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Treatment Name: Sacituzumab Govitecan (Trodelvy®)

Sacituzumab Govitecan (Trodelvy®) is a Chemotherapy Regimen for Breast Cancer - metastatic

How does sacituzumab govitecan work?

Sacituzumab govitecan is an antibody that targets breast cancer cells. Once it binds to the breast cancer cell surface, it then enters the inside of the cancer cell. Once inside the cell, the antibody releases a drug called SN-38, which stops the cell from growing and dividing.

Goals of therapy:

Sacituzumab govitecan is typically given after at least two other therapies for breast cancer have been tried. It is given to shrink tumors and decrease symptoms of breast cancer, but is not commonly given with the goal of cure.

Schedule

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How is sacituzumab govitecan therapy for breast cancer given?

  • Sacituzumab Govitecan intravenous (I.V.) infusion on Days 1 and 8
    • First infusion is given over 3 hours. If well tolerated, subsequent infusions are given over 1 to 2 hours
    • After the infusion, you will be watched for any side effects for 30 minutes

Estimated total infusion time for this treatment:

  • Up to 4 hours or more for Cycle 1, Day 1; as short as 2 hours for all following treatments if well tolerated
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

Sacituzumab govitecan is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, it may be given in the hospital if someone is too sick.

Sacituzumab govitecan is repeated every 21 days. This is known as one Cycle. Each cycle may be repeated until the treatment no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Click here for the common sacituzumab govitecan starting doses.

Side Effects

What are the most common side effects from sacituzumab govitecan (Trodelvy®) for breast cancer?

In clinical studies, the most commonly reported side effects of sacituzumab govitecan (Trodelvy®) are shown here:

  • Nausea (67%)
  • Low white blood cells [neutropenia] (64%)
  • Diarrhea (62%)
  • Fatigue (55%)
  • Low red blood cells [anemia] (50%)
  • Vomiting (49%)
  • Hair loss (36%)
  • Constipation (34%)
  • Decreased appetite (30%)
  • Skin rash (28%)
  • Stomach pain (25%)
  • High blood sugar (24%)
  • Back pain (22%)
  • Low blood magnesium (21%)
  • Headache (21%)
  • Pneumonia or sinus infection (21%)
  • Dizziness (20%)
  • Urinary tract infection [UTI] (20%)
  • Cough (19%)
  • Shortness of breath (19%)
  • Nerve pain (19%)
  • Low blood potassium (18%)
  • Swelling in arms and legs (16%)
  • Joint pain (16%)
  • Itching (16%)
  • Low blood phosphate (15%)
  • Dry skin (14%)
  • Trouble sleeping (14%)
  • Weight loss (14%)
  • Mouth sores (14%)
  • Dehydration (13%)
  • Fever (12%)
  • Weakness (11%)
  • Pain in arms or legs (10%)

On average, 3% of patients discontinue treatment due to unacceptable side effects.

Importantly, not all people who experience a side effect from sacituzumab govitecan will experience it in the same way. It may be mild in some or severe in others, depending upon the individual. Everybody is different. Additionally, side effects may vary over time. For some, side effects may be a reason to delay or switch treatment, reduce the dose, or avoid treatment with a certain medication altogether.

Side effects may be treatable when they occur or preventable by taking certain medications before they happen. When medications are taken to prevent a problem, this is known as prophylaxis, or "prophy" for short.

After starting treatment with sacituzumab govitecan, be sure to come back and watch all of the side effect videos shown below. Each of these videos contain valuable information about side effect management that will hopefully help you to both feel better and stay out of the hospital.

Watch videos on common sacituzumab govitecan therapy side effects below

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue AnemiaAnemiaHair LossHair LossConstipationConstipationPainPain

Monitoring

How often is monitoring needed?

Labs (blood tests) may be checked before each treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.

How often is imaging needed?

Imaging may be checked to see if treatment is working, if there are concerns for disease progression, or if certain side effects occur. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?

Depending upon the results, your doctor may advise to continue sacituzumab govitecan as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

What are the most important things to know about sacituzumab govitecan while receiving therapy?

