ister as a single intravenous drip infusion over 1 hour; do not administer as bolus or push.
Administration of Subcutaneous formulation (2.6)
Follow the Instructions for Use for prefilled syringe
Dose Modifications (2.7)
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:
80 mg per 4 mL (3)
200 mg per 10 mL (3)
400 mg per 20 mL (3)
Prefilled Syringe (PFS) for subcutaneous administration:
A single use PFS providing 162 mg of ACTEMRA in 0.9mL (3)
CONTRAINDICATIONS
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA. (4)
WARNINGS AND PRECAUTIONS
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)
Gastrointestinal (GI) perforation – use with caution in patients who may be at increased risk. (5.2)
Laboratory monitoring – recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. (2.7, 5.3)
Hypersensitivity reactions, including anaphylaxis and death have occurred. (5.5)
Live vaccines – Avoid use with ACTEMRA. (5.8, 7.3)
ADVERSE REACTIONS
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
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF SERIOUS INFECTIONS
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis (RA)
1.2 Polyarticular Juvenile Idiopathic Arthritis (PJIA)
1.3 Systemic Juvenile Idiopathic Arthritis (SJIA)
2 DOSAGE AND ADMINISTRATION
2.1 Rheumatoid Arthritis
2.2 Polyarticular Juvenile Idiopathic Arthritis
2.3 Systemic Juvenile Idiopathic Arthritis
2.4 General Considerations for Administration
2.5 Preparation and Administration Instructions for Intravenous Infusion
2.6 Preparation and Administration Instructions for Subcutaneous Injection for RA
2.7 Dosage Modifications due to Serious Infections or Laboratory Abnormalities
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
5.2 Gastrointestinal Perforations
5.3 Laboratory Parameters
5.4 Immunosuppression
5.5 Hypersensitivity Reactions, Including Anaphylaxis
5.6 Demyelinating Disorders
5.7 Active Hepatic Disease and Hepatic Impairment
5.8 Vaccinations
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience in Rheumatoid Arthritis Patients Treated with Intravenous ACTEMRA (ACTEMRA-IV)
6.2 Clinical Trials Experience in Rheumatoid Arthritis Patients Treated with Subcutaneous ACTEMRA (ACTEMRA-SC)
6.3 Clinical Trials Experience in Polyarticular Juvenile Idiopathic Arthritis Patients Treated With Intravenous ACTEMRA (ACTEMRA-IV)
6.4 Clinical |
