaction studies have not been performed.
H.P. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Class C: H.P. Acthar Gel has been shown to have an embryocidal effect. There are no adequate and well-controlled studies in pregnant women. H.P. Acthar Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.3 Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from H.P. Acthar Gel, when treating a nursing mother, a decision should be made whether to discontinue nursing or to discontinue the drug, considering the risk and benefit to the mother.
8.4 Pediatric Use
H.P. Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious an |
