Important Safety Information and Indication
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.
Starting TUKYSA—With the Help of a Specialty Pharmacy and Seagen Secure®
Support is available to help you start and stay on track with the TUKYSA treatment regimen.
On this page, you can learn more about:
- How TUKYSA (tucatinib) can be sent to you
- Ways that your specialty pharmacy or Seagen Secure® can support you
Your Specialty Pharmacy Will Send TUKYSA to You and Offer Additional Support
A specialty pharmacy understands the unique needs of people living with cancer. Specialty pharmacies also fill prescriptions for medications that may not be available at your local pharmacy.
In most cases, your TUKYSA prescription will be filled in 1 of the following ways:
- Your healthcare provider may send your prescription to a specialty pharmacy, or
- There may be a pharmacy at your healthcare provider’s office or hospital that can fill your prescription for pickup or delivery to your home
Learn below about what you can expect from a specialty pharmacy.
Your Specialty Pharmacy Will Contact Your Insurance Carrier to Determine Your Prescription Coverage
- Your specialty pharmacy will work with your insurance carrier to confirm coverage for your TUKYSA (tucatinib) prescription
- If coverage has been confirmed, your specialty pharmacy will call you to coordinate how you'll receive TUKYSA and collect any additional information needed
Your Specialty Pharmacy Will Send Your Medication to Your Home, Office, or Other Location of Your Choice
- Your specialty pharmacy will need to ensure that someone will be at the delivery location to receive the package
- Your shipping address, insurance coverage, and financial responsibility must be confirmed each time your prescription is filled
Calls From Your Specialty Pharmacy Are Important
- Keep in mind that these calls may come from an 800 number, the specific area code of your specialty pharmacy, or a blocked, unavailable, or unknown number on your caller ID
- Your specialty pharmacy will leave a voicemail asking you to return their call, but because of privacy laws, they may not provide a lot of detail regarding the reason for their call
- Your specialty pharmacy will call you at least 7 days before refilling your prescription--and you can also call to ask about prescription refills
Your Specialty Pharmacy May Connect With You To:
- Offer support
- Answer questions about treatment
- Guide you to resources
Your specialty pharmacy will call you regularly when you first start treatment and will update your healthcare team about your treatment experience.
Seagen Secure®
To learn more about Seagen Secure® and how to enroll:
*Eligibility criteria apply. Pfizer does not guarantee that enrollment will result in assistance and/or reimbursement.
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 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
- a low number of red blood cells (anemia)
- rash
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 negative side effects to the 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 get 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.
REF-7646_FINAL_01/23
Indication
What is TUKYSA?
TUKYSA is a prescription medicine used with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and who have received one or more anti-HER2 breast cancer treatments.
It is not known if TUKYSA is safe and effective in children.
Please see Important Facts about TUKYSA.