Polatuzumab Vedotin

Cytostatic · Monoclonal antibody

Indications

Used in combination with a bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.(Accelerated approval was granted for this indication based on complete response rate.)

Dosage

INFUSION: Adults:1.8 mg/kg as an IV infusion over 90 mins every 21 days for 6 cycles in combination with bendamustine and a rituximab product. Premedicate with an antihistamine and antipyretic at least 30 mins before administering polatuzumab. Polatuzumab, bendamustine and rituximab product might 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 Day 2 when adm with polatuzumab and a rituximab product. The recommended dose of rituximab product is 375 mg/m2 via IV on Day 1 of each cycle. Monitor patients for infusion-related reactions during the infusion and for a minimum of 90 mins following completion of the initial dose. If the prev inf was well tolerated, the subsequent dose of polatuzumab may be adm as a 30-min inf and patients should be monitored during the inf and for at least 30 mins after completion of the…

Administration

Administer as an IV infusion only. Use 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 pore size) and catheter. Reconstitution: Reconstitute immediately before dilution. Reconstitute each 140 mg polatuzumab vial by using a sterile syringe to slowly inject 7.2 mL of SWFI, USP with the stream directed toward the inside wall of the vial to obtain a conc of 20 mg/mL of polatuzumab vedotin-piiq. Swirl the vial gently until completely dissolved. Do not shake. Inspect the reconst soln for discolouration and particulate matter. Dilution: Dilute polatuzumab to a final conc of 0.72-2.7 mg/mL in an IV inf bag with a minimum vol of 50 mL containing 0.9% NaCl inj, 0.45% NaCl inj, or 5% Dextrose inj. Determine the vol of 20 mg/mL reconstituted soln needed based on the required dose. Withdraw the required vol of reconst…

Adverse Effects

Neutropenia, thrombocytopenia, anaemia, peripheral neuropathy, fatigue, diarrhoea, pyrexia, reduced appetite, pneumonia.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Moderate to severe hepatic impairment. Precautions: Peripheral neuropathy. Patients with high tumour burden or rapidly proliferative tumours. Myelosuppression. Mild hepatic impairment.

Interactions

Strong CYP3A inhibitors and inducers.

Advice to Patient

Inform prescriber if you experience any of the following symptoms: Numbness or tingling of the hands or feet or any muscle weakness, fever, chill, rash, breathing problem, cough, pain on urination, confusion, dizziness, loss of balance, difficulty talking or walking, changes in vision, nausea, vomiting, diarrhoea, lethargy, fatigue, anorexia, right upper abdominal discomfort, dark urine, signs of jaundice. Females of reproductive potential and males with female partners of reproductive potential should use contraception during treatment with polatuzumab and for at least 3 months and 5 months after the last dose, respectively.

Pharmacokinetics

Metabolism: Hepatic. Half-life elimination: Terminal: acMMAE: Approx. 12 days at cycle 6. Unconjugated MMAE: Approx. 4 days after the first polatuzumab vedotin-piiq dose.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.