SPECTED ADVERSE REACTIONS, contact TEVA
Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
Renal toxicity when used in combination with cisplatin (5.8).
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed (8.2).
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 Truxima has been demonstrated for the condition(s) of use (e.g.
indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) ofadministration described in its Full Prescribing Information.
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: FATAL INFUSION REACTIONS, SEVERE
MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS
REACTIVATION and PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY (PML)
1 INDICATIONS AND USAGE
1.1 Non-Hodgkin’s Lymphoma (NHL)
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Information
2.2 Recommended Dose for Non-Hodgkin’s Lymphoma (NHL)
2.3 Recommended Dose for Premedication and Prophylactic Medications
2.4 Administration and Storage
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Infusion Reactions
5.2 Severe Mucocutaneous Reactions
5.3 Hepatitis B Virus (HBV) Reactivation
5.4 Progressive Multifocal Leukoencephalopathy (PML)
5.5 Tumor Lysis Syndrome (TLS)
5.6 Infections
5.7 Cardiovascular Adverse Reactions
5.8 Renal Toxicity
5.9 Bowel Obstruction and Perforation
5.10 Immunization
5.11 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience in Lymphoid Malignancies
6.2 Immunogenicity
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
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 Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive,B-Cell NHL
14.2 Previously Untreated, Low-Grade or Follicular, CD20-Positive,B-Cell NHL
14.3 Ninety-Minute Infusions in Previously Untreated Follicular NHL
and Another Indication
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not
listed.
--------------------------------------------------------------
FULL PRESCRIBING INFORMATION
WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS
REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE
MULTIFOCAL LEUKOEN |
