Breast cancer:

Indications for TUKYSA:

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.

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.

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).

Pharmacologic Class:

Tyrosine kinase inhibitor.

Interactions:

Potentiated by strong CYP2C8 inhibitors (eg, gemfibrozil); avoid concomitant use; reduce dose if unavoidable (see Adults); monitor frequently, and 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.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Tabs 50mg—60; 150mg—60, 120

Pricing for TUKYSA

60 tablets of 150mg bottle (Qty: 2)
Appx. price $18880
GoodRx