Respiratory and thoracic cancers:

Indications for: EXKIVITY

In adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Adult Dosage:

Confirm presence of EGFR exon 20 insertion mutations. Swallow whole. 160mg once daily until disease progression or unacceptable toxicity. Concomitant moderate CYP3A inhibitors (if unavoidable): reduce Exkivity dose by approx. 50%; monitor QTc interval more frequently. Dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

Boxed Warning:

QTc prolongation and Torsades de Pointes.

EXKIVITY Warnings/Precautions:

Risk of life-threatening QTc prolongation (including Torsades de Pointes). Correct electrolyte abnormalities prior to initiation. Assess QTc and electrolytes at baseline, then periodically during treatment. Increase monitoring in those with risk factors for QTc prolongation (eg, congenital long QT syndrome, heart disease, electrolyte abnormalities). Monitor for interstitial lung disease (ILD)/pneumonitis; withhold immediately if suspected. Permanently discontinue if ILD/pneumonitis is confirmed. Risk of cardiac toxicity; monitor LVEF at baseline and during treatment; withhold, reduce dose, or permanently discontinue based on severity. Advise to start an antidiarrheal (eg, loperamide) at 1st sign of diarrhea or increased bowel movement. Severe renal (eGFR <30mL/min/1.73m2) or hepatic (total bilirubin >3×ULN and any AST) impairment: not established. Elderly. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception during and for 1 month (females of reproductive potential) or 1 week (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

EXKIVITY Classification:

Kinase inhibitor.

EXKIVITY Interactions:

Avoid concomitant drugs known to prolong QTc interval; if unavoidable, monitor more frequently with ECGs. Avoid concomitant strong or moderate CYP3A inhibitors (eg, itraconazole, ketoconazole); if unavoidable for moderate CYP3A inhibitors, reduce dose (see Adult). Antagonized by strong or moderate CYP3A inducers (eg, rifampin, efavirenz); avoid. Avoid concomitant hormonal contraceptives or other CYP3A substrates (eg, midazolam); if unavoidable, increase CYP3A substrate dose.

Adverse Reactions:

Diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, musculoskeletal pain, lab abnormalities (decreased lymphocytes, increased amylase, increased lipase, decreased potassium, decreased hemoglobin, increased creatinine, decreased magnesium).

Generic Drug Availability:


How Supplied:

Caps—90, 120