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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.

Questions to Ask Your...

A better understanding of your treatments will allow you to ask more questions of your healthcare team. We then hope that with the answers, you will get better results and have greater satisfaction with your care. Because we know it's not always easy to know what questions to ask, we've tried to make it easy for you!

Choose any healthcare provider below to see common questions that you may want to ask of this person. Then, either print each list to bring to your clinic visits, or copy the questions and send them as a message to your healthcare team through your electronic medical record.

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Questions to ask your DoctorNursePharmacist

What do I need to know regarding my blood tests, which are sometimes referred to as "labs"? Monitoring
Unless you have access to them via your electronic chart, we recommend that you always ask for a copy of your labs. There are hundreds, if not thousands, of different blood tests available for your doctor to order. Some are common and some are not. Have your team explain to you what blood tests they have ordered and what the results mean when you do not understand. This way you will have a better understanding if the treatment is working or not. Plus, doctors may prescribe medications when your lab work is abnormal. When your lab work returns to normal you may be able to stop taking these medications, or reduce the dose.
Do I need to see any other doctors? Monitoring
If you have not seen a specialized cancer doctor, known as a medical oncologist for solid tumors such as breast, lung, or prostate cancer, or a hematologist for cancers such as leukemia or lymphoma, it is generally recommended that you do so. A cancer doctor will typically take over coordinating care and monitoring after surgery has been performed to remove the cancer. An oncologist or hematologist will help determine if medications may be needed to get rid of any remaining cancer cells, or to help prevent the cancer from coming back.
What should I do if I receive a bill for something that I thought would be covered by insurance? Cost
On occasion, items may be submitted and denied by insurance for a variety of reasons. Sometimes the medication or procedure is not covered, but sometimes claims are submitted with too little information to be approved by insurance or sometimes claims are submitted with the wrong information (example: miscoded). A denial letter from the insurance company, when issued, usually helps to explain the situation. If you receive an unexpected bill, ask your doctor if there is a financial counselor or someone you can speak with to help you.
Am I able to enjoy an occasional glass of wine or beer now that treatment is over? Healthy Diet
Alcohol can harm your liver and interact with certain medications. Moreover, alcohol is a known risk factor for developing certain types of cancer, therefore it is very important you do not drink alcohol without being cleared to do so by your doctor first. Important Note: this question only applies to those who are of legal drinking age.
What if I'm still experiencing anxiety after treatment? Mindset
Anxiety after treatment is natural and may come and go. If it is physically affecting you or your ability to sleep or socialize with others, talk with your doctor about it, and consider speaking with someone such as a social worker. Talking with someone can be very therapeutic, and may be better than taking medications for anxiety that may have side effects, such as fatigue.
What can I do if my treatment is over and I am still having side effects? Side Effects
It is not always easy to predict if side effects from treatment will go away or when. When speaking with your doctor, try to describe what is troubling to you and how it limits the things you want to do. By setting goals, you can tell if the interventions you make to reduce the side effect are helping you get closer to goal. For example, chemo brain (cancer-related cognitive dysfunction), may limit your short-term memory. Your doctor may be able to recommend treatments, including those that do not have more medications. (Chung NC et al. Oncology. 2018)
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Questions to ask your NurseDoctorPharmacist

