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.
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Tivdak and you
You are not alone.
In up to 60% of women diagnosed with earlier stages of cervical cancer, the cancer will spread to other parts of the body within 2 years after initial treatment. When cancer spreads or comes back, treatments you have taken before for your cervical cancer may not be right for you anymore.
What is Tivdak?
To help you better understand Tivdak, gynecologic oncologist Dr. Cecelia Boardman explains how Tivdak is thought to work.
Tivdak is the first-and-only treatment of its kind approved for advanced cervical cancer that has progressed on or after chemotherapy
Tivdak is unlike any medicine you have taken before for your cervical cancer. It is a different treatment called an antibody-drug conjugate, or ADC, which attacks cells that have a special protein.
How Tivdak is thought to work
Tivdak attaches to a special protein called Tissue Factor on the outside of some types of tumor cells
Tivdak enters the cell
The medicine needed to kill the cell from the inside is released
The special protein, Tissue Factor, is also present on some normal cells. So, Tivdak can still harm normal cells, which can cause side effects.
How Tivdak Could Help You
Results for some patients may last longer than 8 months*
Tivdak was studied in a clinical trial of 101 women with cervical cancer that has returned or has spread and who have received chemotherapy that did not work or is no longer working.
What could this mean for you?
With Tivdak treatment
24%
of women had a
response to Tivdak
(Objective Response: 24 out of 101 patients)
Among the women
who had a response
~30% saw no
detectable tumors
(Complete Response: 7 out of 24 responders)
Among the women
who had a response
>70% saw
their tumors shrink
(Partial Response: 17 out of 24 responders)
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.
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:
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.
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.
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.
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.
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.
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:
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.
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.
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.
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Get to Know Tivdak
Dr. Cecelia Boardman explains how Tivdak is thought to work.