Adverse reactions of Pralsetinib

Pralsetinib may cause serious adverse reactions, including:

1. Pulmonary disorders

Severe or life-threatening interstitial lung disease (pneumonitis) may occur during treatment, which can even lead to death. If you develop new or worsening symptoms such as shortness of breath, cough or fever, you should immediately inform your healthcare provider.

2. Hepatic disorders

Elevations in liver function test parameters may occur, which can be severe in some cases. Healthcare providers will perform blood tests before and during treatment to monitor liver function. You must promptly notify your healthcare provider if you experience symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark tea-colored urine, drowsiness, unusual bleeding or bruising, loss of appetite, nausea and vomiting, or pain in the upper right abdomen.

3. Hypertension

Hypertension is a common adverse reaction and may be severe in some instances. Blood pressure should be monitored regularly during treatment. You should inform your healthcare provider if your blood pressure rises or if you develop symptoms such as confusion, headache, shortness of breath, dizziness or chest pain.

4. Hemorrhagic disorders

Pralsetinib may cause severe, even fatal bleeding. Seek medical attention immediately if you experience symptoms such as hematemesis or coffee-ground-like vomitus, abnormal vaginal bleeding, frequent epistaxis, pink or brown urine, drowsiness or difficulty in awakening, red or black (tarry) stools, confusion, hemoptysis or blood clots in sputum, headache, abnormal cutaneous bleeding or bruising, slurred speech, or heavier-than-normal menstrual bleeding.

5. Tumor lysis syndrome (TLS)

This syndrome is caused by the rapid breakdown of cancer cells, which may lead to renal failure requiring dialysis, cardiac arrhythmias, and sometimes hospitalization. Healthcare providers may conduct blood tests to monitor for this syndrome. Adequate fluid intake should be maintained during treatment. If you develop symptoms such as nausea, shortness of breath, vomiting, muscle cramps, weakness, seizures or swelling, you should immediately contact your healthcare provider or seek emergency medical care.

6. Impaired wound healing

Wounds may fail to heal properly during treatment. If you plan to undergo surgery before or during treatment, you should inform your healthcare provider in advance. Pralsetinib should be discontinued at least 5 days prior to surgery, and your healthcare provider will instruct you on when to resume the medication after surgery.

In addition, before taking pralsetinib, you should inform your healthcare provider of your complete medical history, especially if you have a history of pulmonary or respiratory disorders other than lung cancer, hypertension, hemorrhagic disorders or liver disease, or if you plan to undergo surgery, are pregnant or planning to become pregnant, or are breastfeeding or planning to breastfeed. Pralsetinib may cause fetal harm. Females of reproductive potential must undergo pregnancy testing before initiating treatment and use effective non-hormonal contraceptive methods during treatment and for 2 weeks after the last dose; hormonal contraceptives may be ineffective. Males with female partners of reproductive potential must also use effective contraceptive methods during treatment and for 1 week after the last dose. Breastfeeding is not recommended during treatment and for 1 week after the last dose.

from FDA，2024.03