TIVDAK- tisotumab vedotin injection, powder, for solution 
Seagen Inc.

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SPL MEDGUIDE SECTION

                                                                                                                                           MEDICATION GUIDE
                                                                                                                                             TIVDAK (TIV-dack)
                                                                                                                                          (tisotumab vedotin-tftv)
                                                                                                                                   for injection, for intravenous use

What is the most important information I should know about TIVDAK?
TIVDAK can cause serious side effects, including:

See “What are the possible side effects of TIVDAK? for more information about side effects.

What is TIVDAK?

TIVDAK is a prescription medicine used to treat adults with cervical cancer:

It is not known if TIVDAK is safe and effective in children.

Before receiving TIVDAK, tell your healthcare provider about all of your medical conditions, including if you:

      Females who are able to become pregnant:

      Males with female partners who are able to become pregnant:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

How will I receive TIVDAK?

What are the possible side effects of TIVDAK?
TIVDAK can cause serious side effects, including:

  • blood in your stools or black stools (looks like tar) 
  • blood in your urine 
  • cough up or vomit blood
  • unusual vaginal bleeding 
  • any unusual or heavy bleeding

The most common side effects of TIVDAK include:

  • decreased red blood cell and white blood cell counts 
  • tiredness
  • nausea
  • hair loss (alopecia) 
  • nosebleed 
  • changes in kidney function blood tests 
  • dry eye
  • abnormal blood clotting test results 
  • diarrhea 
  • rash

TIVDAK may cause fertility problems in males, which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of TIVDAK.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of TIVDAK.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about TIVDAK, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about TIVDAK that is written for healthcare professionals.

What are the ingredients in TIVDAK?
Active ingredient: tisotumab vedotin-tftv
Inactive ingredients: d-mannitol, l-histidine, l-histidine monohydrochloride, and sucrose.

Manufactured by: Seagen Inc., Bothell, WA 98021, 1-855-4SEAGEN
Marketed by: Seagen Inc., Bothell, WA 98021 and Genmab US, Inc., Plainsboro, NJ 08536
U.S. License 2257
TIVDAKTM is a trademark owned by Seagen Inc.
©2021 Seagen Inc. and Genmab US, Inc.
For more information, go to www.tivdak.com or call 1-855-4SEAGEN

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                                                                                      Issued: September 2021                                             

Revised: 9/2021
Seagen Inc.