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.
Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late 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.
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 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: 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 (Bardia 2019; Bardia 2021).
Breast cancer, metastatic, hormone receptor-positive, HER2-negative, salvage therapy (off-label use): IV: 10 mg/kg on days 1 and 8 of a 21-day treatment cycle; continue until disease progression or unacceptable toxicity (Rugo 2022).
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 (Tagawa 2021).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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).
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); SN-38 (small molecule moiety of sacituzumab govitecan) exposure may be increased in this patient population due to decreased hepatic UGT1A1 activity.
Refer to adult dosing.
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; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (ASCO [Griggs 2021]).
|
Adverse Reaction |
Occurrence |
Dose Modificationa |
|---|---|---|
|
aDo not re-escalate the sacituzumab govitecan dose after a dose reduction for adverse reactions. | ||
|
Hematologic toxicity | ||
|
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 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 WBC growth factor support. |
|
Second |
Reduce sacituzumab govitecan dose by 50%. | |
|
Third |
Discontinue sacituzumab govitecan. | |
|
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. |
|
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. |
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]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Trodelvy: 180 mg (1 ea) [contains polysorbate 80]
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 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 H1/H2 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 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 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).
Breast cancer, triple negative, locally advanced or metastatic, relapsed or refractory: 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.
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.
Breast cancer, metastatic, hormone receptor-positive, HER2-negative, salvage therapy
Sacituzumab govitecan may be confused with fam-trastuzumab deruxtecan, sarilumab, secukinumab.
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.
Do not substitute sacituzumab govitecan for (or use with) other medications containing irinotecan or its active metabolite SN-38.
Sacituzumab govitecan commonly causes neutropenia (including grades 3 and 4 severe neutropenia), febrile neutropenia, anemia, leukopenia, and thrombocytopenia. Neutropenia is the most common adverse reaction leading to treatment interruption.
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).
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).
Sacituzumab govitecan commonly causes diarrhea, including grades 3 and 4 severe diarrhea; permanent discontinuation due to diarrhea was rare in clinical trials. In addition, neutropenic enterocolitis may rarely occur. Abdominal cramps and increased salivation have also been reported in patients who experience an excessive cholinergic response to treatment.
Sacituzumab govitecan is moderately emetogenic and may cause nausea and vomiting (including grades 3 and 4); 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).
Sacituzumab govitecan commonly causes 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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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 (39% to 51%), decreased serum calcium (46% to 49%), decreased serum glucose (19%), decreased serum sodium (25% to 43%), dehydration (13%; severe dehydration: 2%), hyperglycemia (24%), hypermagnesemia (24%), hypokalemia (16% to 19%), hypomagnesemia (12% to 21%), hypophosphatemia (16%), increased lactate dehydrogenase (28%), weight loss (17%)
Gastrointestinal: Abdominal pain (26% to 31%), constipation (34% to 37%), decreased appetite (28% to 41%), diarrhea (59% to 72%; severe diarrhea: 4%) (table 1), dysgeusia (11%), nausea (57% to 69%; severe nausea: 3%) (table 2), stomatitis (14% to 17%; grades 3/4: 1% to 2%), vomiting (33% to 49%; severe vomiting: 5%) (table 3)
|
Drug ( Sacituzumab Govitecan ) |
Comparator (Single agent chemotherapy) |
Indication |
Number of Patients ( Sacituzumab Govitecan ) |
|---|---|---|---|
|
59% |
17% |
Metastatic triple-negative breast cancer |
258 |
|
63% |
17% |
Metastatic triple-negative breast cancer |
108 |
|
72% |
17% |
Locally advanced or metastatic urothelial cancer |
113 |
|
Drug ( Sacituzumab Govitecan ) |
Comparator (Single agent chemotherapy) |
Indication |
Number of Patients ( Sacituzumab Govitecan ) |
|---|---|---|---|
|
57% |
3% |
Metastatic triple-negative breast cancer |
258 |
|
69% |
3% |
Metastatic triple-negative breast cancer |
108 |
|
66% |
3% |
