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:
- nausea,
- low white blood cell count (neutropenia),
- diarrhea,
- fatigue,
- anemia,
- vomiting,
- hair loss ,
- constipation,
- rash,
- decreased appetite, and
- abdominal pain
Call your doctor at once if you have the following serious side effects:
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
- low levels of sodium in the body with severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
- severe nervous system reaction with very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out.
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 AnswerThis 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 medical caregivers 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 signs of infection such as:
- 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 SlideshowSIDE 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