ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Sacituzumab govitecan: Drug information

Sacituzumab govitecan: Drug information
(For additional information see "Sacituzumab govitecan: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Neutropenia:

Severe or life-threatening neutropenia may occur. Withhold sacituzumab govitecan for ANC <1,500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider granulocyte-colony stimulating factor (G-CSF) for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.

Diarrhea:

Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold sacituzumab govitecan until resolved to ≤ grade 1 and reduce subsequent doses.

Brand Names: US
  • Trodelvy
Brand Names: Canada
  • Trodelvy
Pharmacologic Category
  • Antineoplastic Agent, Anti-Trop-2;
  • Antineoplastic Agent, Antibody Drug Conjugate;
  • Antineoplastic Agent, Monoclonal Antibody;
  • Antineoplastic Agent, Topoisomerase I Inhibitor
Dosing: Adult

Note: Do not substitute sacituzumab govitecan for (or use with) other medications containing irinotecan or its active metabolite SN-38. Calculate the required dose based on the patient's body weight at the beginning of each treatment cycle (or more frequently if the patient's body weight changed by >10% from the previous dose). Withhold sacituzumab govitecan dose on day 1 of any cycle for ANC <1,500/mm3; withhold dose on day 8 of any cycle for ANC <1,000/mm3.

Premedications: Premedicate with antipyretics and H1/H2 antagonists prior to sacituzumab govitecan infusion; corticosteroids may be used if prior infusion-related reactions occurred. Sacituzumab govitecan is associated with a moderate to high emetic potential; antiemetics (either a 2 or 3 drug combination regimen) are recommended to prevent nausea and vomiting. Patients should be provided take home medications with clear instructions for nausea and vomiting prevention and treatment.

Breast cancer, triple negative, locally advanced or metastatic, relapsed or refractory

Breast cancer, triple negative, locally advanced or metastatic, relapsed or refractory: IV: 10 mg/kg on days 1 and 8 of a 21-day treatment cycle (maximum: 10 mg/kg/dose); continue until disease progression or unacceptable toxicity (Ref).

Breast cancer, locally advanced or metastatic, hormone receptor–positive, HER2-negative

Breast cancer, locally advanced or metastatic, hormone receptor–positive, HER2-negative: IV: 10 mg/kg on days 1 and 8 of a 21-day treatment cycle (maximum: 10 mg/kg/dose); continue until disease progression or unacceptable toxicity (Ref).

Urothelial cancer, locally advanced or metastatic

Urothelial cancer, locally advanced or metastatic: IV: 10 mg/kg on days 1 and 8 of a 21-day treatment cycle (maximum: 10 mg/kg/dose); continue until disease progression or unacceptable toxicity (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl >30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, renal elimination of SN-38 (small molecule moiety of sacituzumab govitecan) is minimal.

CrCl ≤30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (no data are available).

End-stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (no data are available).

Dosing: Hepatic Impairment: Adult

Total bilirubin ≤ ULN with AST > ULN or bilirubin >1 to 1.5 times ULN with any AST: No initial dosage adjustment necessary.

Total bilirubin >1.5 times ULN, or AST and ALT >3 times ULN without liver metastases, or AST and ALT >5 times ULN with liver metastases: There are no dosage adjustments provided in the manufacturer's labeling (no initial dosage recommendation can be made).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2 (Ref).

Dosing: Adjustment for Toxicity: Adult
Sacituzumab Govitecan Dosage Adjustments for Adverse Reactionsa

Adverse Reaction

Occurrence

Dose Modificationa

a Do not re-escalate the sacituzumab govitecan dose after a dose reduction for adverse reactions.

b Administer G-CSF as clinically indicated.

c G-CSF = granulocyte-colony stimulating factor.

Hematologic toxicityb

ANC <1,500/mm3

Day 1 of any cycle

Withhold sacituzumab govitecan.

