HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA.
ACTEMRA ® (tocilizumab)
injection, for intravenous use
injection, for subcutaneous use
Initial U.S. Approval: 2010
WARNING: RISK OF SERIOUS INFECTIONS
See full prescribing information for complete boxed warning.
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Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving ACTEMRA. (5.1)
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If a serious infection develops, interrupt ACTEMRA until the infection is controlled. (5.1)
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Perform test for latent TB; if positive, start treatment for TB prior to starting ACTEMRA. (5.1)
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Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1)
RECENT MAJOR CHANGES
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Indications and Usage (1.2) |
04/2013 |
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Dosage and Administration (2.1, 2.2, 2.3, 2.5, 2.6, 2.7) |
10/2013 |
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Warnings and Precautions (5.3, 5.5) |
10/2013 |
INDICATIONS AND USAGE
ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
Rheumatoid Arthritis (RA) (1.1)
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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).
Polyarticular Juvenile Idiopathic Arthritis (PJIA) (1.2)
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Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3)
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Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
DOSAGE AND ADMINISTRATION
ACTEMRA may be used alone or in combination with methotrexate: and in RA, other DMARDs may be used. (2)
Rheumatoid Arthritis (2.1)
Recommended Adult Intravenous (IV) Dosage:
When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
Recommended Adult Subcutaneous (SC) Dosage:
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Patients less than 100 kg weight |
162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response |
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Patients at or above 100 kg weight |
162 mg administered subcutaneously every week |
Polyarticular Juvenile Idiopathic Arthritis (2.2)
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Recommended Intravenous PJIA Dosage Every 4 Weeks |
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Patients less than 30 kg weight |
10 mg per kg |
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Patients at or above 30 kg weight |
8 mg per kg |
Systemic Juvenile Idiopathic Arthritis (2.3)
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Recommended Intravenous SJIA Dosage Every 2 Weeks |
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Patients less than 30 kg weight |
12 mg per kg |
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Patients at or above 30 kg weight |
8 mg per kg |
General Dosing Information (2.4)
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It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN). (2.1, 5.3)
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ACTEMRA doses exceeding 800 mg per infusion are not recommended in RA patients. (2.1, 12.3)
Administration of Intravenous formulation (2.5)
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For adults, PJIA and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% Sodium Chloride for intravenous infusion using aseptic technique.
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For PJIA and SJIA patients less than 30 kg, dilute to 50 mL in 0.9% Sodium Chloride for intravenous infusion using aseptic technique.
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Administer as a single intravenous drip infusion over 1 hour; do not administer as bolus or push.
Administration of Subcutaneous formulation (2.6)
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Follow the Instructions for Use for prefilled syringe
Dose Modifications (2.7)
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Recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.
DOSAGE FORMS AND STRENGTHS
Single-use vials of ACTEMRA (20 mg per mL) for intravenous administration:
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80 mg per 4 mL (3)
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200 mg per 10 mL (3)
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400 mg per 20 mL (3)
Prefilled Syringe (PFS) for subcutaneous administration:
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A single use PFS providing 162 mg of ACTEMRA in 0.9mL (3)
CONTRAINDICATIONS
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ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA. (4)
WARNINGS AND PRECAUTIONS
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Serious Infections – do not administer ACTEMRA during an active infection, including localized infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. (5.1)
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Gastrointestinal (GI) perforation – use with caution in patients who may be at increased risk. (5.2)
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Laboratory monitoring – recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. (2.7, 5.3)
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Hypersensitivity reactions, including anaphylaxis and death have occurred. (5.5)
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Live vaccines – Avoid use with ACTEMRA. (5.8, 7.3)
Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
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Pregnancy: Based on animal data, may cause fetal harm. (8.1)
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Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
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.
Recommended Subcutaneous (SC) Dosage Regimen:
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 laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.7), Warnings and Precautions (5.3), and Adverse Reactions (6.2)].
2.2 Polyarticular Juvenile Idiopathic Arthritis
ACTEMRA may be used alone or in combination with methotrexate. The recommended dosage of ACTEMRA for PJIA patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:
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Do not change dose based solely on a single visit body weight measurement, as weight may fluctuate.
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Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.7)].
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Subcutaneous administration is not approved for PJIA.
2.3 Systemic Juvenile Idiopathic Arthritis
ACTEMRA may be used alone or in combination with methotrexate. The recommended dose of ACTEMRA for SJIA patients given once every 2 weeks as a 60-minute single intravenous drip infusion is:
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