ACTHAR Gel (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Mallinckrodt ARD LLC
Λέξεις κλειδιά
63004-8710
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1. Indications and Usage
1.1 Infantile Spasms Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. 1.2 Multiple Sclerosis Acthar Gel is indicated for the treatment ...
2. Dosage and Administration
2.1 Specific Recommended Dosage Regimen for Infantile Spasms in Infants and Children Under 2 Years of Age In the treatment of infantile spasms, Acthar Gel must be administered intramuscularly. The recommended ...
3. Dosage Forms and Strengths
5 mL multi-dose vial containing 80 USP Units per mL.
4. Contraindications
Acthar Gel is contraindicated: for intravenous administration. in infants under 2 years of age who have suspected congenital infections. with concomitant administration of live or live attenuated vaccines ...
5. Warnings and Precautions
The adverse effects of Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with Acthar Gel, but they might be expected ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Infections <em>[see Warnings and Precautions (5.1)]</em> Cushings Syndrome and Adrenal Insufficiency Upon ...
6.1. 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 ...
6.2. 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 ...
7. Drug Interactions
Formal drug-drug interaction studies have not been performed. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.
8.1. Pregnancy
Risk Summary Based on Acthar Gels pharmacological effect of stimulating an endogenous steroid response <em>[see Clinical Pharmacology ( 12.1)]</em>, Acthar Gel may cause fetal harm when administered to ...
8.2. Lactation
Risk Summary There are no available data on the presence of corticotropin in either human or animal milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits ...
8.4. Pediatric Use
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 can occur in this population <em> ...
11. Description
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. The Acthar Gel manufacturing process converts the initial porcine pituitary extract ...
12.1. Mechanism of Action
The mechanism of action of Acthar Gel in the treatment of infantile spasms is unknown. Acthar Gel and endogenous ACTH stimulate the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and ...
12.3. Pharmacokinetics
ACTH rapidly disappears from the circulation following its intravenous administration; in people, the plasma half-life is about 15 minutes. The pharmacokinetics of Acthar Gel have not been adequately characterized. ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Adequate studies of the carcinogenic potential of Acthar Gel have not been conducted. Mutagenesis The genotoxic potential of Acthar Gel has not been adequately evaluated. Impairment of Fertility ...
14. Clinical Studies
The effectiveness of Acthar Gel as a treatment for infantile spasms was demonstrated in a single blinded (video EEG interpreter blinded) clinical trial in which patients were randomized to receive either ...
16.1. How Supplied
Acthar Gel (repository corticotropin injection) is supplied as 5 mL multi-dose vial (NDC 63004-8710-1) containing 80 USP Units per mL. Acthar Gel (repository corticotropin injection) should be warmed to ...
16.2. Storage and Handling
Store Acthar Gel (repository corticotropin injection) under refrigeration between 2°C to 8°C (36°F to 46°F). Product is stable for the period indicated on the label when stored under the conditions described. ...
17. Patient Counseling Information
Advise caretakers of patients with infantile spasms to read the FDA-approved patient labeling (Medication Guide). Patients should be instructed to take Acthar Gel only as prescribed. They should not stop ...