Trodelvy

Last updated on RxList: 4/14/2021
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.

QUESTION

A lump in the breast is almost always cancer. See Answer
Trodelvy Consumer Information

This medicine can cause severe or life-threatening allergic reactions.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or within 24 hours afterward. Tell your caregiver if you feel dizzy, light-headed, itchy, sweaty, or have a fever, chills, trouble breathing, or swelling in your face or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have:

  • pain or burning when you urinate;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Sacituzumab govitecan can cause severe diarrhea. Tell your doctor right away if you have:

  • diarrhea (the first time it occurs);
  • diarrhea lasting longer than 24 hours (even if you use anti-diarrhea medicine);
  • black or bloody stools;
  • severe or ongoing vomiting, especially if you can't keep liquids down; or
  • a light-headed feeling, like you might pass out.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • diarrhea, nausea, vomiting;
  • stomach pain, loss of appetite, constipation;
  • low blood cell counts;
  • rash;
  • hair loss; or
  • feeling tired.

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.

Read the entire detailed patient monograph for Trodelvy (Sacituzumab Govitecan-hziy for Injection, for IV Use)

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 and Infusion-Related Reactions [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 pooled safety population described in the Warnings and Precautions section reflect exposure to TRODELVY as a single agent in 660 patients from two studies, IMMU-132-01 and IMMU-132-05 which included 366 patients with mTNBC who had received prior systemic chemotherapy for advanced disease. TRODELVY was administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles at doses of 10 mg/kg until disease progression or unacceptable toxicity. Among the 660 patients treated with TRODELVY, the median duration of treatment was 4.1 months (range: 0 to 51 months). In this pooled safety population, the most common (> 25%) adverse reactions were nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite and abdominal pain.

ASCENT Study

The safety of TRODELVY was evaluated in a randomized, active-controlled, open-label trial (ASCENT) in patients with mTNBC who had previously received a taxane and at least two prior therapies. Patients were randomized (1:1) to receive either TRODELVY (n=258) or single agent chemotherapy (n=224) and were treated until disease progression or unacceptable toxicity [see Clinical Studies]. For patients treated with TRODELVY, the median duration of treatment was 4.4 months (range: 0 to 23 months).

Serious adverse reactions occurred in 27% of patients receiving TRODELVY. Serious adverse reactions in > 1% of patients receiving TRODELVY included neutropenia (7%), diarrhea (4%), and pneumonia (3%). Fatal adverse reactions occurred in 1.2% of patients who received TRODELVY, including respiratory failure (0.8%) and pneumonia (0.4%). TRODELVY was permanently discontinued for adverse reactions in 5% of patients. Adverse reactions leading to permanent discontinuation in ≥ 1 % of patients who received TRODELVY were pneumonia (1%) and fatigue (1%).

Adverse reactions leading to a treatment interruption of TRODELVY occurred in 63% of patients. The most frequent (≥5%) adverse reactions leading to a treatment interruption were neutropenia (47%), diarrhea (5%), respiratory infection (5%), and leukopenia (5%).

Adverse reactions leading to a dose reduction of TRODELVY occurred in 22% of patients. The most frequent (>4%) adverse reactions leading to a dose reduction were neutropenia (11%) and diarrhea (5%).

Granulocyte-colony stimulating factor (G-CSF) was used in 44% of patients who received TRODELVY.

Tables 2 and 3 summarize adverse reactions and select laboratory abnormalities, respectively, in the ASCENT study.

Table 2: Adverse Reactions in ≥10% of Patients with mTNBC in ASCENT

Adverse Reaction TRODELVY
(n=258)
Single Agent Chemotherapy
(n=224)
All Grades % Grade 3 - 4 % All Grades % Grade 3 - 4 %
Blood and lymphatic system disorders
Neutropenia i 64 52 44 34
Anemia ii 40 9 28 6
Leukopenia iii 17 11 12 6
Lymphopeniaiv 10 2 6 2
Gastrointestinal disorders
Diarrhea 59 11 17 1
Nausea 57 3 26 0.4
Vomiting 33 2 16 1
Constipation 37 0.4 23 0
Abdominal Pain 30 3 12 1
Stomatitis v 17 2 13 1
General disorders and administration site conditions
Fatiguevi 65 6 50 9
Pyrexia 15 0.4 14 2
Infections and infestation
Urinary tract infection 13 0.4 8 0.4
Upper respiratory tract infection 12 0 3 0
Investigations
Alanine aminotransferase increased 11 1 10 1
Metabolism and nutrition disorders
Decreased appetite 28 2 21 1
Hypokalemia 16 3 13 0.4
Hypomagnesaemia 12 0 6 0
Musculosketal and connective tissue disorders
Back pain 16 1 14 2
Arthralgia 12 0.4 7 0
Nervous system disorders
Headache 18 0.8 13 0.4
Dizziness 10 0 7 0
Psychiatric disorders
Insomnia 11 0 5 0
Respiratory, thoracic and mediastinal disorders
Cough 24 0 18 0.4
Skin and subcutaneous tissue disorders
Alopecia 47 0 16 0
Rash 12 0.4 5 0.4
Pruritus 10 0 3 0
*Single agent chemotherapy included one of the following single-agents: eribulin (n=139), capecitabine (n=33), gemcitabine (n=38), or vinorelbine (except if patient had ≥Grade 2 neuropathy, n=52).
Graded per NCI CTCAE v.5.0.
i. Including neutropenia and neutrophil count decreased
ii. Including anemia, hemoglobin decreased, and red blood cell count decreased
iii. Including leukopenia and white blood cell count decreased
iv. Including lymphopenia and lymphocyte count decreased
v. Including stomatitis, glossitis, mouth ulceration, and mucosal inflammation
vi. Including fatigue and asthenia