ANC <1,000/mm3

Day 8 of any cycle

Withhold sacituzumab govitecan.

Neutropenic fever

Any

Withhold sacituzumab govitecan.

Grade 4 neutropenia (ANC <500/mm3) lasting ≥7 days

OR

Grade 3 or 4 neutropenic fever (ANC <1,000/mm3 and fever ≥38.5°C)

OR

On day of scheduled sacituzumab govitecan dose, grade 3 or 4 neutropenia, which delays dosing by 2 or 3 weeks for recovery to ≤ grade 1

First

Reduce sacituzumab govitecan dose by 25% and administer G-CSFc support.

Second

Reduce sacituzumab govitecan dose by 50% and administer G-CSF.

Third

Discontinue sacituzumab govitecan and administer G-CSF.

On day of scheduled sacituzumab govitecan dose, grade 3 or 4 neutropenia, which delays dosing beyond 3 weeks for recovery to ≤ grade 1

First

Discontinue sacituzumab govitecan and administer G-CSF.

On day of scheduled sacituzumab govitecan dose, grade 3 or 4 non-neutropenic hematologic toxicity, which delays dosing by 2 or 3 weeks for recovery to ≤ grade 1

First

Reduce sacituzumab govitecan dose by 25%.

Second

Reduce sacituzumab govitecan dose by 50%.

Third

Discontinue sacituzumab govitecan.

Grade 3 or 4 non-neutropenic hematologic toxicity, which does not recover to ≤ grade 1 within 3 weeks

First

Discontinue sacituzumab govitecan.

Nonhematologic toxicity

GI toxicity: Diarrhea (grade 3 or 4)

Occurring at the time of a scheduled dose

Withhold sacituzumab govitecan; resume when diarrhea has resolved to ≤ grade 1. Evaluate for infectious causes at onset of diarrhea. If negative, initiate loperamide 4 mg initially, followed by 2 mg with every diarrhea episode up to a maximum of 16 mg/day (discontinue loperamide 12 hours after diarrhea resolves). Initiate additional supportive measures (fluids, electrolytes) as clinically indicated. If an excessive cholinergic response occurs, may consider appropriate anticholinergic (eg, atropine) premedication with subsequent infusions.

GI toxicity: Nausea (grade 3) or vomiting (grade 3 or 4)

Occurring at the time of a scheduled dose

Withhold sacituzumab govitecan; resume with additional supportive measures when resolved to ≤ grade 1.

GI toxicity: Any grade 3 or 4 nausea, vomiting, or diarrhea due to sacituzumab govitecan that is not controlled with antiemetics and/or antidiarrheal treatment

First

Reduce sacituzumab govitecan dose by 25%.

Second

Reduce sacituzumab govitecan dose by 50%.

Third

Discontinue sacituzumab govitecan.

Hypersensitivity

May require permanent discontinuation.

Infusion-related reaction

Slow or interrupt the sacituzumab govitecan infusion if an infusion-related reaction occurs. Permanently discontinue sacituzumab govitecan for grade 4 or life-threatening infusion-related reactions.

Grade 4 nonhematologic toxicity of any duration

OR

Other grade 3 or 4 nonhematologic toxicity lasting >48 hours (despite optimal medical management)

OR

On day of scheduled sacituzumab govitecan dose, grade 3 or 4 nonhematologic toxicity, which delays dosing by 2 or 3 weeks for recovery to ≤ grade 1

First

Reduce sacituzumab govitecan dose by 25%.

Second

Reduce sacituzumab govitecan dose by 50%.

Third

Discontinue sacituzumab govitecan.

Grade 3 or 4 nonhematologic toxicity, which does not recover to ≤ grade 1 within 3 weeks

First

Discontinue sacituzumab govitecan.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations
Bone marrow suppression

Sacituzumab govitecan may cause neutropenia, including grades 3 and 4 and febrile neutropenia. Anemia, leukopenia, lymphocytopenia, and thrombocytopenia have also been reported. Neutropenia was the most common adverse reaction leading to treatment interruption in clinical trials.

