Tivdak
Tivdak (tisotumab) is an antibody-drug conjugate. It’s used to treat advanced and metastatic cervical cancer when other medications haven’t worked well. Tivdak (tisotumab) is given as an injection into your vein (intravenously, or IV) at an infusion center or oncologist’s office, typically once every 3 weeks. Some of the more common side effects of Tivdak (tisotumab) include nausea and fatigue. This medication can also cause serious eye problems, so your oncologist will ask you to get regular eye exams throughout treatment.
What is Tivdak (tisotumab)?
What is Tivdak (tisotumab) used for?
- Advanced or metastatic cervical cancer when other anticancer medications haven’t worked well
How Tivdak (tisotumab) works
Tivdak (tisotumab) is an antibody-drug conjugate (ADC). It’s made up of 2 main parts that work together to kill cancer cells:
- A monoclonal antibody part that finds and binds to cancer cells. In the case of cervical cancer, the monoclonal antibody binds to tissue factor (TF).
- Once Tivdak (tisotumab) is inside the tumor cells, the chemotherapy part of this medication kills the tumor cells.
Drug facts
Side effects of Tivdak (tisotumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low blood cell counts (21-52%)
- Tiredness (50%)
- Nausea (41%)
- Numbness or tingling sensation in hands and feet (39%)
- Nosebleeds (39%)
- Hair loss (39%)
- Eye irritation (37%)
- Bleeding (32%)
- Dry eyes (29%)
- Abnormal kidney tests (29%)
- Abnormal blood clotting tests (26%)
- Rash (25%)
- Diarrhea (25%)
- Abnormal liver tests (17-24%)
- Constipation (23%)
- Stomach pain (23%)
- Corneal problems (21%)
- Muscle pain (21%)
Less Common Side Effects
- Itching
- Vomiting
- Eye itching or inflammation
- Fevers
- Joint pain
- Pain in the arms and legs
- Decreased appetite
- Urinary tract infections
- Weight loss
Tivdak (tisotumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Nerve damage (neuropathy): tingling in the hands or feet, numbness, muscle weakness or twitching, loss of grip, loss of pain or touch
- Serious bleeds: bleeding or bruising that won’t stop or go away, blood in the urine, bloody or black and tarry stools, heavy vaginal bleeding, coughing up blood
- Lung problems: shortness of breath, cough, difficulty breathing
- Severe eye problems: vision changes, blurry vision, vision loss, corneal inflammation or ulcers, eyelid inflammation, dry eyes, red eyes
- Severe allergic or skin problems: rash, peeling of skin, hives, trouble breathing, painful sores or ulcers
The following Tivdak (tisotumab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Dry cough, shortness of breath or trouble breathing
- Eye pain, redness, irritation, or discharge with blurry or decreased vision
- Frequent or severe nosebleeds
- Heavy vaginal bleeding
- Pain, tingling, or numbness in the hands or feet
- Rash, fever, and swollen lymph nodes
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Tivdak (tisotumab)
Pros
- Preferred option for cervical cancer that has spread and doesn’t have any biomarkers
- A more targeted way to get chemotherapy into cancer cells, compared to traditional chemotherapy
- One dose every 3 weeks
Cons
- Need frequent eye exams because it can cause serious eye problems
- Commonly causes bleeding and nerve problems
- Infused into the veins
Pharmacist tips for Tivdak (tisotumab)
- Pay close attention to your skin and speak with your oncologist if you notice any unusual changes. Tivdak (tisotumab) can cause rare but serious skin problems, such as peeling of the skin or blisters or sores.
- You could experience tingling, burning, or muscle weakness a few months after starting Tivdak (tisotumab) infusions. If you develop neuropathy, be sure to notify your oncologist as it can be serious and your oncologist might need to stop or adjust your treatment.
- Bleeding problems, such as nose bleeds or vaginal bleeding, are common and can occur soon after starting treatment with Tivdak (tisotumab). Severe bleeding was rare but you should immediately inform your oncologist if you cough up blood or have severe bleeding.
More tips about preparing before your Tivdak (tisotumab) infusion day
- You need to pick your eye drops up from your pharmacy before your first infusion appointment and bring them to all of your infusion appointments. Your treatment team might not let you get treatment with Tivdak (tisotumab) if you don’t have your eyedrops with you.
- Be sure to go to the eye specialist. You will need to have had your eyes examined before you start Tivdak (tisotumab) treatment.
- If you wear contacts, remove them before you start treatment with Tivdak (tisotumab) and keep them out unless your eye specialist says it’s okay to wear them. You should only wear glasses during this time.
- You can apply cooling pads or eye masks on top of your eyes for an hour to reduce the risk of eye problems. If you aren't able to get cooling pads, your healthcare team might suggest using a clean bag filled with ice. But don't use eye masks with eye holes because your eyes need to be completely covered.
