Exkivity Dosage
Generic name: Mobocertinib 40mg
Dosage form: capsule
Drug class: EGFR inhibitors
Medically reviewed by Drugs.com. Last updated on Feb 3, 2025.
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.
Dose Reductions | Dose Level |
---|---|
First dose reduction | 120 mg once daily |
Second dose reduction | 80 mg once daily |
Recommended dosage modifications of EXKIVITY for adverse reactions are provided in Table 2.
Adverse Reaction | Severity* | EXKIVITY Dosage Modification |
---|---|---|
ULN = upper limit of normal | ||
|
||
QTc Interval Prolongation and Torsades de Pointes |
Grade 2 (QTc interval 481-500 msec) |
First Occurrence
|
Grade 3 (QTc interval ≥501 msec or QTc interval increase of >60 msec from baseline) |
First Occurrence
|
|
Grade 4 (Torsades de Pointes; polymorphic ventricular tachycardia; signs/symptoms of serious arrhythmia) |
|
|
Interstitial Lung Disease (ILD)/pneumonitis |
Any grade |
|
Decreased Ejection Fraction or Heart Failure |
Grade 2 decreased ejection fraction |
|
≥ Grade 2 heart failure or Grade 3 or 4 decreased ejection fraction |
|
|
Diarrhea |
Intolerable or recurrent Grade 2 or Grade 3 |
|
Grade 4 | First Occurrence
|
|
Increased Amylase or Lipase |
Grade 3 without signs or symptoms |
|
Grade 3 with signs or symptoms |
|
|
Grade 4 | First Occurrence
|
|
Other Adverse Reactions |
Intolerable or recurrent Grade 2 or Grade 3 |
|
Grade 4 | First Occurrence
|
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.
Frequently asked questions
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