Mechanism: Exact mechanism is unknown; SN-38 is the active metabolite of the cytotoxic agent irinotecan, a topoisomerase I inhibitor.

Onset: May occur at any time during treatment, including during the first cycle (Ref). Median onset of 16 days has been reported for neutropenia.

Risk factors:

• Patients who are homozygous for the UGT1A1*28 allele; Note: Toxic effects of irinotecan (of which, SN-38 is the active metabolite) have been associated with UGT1A1*28 homozygosity. Clinical trials of sacituzumab govitecan showed a numerically increased incidence of neutropenia in patients with a UGT1A1*28 genotype compared to *1/*28 or *1/*1 (Ref). Additional validation is needed prior to use of genetic testing for clinical decision making related to use of sacituzumab govitecan (Ref).

GI toxicity

Sacituzumab govitecan may cause diarrhea, including grades 3 and 4 diarrhea; permanent discontinuation due to diarrhea occurred rarely in clinical trials. Colitis and neutropenic enterocolitis have been reported rarely. Other GI adverse reactions may include abdominal pain, dyspepsia, and stomatitis. Abdominal cramps and increased salivation have also been reported in patients who experience an excessive cholinergic response to treatment.

Sacituzumab govitecan is associated with moderate to high emetic potential and may cause nausea and vomiting (including grades 3 and 4); premeditation and/or treatment interruption may be required.

Mechanism: Dose-related; related to the pharmacologic action. SN-38 is the active metabolite of the cytotoxic agent irinotecan, a topoisomerase I inhibitor. When compared to irinotecan, sacituzumab govitecan results in lower concentrations of the glucuronidated form of SN-38 which may explain the lower incidence of diarrhea (Ref).

Hypersensitivity

Sacituzumab govitecan may cause hypersensitivity reactions, including severe and life-threatening reactions; anaphylaxis has rarely been reported.

Onset: Rapid; reported within 24 hours of administration in over one-third of patients.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Cardiovascular: Edema (17% to 19%)

Dermatologic: Alopecia (38% to 49%), pruritus (10% to 17%), skin rash (12% to 32%), xeroderma (15%)

Endocrine & metabolic: Decreased serum albumin (32% to 51%), decreased serum glucose (10% to 19%), decreased serum magnesium (18% to 51%), decreased serum phosphate (17% to 41%), decreased serum potassium (22% to 33%), dehydration (13%; severe dehydration: 2%), increased lactate dehydrogenase (16% to 28%), increased serum albumin (32%), increased serum glucose (31% to 59%), increased serum phosphate (16%), increased serum potassium (14%), weight loss (17%)

Gastrointestinal: Abdominal pain (20% to 31%; severe abdominal pain: 2%), constipation (34% to 37%), decreased appetite (21% to 41%; including anorexia), diarrhea (59% to 72%; grades 3/4: 9% to 12%) (table 1), dysgeusia (11%), dyspepsia (11%), nausea (57% to 69%; grades 3/4: 3% to 6%) (table 2), stomatitis (14% to 17%; grades 3/4: 1% to 2%), vomiting (23% to 49%; grades 3/4: 1% to 6%) (table 3)

Sacituzumab Govitecan: Adverse Reaction: Diarrhea

Drug (Sacituzumab Govitecan)

Comparator (Single Agent Chemotherapy)

Indication

Number of Patients (Sacituzumab Govitecan)

Number of Patients (Comparator)

All grades: 62%

All grades: 23%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

Grades 3/4: 10%

Grades 3/4: 1%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

All grades: 72%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

Grades 3/4: 12%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

All grades: 63%

N/A

Metastatic triple-negative breast cancer

108

N/A

Grades 3/4: 9%

N/A

Metastatic triple-negative breast cancer

108

N/A

All grades: 59%

All grades: 17%

Metastatic triple-negative breast cancer

258

224

Grades 3/4: 11%

Grades 3/4: 1%

Metastatic triple-negative breast cancer

258

224

Sacituzumab Govitecan: Adverse Reaction: Nausea

Drug (Sacituzumab Govitecan)