More tips about managing eye-related side effects
- Tivdak (tisotumab) commonly causes mild eye-related side effects, such as eye irritation or dry eyes. However, it can also cause more serious eye problems. If you have any eye changes, such as blurry vision, vision changes, or sensitivity to light, you should notify your oncologist and eye care provider right away.
- Your oncologist will prescribe 3 different eye drops before you start Tivdak (tisotumab). These include a vasoconstrictor to help limit eye-related side effects, a corticosteroid to relieve eye redness, and a lubricating drop to soothe dry eyes.
- Consider using a chart to keep track of your different eye drops and when to use them. You could also use a medication reminder app to help you remember your eye drops.
- Be sure to keep track of your appointments for your eye exams. You will need to have your eyes examined before you start treatment and before each infusion of Tivdak (tisotumab), so usually every 3 weeks. If you forget to get your eye exam, you could have a delay in getting Tivdak (tisotumab) infusions.
Common questions about Tivdak (tisotumab)
Your oncologist will let you know how long you should continue taking Tivdak (tisotumab). Typically, Tivdak (tisotumab) should be taken as long as it’s helping to control your cervical cancer and you’re not having any serious side effects. Your oncologist will monitor the cancer through imaging tests, such as computed tomography (CT) scans or magnetic resonance imaging (MRI). Let your oncology care team know if you have any side effects from Tivdak (tisotumab). Certain side effects, like nausea and diarrhea, can be managed by lifestyle changes or medications. But your oncologist might consider stopping or pausing treatment if you have severe side effects, such as eye problems or nerve damage. Ask your care team if you’ve specific concerns about Tivdak (tisotumab) treatment, and speak with your oncologist before you stop taking Tivdak (tisotumab).
A clinical study showed that on average, people who received Tivdak (tisotumab) for metastatic cervical cancer lived 2 months longer than those who received traditional chemotherapy (11.5 months compared to 9.5 months). A few people (2.4%) who received Tivdak (tisotumab) also saw their cancer completely disappear, compared to none in the group that received chemotherapy. Talk with your oncologist if you’ve more questions about how well Tivdak (tisotumab) works.
Tivdak (tisotumab) commonly causes eye-related side effects, such as dry eyes, red eyes, and eye irritation. In rare, but more serious cases, it can cause eye damage and vision loss. Your care team will put a plan in place to prevent serious eye problems when you start Tivdak (tisotumab). For example, your oncologist will ask you to see an eye specialist before each dose of this medication. They’ll check the health of your eyes and monitor for any changes in vision or vision loss. Your oncologist will also prescribe a few different eye drops for you to use throughout Tivdak (tisotumab) treatment to help ease certain side effects, such as dry eyes and eye redness. Check your vision every day and notify your oncology team right away if you notice any new or worsening eye problems or vision changes. Depending on how serious the symptoms are, your oncologist might ask you to stop Tivdak (tisotumab).
You might experience hair loss after starting Tivdak (tisotumab). Less than half of the people who received Tivdak (tisotumab) in clinical studies reported hair loss. This side effect happens because Tivdak (tisotumab) is a chemotherapy medication that targets fast-growing cells, such as cancer cells or hair cells. But Tivdak (tisotumab) is probably less likely to cause hair loss than traditional chemotherapy. This is because Tivdak (tisotumab) is an ADC that releases chemotherapy directly inside cervical cancer cells. But sometimes, the chemotherapy can get released early into the blood, before reaching the cervical cancer cells, which is why some people can experience hair loss. If you’re concerned about losing your hair while taking Tivdak (tisotumab), talk with your oncology team. They can discuss options for dealing with hair loss, such as cooling caps or lower-cost or free wigs.
More than half of people who took Tivdak (tisotumab) in clinical studies experienced bleeding. The bleeding typically occurred within the first few weeks of starting treatment. The most commonly reported types of bleeding were nosebleeds, blood in the urine, and vaginal bleeding. But bleeding can happen anywhere in the body. If you see any blood in the urine, bloody or black and tarry stools, or vaginal bleeding, notify your oncologist right away. They might need to stop your treatment to give your body a chance to heal. But if you have a more serious bleed inside your body, such as in the lungs or in the brain, your oncologist will likely ask you to stop taking Tivdak (tisotumab).
Having cervical cancer and receiving treatment for cervical cancer can impact fertility. If you’re concerned about fertility problems, it’s important to have a conversation with your healthcare team about whether there are options to preserve fertility before starting cancer treatments. Animal studies suggest that Tivdak (tisotumab) can cause harm during pregnancy. Your healthcare team might have you take a pregnancy test before you start taking the medication. Females who can have children should use effective birth control while taking Tivdak (tisotumab) and for at least 2 months after your last dose. Let your provider know right away if you become pregnant while on this medication.
No, it isn’t recommended to breastfeed while taking Tivdak (tisotumab). There are no studies to show how Tivdak (tisotumab) affects breastfed children. But because of the possibility of serious side effects, don’t breastfeed while taking this medication and for at least 3 weeks after the last dose.
