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

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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

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