  • Premedications such as diphenhydramine (Benadryl®), acetaminophen (Tylenol®), and famotidine (Pepcid®) may be given 30 minutes before treatment starts to help avoid infusion related reactions
  • Diarrhea may be treated with atropine injections in the medical setting, both before and/or after the infusion. Diarrhea at home can affect quality of life and is commonly treated with loperamide (Imodium®) purchased over-the-counter at a pharmacy. You may receive special instructions on how to use loperamide for diarrhea caused by sacituzumab govitecan. Tell your doctor immediately of you have severe diarrhea at home or go to an emergency department immediately
  • If you experience neutropenic fever after any treatment, filgrastim (Neupogen®) or pegfilgrastim (Neulasta®) may given after each following treatment to stimulate production of white blood cells and help avoid long periods of severe neutropenia
  • May cause nausea and vomiting for up to a few days after treatment. Be sure to get a prescription from your doctor for anti-nausea medications such as ondansetron (Zofran®) or prochlorperazine (Compazine®) to take at home if needed
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for metastatic breast cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Sacituzumab Govitecan (Trodelvy®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Sacituzumab Govitecan (Trodelvy®). Depending upon your income, they may be able to help cover the cost of:

  • Sacituzumab Govitecan

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Sacituzumab Govitecan (Trodelvy®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Sacituzumab Govitecan (Trodelvy®)

Individual Drug Label Information

Sacituzumab Govitecan (Trodelvy®)

  • Is an intravenous infusion
  • FDA Black Box Warning for low white blood cell count. Immediately contact your doctor if you experience fever, chills, or other signs of infection 
  • FDA Black Box Warning for severe diarrhea. Contact your doctor if you experience black or bloody stools, dehydration (lightheadedness, dizziness), severe nausea or vomiting, or if you can’t get diarrhea under control within 24 hours 
  • Dosage adjustments may be required for low blood counts or other severe side effects
  • May cause fetal harm if given while pregnant. Females should use effective contraception during treatment and for 6 months after the last dose. Males should use effective contraception during treatment and for 3 months after the last dose. Do not breastfeed while being treated with sacituzumab govitecan and for 1 month after the last dose
General side effects from Sacituzumab Govitecan
  • Nausea and vomiting
  • Low white blood cells and red blood cells
  • Diarrhea or constipation
  • Fatigue and weakness
  • Hair loss
  • Decreased appetite
  • Skin rash
  • Stomach pain
  • High blood sugar
  • Back pain
  • Headache
  • Infection
  • Dizziness 
  • Click on the sacituzumab govitecan (Trodelvy®) package insert below for reported side effects, possible drug interactions, and other sacituzumab govitecan prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

1.) Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med 2019;380:741-751

Created: June 14, 2020 Updated: June 14, 2020

What is Breast Cancer - metastatic?

What is Metastatic Breast Cancer?
A disease of the milk-producing glands known as lobules, milk ducts, or other cells found in the breast. Metastatic breast cancer is one that has moved from the breast to other areas of the body, which may include the brain, liver, or bone. Breast cancer is one of the most common types of cancers in women, but may rarely affect men as well. Known causes of breast cancer include genetic causes, such as the BRCA mutation, or obesity. The effectiveness of the treatment may depend upon the stage at diagnosis.

Types of metastatic breast cancer:
1. Hormone-receptor positive or negative (60 - 65% of patients)

  • Estrogen Receptor positive (ER)+ or negative (ER)-
  • Progestin Receptor positive (PR)+ or negative (PR)-

2. Hormone Epidermal growth factor Receptor-2 (HER-2) positive or negative (20 - 25% of patients)

  • HER-2 +
  • HER-2 -

3. Triple Negative (15 - 18% of patients)

  • ER- and PR- and (HER-2)-
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common Sacituzumab Govitecan Starting Doses

  • Sacituzumab Govitecan 10 mg/kg intravenous (I.V.) infusion on Days 1 and 8
    • First infusion is given over 3 hours. If well tolerated, subsequent infusions are given over 1 to 2 hours

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium