Polivy Special Precautions

Traceability: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Myelosuppression: Serious and severe neutropenia and febrile neutropenia have been reported in patients treated with Polivy as early as the first cycle of treatment. Prophylactic G-CSF administration was required in the clinical development and should be considered. Grade 3 or 4 thrombocytopenia or anemia can also occur with Polivy. Complete blood counts should be monitored prior to each dose of Polivy. More frequent lab monitoring and/or Polivy delays or discontinuation should be considered in patients with Grade 3 or Grade 4 neutropenia and thrombocytopenia (see Dosage & Administration).
Peripheral Neuropathy (PN): Peripheral neuropathy has been reported in patients treated with Polivy as early as the first cycle of treatment, and the risk increases with sequential doses. Patients with pre-existing peripheral neuropathy may experience worsening of this condition. Peripheral neuropathy reported with Polivy treatment is predominantly sensory peripheral neuropathy; however, motor and sensorimotor peripheral neuropathy have also been reported. Patients should be monitored for symptoms of peripheral neuropathy such as hypoesthesia, hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation, muscle weakness, or gait disturbance. Patients experiencing new or worsening peripheral neuropathy may require a delay, dose reduction, or discontinuation of Polivy (see Dosage & Administration).
Infections: Serious, life threatening, or fatal infections, including opportunistic infections, such as pneumonia (including Pneumocystis jirovecii and other fungal pneumonia), bacteremia, sepsis, herpes infection, and cytomegalovirus infection have been reported in patients treated with Polivy (see Adverse Reactions). Reactivation of latent infections has been reported. Patients should be closely monitored during treatment for signs of bacterial, fungal, or viral infections and seek medical advice if signs and symptom appear. Anti-infective prophylaxis should be considered throughout treatement with Polivy.
Polivy should not be administered in the presence of an active severe infection. Polivy and any concomitant chemotherapy should be discontinued in patients who develop serious infections.
Human Immunodeficiency Virus (HIV): Polivy has not been evaluated in patients with HIV. With regard to co-administration of CYP3A-inhibitors see Interactions.
Immunization: Live or live-attenuated vaccines should not be given concurrently with the treatment. Studies have not been conducted in patients who recently received live vaccines.
Progressive Multifocal Leukoencephalopathy (PML): PML has been reported with Polivy treatment (see Adverse Reactions). Patients should be monitored closely for new or worsening neurological, cognitive, or behavioral changes suggestive of PML. Polivy and any concomitant chemotherapy should be withheld if PML is suspected and permanently discontinued if the diagnosis is confirmed.
Tumor Lysis Syndrome (TLS): Patients with high tumor burden and rapidly proliferative tumor may be at increased risk of tumor lysis syndrome. Appropriate measures in accordance with local guidelines should be taken prior to treatment with Polivy. Patients should be monitored closely for tumor lysis syndrome during treatment with Polivy.
Infusion-related reactions: Polivy can cause IRRs, including severe cases. Delayed IRRs as late as 24 hours after receiving Polivy have occurred. An antihistamine and antipyretic should be administered prior to the administration of Polivy, and patients should be monitored closely throughout the infusion. If an IRR occurs, the infusion should be interrupted and appropriate medical management should be instituted (see Dosage & Administration).
Fertility: In non-clinical studies, polatuzumab vedotin has resulted in testicular toxicity, and may impair male reproductive function and fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, men being treated with Polivy are advised to have sperm samples preserved and stored before treatment (see Use in Pregnancy & Lactation).
Hepatic Toxicity: Serious cases of hepatic toxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred in patients treated with Polivy (see Adverse Reactions). Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Liver enzymes and bilirubin level should be monitored. (See Special populations under Dosage & Administration and Pharmacology: Pharmacokinetics: Hepatic impairment under Actions.)
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Effects on ability to drive and use of machines: Polivy has minor influence on the ability to drive and use machines.
Infusion related reactions, peripheral neuropathy, fatigue, and dizziness may occur during treatment with Polivy (see previous text and Adverse Reactions).
Use in Pregnancy: Embryo-Fetal Toxicity: Based on the mechanism of action and nonclinical studies, Polivy can be harmful to the fetus when administered to a pregnant woman (see Pharmacology: Toxicology: Preclinical safety data under Actions). Pregnant woman should be advised regarding risk to the fetus.
Women of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 9 months after the last dose (see Use in Pregnancy & Lactation). Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 6 months after the last dose (see Use in Pregnancy & Lactation).
Use in the Elderly: Among 173 patients treated with Polivy in Study GO29365, 95 (55%) were ≥65 years of age. Patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged <65 (53%). Clinical studies of Polivy did not include sufficient numbers of patients aged ≥65 to determine whether they respond differently from younger patients.