H.P. ACTHAR(repository corticotropin)injection(三)
5.1 Infections
5.2 Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal
5.3 Elevated Blood Pressure, Salt and Water Retention and Hypokalemia
5.4 Vaccination
5.5 Masking Symptoms of Other Diseases
5.6 Gastrointestinal Perforation and Bleeding
5.7 Behavioral and Mood Disturbances
5.8 Comorbid Diseases
5.9 Ophthalmic Effects
5.10 Immunogenicity Potential
5.11 Use in Patients with Hypothyroidism or Liver Cirrhosis
5.12 Negative Effects on Growth and Physical Development
5.13 Decrease in Bone Density
5.14 Use in Pregnancy
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.1.1 Adverse Reactions in Infants and Children Under 2 Years of Age
6.2 Postmarketing Experience
6.2.1 Allergic Reactions
6.2.2 Cardiovascular
6.2.3 Dermatologic
6.2.4 Endocrine
6.2.5 Gastrointestinal
6.2.6 Metabolic
6.2.7 Musculoskeletal
6.2.8 Neurological
6.3 Possible Additional Steroidogenic Effects
6.3.1 Dermatologic
6.3.2 Endocrine
6.3.3 Metabolic
6.3.4 Musculoskeletal
6.3.5 Neurological
6.3.6 Ophthalmic
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED / STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
MEDICATION GUIDE
--------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Infantile spasms:
H.P. Acthar Gel (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.
1.2 Multiple Sclerosis:
H.P. Acthar Gel (repository corticotropin injection) is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.
1.3 Rheumatic Disorders:
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis.
1.4 Collagen Diseases:
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).
1.5 Dermatologic Diseases:
Severe erythema multiforme, Stevens-Johnson syndrome
1.6 Allergic States:
Serum sickness.
1.7 Ophthalmic Diseases:
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis; optic neuritis; chorioretinitis; anterior segment inflammation.
1.8 Respiratory Diseases:
Symptomatic sarcoidosis
1.9 Edematous State:
To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
2 DOSAGE AND ADMINIS |