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Risks and warnings for Tivdak (tisotumab)
Tivdak (tisotumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious eye problems
Tivdak (tisotumab) commonly causes eye-related side effects, typically starting within a month of treatment. Most of the time, these side effects are mild and include symptoms like dry eyes, inflammation of the eyelids, and eye irritation. But sometimes, this medication can cause more serious problems, such as damage to the cornea or loss of vision.
Because of the risk of eye problems, your care team will talk you through ways to care for your eyes while you’re receiving Tivdak (tisotumab). For example, your oncologist will ask you to get eye exams before you start Tivdak (tisotumab) and before every dose to check your eye health. They’ll also prescribe a few different eye drops to help protect your eyes during Tivdak (tisotumab) infusions, such as a corticosteroid eye drop to ease redness and swelling and a vasoconstrictor eye drop to prevent too much Tivdak (tisotumab) from getting to your eyes. They’ll also give you some cooling pads or eye masks to put on top of your eyes during the infusion to lower the risk of eye problems.
Tell your oncologist right away if you notice any new or worsening eye problems, such as blurry vision, vision changes, or eye irritation. Depending on how serious your symptoms, they might lower your dose of Tivdak (tisotumab) or ask you to stop treatment. While eye-related side effects usually got better after stopping Tivdak (tisotumab), they can sometimes become permanent.
Nerve problems
- Risk factors: History of nerve problems
Almost half of the people who received Tivdak (tisotumab) in clinical studies reported nerve-related side effects, usually within 3 months of starting treatment. Symptoms included muscle weakness, tingling or pain in the arms or legs, and loss of sensation in the fingers and toes. Most of the time, nerve-related side effects were mild to moderate.
Let your oncologist know if you experience any new or worsening numbness, pain, burning, tingling, or weakness in your arms or legs. They might need to lower your dose or ask you to stop Tivdak (tisotumab) to ease your symptoms. Studies show that nerve problems did improve in about a quarter of people after their oncologist adjusted the dose or stopped treatment. But if these side effects don’t get better, your oncologist might ask you to consider other options to treat your cancer.
Serious bleeding
Over half of people who took Tivdak (tisotumab) in clinical studies had bleeding, typically within the first few weeks of starting treatment. Bleeding can happen anywhere in the body. But the most commonly reported ones were nosebleeds, blood in the urine, and vaginal bleeds.
Tell your healthcare team right away if you experience serious bleeding. This can include bruises that won’t go away with time or bleeding that’s difficult to stop. Also, let them know if you notice any black or tarry stool or start to cough up blood, because these could be signs that you are bleeding inside your body. Get urgent medical attention if you have a fall, especially if you hit your head, so your care team can check for bleeding inside the brain. Depending on how serious the bleed, your oncologist might need to stop Tivdak (tisotumab) to give your body a chance to heal. Most of the time, the bleeding gets better over time. But if you have bleeding in the brain or lungs, your oncologist will talk with you about other options because you won’t be able to continue Tivdak (tisotumab).
Lung problems (pneumonitis)
Although rare, Tivdak (tisotumab) can cause inflammation of the lungs that can be serious and life-threatening. Notify your oncology care team right away if you experience a cough or trouble breathing. Your oncologist might need you to get an X-ray to check your lungs. Depending on the cause of the lung problems and how severe your symptoms are, your oncologist might need to pause and lower your dose of Tivdak (tisotumab). And if your symptoms are serious, you might have to stop treatment completely.
Serious skin problems
It’s not uncommon to have a rash during Tivdak (tisotumab) treatment. But rarely, Tivdak (tisotumab) can cause more serious skin reactions, including Stevens-Johnson syndrome (SJS). Get medical care right away if you have a rash, especially if you also have fever and chills, along with blistering or peeling skin, or painful sores or ulcers. Depending on how serious your symptoms are, your oncologist might ask you to stop taking Tivdak (tisotumab).
Harm to an unborn baby
Having cervical cancer and receiving treatment for cervical cancer can impact fertility. If you’re concerned about fertility problems, it’s important to have a conversation with your healthcare team about whether there are options to preserve fertility before starting cancer treatments. Based on animal studies, Tivdak (tisotumab) is likely to cause harm to unborn babies. Because of this risk, people who are able to become pregnant should use birth control during Tivdak (tisotumab) treatment to prevent pregnancy. After treatment, they should continue to use birth control for at least another 2 months. Let your oncologist know right away if you become pregnant during this time.
Tivdak (tisotumab) dosage
Typical dosage for Tivdak (tisotumab)
Your oncologist will calculate your dose of Tivdak (tisotumab) based on your body weight (in kilograms, or kg).
The typical dosing is 2 mg/kg (maximum 200 mg) given as an intravenous (IV) infusion over 30 minutes, once every 3 weeks.
What are alternatives to Tivdak (tisotumab)?
Tivdak (tisotumab) images
