POLIVY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 140MG

ROCHE SINGAPORE PTE. LTD.

ROCHE SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**2.2 DOSAGE AND ADMINISTRATION** **General** Substitution by any other biological medicinal product requires the consent of the prescribing physician. In order to prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is Polivy. Polivy therapy should only be administered under the supervision of a healthcare professional experienced in the treatment of cancer patients. Polivy must be reconstituted and diluted using aseptic technique under the supervision of a healthcare professional. Polivy 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 micrometre pore size) and catheter (see _4.2 Special instructions for Use, Handling and Disposal_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Do not administer as an IV push or bolus. For information on MabThera, bendamustine, cyclophosphamide, doxorubicin, or prednisone, refer to their respective full prescribing information. Refer to Table 2 for dose modification recommendations for neutropenia and thrombocytopenia. **Recommended Dosage** _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 for 6 cycles in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP). 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. _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 MabThera for 6 cycles. Polivy, bendamustine, and MabThera can be administered in any order on Day 1 of each cycle. The recommended dose of bendamustine is 90 mg/m2/day on Day 1 and 2 when administered with Polivy and MabThera. _Previously untreated and relapsed or refractory patients:_ If not already premedicated, administer premedication with an antihistamine and anti-pyretic to patients prior to administration of Polivy. The initial dose of Polivy should be administered as a 90-minute intravenous infusion. Patients should be monitored for infusion-related reactions during the infusion and for at least 90 minutes following completion of the initial dose. If the prior infusion was well tolerated, 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. **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** Tables 1, 2 and 3 provides management guidelines for Peripheral Neuropathy, myelosuppression and infusion-related reaction. There are different possible dose modifications for Polivy in patients with previously untreated DLBCL and those who are relapsed or refractory (see Table 1 and Table 2). For dose modifications to manage peripheral neuropathy see Table 1.  For dose modifications to manage myelosuppression see Table 2.  For dose modifications for infusion-related reaction see Table 3.  The infusion rate of Polivy should be slowed or interrupted if the patient develops an infusion-related reaction. Discontinue Polivy immediately and permanently if the patient experiences a life-threatening reaction. **2.2.1 Special Dosage Instructions** **Pediatric use** The safety and efficacy of Polivy in children and adolescents (<18 years) has not been established. **Geriatric use** No dose adjustment of Polivy is required in patients ≥ 65 years of age (see _2.5.5 Geriatric Use_ and _3.2.5 Pharmacokinetics in special populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **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 (see _2.5.6 Renal Impairment_ and _3.2.5 Pharmacokinetics in special populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic Impairment** The administration of Polivy in patients with moderate or severe hepatic impairment (total bilirubin greater than 1.5× upper limit of normal \[ULN\]) should be avoided. No dose adjustment of Polivy is required for patients with mild hepatic impairment \[total bilirubin greater than ULN and less than or equal to 1.5×ULN or aspartate transaminase (AST) greater than ULN\] (see _2.5.7 Hepatic Impairment_ and _3.2.5 Pharmacokinetics in special populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).