What are the precautions for Pralsetinib?

During treatment with Pralsetinib (Pralsetinib), patients should pay attention to the occurrence of interstitial lung disease (ILD)/pneumonitis, hypertension, hepatotoxicity, bleeding, tumor lysis syndrome (TLS), impaired wound healing and other events. Depending on the severity of the condition, patients should suspend, reduce the dose or permanently discontinue Pralsetinib. If symptoms of discomfort occur, they should inform their doctor in time.

1. Interstitial Lung Disease (ILD)/Pneumonitis: Patients treated with Platinib may develop severe, life-threatening and fatal interstitial lung disease (ILD)/pneumonitis, monitor for pulmonary symptoms indicative of ILD/pneumonitis. If a patient develops acute or worsening respiratory symptoms that may be indicative of ILD (e.g., dyspnea, cough, and fever), discontinue Platinib and investigate ILD immediately.

2. Hypertension: Research shows that8% of patients interrupt medication due to high blood pressure, and 4.8% of patients reduce medication due to hypertension. Do not use platinib in patients with uncontrolled hypertension. Optimize blood pressure before use and monitor blood pressure after 1 week and at least monthly thereafter and as clinically indicated. Initiate or adjust antihypertensive treatment appropriately.

3. Hepatotoxicity: Serious liver adverse reactions occurred in 1.5% of patients treated with platinib. 49% of patients experienced elevated AST, including 7% of grade 3 or 4 patients. 37% of patients experienced elevated ALT, including 4.8% of grade 3 or 4 patients. Before starting to take platinib, monitor AST and ALT every 2 weeks for the first 3 months, and then monitor once a month as clinically indicated.

4. Bleeding: Serious bleeding events, including fatal bleeding events, may occur with Platate. Grade ≥ 3 bleeding events occurred in 4.1% of patients treated with GAVRETO, including 1 fatal bleeding event. Platinib should be permanently discontinued in patients with severe or life-threatening bleeding.

5. Tumor lysis syndrome (TLS): Patients may be at risk for TLS if they have rapidly growing tumors, high tumor burden, renal dysfunction, or dehydration. Monitor at-risk patients closely, consider appropriate precautions, including hydration, and treat as clinically indicated.

6. Impaired wound healing: Patients receiving drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway will experience impaired wound healing. Discontinue platinib for at least 5 days before elective surgery and do not give it for at least 2 weeks after major surgery until the wound has completely healed. The safety of resuming platinib after resolution of wound healing complications has not been established.

It is understood that the original drug Platinib has been launched in China, but it has not yet entered the scope of medical insurance. The price of each box of 100mg*120 tablets may be around 60,000 yuan, which is expensive. The price of the European version of 100mg*60 capsules sold overseas may be around 40,000 yuan per box, and the price of the American version may be around 150,000 yuan per box (prices may fluctuate due to exchange rates). The ingredients of domestic and foreign original drugs are basically the same. There are currently no generic versions of Platinib produced and marketed.