নির্দেশনা
Polatuzumab Vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Polatuzumab Vedotin in combination with bendamustine and rituximab is indicated for the treatment of adult patients with diffuse large B-cell lymphoma who have received at least one prior therapy.
Composition
ফার্মাকোলজি
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells. The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanized immunoglobulin G1 (IgG1) monoclonal antibody via a cleavable linker. The monoclonal antibody binds with high affinity and selectivity to CD79b, a cell surface component of the B-cell receptor. CD79b expression is restricted to normal cells within the B-cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in >95% of DLBCL. Upon binding CD79b, polatuzumab vedotin is rapidly internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.
মাত্রা ও সেবনবিধি
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 rituximab for 6 cycles. Polivy, bendamustine, and rituximab 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 rituximab. 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, 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.
প্রতিনির্দেশনা
Polivy is contraindicated in patients with a known hypersensitivity to polatuzumab vedotin or any of the excipients
পার্শ্ব প্রতিক্রিয়া
গর্ভাবস্থায় ও স্তন্যদানকালে
Pregnancy : Polatuzumab Vedotin is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus. Polatuzumab Vedotin can cause fetal harm based on the animal studies and the drug’s mechanism of action. Lactation : It is not known whether polatuzumab vedotin is excreted in human breast milk. No studies have been conducted to assess the impact of Polivy on milk production or its presence in breast milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfeeding infants due to Polivy, women should discontinue breastfeeding during Polivy treatment and for at least 3 months after the last dose.