njection, USP
Up to 24 hours at 2°C to 8°C (36°F to 46°F) or
up to 4 hours at room temperature (9 to 25°C, 47 to 77°F)
0.45% Sodium Chloride
Injection, USP
Up to 18 hours at 2°C to 8°C (36°F to 46°F) or
up to 4 hours at room temperature (9 to 25°C, 47 to 77°F)
5% Dextrose Injection,
USP
Up to 36 hours at 2°C to 8°C (36°F to 46°F) or
up to 6 hours at room temperature (9 to 25°C, 47 to 77°F)
* To ensure product stability, do not exceed specified storage durations.
Limit transportation to 30 minutes at 9°C to 25°C or 12 hours at 2°C to 8°C (refer toinstructions below). The total storage plus transportation times of the diluted productshould not exceed the storage duration specified in Table 2.
Agitation stress can result in aggregation. Limit agitation of diluted product duringpreparation and transportation to administration site. Do not transport diluted productthrough an automated system (e.g. pneumatic tube or automated cart). If the preparedsolution will be transported to a separate facility, remove air from the infusion bag toprevent aggregation. If air is removed, an infusion set with a vented spike is required toensure accurate dosing during the infusion.
No incompatibilities have been observed between POLIVY and intravenous infusionbags with product contacting materials of polyvinyl chloride (PVC) or polyolefins (PO)
such as polyethylene (PE) and polypropylene (PP). No incompatibilities have beenobserved with infusion sets or infusion aids with product-contacting materials of PVC,
PE, polyurethane (PU), polybutadiene (PBD), acrylonitrile butadiene styrene (ABS),polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene propylene (FEP), or
polytetrafluorethylene (PTFE), or with filter membranes composed of polyether sulfone(PES) or polysulfone (PSU).
Administration
Administer POLIVY as an intravenous infusion only.
POLIVY must be administered using a dedicated infusion line equipped with a sterile,non-pyrogenic, low-protein binding in-line or add-on filter (0.2- or 0.22-micron poresize) and catheter.
Do not mix POLIVY with or administer as an infusion with other drugs.
3 DOSAGE FORMS AND STRENGTHS
For Injection: 140 mg of polatuzumab vedotin-piiq as a white to grayish-white lyophilizedpowder in a single-dose vial for reconstitution and further dilution.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Peripheral Neuropathy
POLIVY can cause peripheral neuropathy, including severe cases. Peripheral neuropathy occursas early as the first cycle of treatment and is a cumulative effect [see Adverse Reactions (6.1)].
POLIVY may exacerbate pre-existing peripheral neuropathy.
In Study GO29365, of 173 patients treated with POLIVY, 40% reported new or worseningperipheral neuropathy, with a median time to onset of 2.1 months. The peripheral neuropathywas Grade 1 in 26% of cases, Grade 2 in 12%, and Grade 3 in 2.3%. Peripheral neuropathyresulted in POLIVY dose reduction in 2.9% of treated patients, dose delay in 1.2%, andpermanent discontinuation in 2.9%. Sixty-five percent of patients reported improvement orresolution of peripheral neuropathy after a median of 1 month, and 48% reported completeresolution.
The peripheral neuropathy is predominantly sensory; however, motor and sensorimotorperipheral neuropathy also occur. Monitor for symptoms |
