Trodelvy Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Trodelvy Injection (sacituzumab govitecan) is a prescription antibody-drug conjugate given by IV infusion for certain advanced breast, bladder, and urinary tract cancers. It combines an antibody that targets the Trop-2 protein on cancer cells with an anticancer drug, delivering treatment directly to cancer cells. It is given on a weekly schedule within 21-day treatment cycles and carries risks of low blood cell counts, severe diarrhea, and infusion reactions.

What is Trodelvy Injection

Trodelvy is a prescription cancer medicine given by IV infusion. It combines an antibody that targets a protein called Trop-2 on cancer cells with an anticancer drug, so it can deliver treatment directly to cancer cells. Its generic name is sacituzumab govitecan, and it belongs to the antibody-drug conjugate (ADC) / antineoplastic agent drug class.

Trodelvy Injection uses

• Treats adults with hormone receptor (HR)-positive, HER2-negative breast cancer that has spread or cannot be removed by surgery, in people who already had hormone therapy and at least two other treatments for metastatic disease.
• Treats adults with triple-negative breast cancer that has spread or cannot be removed by surgery, in people who had at least two prior treatments, with at least one for metastatic disease.
• Treats adults with locally advanced or metastatic bladder and urinary tract cancer who already had platinum-based chemotherapy and an immunotherapy medicine.

Benefits of Trodelvy Injection

• Treats certain advanced or metastatic triple-negative breast cancers
• Treats certain HR-positive/HER2-negative advanced breast cancers
• Targets Trop-2 on cancer cells
• Delivers the active chemotherapy metabolite SN-38 to targeted tumor cells
• Can be used alone or, for certain first-line TNBC patients, with pembrolizumab

How Trodelvy Injection works

Trodelvy is made of an antibody that finds and attaches to a protein called Trop-2 on cancer cells. Once attached, the medicine enters the cell and releases an anticancer drug that damages the cell's DNA, causing the cancer cell to die.

Trodelvy Injection dosage

Trodelvy is given by a healthcare provider as an intravenous (IV) infusion into a vein; it is not taken by mouth. It is given once a week, on Day 1 and Day 8 of a 21-day treatment cycle. The first infusion is given over about 3 hours; if it is tolerated well, later infusions may be given faster, over 1 to 2 hours.

Before each dose, you will be given medicines to help prevent infusion reactions, nausea, and vomiting, and may be sent home with medicines and instructions for nausea, vomiting, and diarrhea. You will be monitored during the infusion and for at least 30 minutes after it finishes to check for reactions.

Treatment continues until the cancer gets worse or side effects become too difficult to manage, as decided by your healthcare provider. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

Use exactly as prescribed by your doctor or pharmacist.

Available forms and strengths

• Lyophilized (freeze-dried) powder for solution for injection/infusion, supplied in single-dose vials (180 mg per vial)

Side effects of Trodelvy Injection

Common

• Low white blood cell counts (neutropenia)
• Low red blood cell counts (anemia)
• Diarrhea
• Nausea and vomiting
• Feeling tired or weak (fatigue)
• Hair loss
• Constipation
• Decreased appetite
• Increased blood sugar levels
• Decreased albumin (protein) levels in the blood
• Changes in kidney function tests
• Increased alkaline phosphatase (liver or bone test)
• Decreased magnesium, potassium, and sodium levels
• Urinary tract infection
• Upper respiratory tract infection
• Headache
• Abdominal pain

Serious

• Severe or life-threatening low white blood cell count (neutropenia) that can lead to serious infection
• Severe diarrhea leading to dehydration and kidney problems
• Serious allergic or infusion-related reactions, including life-threatening anaphylaxis
• Severe, uncontrolled nausea or vomiting
• Neutropenic colitis (inflammation of the colon from low white blood cells)
• Lung infection (pneumonia)

Warnings and precautions

• Trodelvy can cause severe and sometimes life-threatening low white blood cell counts (neutropenia), which can lead to serious infections.
• Trodelvy can cause severe diarrhea that may lead to dehydration and kidney problems.
• Do not take this medicine if you have had a severe allergic reaction to it in the past.
• Serious and life-threatening allergic and infusion-related reactions can occur during or shortly after the infusion.
• People who carry a certain gene variant (UGT1A1*28) have a higher chance of side effects like low blood cell counts.
• This medicine may cause fertility problems in women.
• Based on how it works, this medicine could cause birth defects or loss of pregnancy if taken while pregnant.
• Trodelvy can harm an unborn baby. Your healthcare provider should test for pregnancy before starting treatment, and effective birth control is needed during and after treatment.
• It isn't known if Trodelvy passes into breast milk. Breastfeeding should be avoided during treatment and for 1 month after the last dose.
• There is no specific information on using Trodelvy in people with significant kidney problems.
• People with moderate or severe liver problems have not been studied, so safety is not established for them; no dose change is needed for mild liver problems.
• This medicine can cause dizziness, so caution is advised when driving or using machines.

Storage

• Store vials in a refrigerator between 2°C and 8°C.
• Keep in the original carton to protect from light until it is time to prepare the dose.
• Do not freeze.
• Keep out of reach and sight of children.

When to see a doctor

• Call your healthcare provider right away if you notice signs of infection such as fever, chills, cough, shortness of breath, or pain when urinating.
• Call your healthcare provider right away the first time you get diarrhea during treatment, if you have black or bloody stools, signs of dehydration (lightheadedness, dizziness, or faintness), can't keep fluids down, or can't control diarrhea within 24 hours.
• Tell your healthcare provider or nurse right away if during or within 24 hours of your infusion you have facial, lip, tongue, or throat swelling, hives, rash, itching, flushing, fever, trouble breathing or wheezing, dizziness, feeling faint, or chills/shaking.
• Call your healthcare provider right away if you have nausea or vomiting that is not controlled by the medicines you were given.

Alternatives

• Datroway
• Enhertu
• Capecitabine
• Eribulin