TIVDAK® What is the most important information I should know about TIVDAK?

(tisotumab vedotin-tftv)

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.

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What is the most important information I should know about TIVDAK?

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.

Prescribing Information
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Health Professional Information

What is the most important information I should know about TIVDAK?

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.

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