Pralsetinib was approved for marketing by the U.S. Food and Drug Administration (FDA) in September 2020, and subsequently approved in several countries and regions, including China. It is not currently included in China's National Reimbursement Drug List.
Pralsetinib Indications
1. Non-Small Cell Lung Cancer (NSCLC)
Pralsetinib is used to treat metastatic RET fusion-positive non-small cell lung cancer (NSCLC) confirmed by FDA-approved testing methods.
2. Thyroid Cancer
For patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are refractory to radioactive iodine (if radioactive iodine therapy is applicable).
Pralsetinib Dosage and Administration
1. Method of Pralsetinib Administration
(1) Take pralatinib on an empty stomach, at least 1 hour before or 2 hours after a meal.
(2) If vomiting occurs shortly after taking pralatinib, do not take another dose. (3) You will need to check your blood pressure frequently and have regular blood tests.
(4) Do not change the dosage or stop taking the medication without your doctor's permission.
(5) Store at room temperature, away from moisture and high temperatures.
2. Common Dosages of Praltinib
(1) Common Dosage for Adult Non-Small Cell Lung Cancer
400 mg orally daily until disease progression or unacceptable toxicity occurs.
(2) Common Dosage for Adult Thyroid Cancer
400 mg orally daily until disease progression or unacceptable toxicity occurs.
(3) Common Dosage for Children with Thyroid Cancer
12 years and older: 400 mg orally daily until disease progression or unacceptable toxicity occurs.
Side effects of pralatinib
1. Serious side effects of pralatinib
(1) Abnormal bleeding
Bruising, nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that cannot be stopped;
(2) Signs of internal bleeding
Weakness, drowsiness, pink or brown urine, bloody or tarry stools, coughing up blood or vomiting coffee grounds;
(3) Low blood cell count
Fever, fatigue, sore throat, mouth ulcers, skin ulcers, pale skin, cold hands and feet, dizziness or shortness of breath;
(4) Liver problems
Nausea, vomiting, loss of appetite, abdominal pain (right upper quadrant), fatigue, dark urine, jaundice (yellowing of the skin or eyes).
(5) Other serious side effects
Fever, chills; new or worsening cough, shortness of breath or chest pain; severe headache, dizziness, confusion, difficulty speaking; wounds that fail to heal.
2. Common Side Effects of Pralsetinib
High blood pressure; low blood cell count or other abnormal laboratory test results; muscle or joint pain; fatigue; constipation.
Management for Missed Pralsetinib Doses
If you miss a dose of pralsetinib, take it as soon as possible. However, if the next dose is approaching, skip the missed dose. Do not take two doses at once.
