Tisotumab vedotin (Tivdak)

At a glance

Tisotumab vedotin (Tivdak) is an antibody–drug conjugate, often shortened to ADC. It combines an antibody that recognises a target on cells with a cell-killing medicine. It is given by a trained team through a drip into a vein. Although it is targeted treatment, it can affect healthy tissues and needs careful monitoring.

Tivdak requires a specific eye-care programme around every infusion. Bleeding, nerve symptoms and new breathing problems also need close attention. The eye-drop timing and examination schedule differ between US and European instructions, so the treating team should give you a single agreed plan.

Follow your own treatment calendar and the advice from your care team. Keep your medicine names and treatment dates handy to share with other clinicians.

How it works

Tisotumab binds to tissue factor, a protein expressed on certain cells. It carries monomethyl auristatin E, or MMAE, which disrupts cell division after release. Although tissue factor has a role in blood clotting, Tivdak is a cancer medicine and is not a substitute for an anticoagulant or treatment for an ordinary blood clot.

The antibody, its chemical link and the attached medicine form one product. They are not separate medicines that you can take in different amounts yourself. Targeting helps deliver treatment to particular cells, but it does not mean that only cancer cells are affected. Side effects can come from the attached medicine, the antibody, your existing illness or accompanying treatment.

An ADC is different from an immune checkpoint inhibitor, even when both are given in the same treatment plan. A reaction or noticeable side effect is not proof that an ADC is working. Equally, having few side effects does not mean that treatment has failed.

Is this treatment suitable for me?

Tisotumab vedotin is used for selected recurrent or metastatic cervical cancers that have progressed during or after previous systemic treatment, including chemotherapy. Your oncologist will advise whether it is suitable for you, taking account of your cancer type, relevant test results, previous treatment, overall health and the applicable prescribing information and regulatory guidance in your country.

The team reviews the clinical setting, earlier treatment, eye-surface health, bleeding history, nerve symptoms and liver function. A routine tissue-factor test is not a universal requirement under the checked product instructions. Active eye disease or significant bleeding risk needs particular consideration before treatment.

The discussion should cover the aim of treatment, the alternatives, likely appointments and how benefit will be assessed. A target found in a sample is one part of this decision; it does not guarantee a response. Tell the team what matters to you, including independence, work, caring responsibilities and the practical support available at home.

Before treatment

Bring a complete list of prescribed and non-prescribed medicines, vitamins, herbal products and allergies. Mention previous difficult reactions to infusions, infections, diabetes, liver or kidney problems and any pregnancy or breastfeeding. Explain symptoms you already have so a later change is easier to recognise.

An eye-care professional checks visual acuity and examines the front of the eye, including with a slit lamp. Tell the team about previous severe eye inflammation, corneal problems and contact lenses. Blood counts and liver function are assessed. Pregnancy status is checked before starting if pregnancy is possible. US instructions advise avoiding treatment in moderate or severe liver impairment; European instructions note that these patients have not been studied. Report any ongoing vaginal, urinary, bowel or nose bleeding and every blood-thinning medicine.

A nurse or pharmacist should explain the supportive medicines and which ones start before the treatment day. Ask your team to help you plan when to take each medicine. Make sure you know how to reach your hospital's urgent oncology service outside clinic hours. You may find it helpful to save the instructions on your phone or keep a copy at home. A family member or friend can help you remember them.

Discuss fertility preservation before treatment if future parenthood matters to you. Tell the team about dental problems and planned procedures. A procedure may need to be timed around blood counts and infection risk. Do not postpone reporting an active dental infection while waiting for the next routine appointment.

How treatment is given

The usual dose is 2 mg/kg, up to a maximum of 200 mg, as a 30-minute infusion every three weeks. Treatment continues according to response and tolerance. Eye-care measures are part of treatment preparation and should be checked before each infusion.

US instructions prescribe one steroid drop in each eye before infusion, followed by drops three times daily for 72 hours afterwards. The initial prescription and renewals require slit-lamp assessment. European and UK instructions start prescribed preservative-free steroid drops three times daily on the day before infusion and continue for three days afterwards. Do not mix schedules or restart old steroid bottles without advice.

Vasoconstrictor eye drops are given immediately before infusion, and cooling eye pads are used during it. European and UK instructions also continue cooling for 30 minutes afterwards. Lubricating drops are used throughout treatment and for 30 days after the final dose. Avoid contact lenses unless the eye specialist authorises them. Ask the unit to demonstrate the sequence and confirm that all required drops are available before the appointment.

Treatment is delivered through a cannula in a vein, a central line or an implanted port, depending on the plan and available access. Staff check the medicine, your identity, blood results and recent symptoms before starting. The appointment includes preparation and monitoring, so it will usually take longer than the infusion itself.

Tell the nurse immediately if you notice burning, pain, swelling, redness, leakage or tightness around the infusion site. These can mean medicine is leaking outside the vein. Do not wait for the drip to finish. At home, report a site that becomes more painful, blistered or discoloured, even if it looked normal when you left.

