WARNING

Trodelvy (sacituzumab govitecan-hziy) is a medication used to treat certain types of cancer, particularly metastatic triple-negative breast cancer and metastatic urothelial cancer. While it can be effective in treating these cancers, like any medication, it carries risks. Here are some potential risks associated with taking Trodelvy:

• Infusion Reactions: Trodelvy is administered intravenously and can cause infusion reactions, including fever, chills, nausea, vomiting, and shortness of breath. These reactions are usually managed by slowing down the infusion rate or temporarily stopping the infusion.
• Bone Marrow Suppression: Trodelvy can suppress bone marrow function, leading to low levels of white blood cells, red blood cells, and platelets. This can increase the risk of infections, anemia, and bleeding.
• Gastrointestinal Toxicity: Trodelvy can cause severe diarrhea and nausea, which may require treatment or interruption of therapy.
• Hepatotoxicity: Liver problems, including elevated liver enzymes and liver damage, have been reported in patients taking Trodelvy.
• Interstitial Lung Disease (ILD): Trodelvy may cause ILD, a potentially serious lung condition characterized by inflammation and scarring of lung tissue.
• Embryo-Fetal Toxicity: Trodelvy can cause harm to unborn babies, so it should not be used during pregnancy. Women of childbearing age should use effective contraception during treatment and for some time afterward.
• Secondary Malignancies: There may be an increased risk of developing other cancers with Trodelvy treatment.

It’s important for patients to discuss the potential risks and benefits of Trodelvy with their healthcare provider before starting treatment. Healthcare providers will monitor patients closely for any signs of adverse effects and adjust treatment as needed.

Why is this medication prescribed?

Trodelvy (sacituzumab govitecan-hziy) is prescribed for the treatment of certain types of cancer, particularly metastatic triple-negative breast cancer (TNBC) and metastatic urothelial cancer. These cancers are often aggressive and can be challenging to treat, especially when they have spread to other parts of the body.

Trodelvy is a type of medication called an antibody-drug conjugate (ADC). It works by targeting cancer cells with an antibody that binds to a specific protein found on the surface of these cells. Once the antibody attaches to the cancer cell, it delivers a chemotherapy drug directly into the cell, which can help to destroy it.

How should this medicine be used?

Trodelvy (sacituzumab govitecan-hziy) is a prescription medication used to treat certain types of cancer, including metastatic triple-negative breast cancer (TNBC) and metastatic urothelial cancer. It is typically administered intravenously (IV) by a healthcare professional in a clinical setting such as a hospital or infusion center.

Here are the general steps for using Trodelvy:

• Dosage Determination: The appropriate dosage of Trodelvy will be determined by the healthcare provider based on factors such as the patient’s weight, overall health, type of cancer being treated, and previous treatment history.
• Preparation: Before administering Trodelvy, the healthcare provider will prepare the medication according to the manufacturer’s instructions. This typically involves reconstituting the medication and diluting it to the appropriate concentration for IV infusion.
• Administration: Trodelvy is given as an intravenous infusion over a specified period of time, typically ranging from 1 to 3 hours. The infusion is usually administered through a vein in the arm or hand.
• Monitoring: During the infusion, the healthcare provider will closely monitor the patient for any signs of allergic reactions or other adverse effects. Vital signs such as blood pressure, heart rate, and temperature may be monitored periodically during the infusion.
• Follow-Up: After the infusion is complete, the patient may be observed for a short period to ensure there are no immediate adverse reactions. The healthcare provider will provide instructions for any necessary follow-up appointments or monitoring.
• Repeat Infusions: Depending on the specific treatment plan determined by the healthcare provider, Trodelvy may be administered on a regular schedule, such as once every 1 or 2 weeks. The duration of treatment will vary depending on the individual patient’s response to therapy and other factors.

It’s important for patients to adhere to the treatment schedule recommended by their healthcare provider and to report any unusual symptoms or side effects promptly. Additionally, patients should discuss any questions or concerns about Trodelvy with their healthcare team.

Other uses for this medicine

• Trodelvy is primarily indicated for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic urothelial cancer (mUC).
• Clinical trials and research may explore its effectiveness in other types of cancer or in combination with other treatments, but currently, these are the main approved indications for Trodelvy.

What special precautions should I follow?

As for special precautions to follow when using Trodelvy, here are some important considerations:

• Pregnancy and Breastfeeding: Trodelvy can cause harm to unborn babies, so it should not be used during pregnancy. Women of childbearing age should use effective contraception during treatment and for some time afterward. It is not known whether Trodelvy passes into breast milk, so breastfeeding is not recommended during treatment and for some time afterward.
• Infusion Reactions: Trodelvy is administered intravenously and can cause infusion reactions, including fever, chills, nausea, vomiting, and shortness of breath. These reactions are usually managed by slowing down the infusion rate or temporarily stopping the infusion.
• Bone Marrow Suppression: Trodelvy can suppress bone marrow function, leading to low levels of white blood cells, red blood cells, and platelets. This can increase the risk of infections, anemia, and bleeding. Blood counts should be monitored regularly during treatment.
• Gastrointestinal Toxicity: Trodelvy can cause severe diarrhea and nausea, which may require treatment or interruption of therapy. Patients should report any gastrointestinal symptoms to their healthcare provider.
• Hepatotoxicity: Liver problems, including elevated liver enzymes and liver damage, have been reported in patients taking Trodelvy. Liver function should be monitored regularly during treatment.
• Interstitial Lung Disease (ILD): Trodelvy may cause ILD, a potentially serious lung condition characterized by inflammation and scarring of lung tissue. Patients should report any new or worsening respiratory symptoms to their healthcare provider.
• Secondary Malignancies: There may be an increased risk of developing other cancers with Trodelvy treatment. Patients should discuss the potential risks and benefits of treatment with their healthcare provider.