What resources can I use to help me make better choices regarding my diet as I begin cancer treatment? Healthy Diet
Many oncology clinics have a dietician available to help you make positive changes in your diet. If one is not available, your nurse may be able to give you appropriate resources to help you make safe and positive dietary changes.
What kinds of foods should I eat to prepare for treatment? Healthy Diet
Before treatment, ask your nurse if the specific treatment you are receiving is likely to change the way food tastes or if you are likely to lose weight. Now might be a good time to reevaluate what you eat on a daily basis. If you eat a lot of sugary or fatty foods, it would be good to eat more wholesome foods such as vegetables and fruits. Remember, it is not always what you are eating, it is what you are NOT eating that matters as well. Fruits and vegetables may contain valuable cancer-fighting compounds that may help you heal faster. If your healthcare team advises that you avoid vegetables, ask them for the written information that supports this recommendation.
What should I do if I'm not a person who likes to ask for help? Mindset
Your nurse wants to make your life easier, but won't be able to unless you tell him or her what you are struggling with. Know that most health care professionals genuinely want to help you and the questions you ask now will save both you and them time by preventing problems down the road. If you can change your mindset and begin asking for assistance early, it will help them and it will help you. Problems may be able to be prevented and everyone wins!
What type of intravenous (I.V.) access is best for this treatment? Treatment
There are many ways to infuse treatment, including a peripheral I.V. line, a port, a PICC line (pronounced 'pick'), a tunneled catheter, and others. Your doctor, nurse, and sometimes pharmacist will work together to determine what is best for you.
If I'm afraid to start treatment, who is the best person to talk with? Treatment
Your nurse may have experience helping other patients who have received the same treatment recommended to you. If they do not have experience, ask your nurse to schedule another appointment with your Doctor to answer questions. You can also ask your nurse if a social worker is available to talk to. They may be able to help you navigate through many of the fears of starting treatment and help you take the proper steps in addressing them.
How can I ensure I am getting adequate nutrition when I have no appetite during cancer treatment? Healthy Diet
When food becomes unappealing, focus on protein shakes, smoothies, electrolyte replenishing drinks, and broth. Ask your nurse to connect you with a dietician to help you with making food choices that agree with you. When all else fails, eat what you can! Most experts agree that a small snack that sounds delicious and stays down is better than nothing at all.
If I am admitted to the hospital, do I need to bring my home medications with me? Home Medications
It is always helpful to bring your medications so that your healthcare team can see exactly what you are taking and determine if you need any refills before you go home. Importantly, most if not all, medications will be supplied by the hospital. However, some medications such as oral anti-cancer medication or chemotherapy pills may not be routinely stocked and may not be readily available to the hospital's pharmacy. If this is the case, and your doctor wants you to continue to take your oral anti-cancer medication, you may ask the hospital if their policy permits you to use your own medication so that you do not miss doses. If you do bring your medications, and they allow you to use your own supply, it is important to know that hospital staff often require that they oversee the administration of these medicines so that they know exactly what you are taking in order to keep you safe. If they do hold onto your medications, make sure you ask for your them back before you leave since it is common for people to forget. Your nurse may be able to help answer more specific questions about medications brought into the hospital.
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    Questions to ask your PharmacistDoctorNurse

    What foods or drinks, if any, should I be avoiding as I start treatment for cancer? Healthy Diet
    There may be certain foods and/or drinks that interact with your treatment or may increase your risk of certain side effects. Your pharmacist can check for possible drug-food interactions to help you avoid certain foods or drinks that might cause problems when taken with your current medication regimen and cancer treatment.
    How will I know if my cancer medications are working? Monitoring
    Your pharmacist may help you manage side effects allowing you to avoid cancer treatment dose delays or dose reductions. This will hopefully help you get rid of or control the cancer. Your doctor may determine if the medications are working by performing a physical exam during each clinic visit, asking you to get scans of certain body parts (examples may include X-ray, M.R.I. scan, or C.T. scan), or ordering blood tests to help understand if the cancer medications are working. Ask your doctor or clinical pharmacist to explain the results of these tests to you if you are interested.
    What can I do if I'm having trouble figuring out the best times to take my medications? Schedule
    Talk to your pharmacist to try to minimize the number of times per day you need to take medication. Your pharmacist will make sure that the pills you take together at certain times of day are safe and will not interact with each other.
    How long after completion of treatment can I resume a full work schedule? Work
    A pharmacist may be able to give you information about how long certain side effects are likely to last after the last dose is taken. Your doctor can assess your overall health status and provide advice regarding when they feel like you are ready to return to work based upon their assessment of your physical and mental health, as well as their experience with other patients who have taken the same treatment.

    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