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TUKYSA in practiceTUKYSA in practiceTUKYSA in practice

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For TUKYSA® (tucatinib) Prescribing information click here. For Trazimera® (trastuzumab) Prescribing information click here.

Dosing and AdministrationTUKYSA Dosing and Administration Guide DOWNLOAD HERELoadingA regimen that can fit around patients' lives and healthcare system resources

TUKYSA® is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or MBC who have received at least 2 prior anti-HER2 treatment regimens.1

Combine TUKYSA and capecitabine oral therapies with either intravenous or subcutaneous trastuzumab, allowing choice for treatment at hospital, in clinic or at home


For more information about co-administered trastuzumab and capecitabine, please refer to the respective Summary of Product Characteristics.

 
  • Treatment with TUKYSA combination therapy (tucatinib + trastuzumab + capecitabine) should be continued until disease progression or unacceptable toxicity1
  • No dose adjustment is required in patients with mild or moderate hepatic impairment. For patients with severe hepatic impairment (Child-Pugh C), a reduced starting dose of 200 mg TUKYSA orally twice daily is recommended1
  • Concomitant use with strong CYP2C8 inhibitors should be avoided. If coadministration with a strong CYP2C8 inhibitor cannot be avoided, the starting TUKYSA dose should be reduced to 100 mg orally, twice daily. After discontinuation of the strong CYP2C8 inhibitor for 3 elimination half-lives, the TUKYSA dose that was taken prior to initiating the inhibitor should be resumed1
  • TUKYSA should be taken approximately 12 hours apart, at the same time every day, with or without a meal1
  • TUKYSA may be taken at the same time with capecitabine1
  • Tablets should be swallowed whole and not chewed, crushed or split prior to swallowing1
  • In the case of a missed dose, the patient should take their next dose at the regularly scheduled time1
  • No dose adjustment is required in patients with mild, moderate, or severe renal impairment or patients ≥ 65 years. Not studied in patients over 80 years old.
TUKYSA is available in 150 mg and 50 mg tablets to support dose management1

TUKYSA should be permanently discontinued in patients unable to tolerate 150 mg orally, twice daily


Please refer to the TUKYSA Summary of Product Characteristics for full information on dose monitoring and guidance on the management of adverse events.

Please refer to the respective Summary of Product Characteristics for trastuzumab and capecitabine for dose modifications for toxicities suspected to be caused by those therapies.

Modifying the dose of TUKYSA
Recommended TUKYSA dose modifications for adverse reactions1
Adverse ReactionsSeverity* TUKYSA dose modification
DiarrhoeaGrade 1 and 2 No dose modification is required†
Grade 3 without anti-diorrhoeal treatment Initiate or intensify appopriate medical therapy. Interrupt TUKYSA until recovery to ≤Grade 1, then resume TUKYSA at the same dose level 
Grade 3 with anti-diorrhoeal treatment Initiate or internally appropriate medical therapy. Interrupt TUKYSA until recovery to ≤Grade 1, then result TUKYSA at the next lower dose level
Grade 4  Permanantly discontinue TUKYSA
Increased ALT, AST or total bilirubinGrade 1 bilirubin (>ULN to 1.5 x ULN) No dose modification required 
Grade 2 Bilirubin (>1.5 to 3 x ULN)Interrupt TUKYSA until recovery to ≤ Grade 1, then resume TUKYSA at the same dose level
Grade 3 ALT or AST (>5 to 20 x ULN) OR Grade 3 bilirubin (>3 to 10 x ULN) Interrupt TUKYSA until recovery to ≤ Grade 1, then resume TUKYSA at the next level dose level 
Grade 4 ALT or AST (>20 x ULN) OR Grade 4 bilirubin (>10 x ULN) Permanently discontinue TUKYSA 
ALT or AST >3 x ULN AND bilirubin >2 x ULN Permanently discontinue TUKYSA
Other adverse reactions Grade 1 and 2 No dose modification is required 
Grade 3 Interrupt TUKYSA until recovery to ≤ Grade 1, then resume TUKYSA at the next lower dose level 
Grade 4Permanently discontinue TUKYSA 

*Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.1
†Prompt medical management should also be instituted in the event of persistence of concomitant Grade 2 diarrhoea with concomitant Grade >2 nausea and/or vomiting.1


Please refer to the TUKYSA Summary of Product Characteristics for full information on dose monitoring and guidance on the management of adverse events.
Please refer to the respective Summary of Product Characteristics for trastuzumab and capecitabine for dose modifications for toxicities suspected to be caused by those therapies.

Embryo-foetal toxicity and drug interactions

Please refer to the TUKYSA Summary of Product Characteristics
for full information

Pharmaceutical form and storage

Tablets shown not actual size 

Storage
  • TUKYSA does not require any special storage conditions1
  • Shelf life: 2 years;1 do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month

ALT: Alanine Aminotransferase, AST: Aspartate Aminotransferase; MBC: Metastatic Breast Cancer; ULN, upper limit of normal.

References:

  1. TUKYSA Summary of Product Characteristics for the United Kingdom click here.
  2. TUKYSA  Patient Information Leaflet click here.
PP-T1K-GBR-0141 | May 2025

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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