Transcript

((Doctor Boardman))

Treatment for advanced cervical cancer can play a big role in your life. And as a doctor, I always like to walk my patients through their options, which can mean discussing how a treatment works, as well as what the potential benefits and side effects might be. For certain people, I tell them about a treatment called Tivdak, or tisotumab vedotin-tftv, which could be an option for you.

So to help you understand this treatment, let's go through some of the things you need to know.

((Voice-Over))

You may have heard of Tivdak before. It's a prescription medicine used to treat adults with cervical cancer that has returned or spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

TIVDAK was FDA approved based on a clinical study that measured how many patients had a tumor response and how long that response lasted. Continued approval is dependent on the results of an ongoing study to confirm the benefit of TIVDAK.

((Doctor Boardman))

Tivdak is different from other treatments you've taken before for your cervical cancer. While all treatments have certain side effects, it is important to know that eye problems are common with Tivdak and can be serious.

((Voice-Over))

TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment with TIVDAK.

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each dose of TIVDAK, and as needed for any new or worsening signs and symptoms of eye problems. You will be prescribed 3 different types of eye drops before you start treatment to help reduce the risk of eye problems. Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist. Serious side effects of TIVDAK may include eye problems, nerve problems (peripheral neuropathy), bleeding problems (hemorrhage), lung problems, and severe skin reactions. TIVDAK can harm your unborn baby.

These are not all the side effects that you may experience with TIVDAK. Remember to review additional Important Safety Information at the end of this video, which covers more information on the IMPORTANT WARNING for eye problems.

You should also read the Important Facts about TIVDAK, including an IMPORTANT WARNING on tivdak.com.

((Doctor Boardman))

Tivdak is different from traditional chemotherapy because of the way it's thought to work. Unlike treatments you've taken before for your cervical cancer, Tivdak is something called an antibody-drug conjugate or ADC for short. It might sound complicated, but let's take a closer look.

Imagine these are cells in your body. Some types of tumor cells, like in cervical cancer, have a special protein on the outside of the cell called Tissue Factor or TF. Based on lab studies, Tivdak is thought to work by attaching to TF. Once Tivdak attaches, it enters the cell. Then the medicine needed to kill the cell from the inside is released. TF is also present on some normal cells, so Tivdak can still attach to and harm normal cells which can cause side effects.

Now that you understand how Tivdak is thought to work, you might be curious to see how it worked for others. So let's look at the results from a clinical trial of 101 women with cervical cancer that had returned or spread and who had received chemotherapy that did not work or was no longer working. During the trial, researchers looked at different ways to track how well Tivdak worked. One way was to see if the cancer responded to treatment. You might have heard your doctor talk about response before. It's just another way of saying that your tumors either shrank or are no longer detectable. In the trial, 24% of women responded to treatment with Tivdak. If we look even closer, you'll see that among the women who had a response, greater than 70% saw their tumors shrink and about 30% saw no detectable tumors.

I know there's a lot to think about when you're starting a new treatment, but I hope that learning more about Tivdak helps you feel more prepared.

Make sure to reach out to your care team with any questions you have and keep watching for more information about TIVDAK, including an IMPORTANT WARNING.

((Voice-Over))

What is TIVDAK?

TIVDAK is a prescription medicine used to treat adults with cervical cancer:

• that has returned or has spread to other parts of the body, and
• who have received chemotherapy that did not work or is no longer working

TIVDAK was FDA approved based on a clinical study that measured how many patients had a tumor response and how long that response lasted. Continued approval is dependent on the results of an ongoing study to confirm the benefit of TIVDAK.

Important Safety Information

What is the most important information I should know about TIVDAK?

Eye problems are common with TIVDAK and can be serious. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each dose of TIVDAK, and as needed for any new or worsening signs and symptoms of eye problems.

Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

• You should use steroid eye drops before each infusion and as prescribed for 72 hours after each infusion
• You should use vasoconstrictor eye drops right before each infusion
• You should use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

What are the possible side effects of TIVDAK?

Serious side effects of TIVDAK may include:

Eye Problems. See "What is the most important information I should know about TIVDAK?"

Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

• Skin reactions that look like rings (target lesions)
• Rash or itching that continues to get worse
• Blistering or peeling of the skin
• Painful sores or ulcers in your mouth, nose, throat, or genital area
• Fever or flu-like symptoms
• Swollen lymph nodes

The most common side effects of TIVDAK include:

• Decreased red blood cell and white blood cell counts
• Tiredness
• Nausea
• Numbness or tingling in your hands or feet, or muscle weakness (peripheral neuropathy)
• Hair loss (alopecia)
• Nosebleed (epistaxis)
• Eye problems (conjunctival disorders)
• Bleeding (hemorrhage)
• Changes in kidney function blood tests
• Dry eye
• Abnormal blood clotting test results
• Diarrhea
• Rash

Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

What should I tell my healthcare provider before receiving TIVDAK?

Tell your healthcare provider about all your medical conditions, including if you:

• have a history of vision or eye problems
• have numbness or tingling in your hands or feet
• have bleeding problems
• have liver problems
• are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK
• are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
• You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

Males with female partners who are able to become pregnant:

• You should use effective birth control during treatment and for 4 months after the last dose of TIVDAK

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

These are not all the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/Medwatch or call 1-800-FDA-1088.

Please see Important Facts about TIVDAK including IMPORTANT WARNING on tivdak.com.