tely to report symptoms of infusion reactions includingurticaria, hypotension, angioedema, sudden cough, breathing problems, weakness, dizziness,palpitations, or chest pain [see Warnings and Precautions (5.1)].
Severe Mucocutaneous Reactions
Advise patients to contact their healthcare provider immediately for symptoms of severemucocutaneous reactions, including painful sores or ulcers on the mouth, blisters, peeling skin,rash, and pustules [see Warnings and Precautions (5.2)].
Hepatitis B Virus Reactivation
Advise patients to contact their healthcare provider immediately for symptoms of hepatitisincluding worsening fatigue or yellow discoloration of skin or eyes [see Warnings andPrecautions (5.3)].
Progressive Multifocal Leukoencephalopathy (PML)
Advise patients to contact their healthcare provider immediately for signs and symptoms ofPML, including new or changes in neurological symptoms such as confusion, dizziness or lossof balance, difficulty talking or walking, decreased strength or weakness on one side of thebody, or vision problems [see Warnings and Precautions (5.4)].
Tumor Lysis Syndrome (TLS)
Advise patients to contact their healthcare provider immediately for signs and symptoms oftumor lysis syndrome such as nausea, vomiting, diarrhea, and lethargy [see Warnings andPrecautions (5.5)].
Infections
Advise patients to contact their healthcare provider immediately for signs and symptoms of infections including fever, cold symptoms (e.g., rhinorrhea or laryngitis), flu symptoms (e.g.,
cough, fatigue, body aches), earache or headache, dysuria, oral herpes simplex infection, andpainful wounds with erythema and advise patients of the increased risk of infections during andafter treatment with TRUXIMA [see Warnings and Precautions (5.6)].
Cardiovascular Adverse Reactions
Advise patients of the risk of cardiovascular adverse reactions, including ventricular fibrillation,myocardial infarction, and cardiogenic shock. Advise patients to contact their healthcareprovider immediately to report chest pain and irregular heartbeats [see Warnings andPrecautions (5.7)].
Renal Toxicity
Advise patients of the risk of renal toxicity. Inform patients of the need for healthcare providersto monitor kidney function [see Warnings and Precautions (5.8)].
Bowel Obstruction and PerforationAdvise patients to contact their healthcare provider immediately for signs and symptoms ofbowel obstruction and perforation, including severe abdominal pain or repeated vomiting [seeWarnings and Precautions (5.9)].
Embryo-Fetal Toxicity
Advise a pregnant woman of the potential risk to a fetus. Advise female patients that rituximabproducts can cause fetal harm if taken during pregnancy and to use effective contraception duringtreatment with TRUXIMA and for at least 12 months after the last dose of TRUXIMA. Advisepatients to inform their healthcare provider of a known or suspected pregnancy [see Warningsand Precautions (5.11) and Use in Specific Populations (8.1, 8.3)].
Lactation
Advise women not to breastfeed during treatment with TRUXIMA and for 6 months after thelast dose [see Use in Specific Populations (8.2)].
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf
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