Prescription medicine
Tisotumab vedotin Brand names: Tivdak
Tisotumab vedotin (Tivdak) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the tisotumab vedotin FDA label on DailyMed (effective November 20, 2025); every tisotumab vedotin label on DailyMed.
Highlights of the record
FDA label of November 20, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
OCULAR TOXICITY •.
TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ].
Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ].
Adhere to the required premedication and eye care before, during, and after infusion. [see Dosage and Administration (2.2) ].
Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity [see Dosage and Administration (2.3), Warnings and Precautions (5.1) ]. WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning.
TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss and corneal ulceration. ( 5.1 )
Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. ( 2.2 , 5.1 )
Adhere to the required premedication and eye care before, during, and after infusion. […]
Used for
From the label: indications and usageTIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Forms and strengths
- 40 mg/4ml
Injection (powder) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 912 through July 30, 2026
What is tisotumab vedotin used for?
From the label: indications and usageTIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Source: FDA drug label (TIVDAK), SEAGEN INC., effective November 20, 2025 (SPL set c9fe3f32-4219-466e-acb9-3f609b4f4df1), via openFDA; the full label on DailyMed
What does the patient leaflet for tisotumab vedotin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TIVDAK?TIVDAK can cause serious side effects, including: Eye problems. Eye problems are common with TIVDAK, and can also be severe. 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 with TIVDAK. • Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. • Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or 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: o Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion. o Use vasoconstrictor eye drops right before each infusion. o 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. See “ What are the possible side effects of TIVDAK? ” for more information about side effects.
Source: FDA drug label (TIVDAK), SEAGEN INC., effective November 20, 2025 (SPL set c9fe3f32-4219-466e-acb9-3f609b4f4df1), via openFDA; the full label on DailyMed
Is there a generic for tisotumab vedotin (Tivdak)?
No generic tisotumab vedotin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for tisotumab vedotin?
The FDA Adverse Event Reporting System holds 912 reports that list tisotumab vedotin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 68 are coded as a death and 223 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tisotumab vedotin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other