Mobocertinib (Exkivity) is a targeted therapy for non-small cell lung cancer (NSCLC) with specific EGFR exon 20 insertion mutations.

I. Dosage and Administration of Mobocertinib (Exkivity)

Standard Dosage and Administration

(1) The recommended dose is 160 mg once daily, taken with or without food.

(2) Capsules should be swallowed whole. Do not open, chew, or dissolve the contents.

(3) Take the medication at the same time each day to maintain stable blood concentrations.

Dose Adjustment and Special Situations

(1) Missed Dose: If a dose is missed by more than 6 hours, skip the dose and take the next one at the usual time the following day.

(2) Vomiting: If vomiting occurs after taking a dose, do not take an additional dose. Resume the next dose as scheduled the following day.

(3) Renal Impairment: Patients with severe renal impairment require a dose reduction of approximately 50% (e.g., from 160 mg to 80 mg) with enhanced electrocardiogram (ECG) monitoring.

(4) Drug Interactions: Concomitant use with strong or moderate CYP3A inhibitors should be avoided. If co-administration is necessary, reduce the dose and monitor the QTc interval closely.

II. Important Warnings for Mobocertinib (Exkivity)

Cardiac Monitoring and Risk Prevention

(1) Exkivity may cause QT prolongation, which can lead to life-threatening arrhythmias.

(2) Perform regular ECGs and monitor electrolyte levels before and during treatment.

(3) Seek immediate medical attention if dizziness, palpitations, or syncope occur.

(4) Avoid concomitant use of other drugs that prolong the QT interval.

Management of Pulmonary and Cardiac Toxicity

(1) A small number of patients may develop interstitial lung disease (ILD)/pneumonitis, presenting as new or worsening cough, shortness of breath, or chest pain. Suspend treatment and seek medical help immediately if this occurs.

(2) The drug may also cause decreased cardiac function or heart failure. Regular cardiac function assessments are required during treatment.

Management of Gastrointestinal Reactions

(1) Diarrhea is a common adverse reaction, which may lead to dehydration or electrolyte imbalance.

(2) Initiate anti-diarrheal treatment (e.g., loperamide) at the first occurrence of diarrhea and increase fluid and electrolyte intake.

(3) Contact your doctor to adjust the dose or pause treatment if diarrhea is severe or persistent.

Warnings for Special Populations

(1) Pregnancy: Exkivity can cause fetal harm. Females of childbearing potential must use effective non-hormonal contraception during treatment and for 1 month after the last dose.

(2) Males: Male patients with partners of childbearing potential must use effective contraception during treatment and for 1 week after the last dose.

(3) Lactation: Avoid breastfeeding during treatment and for 1 week after the last dose.

III. Healthy Lifestyle Recommendations for Exkivity Patients

Diet and Nutritional Support

(1) Maintain a balanced diet with adequate protein and vitamin intake to support immune function.

(2) For decreased appetite or weight loss, eat small, frequent meals. Consult a dietitian if needed.

(3) Avoid eating grapefruit or drinking grapefruit juice, as it may affect drug efficacy.

Daily Activity and Rest

(1) Engage in moderate activities like walking or yoga based on physical condition to maintain physical and mental well-being.

(2) Ensure sufficient sleep and avoid overexertion to improve treatment tolerance.

For more details, please refer to the full prescribing information for mobocertinib (Exkivity).