Polivy Dosage/Direction for Use

Polivy must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients.
Posology: Diffuse large B-cell lymphoma: Previously untreated patients: The recommended dose of Polivy is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. Polivy, rituximab, cyclophosphamide and doxorubicin can be administered in any order on Day 1 after the administration of prednisone. Prednisone is administered on Days 1-5 of each cycle. Cycles 7 and 8 consist of rituximab as monotherapy.
Refer to the product information of chemotherapy agents given in combination with Polivy for patients with previously untreated DLBCL.
Relapsed or refractory patients: The recommended dose of Polivy is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles. Polivy, bendamustine and rituximab can be administered in any order on Day 1 of each cycle. When administered with Polivy, the recommended dose of bendamustine is 90 mg/m²/day on Day 1 and Day 2 of each cycle and the recommended dose of rituximab is 375 mg/m² on Day 1 of each cycle. Due to limited clinical experience in patients treated with 1.8 mg/kg Polivy at a total dose >240 mg, it is recommended not to exceed the dose 240 mg/cycle.
Previously untreated and relapsed or refractory patients: If not already premedicated, premedication with an antihistamine and anti-pyretic should be administered to patients prior to Polivy.
Delayed or missed doses: If a planned dose of Polivy is missed, it should be administered as soon as possible and the schedule of administration should be adjusted to maintain a 21-day interval between doses.
Dose modifications: The infusion rate of Polivy should be slowed or interrupted if the patient develops an infusion-related reaction. Polivy should be discontinued immediately and permanently if the patient experiences a life-threatening reaction.
For dose modifications to manage peripheral neuropathy (see Precautions) see Table 3 as follows.

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For dose modifications to manage myelosuppression (see Precautions) see Table 4 as follows.

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For dose modifications to manage Infusion-related reactions (see Precautions) see Table 5 as follows.

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Special populations: Elderly: No dose adjustment of Polivy is required in patients ≥65 years of age (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of Polivy is required in patients with creatinine clearance (CrCL) ≥30 mL/min. A recommended dose has not been determined for patients with CrCL <30 mL/min due to limited data.
Hepatic impairment: The administration of Polivy in patients with moderate or severe hepatic impairment (bilirubin greater than 1.5 x upper limit of normal [ULN]) should be avoided.
No adjustment in the starting dose is required when administering Polivy to patients with mild hepatic impairment (bilirubin greater than ULN to less than or equal to 1.5 x ULN or aspartate transaminase [AST] greater than ULN).
Per studied population in mild hepatic impairment (defined as AST or ALT >1.0 to 2.5 x ULN or total bilirubin >1.0 to 1.5 x ULN), there was a not more than 40% increase in unconjugated MMAE exposure, which was not deemed clinically significant.
Paediatric population: The safety and efficacy in children and adolescents less than 18 years have not been established. No data are available.
Method of administration: Polivy is for intravenous use.
The initial dose of Polivy should be administered as a 90-minute intravenous infusion. Patients should be monitored for IRRs/hypersensitivity reactions during the infusion and for at least 90 minutes following completion of the initial dose.
If the prior infusion was well tolerated, the subsequent dose of Polivy may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.
Polivy must be reconstituted and diluted using aseptic technique under the supervision of a healthcare professional. It should be administered as an intravenous infusion through a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter. Polivy must not be administered as intravenous push or bolus.
For instructions on reconstitution and dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
Precaution to be taken before handling or administering the product: Polivy contains a cytotoxic component which is covalently attached to the monoclonal antibody. Follow applicable proper handling and disposal procedure (see Special precautions for disposal and other handling under Cautions for Usage).