Ltd. at 1-877-888-4231 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
Live vaccines – should not be given with Eticovo (5.8, 7.1)
Anakinra – increased risk of serious infection (5.12, 7.2)
Abatacept – increased risk of serious adverse events, includinginfections (5.12, 7.2)
Cyclophosphamide – use with Eticovo is not recommended (7.3)
See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide.
* Biosimilar means that the biological product is approved based on datademonstrating that it is highly similar to an FDA-approved biologicalproduct, known as a reference product, and that there are no clinicallymeaningful differences between the biosimilar product and the referenceproduct. Biosimilarity of Eticovo has been demonstrated for the condition(s)of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), androute(s) of administration described in its Full Prescribing Information.
Revised: 04/2019
-------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SERIOUS INFECTIONS andMALIGNANCIES
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
1.2 Polyarticular Juvenile Idiopathic Arthritis
1.3 Psoriatic Arthritis
1.4 Ankylosing Spondylitis
1.5 Plaque Psoriasis
2 DOSAGE AND ADMINISTRATION
2.1 Adult Patients
2.2 Pediatric Patients
2.3 Preparation of Eticovo
2.4 Monitoring to Assess Safety
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
5.2 Neurologic Reactions
5.3 Malignancies
5.4 Patients With Heart Failure
5.5 Hematologic Reactions
5.6 Hepatitis B Reactivation
5.7 Allergic Reactions
5.8 Immunizations
5.9 Autoimmunity
5.10 Immunosuppression
5.11 Use in Wegener’s Granulomatosis Patients
5.12 Use with Anakinra or Abatacept
5.13 Use in Patients with Moderate to SevereAlcoholic Hepatitis
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Vaccines
7.2 Immune-Modulating Biologic Products
7.3 Cyclophosphamide
7.4 Sulfasalazine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Use in Diabetics
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 ofFertility
14 CLINICAL STUDIES
14.1 Adult Rheumatoid Arthritis
14.2 Polyarticular Juvenile Idiopathic Arthritis (JIA)
14.3 Psoriatic Arthritis
14.4 Ankylosing Spondylitis
14.5 Adult Plaque Psoriasis
14.6 Pediatric Plaque Psoriasis
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the fullprescribing information are not listed.
-------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
WARNING: SERIOUS INFECTIONS and MALIGNANCIES
SERIOUS INFECTIONS
Patients treated with etanercept products are at increased risk for developing serious infections that may leadto hospitalization or death [see Warnings and Precaut
