Pluvicto Side Effects Center

Last updated on RxList: 4/24/2022
Pluvicto Side Effects Center

What Is Pluvicto?

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.

What Are Side Effects of Pluvicto?

Side effects of Pluvicto include:

Dosage for Pluvicto

The recommended dosage of Pluvicto is 7.4 GBq (200 mCi) administered every 6 weeks for up to 6 doses. 

Pluvicto In Children

The safety and effectiveness of Pluvicto in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Pluvicto?

Pluvicto may interact with other medicines.

Tell your doctor all medications and supplements you use.

Pluvicto During Pregnancy and Breastfeeding

The safety and efficacy of Pluvicto have not been established in females so it is unlikely to be used during pregnancy or while breastfeeding. It may harm a fetus. Male patients with female partners of reproductive potential are advised to use effective contraception during treatment with Pluvicto and for 14 weeks after the last dose.

Additional Information

Our Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. 

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Pluvicto Professional Information

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

Adverse Reactions PLUVICTO Plus BSoC
(N = 529)
BSoC
(N = 205)
All Grades (%) Grades 3 to 4 (%) All Grades (%) Grades 3 to 4 (%)
General disorders
Fatigue 43 6 23 1.5
Decreased appetite 21 1.9 15 0.5
Weight decreased 11 0.4 9 0
Peripheral edemaa 10 0.4 7 0.5
Pyrexia 7 0.4 3.4 0
Gastrointestinal disorders
Dry mouthb 39 0 0.5 0
Nausea 35 1.3 17 0.5
Constipation 20 1.1 11 0.5
Vomitingc 19 0.9 6 0.5
Diarrhea 19 0.8 2.9 0.5
Abdominal paind 11 1.1 6 0.5
Blood and lymphatic system disorders
Anemia 32 13 13 4.9
Thrombocytopenia 17 8 4.4 1
Renal and urinary disorders
Urinary tract infectione 12 3.8 1 0.5
Acute kidney injuryf 9 3.2 6 2.9
Nervous system disorders
Dizziness 8 0.9 4.4 0
Headache 7 0.8 2 0
Dysgeusiag 7 0 1.5 0
Abbreviation: BSoC, best standard of care.
aPeripheral edema includes peripheral edema, fluid retention, and fluid overload.
bDry mouth includes dry mouth, aptyalism, and dry throat.
cVomiting includes vomiting and retching.
dAbdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, abdominal tenderness, and gastrointestinal pain.
eUrinary tract infection includes urinary tract infection, cystitis, and cystitis bacterial.
fAcute kidney injury includes blood creatinine increased, acute kidney injury, renal failure, and blood urea increased.
gDysgeusia includes dysgeusia and taste disorder.

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

Labo ratory Abno rmalities PLUVICTO Plus BSoCa BSoCb
All Grades (%) Grades 3 to 4 (%) All Grades (%) Grades 3 to 4 (%)
Chemistry
Decreased calcium 39 2.5 28 3
Decreased sodium 33 0.6c 23 1
Increased aspartate aminotransferase 28 1.1 18 1c
Increased creatinine 24 0.9c 14 0.5c
Increased potassium 24 0.6 18 0.5c
Increased sodium 11 0c 5 0c
Hematology
Decreased lymphocytes 85 47 51 18
Decreased hemoglobin 63 15c 34 7c
Decreased leukocytes 56 7 22 2
Decreased platelets 45 9 20 2.5
Decreased neutrophils 28 4.5 9 0.5
Abbreviation: BSoC, best standard of care.
aThe denominator used to calculate the rate for each laboratory parameter varied from 506 to 529 based on the number of patients with a baseline value and at least one post-treatment value.
bThe denominator used to calculate the rate for each laboratory parameter varied from 194 to 198 based on the number of patients with a baseline value and at least one post-treatment value.
cNo Grade 4 laboratory abnormalities worsening from baseline were reported.

DRUG INTERACTIONS

No Information provided

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

IMAGES

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© Pluvicto Patient Information is supplied by Cerner Multum, Inc. and Pluvicto Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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