H.P. Acthar (Page 3 of 6)

6.2 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.

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 General Disorders and Administration Site Conditions

Injection site reactions.

6.2.7 Metabolic

Hypokalemic alkalosis (infants only).

6.2.8 Musculoskeletal

Muscle weakness and vertebral compression fractures (infants only).

6.2.9 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 and other adverse reactions in this population are discussed in Warnings and Adverse Reactions in Infants and Children Under 2 Years of Age [see Sections 5 and 6.1.1].

The efficacy of H.P. Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial [see Clinical Studies (14) ]. A responding patient was defined as having both complete cessation of spasms and elimination of hypsarrhythmia.

Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials [see Adverse Reactions (6.1.1) ]. While the types of adverse reactions seen in infants and children under 2 years of age 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. Effects on growth are of particular concern [see Warnings and Precautions (5.12) ]. Serious adverse reactions observed in adults may also occur in children [see Warnings and Precautions (5) ].

10 OVERDOSAGE

While chronic exposure to H.P. Acthar Gel at high doses can be associated with a variety of potential serious adverse effects, it is not expected that a single high dose, or even several large doses, has the potential for serious adverse effects compared to a standard dose. There have been no reports of death or acute overdose symptoms from H.P. Acthar Gel in clinical studies or in the published literature.

The intramuscular route of administration makes it unlikely that an inadvertent acute overdose will occur. The typical daily dose of H.P. Acthar Gel to treat an infant that has a BSA of 0.4 m2 would be 60 U/day. Using the 1-cc syringe supplied with H.P. Acthar Gel, the maximum amount that can be injected is 80 U/injection, which is a well-tolerated single dose.

11 DESCRIPTION

H.P. Acthar Gel is a highly purified sterile preparation of the adrenocorticotropic hormone in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection. Also contains 0.5% phenol, not more than 0.1% cysteine (added), sodium hydroxide and/or acetic acid to adjust pH and water for injection.

ACTH is a 39 amino acid peptide with the following chemical formula:

H- Ser- Tyr- Ser- Met- Glu- His- Phe- Arg- Trp- Gly-
1 2 3 4 5 6 7 8 9 10
Lys- Pro- Val- Gly- Lys- Lys- Arg- Arg- Pro- Val-
11 12 13 14 15 16 17 18 19 20
Lys- Val- Try- Pro- Asp- Gly- Ala- Glu- Asp- Gln-
21 22 23 24 25 26 27 28 29 30
Leu- Ala- Glu- Ala- Phe- Pro- Leu- Glu- Phe- OH-
31 32 33 34 35 36 37 38 39

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