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Exkivity Dosage

Drug Detail:Exkivity (Mobocertinib)

Generic Name: Mobocertinib 40mg

Dosage Form: capsule

Drug Class: EGFR inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

Select patients with locally advanced or metastatic NSCLC for treatment with EXKIVITY based on the presence of EGFR exon 20 insertion mutations [see Clinical Studies (14)]. 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 [see Clinical Pharmacology 12.3], 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.

Table 1: Recommended EXKIVITY Dose Reductions
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.

Table 2: Recommended Dosage Modifications for EXKIVITY Adverse Reactions
Adverse Reaction Severity* EXKIVITY Dosage Modification
ULN = upper limit of normal
*
Graded per Common Terminology Criteria for Adverse Events Version 5.0
QTc Interval Prolongation and Torsades de Pointes
[see Warnings and Precautions (5.1)]		 Grade 2
(QTc interval 481-500 msec)		 First Occurrence
  • Withhold EXKIVITY until ≤ Grade 1 or baseline.
  • Upon recovery, resume EXKIVITY at the same dose.
Recurrence
  • Withhold EXKIVITY until ≤ Grade 1 or baseline.
  • Upon recovery, resume EXKIVITY at the next lower dose or permanently discontinue EXKIVITY.
Grade 3
(QTc interval ≥501 msec or QTc interval increase of >60 msec from baseline)		 First Occurrence
  • Withhold EXKIVITY until ≤ Grade 1 or baseline.
  • Upon recovery, resume EXKIVITY at the next lower dose or permanently discontinue EXKIVITY.
Recurrence
  • Permanently discontinue EXKIVITY.
Grade 4
(Torsades de Pointes; polymorphic ventricular tachycardia; signs/symptoms of serious arrhythmia)
  • Permanently discontinue EXKIVITY.
Interstitial Lung Disease (ILD)/pneumonitis
[see Warnings and Precautions (5.2)]		 Any grade
  • Withhold EXKVITY if ILD/pneumonitis is suspected.
  • Permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed.
Decreased Ejection Fraction or Heart Failure
[see Warnings and Precautions (5.3)]		 Grade 2 decreased ejection fraction
  • Withhold EXKIVITY until ≤ Grade 1 or baseline.
  • If recovered to baseline within 2 weeks, resume EXKIVITY at the same dose or the next lower dose.
  • If not recovered to baseline within 2 weeks, permanently discontinue EXKIVITY.
≥ Grade 2 heart failure or Grade 3 or 4 decreased ejection fraction
  • Permanently discontinue EXKIVITY.
Diarrhea
[see Warnings and Precautions (5.4)]		 Intolerable or recurrent Grade 2 or Grade 3
  • Withhold EXKIVITY until ≤ Grade 1.
  • Resume EXKIVITY at the same dose or the next lower dose.
Grade 4 First Occurrence
  • Withhold EXKIVITY until ≤ Grade 1.
  • Resume EXKIVITY at the next lower dose.
Recurrence
  • Permanently discontinue EXKIVITY.
​Increased Amylase or Lipase
[see Adverse Reactions (6.1)]		 Grade 3 without signs or symptoms
  • Withhold EXKIVITY until ≤ Grade 1.
  • Resume EXKIVITY at the same dose or next lower dose.
  • If not recovered to ≤ Grade 1 within 2 weeks, permanently discontinue EXKIVITY.
Grade 3 with signs or symptoms
  • Withhold EXKIVITY until ≤ Grade 1.
  • Resume EXKIVITY at the next lower dose.
  • If not recovered to ≤ Grade 1 within 2 weeks, permanently discontinue EXKIVITY.
Grade 4 First Occurrence
  • Withhold EXKIVITY until ≤ Grade 1.
  • Resume EXKIVITY at the next lower dose if recovery occurs within 2 weeks.
  • Permanently discontinue EXKIVITY if recovery does not occur within 2 weeks.
Recurrence
  • Permanently discontinue EXKIVITY.
Other Adverse Reactions
[see Adverse Reactions (6.1)]		 Intolerable or recurrent Grade 2 or Grade 3
  • Withhold EXKIVITY until ≤ Grade 1.
  • Resume EXKIVITY at the same dose or the next lower dose.
Grade 4 First Occurrence
  • Withhold EXKIVITY until ≤ Grade 1.
  • Resume EXKIVITY at the next lower dose if recovery occurs within 2 weeks.
  • Permanently discontinue EXKIVITY if recovery does not occur within 2 weeks.
Recurrence
  • Permanently discontinue EXKIVITY.

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 [see Drug Interactions (7.1)].

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