TIVDAK® Boxed Warning

(tisotumab vedotin-tftv)

WARNING: 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)].

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Health Professional Information

Boxed Warning

WARNING: 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)].
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