TUKYSA® What are the possible side effects of TUKYSA?

(tucatinib)

What are the possible side effects of TUKYSA?

TUKYSA may cause serious side effects, including:
•
Diarrhea. Diarrhea is common with TUKYSA and can sometimes be severe. Tell your healthcare provider if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can lead to loss of too much body fluids (dehydration), low blood pressure, kidney problems and death. Your healthcare provider may prescribe medicines to treat your diarrhea during treatment with TUKYSA.
•
Liver Problems. TUKYSA can cause severe liver problems. Your healthcare provider will do blood tests to check your liver function before and every 3 weeks during treatment with TUKYSA, or as needed. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including:
o
itching
o
yellowing of your skin or eyes
o
dark or brown urine (tea-colored)
o
pain in the upper right side of your stomach-area (abdomen)
o
feel very tired
o
decreased appetite
o
bleeding or bruising more easily than normal

The most common side effects of TUKYSA in combination with trastuzumab and capecitabine in adults with HER2-positive breast cancer include: 

•
diarrhea
•
rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet
•
nausea
•
increased liver function blood tests
•
vomiting
•
mouth sores (stomatitis)
•
decreased appetite
•
low red blood cell counts (anemia)
•
rash

The most common side effects of TUKYSA in combination with trastuzumab in adults with RAS wild-type HER2-positive colorectal cancer include:

•
diarrhea
•
tiredness
•
rash
•
nausea
•
stomach-area (abdomen) pain
•
infusion-related reactions
•
fever

Your healthcare provider may change your dose of TUKYSA, temporarily stop, or permanently stop treatment with TUKYSA if you have certain side effects.
TUKYSA may cause fertility problems in males and females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of TUKYSA. 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 TUKYSA?

What are the possible side effects of TUKYSA?

TUKYSA may cause serious side effects, including:
•
Diarrhea. Diarrhea is common with TUKYSA and can sometimes be severe. Tell your healthcare provider if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can lead to loss of too much body fluids (dehydration), low blood pressure, kidney problems and death. Your healthcare provider may prescribe medicines to treat your diarrhea during treatment with TUKYSA.
•
Liver Problems. TUKYSA can cause severe liver problems. Your healthcare provider will do blood tests to check your liver function before and every 3 weeks during treatment with TUKYSA, or as needed. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including:
o
itching
o
yellowing of your skin or eyes
o
dark or brown urine (tea-colored)
o
pain in the upper right side of your stomach-area (abdomen)
o
feel very tired
o
decreased appetite
o
bleeding or bruising more easily than normal

The most common side effects of TUKYSA in combination with trastuzumab and capecitabine in adults with HER2-positive breast cancer include: 

•
diarrhea
•
rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet
•
nausea
•
increased liver function blood tests
•
vomiting
•
mouth sores (stomatitis)
•
decreased appetite
•
low red blood cell counts (anemia)
•
rash

The most common side effects of TUKYSA in combination with trastuzumab in adults with RAS wild-type HER2-positive colorectal cancer include:

•
diarrhea
•
tiredness
•
rash
•
nausea
•
stomach-area (abdomen) pain
•
infusion-related reactions
•
fever

Your healthcare provider may change your dose of TUKYSA, temporarily stop, or permanently stop treatment with TUKYSA if you have certain side effects.
TUKYSA may cause fertility problems in males and females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of TUKYSA. 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 TUKYSA?

What are the possible side effects of TUKYSA?

TUKYSA may cause serious side effects, including:
•
Diarrhea. Diarrhea is common with TUKYSA and can sometimes be severe. Tell your healthcare provider if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can lead to loss of too much body fluids (dehydration), low blood pressure, kidney problems and death. Your healthcare provider may prescribe medicines to treat your diarrhea during treatment with TUKYSA.
•
Liver Problems. TUKYSA can cause severe liver problems. Your healthcare provider will do blood tests to check your liver function before and every 3 weeks during treatment with TUKYSA, or as needed. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including:
o
itching
o
yellowing of your skin or eyes
o
dark or brown urine (tea-colored)
o
pain in the upper right side of your stomach-area (abdomen)
o
feel very tired
o
decreased appetite
o
bleeding or bruising more easily than normal

The most common side effects of TUKYSA in combination with trastuzumab and capecitabine in adults with HER2-positive breast cancer include: 

•
diarrhea
•
rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet
•
nausea
•
increased liver function blood tests
•
vomiting
•
mouth sores (stomatitis)
•
decreased appetite
•
low red blood cell counts (anemia)
•
rash

The most common side effects of TUKYSA in combination with trastuzumab in adults with RAS wild-type HER2-positive colorectal cancer include:

•
diarrhea
•
tiredness
•
rash
•
nausea
•
stomach-area (abdomen) pain
•
infusion-related reactions
•
fever

Your healthcare provider may change your dose of TUKYSA, temporarily stop, or permanently stop treatment with TUKYSA if you have certain side effects.
TUKYSA may cause fertility problems in males and females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of TUKYSA. 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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