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What are polivy's most reported adverse reactions?

See the DrugPatentWatch profile for polivy

Most Common Adverse Reactions to Polivy

Polivy (polatuzumab vedotin-piiq), used with bendamustine and rituximab for relapsed or refractory diffuse large B-cell lymphoma, has these most reported adverse reactions from clinical trials, occurring in 20% or more of patients:

- Neutropenia (41%)
- Thrombocytopenia (36%)
- Anemia (36%)
- Peripheral neuropathy (25%)
- Fatigue (24%)
- Diarrhea (23%)
- Pyrexia (21%)

These rates come from the phase 2 GO29365 trial (N=80), where Polivy was combined with BR.[1][2]

Grade 3-4 Severe Reactions

Serious reactions (grade 3 or higher) were frequent, including:
- Neutropenia (41%)
- Thrombocytopenia (23%)
- Anemia (14%)

Nearly all patients (96%) experienced at least one adverse reaction, with 70% facing grade 3-4 events.[1][2]

Reactions Leading to Discontinuation or Death

About 18% discontinued due to adverse reactions, mainly peripheral neuropathy, pneumonia, and thrombocytopenia. Fatal events linked to treatment included pneumonia (3%), sepsis (2%), and others like sudden death or diffusion lung disease (each 1%).[1]

Peripheral Neuropathy Specifics

Peripheral neuropathy affected 44% overall (53% any grade with BR combo), with 40% grade 1-2 and 14% grade 3. It was the top reason for stopping Polivy (14% of cases), often sensory and resolving over time.[1][2]

Infection Risks

Infections hit 89% of patients, with 50% grade 3-4 cases like pneumonia (18%), sepsis (11%), and urinary tract infections (7%). Prophylaxis for Pneumocystis jirovecii and antivirals is recommended.[1]

Comparison to Bendamustine-Rituximab Alone

In trials, Polivy-BR raised rates of cytopenias, neuropathy, and fatigue versus BR alone (e.g., neutropenia 41% vs. 13%; neuropathy 44% vs. 4%).[1]

Sources
[1]: Polivy Prescribing Information (Genentech, 2023)
[2]: Drugs.com - Polivy Side Effects



Other Questions About Polivy :

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