information regarding the presence of polatuzumab vedotin-piiq in human milk, theeffects on the breastfed child, or milk production. Because of the potential for serious adverse reactions in a breastfed children, advise women not to breastfeed during treatment with POLIVYand for at least 2 months after the last dose.
8.3 Females and Males of Reproductive Potential
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating POLIVY [see Usein Specific Populations (8.1)].
Contraception
Females
POLIVY can cause embryo-fetal harm when administered to pregnant women [see Use inSpecific Populations (8.1)]. Advise females of reproductive potential to use effectivecontraception during treatment with POLIVY and for 3 months after the final dose [seeNonclinical Toxicology (13.1)].
Males
Based on genotoxicity findings, advise males with female partners of reproductive potential touse effective contraception during treatment with POLIVY and for at least 5 months after thefinal dose [see Nonclinical Toxicity (13.1)].
Infertility
Based on findings from animal studies, POLIVY may impair male fertility. The reversibility ofthis effect is unknown [see Nonclinical Toxicology (13.1)].
8.4 Pediatric Use
Safety and effectiveness of POLIVY have not been established in pediatric patients.
8.5 Geriatric Use
Among 173 patients treated with POLIVY in Study GO29365, 95 (55%) were ≥65 years of age.
Patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) thanpatients aged <65 (53%). Clinical studies of POLIVY did not include sufficient numbers ofpatients aged ≥65 to determine whether they respond differently from younger patients.
8.6 Hepatic Impairment
Avoid the administration of POLIVY in patients with moderate or severe hepatic impairment(bilirubin greater than 1.5 × ULN). Patients with moderate or severe hepatic impairment arelikely to have increased exposure to MMAE, which may increase the risk of adverse reactions.
POLIVY has not been studied in patients with moderate or severe hepatic impairment [seeClinical Pharmacology (12.3) and Warnings and Precautions (5.7)].
No adjustment in the starting dose is required when administering POLIVY to patients with mildhepatic impairment (bilirubin greater than ULN to less than or equal to 1.5 × ULN or ASTgreater than ULN).
11 DESCRIPTION
Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate (ADC) consisting ofthree components: 1) the humanized immunoglobulin G1 (IgG1) monoclonal antibody specificfor human CD79b; 2) the small molecule anti-mitotic agent MMAE; and 3) a protease-cleavablelinker maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) thatcovalently attaches MMAE to the polatuzumab antibody.
Polatuzumab vedotin-piiq has an approximate molecular weight of 150 kDa. An average of3.5 molecules of MMAE are attached to each antibody molecule. Polatuzumab vedotin-piiq isproduced by chemical conjugation of the antibody and small molecule components. Theantibody is produced by mammalian (Chinese hamster ovary) cells, and the small moleculecomponents are produced by chemical synthesis.
POLIVY (polatuzumab vedotin-piiq) for injection is supplied as a sterile, white to grayish-white,preservative-free, lyophilized powder, which has a cake-like appearance, for intravenousinfusion after reco |
