LIVY (polatuzumab vedotin-piiq) for injection is a preservative-free, white to grayish-whitelyophilized powder, which has a cake-like appearance, supplied in a single-dose vial. Eachcarton (NDC 50242-105-01) contains one 140 mg single-dose vial.
16.2 Storage and Handling
Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do notuse beyond the expiration date shown on the carton. Do not freeze. Do not shake.
POLIVY is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
17 PATIENT COUNSELING INFORMATION
Peripheral Neuropathy
Advise patients that POLIVY can cause peripheral neuropathy. Advise patients to report to theirhealthcare provider any numbness or tingling of the hands or feet or any muscle weakness [seeWarnings and Precautions (5.1)].
Infusion-Related Reactions
Advise patients to contact their healthcare provider if they experience signs and symptoms ofinfusion reactions including fever, chills, rash or breathing problems within 24 hours of infusion[see Warnings and Precautions (5.2)].
Myelosuppression
Advise patients to report signs or symptoms of bleeding or infection immediately. Advisepatients of the need for periodic monitoring of blood counts [see Warnings and Precautions(5.3)].
Infections
Advise patients to contact their healthcare provider if a fever of 38°C (100.4°F) or greater orother evidence of potential infection such as chills, cough, or pain on urination develops. Advisepatients of the need for periodic monitoring of blood counts [see Warnings and Precautions(5.4)].
Progressive Multifocal Leukoencephalopathy
Advise patients to seek immediate medical attention for new or changes in neurologicalsymptoms such as confusion, dizziness, or loss of balance; difficulty talking or walking; orchanges in vision [see Warnings and Precautions (5.5)].
Tumor Lysis Syndrome
Advise patients to seek immediate medical attention for symptoms of tumor lysis syndrome suchas nausea, vomiting, diarrhea, and lethargy [see Warnings and Precautions (5.6)].
Hepatotoxicity
Advise patients to report symptoms that may indicate liver injury, including fatigue, anorexia,right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.7)].
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus. Advise females tocontact their healthcare provider if they become pregnant, or if pregnancy is suspected, duringtreatment with POLIVY [see Warnings and Precautions (5.8) and Use in Specific Populations(8.1)].
Females and Males of Reproductive Potential
Advise females of reproductive potential, and males with female partners of reproductivepotential, to use effective contraception during treatment with POLIVY and for at least 3 monthsand 5 months after the last dose, respectively [see Use in Specific Populations (8.3)].
Lactation
Advise women not to breastfeed while receiving POLIVY and for at 2 months after the last dose[see Use in Specific Populations (8.2)].
https://www.gene.com/download/pdf/polivy_prescribing.pdf
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