Colorectal and other GI cancers:

Indications for: QINLOCK

In adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Adult Dosage:

Swallow whole. 150mg once daily until disease progression or unacceptable toxicity. Concomitant moderate CYP3A4 inducer (if unavoidable): give 150mg twice daily. Dose modifications: see full labeling.

Children Dosage:

Not established.

QINLOCK Warnings/Precautions:

Risk of new primary cutaneous malignancies. Perform skin exams prior to initiation and during therapy. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Uncontrolled hypertension: do not initiate. Control BP prior to initiation; monitor and treat during therapy as appropriate. Cardiac dysfunction. Assess ejection fraction by echocardiogram or MUGA scan prior to initiation, during therapy, and as clinically indicated. Permanently discontinue if Grade 3/4 left ventricular systolic dysfunction occurs. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Safety of resuming therapy after resolution of wound healing complications has not been established. Photosensitivity: limit UV exposure during and for at least 1 week after discontinuation. Moderate or severe hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for ≥1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 week after the last dose).

QINLOCK Classification:

Tyrosine kinase inhibitor.

QINLOCK Interactions:

Potentiated by strong CYP3A4 inhibitors; monitor frequently. Antagonized by strong CYP3A4 inducers; avoid concomitant use. May be antagonized by moderate CYP3A4 inducers; avoid concomitant use; if unavoidable, increase dosing frequency (see Adult dose).

Adverse Reactions:

Alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, vomiting; lab abnormalities (eg, increased lipase, decreased phosphate).

Generic Drug Availability:

NO

How Supplied:

Tabs—90