Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
SACI
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
For the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), in patients who have received ≥ 2 therapies, with at least 1 therapy used to treat metastatic disease. (See NDFP form for details.)
sacituzumab govitecan
New Drug Funding Program
(Sacituzumab Govitecan - Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer)
(NDFP Website
)
REPEAT EVERY 21 DAYS
Until disease progression or unacceptable toxicity (see NDFP form for details).
Moderate (+ NK-1 RA)
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Pre-medications:
- Prophylaxis for infusion reaction
- Administer antipyretics, H1 and H2 blockers prior to infusion.
- Administer antipyretics, H1 and H2 blockers prior to infusion.
- Prophylaxis for cholinergic response
- Patients with excessive cholinergic response (e.g., abdominal cramping, diarrhea, salivation) can receive appropriate premedication (e.g., atropine) for subsequent treatments.
Other Supportive Care:
- For non-infectious diarrhea, promptly initiate loperamide 4 mg, followed by 2 mg with every episode of diarrhea (up to a maximum of 16 mg daily). Discontinue loperamide 12 hours after diarrhea resolves.
Doses should be modified according to the protocol by which the patient is being treated.
Patients with known reduced UGT1A1 activity (e.g. Gilbert's syndrome or homozygous for the UGT1A1*28 allele) may have an increased risk for neutropenia, febrile neutropenia, anemia, or other adverse effects and should be closely monitored. Acute early-onset or unusually severe adverse reactions may indicate reduced UGT1A1 enzyme activity. Hold or discontinue sacituzumab govitecan as clinically indicated.
Do NOT substitute sacituzumab govitecan for or use with other drugs containing irinotecan or its active metabolite, SN-38.
Dosage with toxicity
| Dose Level | Sacituzumab Dose (mg/kg) |
| 0 | 10 |
| -1 | 7.5 |
| -2 | 5 |
| -3 | Discontinue |
Hematologic Toxicity:
| Toxicity | Action |
| Grade 3 neutropenia |
Hold* until resolved. If treatment delayed by 1 week, resume at same dose, consider G-CSF support. If treatment delayed by 2-3 weeks, resume at 1 dose level ↓ and administer G-CSF. Discontinue if 3rd occurrence. |
| Grade 4 neutropenia |
Hold* until resolved. If lasts > 7 days or treatment delayed by 2-3 weeks, resume at 1 dose level ↓ and administer G-CSF. Discontinue if 3rd occurrence. |
| Febrile neutropenia |
Hold* until resolved. Resume at 1 dose level ↓ and administer G-CSF. Discontinue if 3rd occurrence. |
| Other Grade 3 or 4 hematologic toxicity (e.g., anemia and thrombocytopenia) |
Hold* until resolved. If treatment delayed by 2-3 weeks, resume at 1 dose level ↓. Discontinue if 3rd occurrence. |
*On day 1, do not resume until ANC ≥ 1.5 x 109/L, Platelets ≥ 75 x 109/L, Hgb ≥ 100 g/L, and non-hematologic toxicities recover to ≤ Grade 1.
On day 8, do not resume until ANC ≥ 1 x 109/L, Platelets ≥ 75 x 109/L, Hgb ≥ 100 g/L, and non-hematologic toxicities recover to ≤ Grade 1.
Discontinue sacituzumab govitecan if dose is held for > 3 weeks.
Non-hematologic Toxicity:
| Toxicity | Action |
| Grade 3 or 4 nausea / vomiting / diarrhea** | Hold* until resolved. Resume at 1 dose level ↓. Discontinue if 3rd occurrence. |
|
Other Grade 3 non-hematologic toxicity (persisting > 48h despite medical management or requiring dose hold for 2-3 weeks) Other Grade 4 non-hematologic toxicity |
Hold* until resolved. Resume at 1 dose level ↓. Discontinue if 3rd occurrence. |
*On day 1, do not resume until ANC ≥ 1.5 x 109/L, Platelets ≥ 75 x 109/L, Hgb ≥ 100 g/L, and non-hematologic toxicities recover to ≤ Grade 1.
On day 8, do not resume until ANC ≥ 1 x 109/L, Platelets ≥ 75 x 109/L, Hgb ≥ 100 g/L, and non-hematologic toxicities recover to ≤ Grade 1.
Discontinue sacituzumab govitecan if dose is held for > 3 weeks.
**Not controlled with supportive care (antiemetics or anti-diarrheals).
Management of Infusion-related reactions
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
| Grade | Management | Re-challenge |
| 1 or 2 |
|
|
| 3 or 4 |
|
|
Hepatic Impairment
Sacituzumab govitecan exposure in patients with mild hepatic impairment is similar to patients with normal hepatic function.
| Bilirubin | AST | Sacituzumab Dose | |
| < ULN | and | > ULN | No dose adjustment required. |
| >1 to 1.5 x ULN | and | Any | |
| >1.5 to 3.0 × ULN | and | Any | Not studied. |
| > 3 x ULN | and | Any | Avoid; not studied. |
Renal Impairment
Renal elimination contributes minimally to the excretion of SN-38. There are no data on the use of sacituzumab govitecan in patients with severe renal impairment (CrCl 15-29 mL/min), or end-stage renal disease (CrCl < 15 mL/min).
Dosage in the Elderly
No dose adjustment is required in patients > 65 years. Safety and efficacy were similar between patients > 65 years and younger patients.
Refer to sacituzumab govitecan drug monograph(s) for additional details of adverse effects.
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to sacituzumab govitecan drug monograph(s) for additional details.
Administration
Do NOT substitute sacituzumab govitecan for or use with other drugs containing irinotecan or its active metabolite, SN-38.
- After reconstitution, dilute in an infusion bag with NS to a concentration of 1.1 to 3.4 mg/mL.
- The infusion bag must be made of polyvinyl chloride, polyolefin (polypropylene and/or polyethylene) or ethylene vinyl acetate to minimize foaming.
- Do not shake. Protect the infusion bag from light.
- Administer as an IV infusion only. Do NOT administer as an IV push or bolus.
- Infuse over 3 hours for the first infusion. If well tolerated, infuse over 1-2 hours for subsequent infusions.
- Observe patients during and for at least 30 minutes after each infusion.
- Do not mix or infuse with other agents.
- Flush IV line with 20 mL of NS at the end of infusion.
- Store unopened vials between 2°C to 8°C in the original carton. Protect from light. Do not freeze.
Contraindications
- Patients who are hypersensitive to this drug or any of its components
Pregnancy/Lactation
- This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after treatment the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
- Breastfeeding is not recommended during treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if applicable).
- Fertility effects: Female fertility may be affected.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
Closely monitor for toxicity in patients with known reduced UGT1A1 activity, or in patients with acute early-onset or unusually severe adverse reactions that may indicate reduced UGT1A1 enzyme activity.
Recommended Clinical Monitoring
-
CBC; Baseline and before each dose
-
Liver function tests; Baseline and as clinically indicated
-
Renal function tests; Baseline and as clinically indicated
-
Electrolytes; Baseline and as clinically indicated (especially in patients with diarrhea)
-
Clinical toxicity assessment for infection, infusion reaction, diarrhea and other GI effects; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med 2021 Apr 22;384(16):1529-1541.
CADTH reimbursement recommendation: Sacituzumab govitecan (for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer). February 2022.
Sacituzumab govitecan drug monograph. Ontario Health (Cancer Care Ontario).
December 2023 Updated Dose modifications section
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.