Question 1

What is Trodelvy?

Accepted Answer

Trodelvy is a type of targeted therapy called an antibody-drug conjugate. It is composed of a monoclonal antibody that is chemically linked to a chemotherapy drug.

The antibody portion of the medication is designed to recognize and attach to specific proteins on the surface of cancer cells. Once attached, the medication enters the cell and releases the chemotherapy component to help stop the growth and spread of the cancer.

Question 2

What is Trodelvy used for?

Accepted Answer

Trodelvy is used to treat:

triple-negative breast cancer

hormone receptor-positive, HER2-negative breast cancer

urothelial cancer

Question 3

How does Trodelvy work?

Accepted Answer

Targeted Delivery

Trodelvy is an antibody-drug conjugate, which means it combines a monoclonal antibody with a chemotherapy medication. The antibody portion is designed to recognize and attach to a protein called Trop-2, which is found on the surface of many types of cancer cells.

Mechanism of Action

The process of how Trodelvy works involves several steps:

Binding: The antibody travels through the body and attaches to the Trop-2 protein on the cancer cell surface.

Internalization: Once attached, the cancer cell absorbs the entire Trodelvy molecule.

Release: Inside the cell, the chemotherapy drug (SN-38) is released from the antibody.

Cell Death: The chemotherapy drug prevents the cancer cell from repairing its DNA. This damage stops the cell from dividing and eventually causes it to die.

By targeting cells that express Trop-2, Trodelvy aims to deliver a potent dose of chemotherapy directly to the tumor while minimizing exposure to healthy cells that lack this protein.

Question 4

What are the active ingredients in Trodelvy?

Accepted Answer

The active ingredient in Trodelvy is sacituzumab .

Question 5

What are the side effects of Trodelvy?

Accepted Answer

Common side effects of Trodelvy may include:

diarrhea

nausea

fatigue

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Trodelvy?

Accepted Answer

Trodelvy belongs to the antibody-drug conjugate drug class.

Question 7

What is the dosage of Trodelvy and how do I take it?

Accepted Answer

Administration

Trodelvy is given as an infusion into a vein (intravenous or IV) by a healthcare professional in a medical setting, such as a clinic or hospital. It is not a medication you take at home.

Treatment Schedule

This medication is usually administered in treatment cycles. A common schedule involves receiving an infusion on specific days of a 21-day cycle, such as Day 1 and Day 8. Your healthcare provider will determine the appropriate schedule and how many cycles you need based on your condition and how you respond to the treatment.

Before the Infusion

To help prevent certain side effects, your healthcare provider may give you other medications before each Trodelvy infusion. These premedications are often used to help reduce the risk of:

Nausea and vomiting

Infusion-related reactions

What to Expect During the Infusion

The first infusion of Trodelvy usually takes longer than later doses so that your medical team can monitor you closely for any reactions. If you tolerate the first dose well, subsequent infusions may be given over a shorter period. Your healthcare provider will continue to monitor you during and for a period after each infusion.

Missed Doses

Because this medication is given by a healthcare professional, it is important to keep all your scheduled appointments. If you miss an appointment for an infusion, contact your doctor or clinic right away to reschedule.

Question 8

Is Trodelvy safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy Risks

Trodelvy can cause harm to a fetus if taken during pregnancy. Healthcare providers typically require a pregnancy test for individuals of reproductive potential before starting this medication. If you are pregnant or planning to become pregnant, it is important to discuss the risks with your medical team.

Contraception

Because of the risks to a developing fetus, specific precautions regarding birth control are recommended:

For females: Use effective contraception during treatment and for 6 months after the last dose.

For males: Use effective contraception during treatment and for 3 months after the last dose if your partner can become pregnant.

Breastfeeding Considerations

It is currently unknown if Trodelvy passes into breast milk. Due to the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended during treatment and for at least 1 month following the final dose. Consult with a healthcare provider to discuss safe infant feeding options during this period.

Question 9

What forms and strengths does Trodelvy come in?

Accepted Answer

Trodelvy is supplied as a sterile, preservative-free, lyophilized powder in a single-dose vial. It is intended for reconstitution and further dilution by a healthcare professional before use.

This medication is administered only as an intravenous infusion. It is not given as an intravenous push or bolus, and it is not available in oral forms such as tablets or capsules.

Question 10

What is the FDA approval status of Trodelvy?

Accepted Answer

FDA Approval Status

Trodelvy received its initial FDA approval in April 2020. It is currently approved for several indications involving metastatic or unresectable cancers that have not responded to previous treatments.

Approved Indications

The FDA has approved Trodelvy for the following uses:

Triple-Negative Breast Cancer (TNBC): For adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of which was for metastatic disease.

HR-Positive, HER2-Negative Breast Cancer: For adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Urothelial Cancer: For adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. This indication was granted under accelerated approval based on tumor response rate and duration of response.

Boxed Warning

Trodelvy carries a boxed warning, the most serious safety notification required by the FDA, for two specific risks:

Severe Neutropenia: The medication can cause a severe drop in white blood cell counts (neutropenia), which can lead to serious infections. Healthcare providers monitor blood counts before each dose and may delay or reduce the dosage if levels are too low.

Severe Diarrhea: Treatment can cause severe diarrhea, which may lead to dehydration. Patients are advised to start antidiarrheal medication and contact their doctor at the first sign of loose stools.

Question 11

What should I know about Trodelvy and cost?

Accepted Answer

Trodelvy is a specialty medication administered as an intravenous (IV) infusion by a healthcare professional. Because it is given in a clinical setting rather than purchased at a retail pharmacy, the total cost typically includes the price of the drug as well as fees for the infusion procedure and medical supplies.

Several factors can influence the final cost of treatment:

Insurance coverage: Most private insurance plans and Medicare cover Trodelvy, but your out-of-pocket expenses will depend on your plan's specific deductibles, copays, or coinsurance.

Treatment location: Costs may vary depending on whether the infusion is administered in a hospital, an outpatient clinic, or a private doctor's office.

Dosage: The amount of medication prescribed is based on your body weight, which directly impacts the cost per treatment cycle.

Financial assistance or patient support programs may be available through the manufacturer for those who qualify. It is recommended to contact your insurance provider or the billing department at your treatment facility for a detailed estimate of your expected costs.

Trodelvy

Medication Quick Facts

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How It Works

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Dosage & How to Take

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