For the administration of Sunvozertinib in special populations, the dosage regimen should be adjusted based on individual conditions, with a key focus on the medication safety in patients with hepatic and renal insufficiency, the elderly, pregnant women, lactating women, children and patients with a history of allergies. The specific regimen must strictly follow the doctor’s advice.
Precautions for Administration in Special Populations
1. Patients with Hepatic or Renal Insufficiency
Hepatic insufficiency: Sunvozertinib should be used with caution in patients with mild to moderate hepatic insufficiency and is contraindicated in those with severe hepatic insufficiency. If necessary, the dosage should be adjusted under the guidance of a doctor.
Renal insufficiency: No dosage adjustment is required for patients with mild to moderate renal insufficiency, but close monitoring for adverse reactions is necessary; the drug should be used with caution in patients with severe renal insufficiency. In the absence of clear clinical data, consultation with a specialist is recommended.
2. Elderly Patients (≥65 years old)
The physiological functions of elderly patients are impaired, making them potentially more sensitive to drug metabolism and adverse effects. The dosage should be adjusted according to their overall health status, and enhanced safety monitoring should be conducted during the medication period.
3. Pregnant and Lactating Women
Pregnant women
Animal studies have demonstrated embryotoxicity of Sunvozertinib, and the drug is contraindicated during pregnancy. Women of childbearing age should take effective contraceptive measures during the medication period and for a certain period after drug discontinuation.
Lactating women
There is no available data on whether Sunvozertinib is excreted in human milk, but the potential risks are considered high. It is recommended to suspend breastfeeding during the medication period.
4. Children and Adolescents
The safety and efficacy of Sunvozertinib in individuals under 18 years of age have not been established. The use of the drug in this population should be decided by a specialist only after a comprehensive assessment of the benefits and risks.
5. Patients with Allergic Diathesis
Sunvozertinib is contraindicated in patients with a known allergy to sunvozertinib or any of its excipients. In case of allergic reactions such as rash or dyspnea after medication, the drug should be discontinued immediately and medical attention sought without delay.
Other Precautions
Drug-drug Interactions
Sunvozertinib may interact with other drugs (e.g., potent CYP3A4 inducers/inhibitors). Patients must inform their doctors of the full medication history before taking concomitant medications.
Medication Monitoring
During treatment, regular examinations including blood routine, hepatic and renal function tests and electrocardiogram (ECG) should be performed to timely evaluate drug-related adverse reactions (e.g., interstitial lung disease, QT interval prolongation, etc.).
Sunvozertinib is a prescription drug, and all dosage regimens must be formulated under the guidance of a doctor. Patients shall not adjust the dosage or discontinue the drug without medical advice. Immediate medical attention is required in case of severe adverse reactions or changes in the patient’s condition.
