Exkivity Dosage

Recommended Evaluation and Testing Before Initiating EXKIVITY

​Before initiating EXKIVITY, evaluate QTc and electrolytes and correct abnormalities in sodium, potassium, calcium, and magnesium.

Patient Selection

Select patients with locally advanced or metastatic NSCLC for treatment with EXKIVITY based on the presence of EGFR exon 20 insertion mutations. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

​The recommended dosage of EXKIVITY is 160 mg orally once daily until disease progression or unacceptable toxicity.

​Take EXKIVITY with or without food, at the same time each day. Swallow EXKIVITY capsules whole. Do not open, chew or dissolve the contents of the capsules.

​If a dose is missed by more than 6 hours, skip the dose and take the next dose the following day at its regularly scheduled time.

​If a dose is vomited, do not take an additional dose. Take the next dose as prescribed the following day.

Dosage Modifications for Adverse Reactions

EXKIVITY dose reduction levels for adverse reactions are summarized in Table 1.

Recommended dosage modifications of EXKIVITY for adverse reactions are provided in Table 2.

Dosage Modifications for Moderate CYP3A Inhibitors

Avoid concomitant use of moderate CYP3A inhibitors with EXKIVITY. If concomitant use of a moderate CYP3A inhibitor cannot be avoided, reduce the EXKIVITY dose by approximately 50% (i.e., from 160 to 80 mg, 120 to 40 mg, or 80 to 40 mg) and monitor the QTc interval more frequently. After the moderate CYP3A inhibitor has been discontinued for 3 to 5 elimination half-lives, resume EXKIVITY at the dose taken prior to initiating the moderate CYP3A inhibitor.

​2.6 Dosage Modifications for Patients with Severe Renal Impairment

​Reduce the EXKIVITY dose by approximately 50% (i.e., from 160 to 80 mg, 120 to 40 mg, or 80 to 40 mg) and monitor the QTc interval more frequently for patients with severe renal impairment.