TUKYSA Is Part of a Chemotherapy-Free Treatment Regimen
TUKYSA (tucatinib) is taken with another medicine called trastuzumab.
On this page, you can learn more about:
- TUKYSA dosing and how to take TUKYSA with trastuzumab
- Possible side effects with the TUKYSA regimen
Select Important Safety Information
What should I tell my healthcare provider before taking TUKYSA?
Before taking TUKYSA, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems.
- are pregnant or plan to become pregnant. TUKYSA can harm your unborn baby.
Females who can become pregnant: Your healthcare provider will do a pregnancy test before you start taking TUKYSA. Use effective birth control (contraception) during TUKYSA treatment and for 1 week after the last dose of TUKYSA. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TUKYSA.
Males with a female partner who can become pregnant: Use effective birth control during TUKYSA treatment and for 1 week after the last dose of TUKYSA. - are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed during treatment with TUKYSA and for 1 week after the last dose of TUKYSA.
TUKYSA Dosing and How to Take With Trastuzumab
Can I chew or crush the TUKYSA tablets?
Swallow TUKYSA tablets whole. Do not chew, crush, or split TUKYSA tablets before swallowing. Do not take TUKYSA tablets if they are broken, cracked, or damaged.
What if I vomit or miss a dose of TUKYSA?
If you vomit or miss a dose of TUKYSA, take your next dose at your regular time.
Start and stay on your treatment regimen with
the TUKYSA Treatment Tracker
Downloadthe TUKYSA Treatment Tracker
Possible Side Effects
Your healthcare provider will discuss possible side effects before you take TUKYSA (tucatinib).
In the clinical trial, 6% of people had to stop treatment with TUKYSA because of side effects.
Here are common and serious side effects that were seen in the clinical trial.
Common Side Effects
The most common side effects of TUKYSA (tucatinib) and trastuzumab were:
- These are not all the possible side effects of TUKYSA and trastuzumab
- Nearly everyone in the trial had some 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
Side effects: Unwanted reactions to a drug. Common side effects are those that happen often and to many people. They may be serious if they require emergency medical care.
Serious Side Effects
During treatment with TUKYSA, serious side effects may occur and should be treated by your healthcare provider as early as possible.
- 22% of people treated with TUKYSA and trastuzumab had serious side effects
- The most common serious side effects were blockage of the intestine, urinary tract infection, pneumonia, stomach-area (abdomen) pain, and tear (perforation) in the rectum
Be sure to tell your healthcare provider about any side effects you have. They may be able to help you find ways to manage them. Your healthcare provider may change your dose of TUKYSA, temporarily stop, or permanently stop treatment with TUKYSA if you have certain side effects.
Important Safety Information
What are the possible side effects of TUKYSA?
TUKYSA may cause serious side effects, including:
- Diarrhea (watery, loose, or frequent stools) is common and can sometimes be severe. Tell your healthcare provider if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can cause a 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, including severe cases. Your healthcare provider will test your blood to check your liver function before starting 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 itching, yellowing of your skin or eyes, dark or brown urine (tea-colored), pain in the right upper stomach area (abdomen), feeling very tired, decreased appetite, or bleeding or bruising more easily than normal.
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 the possible side effects of TUKYSA. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.
What should I tell my healthcare provider before taking TUKYSA?
Before taking TUKYSA, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems.
- are pregnant or plan to become pregnant. TUKYSA can harm your unborn baby.
Females who can become pregnant: Your healthcare provider will do a pregnancy test before you start taking TUKYSA. Use effective birth control (contraception) during TUKYSA treatment and for 1 week after the last dose of TUKYSA. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TUKYSA.
Males with a female partner who can become pregnant: Use effective birth control during TUKYSA treatment and for 1 week after the last dose of TUKYSA. - are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed during treatment with TUKYSA and for 1 week after the last dose of TUKYSA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TUKYSA may affect the way your other medicines work, and other medicines may affect the way TUKYSA works. Keep a list of all the medicines you take and show it to your healthcare provider and pharmacist every time you get a new medicine.
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Indication
What is TUKYSA?
TUKYSA is a prescription medicine used with the medicine trastuzumab to treat adults with RAS wild-type human epidermal growth factor receptor-2 (HER2) positive colorectal cancer that has spread to other parts of the body (metastatic), or cannot be removed by surgery, and who have received treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and it did not work or is no longer working.
This use is approved based on a clinical study that measured how many patients had a tumor response and how long that response lasted. Studies are ongoing to confirm the benefit of TUKYSA for this use.
It is not known if TUKYSA is safe and effective in children.