Locally advanced or metastatic urothelial cancer |
113 |
|
Drug ( Sacituzumab Govitecan ) |
Comparator (Single agent chemotherapy) |
Indication |
Number of Patients ( Sacituzumab Govitecan ) |
|---|---|---|---|
|
33% |
16% |
Metastatic triple-negative breast cancer |
258 |
|
49% |
16% |
Metastatic triple-negative breast cancer |
108 |
|
34% |
16% |
Locally advanced or metastatic urothelial cancer |
113 |
Genitourinary: Hematuria (16%), urinary tract infection (13% to 21%)
Hematologic & oncologic: Anemia (40% to 52%; grades 3/4: 9% to 12%) (table 4), leukopenia (17% to 91%, grades 3/4: 11% to 41%) (table 5), lymphocytopenia (10% to 71%; grades 3/4: 2% to 35%), neutropenia (64%; grades 3/4: 43% to 52%) (table 6), prolonged prothrombin time (33% to 60%; grades 3/4: 6% to 12%), thrombocytopenia (14%; grades 3/4: 3%)
|
Drug ( Sacituzumab Govitecan ) |
Comparator (Single agent chemotherapy) |
Indication |
Number of Patients ( Sacituzumab Govitecan ) |
|---|---|---|---|
|
40% |
28% |
Metastatic triple-negative breast cancer |
258 |
|
9% |
6% |
Metastatic triple-negative breast cancer |
258 |
|
52% |
N/A |
Metastatic triple-negative breast cancer |
108 |
|
12% |
N/A |
Metastatic triple-negative breast cancer |
108 |
|
Drug ( Sacituzumab Govitecan ) |
Comparator (Single agent chemotherapy) |
Indication |
Number of Patients ( Sacituzumab Govitecan ) |
|---|---|---|---|
|
17% |
12% |
Metastatic triple-negative breast cancer |
258 |
|
11% |
6% |
Metastatic triple-negative breast cancer |
258 |
|
91% |
N/A |
Metastatic triple-negative breast cancer |
108 |
|
26% |
N/A |
Metastatic triple-negative breast cancer |
108 |
|
78% |
N/A |
Locally advanced or metastatic urothelial cancer |
113 |
|
38% |
N/A |
Locally advanced or metastatic urothelial cancer |
113 |
|
Drug ( Sacituzumab Govitecan ) |
Comparator (Single agent chemotherapy) |
Indication |
Number of Patients ( Sacituzumab Govitecan ) |
|---|---|---|---|
|
64% |
44% |
Metastatic triple-negative breast cancer |
258 |
|
52% |
34% |
Metastatic triple-negative breast cancer |
258 |
|
64% |
N/A |
Metastatic triple-negative breast cancer |
108 |
|
43% |
N/A |
Metastatic triple-negative breast cancer |
108 |
|
61% |
N/A |
N/A |
795 |
Hepatic: Increased serum alanine aminotransferase (11% to 35%), increased serum alkaline phosphatase (36% to 57%), increased serum aspartate aminotransferase (26% to 45%)
Hypersensitivity: Hypersensitivity reaction (37%)
Infection: Infection (50%; serious infection: 18%)
Nervous system: Dizziness (10% to 22%), fatigue (57% to 68%), headache (18% 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%), increased serum creatinine (32%)
Respiratory: Cough (17% to 24%), dyspnea (16% to 21%), respiratory tract infection (26%), upper respiratory tract infection (12%)
Miscellaneous: Fever (14% to 19%)
1% to 10%:
Cardiovascular: Venous thromboembolism (9%)
Gastrointestinal: Intestinal obstruction (3%)
Hematologic & oncologic: Febrile neutropenia (6% to 10%)
Immunologic: Antibody development (2%)
Infection: Bacteremia (≤9%), sepsis (≤9%)
Respiratory: Pleural effusion (2%), pneumonia (2% to 4%)
<1%:
Gastrointestinal: Neutropenic enterocolitis
Hypersensitivity: Anaphylaxis
Frequency not defined:
Gastrointestinal: Anorexia, esophagitis
Infection: Influenza
Neuromuscular & skeletal: Asthenia
Ophthalmic: Periorbital edema
Respiratory: Epistaxis, respiratory failure
Severe hypersensitivity to sacituzumab govitecan or any component of the formulation.
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 for the UGT1A1*28 allele may be at increased risk for adverse reactions. Early acute-onset or unusually severe adverse reactions may be indicative of reduced UGT1A1 enzyme activity.
Substrate of UGT1A1
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
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
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
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
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
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
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
Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of 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 Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
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
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
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.
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.
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.
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 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.
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).
Distribution: Vd: Sacituzumab govitecan: 2.96 L.
Metabolism: SN-38 (small molecule moiety of sacituzumab govitecan) is metabolized via UGT1A1.
Half-life elimination: Sacituzumab govitecan: 15.3 hours; free SN-38: 19.7 hours.
Excretion: Clearance: Sacituzumab govitecan: 0.14 L/hour.
Solution (reconstituted) (Trodelvy Intravenous)
180 mg (per each): $2,678.66
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