It’s essential for patients to discuss any questions or concerns about Trodelvy with their healthcare provider before starting treatment. Healthcare providers will monitor patients closely for any signs of adverse effects and adjust treatment as needed.

What special dietary instructions should I follow?

Regarding special dietary instructions for Trodelvy, there are no specific dietary restrictions associated with this medication. However, it’s essential to maintain a healthy and balanced diet to support overall health and well-being during cancer treatment. Eating a variety of nutritious foods, staying hydrated, and following any dietary recommendations provided by your healthcare provider or registered dietitian can be beneficial.

What should I do if I forget a dose?

If you forget a dose of Trodelvy, contact your healthcare provider or healthcare team for guidance. It’s essential to follow their instructions carefully. Depending on the specific circumstances, your healthcare provider may recommend rescheduling the missed dose or adjusting your treatment plan accordingly. Avoid doubling the dose to make up for a missed dose unless instructed to do so by your healthcare provider.

What side effects can this medication cause?

Trodelvy (sacituzumab govitecan-hziy) can cause a range of side effects, which can vary in severity from person to person. Common side effects of Trodelvy include:

• Nausea and vomiting: These are common side effects of Trodelvy treatment. Your healthcare provider may prescribe medications to help manage these symptoms.
• Diarrhea: Trodelvy can cause diarrhea, which may be severe in some cases. It’s important to stay hydrated and notify your healthcare provider if diarrhea persists or becomes severe.
• Fatigue: Feeling tired or weak is a common side effect of Trodelvy treatment. It’s essential to get plenty of rest and conserve your energy during treatment.
• Decreased appetite: Some people may experience a loss of appetite while taking Trodelvy.
• Hair loss: Hair loss, or alopecia, may occur with Trodelvy treatment. This side effect is usually temporary and reversible once treatment is completed.
• Anemia: Trodelvy can lower red blood cell counts, leading to anemia. Symptoms of anemia may include fatigue, weakness, and pale skin.
• Neutropenia: Trodelvy can lower white blood cell counts, specifically neutrophils, which can increase the risk of infection.
• Thrombocytopenia: Trodelvy can lower platelet counts, which can increase the risk of bleeding or bruising.
• Liver problems: Trodelvy may cause liver toxicity, leading to elevated liver enzymes or liver damage. Your healthcare provider may monitor your liver function regularly during treatment.
• Interstitial lung disease (ILD): In rare cases, Trodelvy may cause interstitial lung disease, a serious lung condition characterized by inflammation and scarring of lung tissue. Symptoms may include cough, difficulty breathing, or chest pain.

These are not all the possible side effects of Trodelvy. Other side effects may occur. It’s essential to discuss any concerns or side effects with your healthcare provider. They can provide guidance on managing side effects and determine if any adjustments to your treatment plan are necessary.

What should I know about storage and disposal of this medication?

Storage and disposal of Trodelvy:

Storage:

• Trodelvy should be stored at the temperature recommended by the manufacturer, typically between 2°C to 8°C (36°F to 46°F).
• Keep Trodelvy in its original packaging until ready for use to protect it from light.
• Do not freeze Trodelvy.
• Follow any specific storage instructions provided by your healthcare provider or pharmacist.

Disposal:

• Unused or expired Trodelvy should be disposed of properly according to local regulations.
• Do not dispose of Trodelvy in household trash. Follow any specific disposal instructions provided by your healthcare provider, pharmacist, or local waste disposal authorities.
• Some pharmacies or healthcare facilities may offer disposal services for unused or expired medications.

In case of emergency/overdose

• In case of emergency or overdose, such as an infusion reaction or severe toxicity, seek immediate medical attention by calling emergency services or going to the nearest emergency room.
• Provide healthcare providers with as much information as possible, including the name of the medication (Trodelvy), dosage, and any symptoms experienced.
• Healthcare providers will administer appropriate treatment based on the specific situation and symptoms presented.

What other information should I know?

• Inform all healthcare providers involved in your care that you are receiving Trodelvy treatment.
• Attend all scheduled appointments for monitoring and follow-up with your healthcare provider.
• Report any new or worsening symptoms, side effects, or concerns to your healthcare provider promptly.
• Follow any additional instructions provided by your healthcare provider, such as dietary recommendations, lifestyle modifications, or precautions to reduce the risk of complications.
• Keep a list of all medications, including prescription and over-the-counter drugs, vitamins, and supplements, and share it with your healthcare provider to avoid potential drug interactions.
• Be aware of potential drug interactions with Trodelvy and inform your healthcare provider of any other medications you are taking.
• If you have any questions or concerns about Trodelvy or your treatment plan, don’t hesitate to discuss them with your healthcare provider or pharmacist.

Remember, always follow your healthcare provider’s instructions and guidance regarding the use, storage, disposal, and management of Trodelvy to ensure safe and effective treatment.