WARNING

Tisotumab vedotin-tftv is a targeted therapy used in the treatment of certain types of cancer, notably cervical cancer. While it can be effective in fighting cancer, like all medications, it comes with potential risks. Some of the risks associated with tisotumab vedotin-tftv include:

• Side Effects: Common side effects may include fatigue, nausea, diarrhea, and hair loss. These side effects can vary in severity and may require medical management.
• Infusion Reactions: Some individuals may experience infusion-related reactions, such as fever, chills, or allergic reactions, during or shortly after receiving the medication.
• Nerve Damage: Tisotumab vedotin-tftv can cause nerve damage (neuropathy), leading to symptoms such as numbness, tingling, or weakness in the hands and feet.
• Decreased Blood Cell Counts: This medication may reduce the levels of certain types of blood cells, including white blood cells, red blood cells, and platelets, which can increase the risk of infections, anemia, and bleeding.
• Liver Toxicity: Tisotumab vedotin-tftv may cause liver toxicity, resulting in elevated liver enzymes and potential liver damage.
• Risk of Secondary Cancers: There is a potential risk of developing secondary cancers as a result of treatment with tisotumab vedotin-tftv.
• Pregnancy Risk: This medication can harm an unborn baby, so it should not be used during pregnancy. Women of childbearing potential should use effective contraception during treatment and for a period after discontinuing the medication.
• Drug Interactions: Tisotumab vedotin-tftv may interact with other medications, potentially affecting their efficacy or increasing the risk of side effects.

It’s essential for patients considering or receiving tisotumab vedotin-tftv to discuss these risks thoroughly with their healthcare provider and to report any concerning symptoms promptly during treatment.

Why is this medication prescribed?

Tisotumab vedotin-tftv is prescribed for the treatment of certain types of cancer, notably recurrent or metastatic cervical cancer that has progressed after receiving chemotherapy. It is specifically indicated for patients who have disease progression during or after treatment with a platinum-containing chemotherapy and whose disease cannot be adequately treated with radiation therapy.

Tisotumab vedotin-tftv is a targeted therapy that works by delivering a toxic payload directly to cancer cells, which express the tissue factor protein. By binding to tissue factor on the surface of cancer cells, it delivers a cytotoxic agent, which helps to kill the cancer cells while minimizing damage to healthy cells.

How should this medicine be used?

Tisotumab vedotin-tftv is typically administered intravenously by a healthcare professional. Here are the general steps for how it is used:

• Preparation: The medication is supplied as a solution in a vial or infusion bag. Healthcare professionals will prepare the medication according to the prescribed dosage and administration instructions.
• Administration: Tisotumab vedotin-tftv is infused into a vein (intravenously) over a period of time, typically ranging from 30 minutes to an hour. The infusion is usually administered in a hospital or clinic setting where healthcare providers can monitor the patient for any adverse reactions.
• Monitoring: During and after the infusion, healthcare providers will closely monitor the patient for any signs of adverse reactions, such as infusion-related reactions, allergic reactions, or other side effects.
• Dosage and Schedule: The dosage and administration schedule of tisotumab vedotin-tftv may vary depending on factors such as the patient’s weight, overall health, and response to treatment. Typically, it is administered once every three weeks until disease progression or unacceptable toxicity occurs.
• Follow-up: After each infusion, patients may be scheduled for follow-up appointments to monitor their response to treatment and assess for any adverse effects. The treatment plan may be adjusted based on the patient’s individual needs and tolerability.

It’s important for patients to follow all instructions provided by their healthcare provider regarding the administration of tisotumab vedotin-tftv and to report any concerns or changes in their condition promptly.

Other uses for this medicine

Tisotumab vedotin-tftv is primarily used for the treatment of certain types of cancer, specifically recurrent or metastatic cervical cancer that has progressed after receiving chemotherapy. However, researchers are continually investigating its potential use in other types of cancer or in combination with other treatments.

What special precautions should I follow?

As for special precautions to follow when using tisotumab vedotin-tftv, here are some important points:

