t be givenwith RENFLEXIS. Bring pediatric patients up to date with allvaccinations prior to initiating RENFLEXIS. At least a six monthaiting period following birth is recommended before theadministration of live vaccines to infants exposed in utero to infliximab
products (5.15)
ADVERSE REACTIONS
Most common adverse reactions (>10%) – infections (e.g. upper respiratory,sinusitis, and pharyngitis), infusion-related reactions, headache, andabdominal pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp& Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 orFDA at 1-800-FDA1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Use with anakinra or abatacept– increased risk of serious infections (7.1)
USE IN SPECIFIC POPULATIONS
• Pediatric Use – Infliximab products have not been studied in childrenwith Crohn’s disease or ulcerative colitis <6 years of age. (8.4)
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 biological product,known as a reference product, and that there are no clinically meaningfuldifferences between the biosimilar product and the reference product.Biosimilarity of RENFLEXIS has been demonstrated for the condition(s) ofuse (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), androute(s) of administration described in its Full Prescribing Information.
Revised: 03/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: SERIOUS INFECTIONS AND MALIGNANCY
1 INDICATIONS AND USAGE
1.1 Crohn’s Disease
1.2 Pediatric Crohn’s Disease
1.3 Ulcerative Colitis
1.4 Rheumatoid Arthritis
1.5 Ankylosing Spondylitis
1.6 Psoriatic Arthritis
1.7 Plaque Psoriasis
2 DOSAGE AND ADMINISTRATION
2.1 Crohn’s Disease
2.2 Pediatric Crohn’s Disease
2.3 Ulcerative Colitis
2.4 Rheumatoid Arthritis
2.5 Ankylosing Spondylitis
2.6 Psoriatic Arthritis
2.7 Plaque Psoriasis
2.8 Monitoring to Assess Safety
2.9 Administration Instructions Regarding Infusion Reactions
2.10 General Considerations and Instructions for Preparation andAdministration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS (see Boxed WARNINGS)
5.1 Serious Infections
5.2 Malignancies
5.3 Hepatitis B Virus Reactivation
5.4 Hepatotoxicity
5.5 Patients with Heart Failure
5.6 Hematologic Reactions
5.7 Hypersensitivity
5.8 Cardiovascular and Cerebrovascular ReactionsDuring and After Infusion
5.9 Neurologic Reactions
5.10 Use with Anakinra
5.11 Use with Abatacept
5.12 Concurrent Administration with other Biological Therapeutics
5.13 Switching Between Biological Disease-ModifyingAntirheumatic Drugs (DMARDs)
5.14 Autoimmunity
5.15 Live Vaccines/Therapeutic Infectious Agents
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
7.1 Use with Anakinra or Abatacept
7.2 Use with Tocilizumab
7.3 Use with Other Biological Therapeutics
7.4 Methotrexate (MTX) and Other Concomitant Medications
7.5 Immunosuppressants
7.6 Cytochrome P450 Substrates
7.7 Live Vaccines/Therapeutic Infectious Agents
8 USE IN SPECI |
