TM Owner Seagen / Genmab
Tisotumab Vedotin IV 40mg Vial
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Indications & Clinical Uses
- "Tisotumab Vedotin IV" is not an approved trade name; it is the generic drug name plus its route of administration.
- The actual FDA-approved brand is TIVDAK (tisotumab vedotin-tftv), 40 mg per single-dose vial, marketed by Seagen Inc. and Genmab US, Inc., and the content here is sourced from Tivdak's US prescribing information.
- Tivdak is an antibody-drug conjugate that targets tissue factor on tumour cells and delivers a microtubule-disrupting agent directly into them.
- It is indicated for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy.
- Tivdak is given by intravenous infusion in a clinic or hospital every 3 weeks - it is never self-administered at home.
Side Effects
- Tivdak carries a boxed warning for OCULAR TOXICITY, which can cause changes in vision, including severe vision loss, and corneal ulceration.
- Common reactions occurring in a quarter or more of patients include a drop in haemoglobin, peripheral neuropathy (numbness or tingling in the hands and feet), conjunctival and other eye reactions, nausea, fatigue, raised liver enzymes, nosebleeds, hair loss and bleeding.
- Report any change in vision, eye pain, redness or sensitivity to light immediately, and report new numbness, tingling or weakness in the hands or feet, since dose changes may be needed.
Precautions & Warnings
- Because of the ocular toxicity warning, you need an eye examination before starting Tivdak and again before each of the first nine treatment cycles, and you must follow a prescribed eye-care routine of corticosteroid eye drops, a vasoconstrictor drop, cooling eye pads during the infusion, and lubricating drops; contact lenses should not be worn during treatment unless your eye specialist says it is safe.
- Tivdak can harm an unborn baby, so effective contraception is required during treatment and for a period afterwards for patients who can become pregnant and for male patients with partners who can become pregnant.
- Peripheral neuropathy may require dose delay, reduction or discontinuation if it worsens.
- Tivdak is for intravenous infusion only, given over 30 minutes - it must never be given as a rapid injection.
Avoid Interactions
- Tell your healthcare provider and pharmacist about every medicine and supplement you use, including other eye medicines, since combining several eye drops around infusion days needs careful timing to follow the required eye-care routine correctly.
- There is no established food or dietary interaction, since Tivdak is given by infusion rather than taken by mouth.
- Because peripheral neuropathy and low blood counts are known effects, other medicines that also affect nerves or bone marrow, such as certain chemotherapy agents, should be used with added caution and monitoring.
- Report any new eye drop, supplement or over-the-counter medicine to your cancer care team before your next infusion.
References
Frequently Asked Questions
"Tisotumab Vedotin IV" is not a real brand name - the approved product is Tivdak. It treats adults with recurrent or metastatic cervical cancer whose disease has grown or spread despite previous chemotherapy. It is an antibody-drug conjugate given by IV infusion, never taken by mouth.
Tivdak is given as an intravenous infusion over 30 minutes, once every 3 weeks, at a clinic or hospital. Treatment continues until the cancer progresses or side effects become unacceptable. You cannot give it to yourself at home or as a rapid injection.
Common Tivdak side effects include low haemoglobin, numbness or tingling in the hands and feet, eye irritation, nausea, fatigue and hair loss. Its boxed warning is for ocular toxicity, including severe vision loss and corneal ulcers, so any eye symptom needs prompt attention.
Avoid wearing contact lenses during Tivdak treatment unless your eye specialist approves it, and do not skip the required eye drop routine around each infusion. Effective contraception is required during and after treatment, since Tivdak can harm an unborn baby.
You need an eye examination before starting Tivdak and before each of the first nine infusion cycles, because of its ocular toxicity warning. Between visits, follow the prescribed steroid, vasoconstrictor and lubricating eye drop routine exactly as your care team directs.
Tivdak's boxed warning is for ocular toxicity - it can cause changes in vision, including severe vision loss, and corneal ulceration. This is why regular eye exams and a strict eye-care drop routine are required before and throughout treatment.

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