TIVDAK® What are the possible side effects of TIVDAK?

(tisotumab vedotin-tftv)

What are the possible side effects of TIVDAK?

TIVDAK can cause serious side effects, including: 
  • See “What is the most important information I should know about TIVDAK?”  
  • Peripheral neuropathy. Nerve problems called peripheral neuropathy are common with TIVDAK, and can also be serious. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.
  • Bleeding (hemorrhage). Bleeding problems are common with TIVDAK, and can also be serious. Tell your healthcare provider or get medical help right away if you get signs or symptoms of bleeding during treatment with TIVDAK, 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
  • Lung problems.  TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.
  • Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you get signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:
  • skin reactions that look like rings (target lesions)
  • rash or itching that continues to get worse 
  • blistering or peeling of the skin
  • painful sores or ulcers in your mouth, nose, throat, or genital area
  • fever or flu-like symptoms 
  • swollen lymph nodes 
The most common side effects of TIVDAK include:
  • decreased red blood cell counts  
  • numbness or tingling in your hands or feet
  • eye problems (conjunctival disorders)
  • nausea
  • tiredness
  • changes in liver function blood tests
  • nosebleed  
  • hair loss (alopecia)
  • bleeding (hemorrhage)
TIVDAK may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of 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.

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Health Professional Information

What are the possible side effects of TIVDAK?

What are the possible side effects of TIVDAK?

TIVDAK can cause serious side effects, including: 
  • See “What is the most important information I should know about TIVDAK?”  
  • Peripheral neuropathy. Nerve problems called peripheral neuropathy are common with TIVDAK, and can also be serious. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.
  • Bleeding (hemorrhage). Bleeding problems are common with TIVDAK, and can also be serious. Tell your healthcare provider or get medical help right away if you get signs or symptoms of bleeding during treatment with TIVDAK, 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
  • Lung problems.  TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.
  • Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you get signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:
  • skin reactions that look like rings (target lesions)
  • rash or itching that continues to get worse 
  • blistering or peeling of the skin
  • painful sores or ulcers in your mouth, nose, throat, or genital area
  • fever or flu-like symptoms 
  • swollen lymph nodes 
The most common side effects of TIVDAK include:
  • decreased red blood cell counts  
  • numbness or tingling in your hands or feet
  • eye problems (conjunctival disorders)
  • nausea
  • tiredness
  • changes in liver function blood tests
  • nosebleed  
  • hair loss (alopecia)
  • bleeding (hemorrhage)
TIVDAK may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of 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.
Prescribing Information
Download Prescribing Information

Health Professional Information

What are the possible side effects of TIVDAK?

What are the possible side effects of TIVDAK?

TIVDAK can cause serious side effects, including: 
  • See “What is the most important information I should know about TIVDAK?”  
  • Peripheral neuropathy. Nerve problems called peripheral neuropathy are common with TIVDAK, and can also be serious. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.
  • Bleeding (hemorrhage). Bleeding problems are common with TIVDAK, and can also be serious. Tell your healthcare provider or get medical help right away if you get signs or symptoms of bleeding during treatment with TIVDAK, 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
  • Lung problems.  TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.
  • Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you get signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:
  • skin reactions that look like rings (target lesions)
  • rash or itching that continues to get worse 
  • blistering or peeling of the skin
  • painful sores or ulcers in your mouth, nose, throat, or genital area
  • fever or flu-like symptoms 
  • swollen lymph nodes 
The most common side effects of TIVDAK include:
  • decreased red blood cell counts  
  • numbness or tingling in your hands or feet
  • eye problems (conjunctival disorders)
  • nausea
  • tiredness
  • changes in liver function blood tests
  • nosebleed  
  • hair loss (alopecia)
  • bleeding (hemorrhage)
TIVDAK may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of 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.

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