• Pregnancy and Contraception: Tisotumab vedotin-tftv can cause harm to an unborn baby, so it should not be used during pregnancy. Women of childbearing potential should use effective contraception during treatment and for a period after discontinuing the medication.
• Liver Function Monitoring: Since tisotumab vedotin-tftv can cause liver toxicity, patients may require monitoring of liver function tests (such as liver enzyme levels) during treatment to assess for any signs of liver damage.
• Infusion Reactions: Infusion-related reactions, including fever, chills, and allergic reactions, can occur during or shortly after receiving tisotumab vedotin-tftv. Patients should be closely monitored during infusion and may receive premedications to reduce the risk of infusion reactions.
• Nerve Damage: Tisotumab vedotin-tftv can cause nerve damage (neuropathy), leading to symptoms such as numbness, tingling, or weakness in the hands and feet. Patients should report any new or worsening symptoms to their healthcare provider promptly.
• Blood Cell Counts: Tisotumab vedotin-tftv may cause decreases in certain types of blood cells, including white blood cells, red blood cells, and platelets. Regular monitoring of blood cell counts may be necessary during treatment.
• Drug Interactions: Tisotumab vedotin-tftv may interact with other medications, potentially affecting their efficacy or increasing the risk of side effects. Patients should inform their healthcare provider about all medications they are taking, including prescription drugs, over-the-counter medications, and herbal supplements.
• Special Populations: There may be specific precautions for certain patient populations, such as those with pre-existing liver or kidney conditions. Patients should discuss their medical history with their healthcare provider before starting treatment with tisotumab vedotin-tftv.

It’s essential for patients to discuss any questions or concerns about tisotumab vedotin-tftv with their healthcare provider and to follow all instructions provided for safe and effective use of the medication.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Tisotumab vedotin-tftv. However, maintaining a healthy and balanced diet is generally recommended to support overall health and well-being during cancer treatment.

What should I do if I forget a dose?

If you miss a scheduled dose of Tisotumab vedotin-tftv, it’s important to contact your healthcare provider or treatment team as soon as possible for guidance. They will advise you on the appropriate course of action, which may include rescheduling the missed dose or adjusting your treatment plan. It’s essential not to try to make up for a missed dose without consulting your healthcare provider first, as they will provide specific instructions based on your individual circumstances.

What side effects can this medication cause?

Tisotumab vedotin-tftv, like many medications, can cause side effects. These side effects can vary in severity from mild to severe and may affect different individuals differently. Some of the common side effects associated with tisotumab vedotin-tftv include:

• Fatigue: Feeling tired or weak is a common side effect of tisotumab vedotin-tftv.
• Nausea and vomiting: Some individuals may experience nausea and vomiting during or after treatment with tisotumab vedotin-tftv.
• Diarrhea: Diarrhea can occur as a side effect of tisotumab vedotin-tftv treatment.
• Hair loss: Some patients may experience hair loss or thinning (alopecia) as a result of tisotumab vedotin-tftv treatment.
• Infusion reactions: Infusion-related reactions, such as fever, chills, or allergic reactions, may occur during or shortly after receiving tisotumab vedotin-tftv.
• Nerve damage (neuropathy): Tisotumab vedotin-tftv can cause nerve damage, leading to symptoms such as numbness, tingling, or weakness in the hands and feet.
• Decreased blood cell counts: Tisotumab vedotin-tftv may cause decreases in certain types of blood cells, including white blood cells, red blood cells, and platelets, which can increase the risk of infections, anemia, and bleeding.
• Liver toxicity: Tisotumab vedotin-tftv may cause liver toxicity, resulting in elevated liver enzymes and potential liver damage.
• Other side effects: Other less common side effects may include headache, abdominal pain, constipation, decreased appetite, and muscle pain.

It’s important for patients to discuss any concerns or side effects they experience with their healthcare provider, as they can provide guidance and support to manage these side effects effectively. Additionally, patients should report any severe or persistent side effects to their healthcare provider immediately.

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

Storage and Disposal:

Storage:

• Tisotumab vedotin-tftv should be stored according to the manufacturer’s instructions, typically at controlled room temperature away from excessive heat and moisture.
• Keep the medication out of reach of children and pets.
• Do not freeze tisotumab vedotin-tftv.

Disposal:

• Unused or expired tisotumab vedotin-tftv should be disposed of properly.
• Do not flush the medication down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist.
• Consult your healthcare provider, pharmacist, or local waste disposal facility for guidance on how to properly dispose of tisotumab vedotin-tftv.

In case of emergency/overdose

• If you believe you have overdosed on tisotumab vedotin-tftv or are experiencing severe or life-threatening symptoms, such as difficulty breathing or loss of consciousness, seek immediate medical attention.
• Contact your healthcare provider, emergency services, or local poison control center for assistance.
• Be prepared to provide information about the medication, including the dosage and time of ingestion, as well as your current symptoms.

What other information should I know?

• Inform all healthcare providers involved in your care, including doctors, nurses, and pharmacists, that you are receiving tisotumab vedotin-tftv.
• Attend all scheduled appointments for monitoring and follow-up during treatment with tisotumab vedotin-tftv.
• Report any new or worsening symptoms to your healthcare provider promptly.
• Be aware of potential drug interactions with other medications, and inform your healthcare provider of all medications you are taking.
• Follow all instructions provided by your healthcare provider for safe and effective use of tisotumab vedotin-tftv.

By following these guidelines and staying informed about the proper use, storage, and disposal of tisotumab vedotin-tftv, you can help ensure the safe and effective management of your treatment.