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Trodelvy

Last reviewed on RxList: 4/29/2020
Trodelvy Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Trodelvy?

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate used to treat adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

What Are Side Effects of Trodelvy?

Side effects of Trodelvy include:

Dosage for Trodelvy

The recommended dose of Trodelvy is 10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity.

Trodelvy In Children

Safety and effectiveness of Trodelvy have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Trodelvy?

Trodelvy may interact with other medicines such as:

  • UGT1A1 inhibitors or inducers

Tell your doctor all medications and supplements you use.

Trodelvy During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Trodelvy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Male patients with female partners of reproductive potential are advised to use effective contraception during treatment with Trodelvy and for 3 months after the last dose. There is no information regarding the presence of Trodelvy or SN-38 in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended while using Trodelvy and for 1 month after the last dose.

Additional Information

Our Trodelvy (sacituzumab govitecan-hziy) for 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.

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

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Trodelvy Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Neutropenia [see WARNINGS AND PRECAUTIONS]
  • Diarrhea [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Nausea and Vomiting [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 clinical practice.

The data described in the Warnings and Precautions section reflect exposure to TRODELVY as a single agent in a single-arm, open-label study (IMMU-132-01) in 408 patients with mTNBC and other malignancies who had received prior systemic therapeutic regimen for advanced disease. TRODELVY was administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles at doses up to 10 mg/kg until disease progression or unacceptable toxicity.

The data in Table 2 reflect exposure to TRODELVY in a subset of 108 patients with mTNBC who had received at least two prior treatments for metastatic disease in study (IMMU-132-01). Patients received TRODELVY 10 mg/kg via intravenous infusion on Days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity. The median treatment duration in these 108 patients was 5.1 months (range: 0-51 months).

Serious adverse reactions were reported in 31% of the patients. The most frequent serious adverse reactions (reported in >1%) of the patients receiving TRODELVY were febrile neutropenia (6%) vomiting (5%), nausea (3%), dyspnea (3%), diarrhea (4%), anemia (2%), pleural effusion, neutropenia, pneumonia, dehydration (each 2%).

TRODELVY was permanently discontinued for adverse reactions in 2% of patients. Adverse reactions leading to discontinuation were anaphylaxis, anorexia/fatigue, headache (each <1%, 1 patient for each event). Forty-five percent (45%) of patients experienced an adverse reaction leading to treatment interruption. The most common adverse reaction leading to treatment interruption was neutropenia (33%). Adverse reactions leading to dose reduction occurred in 33% of patients treated with TRODELVY, with 24% having one dose reduction and 9% with two dose reductions. The most common adverse reaction leading to dose reductions was neutropenia/febrile neutropenia.

Adverse reactions occurring in ≥10% of patients with mTNBC in the IMMU-132-01 study are summarized in Table 2.

Table 2: Adverse Reactions in ≥ 10% of Patients with mTNBC in IMMU-132-01

Adverse ReactionTRODELVY
(n=108)
Grade 1-4
(%)
Grade 3-4
(%)
Any adverse reaction10071
Gastrointestinal disorders9521
  Nausea696
  Diarrhea639
  Vomiting496
  Constipation341
  Abdominal paini261
  Mucositisii141
General disorders and administration site conditions779
  Fatigueiii578
  Edemaiv190
  Pyrexia140
Blood and lymphatic system disorders7437
  Neutropenia6443
  Anemia5212
  Thrombocytopenia143
Metabolism and nutrition disorders6822
  Decreased appetite301
  Hyperglycemia244
  Hypomagnesemia211
  Hypokalemia192
  Hypophosphatemia169
  Dehydration135
Skin and subcutaneous tissue disorders634
  Alopecia380
  Rashv313
  Pruritus170
  Dry Skin150
Nervous system disorders564
  Headache231
  Dizziness220
  Neuropathyvi240
  Dysgeusia110
Infections and infestations5512
  Urinary Tract Infection213
  Respiratory Infectionvii263
Musculoskeletal and connective tissue disorders541
  Back pain230
  Arthralgia170
  Pain in extremity110
Respiratory, thoracic and mediastinal disorders545
  Coughviii220
  Dyspneaix213
Psychiatric disorders261
  Insomnia130
Graded per NCI CTCAE v. 4.0
i. Including abdominal pain, distention, pain (upper), discomfort, tenderness
ii Including stomatitis, esophagitis, and mucosal inflammation
iii Including fatigue and asthenia
iv Including edema; and peripheral, localized, and periorbital edema
v Including rash; maculopapular, erythematous, generalized rash; dermatitis acneiform; skin disorder, irritation, and exfoliation
vi Including gait disturbance, hypoesthesia, muscular weakness, paresthesia, peripheral and sensory neuropathy
vii Including lower and upper respiratory tract infection, pneumonia, influenza, viral upper respiratory infection, bronchitis and respiratory syncytial virus infection viii Includes cough and productive cough ix Includes dyspnea and exertional dyspnea

Table 3: Laboratory Abnormalities observed in >10% of Patients while receiving TRODELVY

Laboratory AbnormalityTRODELVY
(n=108)
All Grades
(%)
Grade 3-4
(%)
Hematology
Decreased hemoglobin936
Decreased leukocytes9126
Decreased neutrophils8232
Increased activated partial thromboplastin time6012
Decreased platelets303
Chemistry
Increased alkaline phosphatase572
Decreased magnesium513
Decreased calcium493
Increased glucose483
Increased aspartate aminotransferase453
Decreased albumin391
Increased alanine aminotransferase352
Decreased potassium303
Decreased phosphate295
Decreased sodium254.7
Increased magnesium244
Decreased glucose192

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other sacituzumab govitecan products may be misleading.

The analysis of immunogenicity of TRODELVY in serum samples from 106 patients with mTNBC was evaluated using an electrochemiluminescence (ECL)-based immunoassay to test for anti-sacituzumab govitecan-hziy antibodies. Detection of the anti-sacituzumab govitecan-hziy antibodies was done using a 3-tier approach: screen, confirm, and titer. Persistent anti-sacituzumab govitecan-hziy antibodies developed in 2% (2/106) of patients.

Read the entire FDA prescribing information for Trodelvy (Sacituzumab Govitecan-hziy for Injection, for IV Use)

QUESTION

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Related Resources for Trodelvy

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

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