Trials Experience in Systemic Juvenile Idiopathic Arthritis Patients Treated with Intravenous ACTEMRA (ACTEMRA-IV)
6.5 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Other Drugs for Treatment of Rheumatoid Arthritis
7.2 Interactions with CYP450 Substrates
7.3 Live Vaccines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Rheumatoid Arthritis –Intravenous Administration
14.2 Rheumatoid Arthritis–Subcutaneous Administration
14.3 Polyarticular Juvenile Idiopathic Arthritis-Intravenous Administration
14.4 Systemic Juvenile Idiopathic Arthritis-Intravenous Administration
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis (RA)
ACTEMRA® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
1.2 Polyarticular Juvenile Idiopathic Arthritis (PJIA)
ACTEMRA® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
1.3 Systemic Juvenile Idiopathic Arthritis (SJIA)
ACTEMRA® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
2 DOSAGE AND ADMINISTRATION
2.1 Rheumatoid Arthritis
ACTEMRA may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an intravenous infusion or as a subcutaneous injection.
Recommended Intravenous (IV) Dosage Regimen:
The recommended dosage of ACTEMRA for adult patients given as a 60-minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see DOSAGE AND ADMINISTRATION (2.7), WARNINGS AND PRECAUTIONS (5.3), and ADVERSE REACTIONS (6.1)].
Doses exceeding 800 mg per infusion are not recommended in RA patients [see CLINICAL PHARMACOLOGY (12.3)].
Recommended Subcutaneous (SC) Dosage Regimen:
Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
Patients at or above 100 kg weight 162 mg administered subcutaneously every week
When transitioning from ACTEMRA intravenous therapy to subcutaneous administration administer the first subcutaneous dose instead of the next scheduled intravenous dose.
Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every other week dosing is recommended for management of certain dose-related laborato |