Comparator (Single agent chemotherapy)

Indication

Number of Patients (Sacituzumab Govitecan)

Number of Patients (Comparator)

59%

35%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

All grades: 66%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

Grades 3/4: 4%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

All grades: 69%

N/A

Metastatic triple-negative breast cancer

108

N/A

Grades 3/4: 6%

N/A

Metastatic triple-negative breast cancer

108

N/A

All grades: 57%

All grades: 26%

Metastatic triple-negative breast cancer

258

224

Grades 3/4: 3%

Grades 3/4: 0.4%

Metastatic triple-negative breast cancer

258

224

Sacituzumab Govitecan: Adverse Reaction: Vomiting

Drug (Sacituzumab Govitecan)

Comparator (Single agent chemotherapy)

Indication

Number of Patients (Sacituzumab Govitecan)

Number of Patients (Comparator)

23%

16%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

All grades: 34%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

Grades 3/4: 1%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

All grades: 49%

N/A

Metastatic triple-negative breast cancer

108

N/A

Grades 3/4: 6%

N/A

Metastatic triple-negative breast cancer

108

N/A

All grades: 33%

All grades: 16%

Metastatic triple-negative breast cancer

258

224

Grades 3/4: 2%

Grades 3/4: 1%

Metastatic triple-negative breast cancer

258

224

Genitourinary: Hematuria (16%), urinary tract infection (13% to 21%)

Hematologic & oncologic: Decreased hemoglobin (71% to 94%; grades 3/4: 6% to 18%), decreased platelet count (21% to 30%; grades 3/4: 1% to 3%) (table 4), decreased neutrophils (67% to 83%; grades 3/4: 32% to 53%) (table 5), eosinophilia (13%), leukopenia (78% to 91%, grades 3/4: 26% to 41%) (table 6), lymphocytopenia (65% to 88%; grades 3/4: 21% to 35%), prolonged partial thromboplastin time (33% to 60%; grades 3/4: 6% to 12%)

Sacituzumab Govitecan: Adverse Reaction: Decreased Hemoglobin

Drug (Sacituzumab Govitecan)

Comparator (Single agent chemotherapy)

Indication

Number of Patients (Sacituzumab Govitecan)

Number of Patients (Comparator)

All grades: 73%

All grades: 59%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

Grades 3/4: 8%

Grades 3/4: 5%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

All grades: 71%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

Grades 3/4: 18%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

All grades: 94%

All grades: 57%

Metastatic triple-negative breast cancer

258

224

Grades 3/4: 9%

Grades 3/4: 6%

Metastatic triple-negative breast cancer

258

224

All grades: 93%

N/A

Metastatic triple-negative breast cancer

108

N/A

Grades 3/4: 6%

N/A

Metastatic triple-negative breast cancer

108

N/A

Sacituzumab Govitecan: Adverse Reaction: Decreased Neutrophils

Drug (Sacituzumab Govitecan)

Comparator (Single agent chemotherapy)

Indication

Number of Patients (Sacituzumab Govitecan)

Number of Patients (Comparator)

All grades: 83%

All grades: 67%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

Grades 3/4: 53%

Grades 3/4: 40%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

All grades: 67%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

Grades 3/4: 43%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

All grades: 78%

All grades: 48%

Metastatic triple-negative breast cancer

258

224

Grades 3/4: 49%

Grades 3/4: 36%

Metastatic triple-negative breast cancer

258

224

All grades: 82%

N/A

Metastatic triple-negative breast cancer

108

N/A

Grades 3/4: 32%

N/A

Metastatic triple-negative breast cancer

108

N/A

Sacituzumab Govitecan: Adverse Reaction: Leukopenia

Drug (Sacituzumab Govitecan)

