Polatuzumab Vedotin

Polatuzumab Vedotin is a prescription medication used for the treatment of diffuse large B-cell lymphoma.

• Polatuzumab Vedotin is available under the following different brand names: Polivy, Polatuzumab Vedotin-piiq

Common side effects of Polatuzumab Vedotin include:

• fever,
• cough,
• tiredness,
• other signs of infection,
• nerve problems,
• diarrhea, and
• loss of appetite

Serious side effects of Polatuzumab Vedotin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• problems with speech thought, vision, or muscle movement,
• fever,
• chills,
• itching,
• lightheadedness,
• wheezing,
• chest tightness,
• easy bruising,
• unusual bleeding (nosebleeds, bleeding gums),
• muscle weakness,
• cough with mucus,
• chest pain,
• shortness of breath,
• pale skin,
• cold hands and feet,
• numbness, tingling, pain, or burning sensation in the hands or feet,
• weakness,
• trouble walking,
• night sweats,
• cough,
• mouth sores,
• swollen glands,
• shallow breathing,
• pain or burning when you urinate,
• weight loss,
• flu-like symptoms,
• tingly or painful blistering rash on one side of the body,
• loss of appetite,
• stomach pain (upper right side),
• dark urine,
• yellow of the skin or eyes (jaundice),
• confusion,
• muscle cramps,
• nausea,
• vomiting,
• fast or slow heart rate,
• decreased urination, and
• tingling in the hands and feet or around your mouth

Rare side effects of Polatuzumab Vedotin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 140 mg/vial (single-dose vial)

Diffuse Large B-Cell Lymphoma

Adult dosage

• Day 1
  • Rituximab product 375 mg/m² IV PLUS
  • Bendamustine 90 mg/m² IV PLUS
  • Polatuzumab Vedotin 1.8 mg/kg IV
  • May administer drugs in any sequence on Day 1
• Day 2
  • Bendamustine 90 mg/m² IV

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Polatuzumab Vedotin has severe interactions with the following drug:
  • dichlorphenamide
• Polatuzumab Vedotin has serious interactions with the following drugs:
  • abametapir
  • fexinidazole
  • tucatinib
  • voxelotor
• Polatuzumab Vedotin has moderate interactions with at least 58 other drugs.
• Polatuzumab Vedotin has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • ceritinib
  • cyclophosphamide
  • larotrectinib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aminosalicylic acid?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aminosalicylic acid?”

Cautions

• Infusion-related reactions reported; delayed infusion-related reactions may occur as late as 24 hr after receiving polatuzumab
• Serious or severe myelosuppression (eg, neutropenia, thrombocytopenia, anemia) may occur; monitor complete blood cell count during treatment
• Fatal and/or serious infections reported, including opportunistic infections such as sepsis, pneumonia (including Pneumocystis jiroveci and other fungal pneumonia), herpes virus infection, and cytomegalovirus infection; closely monitor for signs and symptoms of infection
• Progressive multifocal leukoencephalopathy (PML) reported after treatment; monitor for new or worsening neurological, cognitive, or behavioral changes; hold polatuzumab and any concomitant chemotherapy if PML is suspected, and permanently discontinue if the diagnosis is confirmed
• Patients with high tumor burden and the rapidly proliferative tumors may be at increased risk of tumor lysis syndrome; closely monitor and take appropriate measures, including tumor lysis syndrome prophylaxis
• Serious cases of hepatotoxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred; preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk of hepatotoxicity; monitor liver enzymes and bilirubin level
• Based on the mechanism of action and findings from animal studies, fetal harm may occur when administered to a pregnant woman (see Pregnancy)
• Peripheral neuropathy
  • Peripheral neuropathy, including severe cases, may occur as early as the first cycle of treatment and is a cumulative effect; may exacerbate preexisting peripheral neuropathy
  • Monitor for symptoms of peripheral neuropathy (eg, hypoesthesia, hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation, weakness, gait disturbance)
• Drug interactions overview
• MMAE is a CYP3A4 substrate
• Strong CYP3A inhibitors
• Concomitant use with a strong CYP3A4 inhibitor may increase unconjugated MMAE AUC, which may increase Polatuzumab Vedotin toxicities
• Monitor for signs of toxicity
• Strong CYP3A inducers
• Concomitant use with a strong CYP3A4 inducer may decrease unconjugated MMAE AUC

Pregnancy and Lactation

• Based on findings from animal studies and its mechanism of action, fetal harm may occur
• No data is available for pregnant women to inform a drug-associated risk
• Verify pregnancy status in females of reproductive potential before initiating treatment
• Advise pregnant women of potential fetal risks
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 3 months after the final dose
  • Males with female partners of reproductive potential: Based on genotoxicity findings, use effective contraception during treatment and for at least 5 months after the final dose
• Infertility
  • Based on findings from animal studies, male fertility may be impaired; reversibility is unknown
• Lactation
  • There is no information regarding the presence of Polatuzumab Vedotin-piiq in human milk, the effects on the breastfed child, or milk production
  • Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 2 months after the last dose