Pluvicto Side Effects Center

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Myelosuppression [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PLUVICTO was evaluated in the VISION study in patients with progressive, PSMA-positive mCRPC [see Clinical Studies]. Of the 831 patients randomized, 734 patients received at least one dose of randomized treatment. Patients received at least one dose of either PLUVICTO 7.4 GBq (200 mCi) administered every 6 to 10 weeks plus BSoC (N = 529) or BSoC alone (N = 205). The median duration of exposure to randomized treatment was 7.8 months (range, 0.3 to 24.9) for patients who received PLUVICTO plus BSoC. Among patients who received PLUVICTO plus BSoC, the median number of doses of PLUVICTO received was 5 (range, 1 to 6). The median cumulative dose of PLUVICTO was 37.5 GBq (range, 7.0 to 48.3). The median duration of follow-up was 14.8 months for patients receiving PLUVICTO plus BSoC.

Serious adverse reactions occurred in 36% of patients who received PLUVICTO plus BSoC. Serious adverse reactions in > 1% of patients who received PLUVICTO plus BSoC included hemorrhage (4%), musculoskeletal pain (3.8%), sepsis (3.2%), anemia (2.8%), urinary tract infection (2.6%), acute kidney injury (1.7%), pneumonia (1.7%), pancytopenia (1.3%), pyrexia (1.3%), spinal cord compression (1.1%), and pulmonary embolism (1.1%).

Fatal adverse reactions occurred in 2.8% of patients who received PLUVICTO plus BSoC, including sepsis (0.9%), pancytopenia (0.6%), hepatic failure (0.4%), intracranial hemorrhage (0.2%), subdural hematoma (0.2%), ischemic stroke (0.2%), COVID-19 (0.2%), and aspiration pneumonia (0.2%).

PLUVICTO was permanently discontinued due to adverse reactions in 12% of patients. Adverse reactions leading to permanent discontinuation of PLUVICTO in ≥ 1% of patients who received PLUVICTO plus BSoC were anemia (2.8%), thrombocytopenia (2.8%), and leukopenia (including neutropenia) (1.7%).

Adverse reactions leading to a dose interruption of PLUVICTO occurred in 16% of patients. The most frequent (≥ 3%) adverse reactions leading to a dose interruption of PLUVICTO in patients who received PLUVICTO plus BSoC were anemia (5%) and thrombocytopenia (3.6%).

Adverse reactions leading to a dose reduction of PLUVICTO occurred in 6% of patients. The most frequent (≥ 1%) adverse reactions leading to a dose reduction of PLUVICTO in patients who received PLUVICTO plus BSoC were thrombocytopenia (1.9%) and anemia (1.3%).

The most common adverse reactions (≥ 20%) occurring at a higher incidence in patients who received PLUVICTO plus BSoC were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation.

The most common laboratory abnormalities that worsened from baseline in ≥ 30% of patients who received PLUVICTO plus BSoC were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium.

Table 3 and Table 4 summarize the incidence of adverse reactions and laboratory abnormalities, respectively.

Table 3: Adverse Reactions (≥ 5%) in Patients with PSMA-positive mCRPC Who Received PLUVICTO Plus BSoC in VISION

Clinically relevant adverse reactions in < 5% of patients who received PLUVICTO plus BSoC included dry eye, vertigo, and pancytopenia (including bicytopenia).

Table 4: Select Laboratory Abnormalities (≥ 10%) That Worsened from Baseline in Patients With PSMA-positive mCRPC Who Received PLUVICTO Plus BSoC (Between Arm Difference of ≥ 5% All Grades) in VISION

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan)