Administration of eye drops
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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THE INFUSION
An infusion given once every 3 weeks
Your care team will work with you to decide how many infusions you will need.
Each Tivdak infusion appointment includes:
In Chair Time ~1 hour
Administration of eye drops
Placement of cold packs over your eye area
Infusion
Before starting Tivdak, tell your care team about any other medications you take
It’s important to tell your care team 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. You should also let your other care teams know that you're starting treatment with Tivdak.
SIDE EFFECTS
The most common serious side effects were problems moving food and poop through your gut (ileus), bleeding, pneumonia, tingling or numbness in the hands and feet, sepsis, constipation, and fever.
The most common side effects of Tivdak were:
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
These are not all the possible side effects of Tivdak. Any of these things can begin to happen in the days following your infusion. A side effect does not necessarily mean you have to stop treatment. Your oncologist may need to change, pause, or stop your treatment if you have new or worsening side effects. For more information, see Important Facts about Tivdak.
Do I need to stop treatment if I have a side effect?
Your oncologist may need to change, pause, or stop your treatment if you have certain side effects. If you notice any new or worsening side effects, tell your care team right away.
Is there anything I can do to help reduce side effects?
Tivdak Required Eye Care may help reduce the risk of eye problems. Your care team may also recommend other medications to help treat possible side effects such as nausea, constipation, and/or diarrhea. Talk to your care team about any discomfort or side effects you are experiencing.
Helpful Tivdak information
To help you better understand Tivdak, gynecologic oncologist Dr. Cecelia Boardman explains how Tivdak is thought to work.
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.