Dosage of Exkivity

1.Recommended Evaluation and Testing Before Initiating Exkivity

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

2.Patient Selection

Select patients with locally advanced or metastatic NSCLC for treatment with Exkivity based on the presence of EGFR exon 20 insertion mutations .

3.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.

4.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. 

5.Dosage Modifications for Moderate CYP3A Inhibitors

Moderate CYP3A inhibitor cannot be avoided, reduce the Exkivity dose by approximately 50% .Exkivity at the dose taken prior to initiating the moderate CYP3A inhibitor.

6.Dosage Modifications for Patients with Severe Renal Impairment

Reduce the Exkivity dose by approximately 50%.

from FDA，2023.09