Seattle Genetics, to announce the approval of TUKYSA™ (tucatinib) tablets, for oral use, by the U.S. Food and Drug Administration (FDA) on 04/17/2020.
|Seattle Genetics, to announce the approval of TUKYSA™ (tucatinib) tablets, for oral use, by the U.S. Food and Drug Administration (FDA) on 04/17/2020. TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.|
The recommended dosage of TUKYSA is 300 mg administered orally twice daily.
Please see Important Safety Information below and click to access the Full Prescribing Information for TUKYSA.¹
|*The NDC has been “zero‑filled” to ensure creation of an 11‑digit code that meets Health Insurance Portability and Accountability Act (HIPAA) standards. The zero‑fill location is indicated in bold.|
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Serious adverse reactions occurred in 26% of patients who received TUKYSA; those occurring in ≥2% of patients were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.
Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).
The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.
In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased phosphate, increased ALT, decreased potassium, and increased AST.
The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.
For more information, please visit http://www.tukysahcp.com.