Table 3: Select Laboratory Abnormalities in >10% of Patients with mTNBC in ASCENT

Laboratory Abnormality TRODELVY
(n=258)
Single Agent Chemotherapy
(n=224)
All Grades (%) Grade 3 - 4 (%) All Grades (%) Grade 3 - 4 (%)
Decreased hemoglobin 94 9 57 6
Decreased leukocytes 86 41 53 25
Decreased neutrophils 78 49 48 36
Decreased lymphocytes 88 31 40 24
Decreased platelets 23 1.2 25 2.7

Study IMMU-132-01

The safety of TRODELVY was evaluated in a single-arm, open-label study (IMMU-132-01) in patients with mTNBC and other malignancies, which included 108 patients with mTNBC who had received at least two prior treatments for metastatic disease [see Clinical Studies]. 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 median treatment duration in these 108 patients was 5.1 months (range: 0-51 months).

Serious adverse reactions occurred in 31% of the patients. Serious adverse reactions in >1% of patients receiving TRODELVY included 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 permanent discontinuation were anaphylaxis, anorexia/fatigue, headache (each 0.9%). 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 4: Adverse Reactions in ≥ 10% of Patients with mTNBC in IMMU-132-01

Adverse Reaction TRODELVY
(n=108)
Grade 1-4 (%) Grade 3-4 (%)
Any adverse reaction 100 71
Gastrointestinal disorders 95 21
Nausea 69 6
Diarrhea 63 9
Vomiting 49 6
Constipation 34 1
Abdominal paini 26 1
Mucositisii 14 1
General disorders and administration site conditions 77 9
Fatigueiii 57 8
Edemaiv 19 0
Pyrexia 14 0
Blood and lymphatic system disorders 74 37
Neutropenia 64 43
Anemia 52 12
Thrombocytopenia 14 3
Metabolism and nutrition disorders 68 22
Decreased appetite 30 1
Hyperglycemia 24 4
Hypomagnesemia 21 1
Hypokalemia 19 2
Hypophosphatemia 16 9
Dehydration 13 5
Skin and subcutaneous tissue disorders 63 4
Alopecia 38 0
Rashv 31 3
Pruritus 17 0
Dry Skin 15 0
Nervous system disorders 56 4
Headache 23 1
Dizziness 22 0
Neuropathyvi 24 0
Dysgeusia 11 0
Infections and infestations 55 12
Urinary Tract Infection 21 3
Respiratory Infectionvii 26 3
Musculoskeletal and connective tissue disorders 54 1
Back pain 23 0
Arthralgia 17 0
Pain in extremity 11 0
Respiratory, thoracic and mediastinal disorders 54 5
Coughviii 22 0
Dyspneaix 21 3
Psychiatric disorders 26 1
Insomnia 13 0
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 5: Laboratory Abnormalities observed in ≥10% of Patients while receiving TRODELVY

Laboratory Abnormality TRODELVY
(n=108)
All Grades (%) Grade 3-4 (%)
Hematology
Decreased hemoglobin 93 6
Decreased leukocytes 91 26
Decreased neutrophils 82 32
Increased activated partial thromboplastin time 60 12
Decreased platelets 30 3
Chemistry
Increased alkaline phosphatase 57 2
Decreased magnesium 51 3
Decreased calcium 49 3
Increased glucose 48 3
Increased aspartate aminotransferase 45 3
Decreased albumin 39 1
Increased alanine aminotransferase 35 2
Decreased potassium 30 3
Decreased phosphate 29 5
Decreased sodium 25 4.7
Increased magnesium 24 4
Decreased glucose 19 2

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.

DRUG INTERACTIONS

Effect Of Other Drugs On TRODELVY

UGT1A1 Inhibitors

Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38 [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers

Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Avoid administering UGT1A1 inducers with TRODELVY.

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

© 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.

Health Solutions From Our Sponsors