Comparator (Single agent chemotherapy)

Indication

Number of Patients (Sacituzumab Govitecan)

Number of Patients (Comparator)

All grades: 88%

All grades: 73%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

Grades 3/4: 38%

Grades 3/4: 26%

Locally advanced or metastatic HR-positive, HER2-negative breast cancer

268

249

All grades: 78%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

Grades 3/4: 38%

N/A

Locally advanced or metastatic urothelial cancer

113

N/A

All grades: 86%

All grades: 53%

Metastatic triple-negative breast cancer

258

224

Grades 3/4: 41%

Grades 3/4: 25%

Metastatic triple-negative breast cancer

258

224

All grades: 91%

N/A

Metastatic triple-negative breast cancer

108

N/A

Grades 3/4: 26%

N/A

Metastatic triple-negative breast cancer

108

N/A

Hepatic: Increased serum alanine aminotransferase (21% to 35%), increased serum alkaline phosphatase (23% to 57%), increased serum aspartate aminotransferase (15% to 45%)

Hypersensitivity: Hypersensitivity reaction (35%)

Infection: Infection (50%; serious infection: 18%)

Nervous system: Dizziness (10% to 22%), fatigue (57% to 68%; including asthenia), headache (16% to 23%), insomnia (11% to 13%), neuropathy (24%; peripheral neuropathy: 12%)

Neuromuscular & skeletal: Arthralgia (12% to 17%), back pain (16% to 23%), limb pain (11%)

Renal: Acute kidney injury (24%), decreased creatinine clearance (24%), increased serum creatinine (32%)

Respiratory: Cough (12% to 24%), dyspnea (16% to 21%; severe dyspnea: 3%), respiratory tract infection (26%), upper respiratory tract infection (12%)

Miscellaneous: Fever (14% to 19%)

1% to 10%:

Cardiovascular: Hypotension (5%), venous thromboembolism (9%)

Dermatologic: Skin hyperpigmentation (3%)

Endocrine & metabolic: Hypocalcemia (3%), hypokalemia (10%), hyponatremia (2%)

Gastrointestinal: Colitis (including neutropenic enterocolitis: 2%), intestinal obstruction (3%)

Genitourinary: Proteinuria (1%)

Hematologic & oncologic: Febrile neutropenia (4% to 10%)

Immunologic: Antibody development (1%; neutralizing: <1%)

Infection: Bacteremia (≤9%), sepsis (≤9%)

Nervous system: Pain (5%)

Respiratory: Nasal congestion (3%), pleural effusion (2%), pneumonia (2% to 4%), rhinorrhea (5%)

<1%:

Gastrointestinal: Enteritis

Hypersensitivity: Anaphylaxis

Contraindications

Severe hypersensitivity to sacituzumab govitecan or any component of the formulation.

Warnings/Precautions

Special populations:

• Older age: In some studies, patients ≥65 years of age experienced a higher discontinuation rate due to adverse reactions (compared to patients <65 years of age).

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Reduced UGT1A1 activity: Patients who are homozygous or heterozygous for the UGT1A1*28 allele may be at increased risk for adverse reactions (compared to wild-type). Early acute-onset or unusually severe adverse reactions may be indicative of reduced UGT1A1 enzyme activity.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Trodelvy: Sacituzumab govitecan-hziy 180 mg (1 ea) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Trodelvy Intravenous)

180 mg (per each): $2,884.63

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Trodelvy: 180 mg (1 ea) [contains polysorbate 80]

Administration: Adult

IV: Administer the initial sacituzumab govitecan infusion over 3 hours; may administer subsequent infusions over 1 to 2 hours if prior infusions were tolerated. Protect infusion bag from light during infusion; however, tubing does not need to be protected from light during infusion and light-protective tubing is not necessary. After infusion is complete, flush infusion line with 20 mL NS. Observe patients during infusion and for at least 30 minutes after each infusion. If more than 1 infusion bag is necessary to administer the full dose, infuse the bags sequentially. Administer infusion within 6 hours (including infusion time) after refrigeration.