Also report flushing, itching, shivering, chest or back discomfort, wheezing, dizziness or swelling during treatment. Staff can stop or slow the infusion and assess you. Do not adjust the pump or line yourself. If a line remains in place, follow its cleaning and dressing instructions and report fever, tenderness or drainage around it.

If an appointment is missed, contact the treatment unit to arrange the next dose. Do not simply wait for the following cycle or seek an extra dose elsewhere. The correct restart date depends on why the dose was missed, the treatment schedule and recovery from side effects.

Monitoring your treatment

Blood tests usually check infection-fighting cells, red cells, platelets, kidney function and liver function. Some abnormalities cause no early symptoms. A reassuring blood test does not make a new symptom safe to ignore, and feeling well is not a reason to miss monitoring.

US instructions require eye examinations before treatment, before each cycle for the first nine cycles and as clinically indicated. European and UK instructions require baseline examination and further specialist assessment as clinically indicated, with inspection of the eyes and normal eye movement, and a check for symptoms before every dose. Any new or worsening ocular symptom needs prompt assessment regardless of the routine schedule. The team also checks bleeding, blood counts, nerve function and liver tests and assesses treatment response.

Your team compares examinations, symptoms and relevant scans or disease tests over time. Ask when the first response assessment is planned and what the result could change. A treatment break or lower dose may protect you from accumulating harm while allowing further treatment. It is not automatically evidence that the cancer has worsened. Never try to compensate for a reduced dose with supplements or closer appointments.

Common side effects

Side effects vary between people and between treatment combinations. You may experience several, a few or none of those described. Tell the team about symptoms that interfere with eating, sleeping, walking or usual tasks; a problem does not need to be severe before support is worthwhile.

Eye-surface symptoms

Redness, irritation, dry eyes or changes in vision can occur. Report symptoms early even if you are using all drops correctly. Eye care reduces risk but cannot eliminate it. Do not drive if vision is affected, and do not use contact lenses as a way to avoid blurred vision.

Nosebleeds and other bleeding

Nosebleeds can occur, but persistent, recurrent or heavy bleeding needs advice. Tell the team about vaginal bleeding, blood in urine or stool, or new bruising. Do not assume bleeding is necessarily caused by the original illness or that it is harmless because it has happened before.

Nerve changes and hair loss

Tingling, numbness or weakness can affect hands and feet. Report changes before they impair walking or fine tasks. Hair loss can also occur; ask about scalp care and practical support. Neither hair loss nor neuropathy indicates how well the cancer is responding.

Tiredness and reduced stamina

Plan important tasks for the part of the day when you have most energy and accept practical help. Short periods of gentle activity can be useful, with rest between them. Sudden marked weakness, breathlessness, dizziness or a racing heart needs assessment for causes such as anaemia, infection or dehydration. Do not assume every new limitation is ordinary treatment fatigue.

Nausea, appetite and bowel changes

Take prescribed anti-sickness medicines on the agreed schedule. Small regular meals, cool foods and frequent sips can be easier to manage. Tell the team if you cannot keep medicines or fluids down, are passing little urine or are losing weight. A dietitian can help when eating becomes difficult.

Record loose stools and whether there is pain, blood or fever. Severe diarrhoea, repeated vomiting or a swollen painful abdomen needs prompt advice. Constipation can be worsened by anti-sickness drugs and pain relief; use the bowel plan your team recommends. Do not repeatedly add laxatives or anti-diarrhoeal medicines without checking when there is significant pain or other new illness.

Low blood counts

A low white cell count can make infection progress quickly. Follow the urgent-help instructions below. Low red cells can cause tiredness, pallor or breathlessness; sometimes transfusions are needed. Low platelets can cause easy bruising, nosebleeds, bleeding gums or tiny red-purple spots. Report new bleeding and avoid starting aspirin or anti-inflammatory painkillers without checking. Do not stop a prescribed blood thinner yourself; the team must balance bleeding and clotting risks.

Mouth comfort and skin care

Use a soft toothbrush and the mouth-care products advised by your team. Report ulcers, white patches or soreness that limits eating, because infection or dehydration may need treatment. Avoid very hot, acidic or spicy foods if they sting. Moisturise dry skin with a simple fragrance-free product and protect it from strong sunlight. Painful skin, blisters or rapidly worsening redness need medical assessment rather than a new cosmetic product.

Important side effects

Severe eye injury

Tivdak can cause significant conjunctival and corneal injury, including ulcers, scarring and severe loss of vision. Eye problems may continue or appear after treatment. Severe pain, marked light sensitivity, worsening redness or a sudden vision change needs urgent eye assessment. Follow the eye-care plan even when there are no symptoms. Significant eye injury may require a pause, dose reduction or permanent discontinuation; conjunctival or corneal scarring requires permanent discontinuation.

Major haemorrhage

Bleeding can be serious, including internal bleeding. Vomiting blood, black stools, substantial bleeding, dizziness with bleeding or a severe new headache requires urgent care. Blood-thinning medicines need careful review, but should not be stopped independently because clotting risks also matter.

