Tukysa

— THERAPEUTIC CATEGORIES —
  • Breast cancer
  • Colorectal and other GI cancers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tukysa Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tucatinib 50mg, 150mg; tabs.

    Pharmacological Class

    Tyrosine kinase inhibitor.

    How Supplied

    Tabs 50mg—60; 150mg—60, 120

    Manufacturer

    Seagen, Inc.

    Generic Availability

    NO

    Tukysa Indications

    Indications

    In combination with trastuzumab and capecitabine, for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received 1 or more prior anti-HER2-based regimens in the metastatic setting.

    Tukysa Dosage and Administration

    Adult

    Swallow whole. Take approx. 12hrs apart and at the same time each day. 300mg twice daily (in combination with trastuzumab and capecitabine; refer to the respective full product labeling for additional information) until disease progression or unacceptable toxicity. Concomitant strong CYP2C8 inhibitors (if unavoidable): 100mg twice daily. Severe hepatic impairment (Child-Pugh C): 200mg twice daily. Dose modifications for adverse reactions: see full labeling.

    Children

    Not established.

    Tukysa Contraindications

    Not Applicable

    Tukysa Boxed Warnings

    Not Applicable

    Tukysa Warnings/Precautions

    Warnings/Precautions

    Risk of severe diarrhea (including dehydration, hypotension, acute kidney injury, death); give antidiarrheal if occurs. Perform diagnostic tests as needed to exclude other causes of diarrhea. Risk of severe hepatotoxicity. Monitor liver function tests prior to initiation, every 3 weeks during, then as clinically indicated. Severe renal impairment (CrCl <30mL/min): not recommended. Severe hepatic impairment: see Adults. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for at least 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 1 week after the last dose).

    Tukysa Pharmacokinetics

    Metabolism

    CYP2C8 (primarily), CYP3A. 

    Elimination

    Fecal (86%), renal (4.1%). Half-life: ~8.5 hours

    Tukysa Interactions

    Interactions

    Potentiated by strong CYP2C8 inhibitors (eg, gemfibrozil); avoid concomitant use; reduce dose if unavoidable (see Adults); monitor frequently for moderate CYP2C8 inhibitors. Antagonized by strong CYP3A or moderate CYP2C8 inducers (eg, rifampin); avoid. Potentiates CYP3A substrates (eg, midazolam); avoid concomitant use; decrease CYP3A substrate dose if unavoidable. Potentiates P-gp substrates (eg, digoxin); consider dose reduction of P-gp substrate.

    Tukysa Adverse Reactions

    Adverse Reactions

    Diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, rash, infusion-related reactions, pyrexia.

    Tukysa Clinical Trials

    See Literature

    Tukysa Note

    Not Applicable

    Tukysa Patient Counseling

    See Literature

    Tukysa Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tucatinib 50mg, 150mg; tabs.

    Pharmacological Class

    Tyrosine kinase inhibitor.

    How Supplied

    Tabs 50mg—60; 150mg—60, 120

    Manufacturer

    Seagen, Inc.

    Generic Availability

    NO

    Tukysa Indications

    Indications

    In combination with trastuzumab, for the treatment of adults with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

    Tukysa Dosage and Administration

    Adult

    Select patients based on the presence of HER2 overexpression or gene amplification, or RAS wild-type. Swallow whole. Take approx. 12hrs apart and at the same time each day. 300mg twice daily (in combination with trastuzumab; refer to the respective full product labeling for additional information) until disease progression or unacceptable toxicity. Concomitant strong CYP2C8 inhibitors (if unavoidable): 100mg twice daily. Severe hepatic impairment (Child-Pugh C): 200mg twice daily. Dose modifications for adverse reactions: see full labeling.

    Children

    Not established.

    Tukysa Contraindications

    Not Applicable

    Tukysa Boxed Warnings

    Not Applicable

    Tukysa Warnings/Precautions

    Warnings/Precautions

    Risk of severe diarrhea (including dehydration, hypotension, acute kidney injury, death); give antidiarrheal if occurs. Perform diagnostic tests as needed to exclude other causes of diarrhea. Risk of severe hepatotoxicity. Monitor liver function tests prior to initiation, every 3 weeks during, then as clinically indicated. Severe renal impairment (CrCl <30mL/min): not recommended. Severe hepatic impairment: see Adults. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for at least 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 1 week after the last dose).

    Tukysa Pharmacokinetics

    Metabolism

    CYP2C8 (primarily), CYP3A. 

    Elimination

    Fecal (86%), renal (4.1%). Half-life: ~8.5 hours

    Tukysa Interactions

    Interactions

    Potentiated by strong CYP2C8 inhibitors (eg, gemfibrozil); avoid concomitant use; reduce dose if unavoidable (see Adults); monitor frequently for moderate CYP2C8 inhibitors. Antagonized by strong CYP3A or moderate CYP2C8 inducers (eg, rifampin); avoid. Potentiates CYP3A substrates (eg, midazolam); avoid concomitant use; decrease CYP3A substrate dose if unavoidable. Potentiates P-gp substrates (eg, digoxin); consider dose reduction of P-gp substrate.

    Tukysa Adverse Reactions

    Adverse Reactions

    Diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, rash, infusion-related reactions, pyrexia.

    Tukysa Clinical Trials

    See Literature

    Tukysa Note

    Not Applicable

    Tukysa Patient Counseling

    See Literature

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