Medical Information

The contraindications for Lumakras/AMG510 mainly include patients with severe liver injury and pregnant women, and strict adherence to medication contraindications is necessary to ensure safety.

1. Taboos for patients with severe liver injury

(1) Prohibition basis: Sotolaxib is contraindicated in patients with Child Pugh C grade liver dysfunction who lack safety data and may have significant abnormalities in drug metabolism.

(2) Monitoring requirements: Child Pugh B patients need to closely monitor liver function. If AST/ALT>3 × ULN with elevated bilirubin occurs, the medication should be permanently discontinued.

2. Absolute taboos for pregnant women

(1) Embryotoxicity: Animal experiments have shown that Sotoraxib can cause embryo death and malformation. It is contraindicated during pregnancy and the pregnancy status should be confirmed before use.

(2) Contraceptive requirements: Women of childbearing age must take effective contraceptive measures during the medication period and within one week after the last dose.

3 Breastfeeding Risk Warning

(1) Drug transfer: Sotolabib may be secreted through breast milk, and lactating women need to stop breastfeeding or terminate treatment.

(2) Alternative solution: It is recommended to use breast milk substitutes to feed infants and avoid the risk of drug exposure.

4 Joint pain and muscle symptom management

(1) Observation period treatment: Mild joint pain or muscle stiffness can be treated with hot compress and moderate activity, and most of them will relieve on their own with prolonged medication time.

(2) Drug intervention: Non steroidal anti-inflammatory drugs can be used for short-term treatment of persistent pain, but monitoring of gastrointestinal and renal function is necessary.

(3) Activity adjustment: Avoid vigorous exercise and use assistive devices to reduce joint load if necessary.

5 measures to deal with nausea and vomiting

(1) Supporting treatment: Mild nausea can be treated by adjusting the medication time (such as before bedtime), combined with antiemetic drugs such as 5-HT3 receptor antagonists or dexamethasone.

(2) Dose adjustment: If antiemetic treatment is ineffective for grade 3-4 nausea and vomiting, the medication should be suspended until the symptoms are ≤ grade 1. After recovery, the dosage should be gradually reduced from 480mg to 240mg.

(3) Principle of supplementary medication: If vomiting occurs after taking the medication, do not take it again. Continue to take the original dose the next day; If missed for more than 6 hours, skip and avoid double dosage.