Prior to each dose, premedicate with antipyretics and H 1/H 2 antagonists; corticosteroids may be administered if an infusion-related reaction occurred with a prior dose. Slow or interrupt the infusion if an infusion-related reaction develops; permanently discontinue for life-threatening infusion-related reactions.

Sacituzumab govitecan is associated with a moderate to high emetic potential; antiemetics (either a 2 or 3 drug combination regimen) are recommended to prevent nausea and vomiting.

Do not administer as an IV push or bolus. Do not administer with other medications.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH [group 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Use: Labeled Indications

Breast cancer, locally advanced or metastatic:

Treatment of unresectable locally advanced or metastatic triple-negative breast cancer in adults who have received 2 or more prior systemic therapies, at least one of which was for metastatic disease.

Treatment of unresectable locally advanced or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative (IHC 0, IHC 1+, or IHC 2+/ISH−) breast cancer in adults who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.

Urothelial cancer, locally advanced or metastatic: Treatment of locally advanced or metastatic urothelial cancer in adults who have previously received platinum-containing chemotherapy and either programmed death receptor-1 or programmed death-ligand 1 inhibitor.

Medication Safety Issues
Sound-alike/look-alike issues:

Sacituzumab govitecan may be confused with fam-trastuzumab deruxtecan, sarilumab, secukinumab.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

Other safety concerns:

Do not substitute sacituzumab govitecan for (or use with) other medications containing irinotecan or its active metabolite SN-38.

Metabolism/Transport Effects

Substrate of UGT1A1

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Irinotecan Products: May enhance the adverse/toxic effect of Sacituzumab Govitecan. Risk X: Avoid combination

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Mitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapy

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

UGT1A1 Inducers: May decrease serum concentrations of the active metabolite(s) of Sacituzumab Govitecan. Specifically, concentrations of SN-38 may be decreased. Risk X: Avoid combination

UGT1A1 Inhibitors: May increase serum concentrations of the active metabolite(s) of Sacituzumab Govitecan. Specifically, concentrations of SN-38 may be increased. Risk X: Avoid combination

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 6 months after the last sacituzumab govitecan dose. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last dose of sacituzumab govitecan.

Pregnancy Considerations

Based on the mechanism of action, in utero exposure to sacituzumab govitecan may cause fetal harm.

Sacituzumab govitecan is composed of sacituzumab linked to SN-38. Sacituzumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest fetal IgG exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). SN-38 is the genotoxic component.

Breastfeeding Considerations

It is not known if sacituzumab govitecan or SN-38 are present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 1 month after the last sacituzumab govitecan dose.

Monitoring Parameters

Monitor blood counts prior to dose on days 1 and 8 of each cycle and as clinically necessary (especially in patients known to be homozygous or heterozygous for UGT1A1*28). Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor for neutropenic fever, hypersensitivity reactions, and infusion-related reactions (observe during and for at least 30 minutes after infusion). Monitor (including patient self-monitoring, after clear clinician instruction) for diarrhea, nausea, and vomiting, as well as a clinical indication for additional antiemetics and/or supportive measures (eg, fluids, electrolytes). Closely monitor for adverse reactions in patients with known reduced UGT1A1 activity.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Sacituzumab govitecan is an antibody drug conjugate that consists of a humanized antitrophoblast cell-surface antigen 2 (Trop-2) monoclonal antibody coupled to the topoisomerase 1 inhibitor SN-38 via a cleavable linker (Bardia 2019). Trop-2 is a transmembrane glycoprotein that is highly expressed in many epithelial cancer cell surfaces (Tagawa 2021). TROP-2 is associated with cancer cell growth and has been detected in breast cancer cells (including triple-negative breast cancer cells). Sacituzumab govitecan binds to Trop-2 and is internalized; SN-38 is released in tumors both intracellularly and in the tumor microenvironment, leading to DNA damage, apoptosis, and cell death (Bardia 2019).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vdss: Sacituzumab govitecan: 3.6 L.