Lung inflammation and severe skin reactions

A new cough or breathlessness can be caused by pneumonitis and needs prompt assessment. Persistent or recurrent moderate pneumonitis requires treatment to be withheld; severe pneumonitis requires permanent discontinuation. Severe skin reactions, including Stevens–Johnson syndrome, have also been reported. A painful spreading rash, blisters, peeling skin or sores involving the mouth, eyes or genitals needs urgent care. The team immediately withholds Tivdak while a suspected severe skin reaction is assessed and permanently stops it if a severe reaction is confirmed. Do not treat such a rash with cosmetic creams and wait for it to settle.

Severe infection or an allergic reaction

A serious infection can occur even without a high temperature, especially if steroids or fever-reducing medicines are being taken. New confusion, marked drowsiness, rapid breathing or collapse requires emergency care. Sudden throat swelling, severe wheezing or faintness can indicate a severe allergic reaction. These symptoms should not be managed by waiting at home for the next scheduled review.

Other medicines and vaccinations

Strong CYP3A4 inhibitors, including some antifungal and antiviral medicines, may increase exposure to MMAE and the risk of side effects. Strong enzyme inducers, such as rifampicin, may reduce MMAE exposure and also need checking. Blood thinners and medicines that increase bleeding also need review. Give the pharmacist a complete list of eye drops as well as tablets, injections and supplements.

Ask the oncology pharmacist to check new prescriptions, over-the-counter remedies and herbal or traditional products. Products described as natural are not necessarily safe with cancer treatment. Do not use an unproven supplement in place of an essential supportive medicine. Keep the team informed about medicines prescribed by other specialists so that advice is coordinated.

Discuss influenza, COVID-19 and other vaccines with the team. Non-live vaccines may be suitable, although the response can be reduced during treatment. Live vaccines require specific specialist advice. Timing after treatment depends on immune recovery and the complete regimen; there is no single waiting interval that is correct for every ADC-treated patient.

Everyday life

Eating does not determine absorption of this intravenous medicine. Aim for enough food and fluids, adjusting for nausea and following any kidney, heart or diabetes restrictions. Avoid a restrictive anticancer diet that causes weight loss. Discuss alcohol with the team, particularly if liver tests are abnormal or other medicines cause sedation.

Work may remain possible with flexible hours and time for appointments. Increase activity gradually and avoid tasks that become unsafe because of fatigue, poor balance or impaired vision. Do not drive if dizzy, sleepy, visually affected or unable to use the pedals safely. Sedating premedicines can also affect driving, so arrange transport for early appointments until you know the plan.

Plan transport for eye and infusion appointments and keep the drop schedule where you can mark each dose. Arrange help if vision or neuropathy affects cooking, stairs or driving. A symptom diary can help distinguish ongoing bleeding from a new or worsening pattern that needs review.

Discuss travel before booking, especially long journeys or travel far from urgent care. Carry your treatment summary and enough supportive medicines. Use careful hand hygiene and food safety; avoid close contact with people who are clearly infectious. Complete social isolation is not automatically required. Ask about additional precautions when blood counts are very low.

Sex is often possible if comfortable, with the pregnancy precautions below and any advice about infection or bleeding. Ask the team whether barrier protection is needed after a dose to reduce exposure to drug residues in body fluids; the interval depends on the treatment. Caregivers cleaning urine, stool or vomit should follow the unit's handling advice, wear gloves when instructed and wash their hands afterwards. Keep medicines away from children and pets.

Fertility, pregnancy and breastfeeding

Use effective contraception during treatment and for at least two months after the final dose if you could become pregnant. A treated man with a partner who could become pregnant should use effective contraception during treatment and for at least four months afterwards. Do not breastfeed during treatment or for at least three weeks after the final dose.

Pregnancy should be discussed before treatment and reported promptly if it occurs or is suspected. Loss of periods does not reliably mean pregnancy is impossible. Vomiting or severe diarrhoea can interfere with oral contraception; seek advice about additional protection if this happens. Accompanying medicines may require longer precautions than the ADC itself, so obtain one clear end date for the complete regimen.

Fertility may be affected by treatment and previous therapies, and recovery cannot be guaranteed. Discuss sperm, egg or embryo preservation before starting when feasible. The interval for avoiding pregnancy is a safety precaution and does not itself establish whether fertility has recovered.

After treatment

Continue lubricating eye drops for 30 days after the last dose and attend any further eye follow-up advised. New eye symptoms after that period still need assessment; the 30-day drop instruction is not a guarantee that all risk has ended. Persistent neuropathy or bleeding also requires follow-up.

Keep attending the recommended blood tests, scans and clinical reviews. Retain a treatment summary with the exact ADC name, dates, significant reactions and any ongoing medication. Tell new clinicians about past treatment when an unexplained symptom is assessed. Continue contraception, breastfeeding restrictions and prescribed supportive medicines for their own specified periods, counted from the relevant final dose.

Recovery can be gradual and may involve physical rehabilitation, dietary support or help with anxiety and sleep. A follow-up visit is also an opportunity to discuss returning to work, travel and persistent symptoms. New severe symptoms still need urgent assessment between appointments; finishing treatment does not remove the need for the urgent-care plan.

Common questions