TIVDAK® Patient Counseling Information

(tisotumab vedotin-tftv)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Ocular Adverse Reactions

•
Inform patients about the eye exam they will receive with an eye care provider before starting TIVDAK, before each of the first nine cycles and as clinically indicated [see Warnings and Precautions (5.1)].
•
Inform patients about the ocular signs or symptoms the eye care provider will review before each cycle [see Warnings and Precautions (5.1)].
•
Inform patients that ocular adverse reactions may occur during treatment with TIVDAK and to contact their healthcare provider if they experience new or worsening ocular signs and symptoms [see Warnings and Precautions (5.1)].
•
Instruct patients to bring their eye drops to each infusion and advise on how to administer the eye drops throughout treatment [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].
•
Inform patients to avoid wearing contact lenses during treatment unless directed by an eye care provider [see Dosage and Administration (2.2)].

Peripheral Neuropathy

•
Advise patients to report to their healthcare provider any numbness and tingling of the hands or feet or muscle weakness [see Warnings and Precautions (5.2)].

Hemorrhage

•
Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual severe bleeding or hemorrhage [see Warnings and Precautions (5.3)].

Pneumonitis

•
Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.4)].

Severe Cutaneous Adverse Reactions

•
Inform patients of the signs and symptoms of severe cutaneous adverse reactions, including life-threatening and potentially fatal SJS, which include target lesions, worsening skin reactions, blistering or peeling of the skin, painful sores in mouth, nose, throat, or genital area, fever or flu-like symptoms, and swollen lymph nodes [see Warnings and Precautions (5.5)].
•
Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of severe cutaneous adverse reactions, including SJS [see Warnings and Precautions (5.5)].

Embryo-Fetal Toxicity

•
Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].
•
Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

Lactation

•
Advise women not to breastfeed during treatment with TIVDAK and for 3 weeks after the last dose [see Use in Specific Populations (8.2)].

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
TIVDAK® is a trademark owned by Seagen Inc.
©2024 Seagen Inc. and Genmab US, Inc.
USPI-761208-v04

Find TIVDAK® medical information:

Find TIVDAK® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

TIVDAK® Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Ocular Adverse Reactions

•
Inform patients about the eye exam they will receive with an eye care provider before starting TIVDAK, before each of the first nine cycles and as clinically indicated [see Warnings and Precautions (5.1)].
•
Inform patients about the ocular signs or symptoms the eye care provider will review before each cycle [see Warnings and Precautions (5.1)].
•
Inform patients that ocular adverse reactions may occur during treatment with TIVDAK and to contact their healthcare provider if they experience new or worsening ocular signs and symptoms [see Warnings and Precautions (5.1)].
•
Instruct patients to bring their eye drops to each infusion and advise on how to administer the eye drops throughout treatment [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].
•
Inform patients to avoid wearing contact lenses during treatment unless directed by an eye care provider [see Dosage and Administration (2.2)].

Peripheral Neuropathy

•
Advise patients to report to their healthcare provider any numbness and tingling of the hands or feet or muscle weakness [see Warnings and Precautions (5.2)].

Hemorrhage

•
Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual severe bleeding or hemorrhage [see Warnings and Precautions (5.3)].

Pneumonitis

•
Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.4)].

Severe Cutaneous Adverse Reactions

•
Inform patients of the signs and symptoms of severe cutaneous adverse reactions, including life-threatening and potentially fatal SJS, which include target lesions, worsening skin reactions, blistering or peeling of the skin, painful sores in mouth, nose, throat, or genital area, fever or flu-like symptoms, and swollen lymph nodes [see Warnings and Precautions (5.5)].
•
Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of severe cutaneous adverse reactions, including SJS [see Warnings and Precautions (5.5)].

Embryo-Fetal Toxicity

•
Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].
•
Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

Lactation

•
Advise women not to breastfeed during treatment with TIVDAK and for 3 weeks after the last dose [see Use in Specific Populations (8.2)].

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
TIVDAK® is a trademark owned by Seagen Inc.
©2024 Seagen Inc. and Genmab US, Inc.
USPI-761208-v04
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.