Metabolism: SN-38 (small molecule moiety of sacituzumab govitecan) is metabolized via UGT1A1.

Half-life elimination: Sacituzumab govitecan: 23.4 hours; free SN-38: 17.6 hours.

Excretion: Clearance: Sacituzumab govitecan: 0.13 L/hour.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Trodelvy;
  • (AT) Austria: Trodelvy;
  • (AU) Australia: Trodelvy;
  • (BE) Belgium: Trodelvy;
  • (CH) Switzerland: Trodelvy;
  • (CZ) Czech Republic: Trodelvy;
  • (ES) Spain: Trodelvy;
  • (FI) Finland: Trodelvy;
  • (FR) France: Trodelvy;
  • (GB) United Kingdom: Trodelvy;
  • (HU) Hungary: Trodelvy;
  • (IE) Ireland: Trodelvy;
  • (IT) Italy: Trodelvy;
  • (LT) Lithuania: Trodelvy;
  • (NO) Norway: Trodelvy;
  • (PL) Poland: Trodelvy;
  • (PR) Puerto Rico: Trodelvy;
  • (PT) Portugal: Trodelvy;
  • (RO) Romania: Trodelvy;
  • (SA) Saudi Arabia: Trodelvy;
  • (SE) Sweden: Trodelvy;
  • (SK) Slovakia: Trodelvy
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):5930597. [PubMed 3960626]
  3. Bardia A, Hurvitz SA, Tolaney SM, et al; ASCENT Clinical Trial Investigators. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541. doi:10.1056/NEJMoa2028485 [PubMed 33882206]
  4. Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med. 2019;380(8):741-751. doi:10.1056/NEJMoa1814213 [PubMed 30786188]
  5. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. [PubMed 6423951]
  6. Fenn KM, Kalinsky K. Sacituzumab govitecan: antibody-drug conjugate in triple-negative breast cancer and other solid tumors. Drugs Today (Barc). 2019;55(9):575-585. doi:10.1358/dot.2019.55.9.3039669 [PubMed 31584574]
  7. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  8. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  9. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. doi:10.1034/j.1600-0536.2002.4705104.x [PubMed 12534540]
  10. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  11. National Institute for Occupational Safety and Health (NIOSH) notice. Centers for Disease Control and Prevention website. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated May 12, 2020. Accessed May 22, 2020.
  12. Ocean AJ, Starodub AN, Bardia A, et al. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: safety and pharmacokinetics. Cancer. 2017;123(19):3843-3854. doi:10.1002/cncr.30789 [PubMed 28558150]
  13. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
  14. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
  15. Rugo HS, Bardia A, Marmé F, et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023;402(10411):1423-1433. doi:10.1016/S0140-6736(23)01245-X [PubMed 37633306]
  16. Rugo HS, Bardia A, Marmé F, et al; TROPiCS-02 Study Investigators. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022:JCO2201002. doi:10.1200/JCO.22.01002 [PubMed 36027558]
  17. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8960):1312-1313. doi:10.1016/s0140-6736(95)90963-x [PubMed 7746084]
  18. Tagawa ST, Balar AV, Petrylak DP, et al. TROPY-U-01: a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. J Clin Oncol. 2021;39(22):2474-2485. doi:10.1200/JCO.20.03489 [PubMed 33929895]
  19. Trodelvy (sacituzumab govitecan) [prescribing information]. Foster City, CA: Gilead Sciences Inc; February 2023.
  20. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed May 22, 2020.
Topic 127999 Version 107.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