Vientiane, Laos - November 20, 2023 - BigBear Pharma, a leading biopharmaceutical company focused on developing and commercializing innovative cancer therapies, announced that Selpercatinib (SEPADX) has been approved by the Lao Ministry of Health.
The generic name of Selpercatinib (SEPADX) is Selpercatinib. It was approved for medical use in the United States in May 2020.
Approved Indications
1. Non-Small Cell Lung Cancer
For the treatment of adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer.
2. Medullary Thyroid Cancer and Differentiated Thyroid Cancer
For the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, and patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine refractory (if radioactive iodine is applicable).
Dosage and Administration
This product is an oral capsule, taken twice daily (approximately every 12 hours). Swallow whole, do not crush or chew. The specific dose should be as prescribed by a physician. The standard dose is based on body weight:
Body weight less than 50 kg: 120 mg twice daily.
Body weight 50 kg or greater: 160 mg twice daily.
If the next dose is more than 6 hours away, the missed dose can be taken; otherwise, it should be skipped. Do not take a double dose at once.
Side Effects
This product may cause the following side effects. Closely monitor your physical condition during treatment.
1. Common Side Effects (may affect more than 25% of patients)
Including edema (body swelling), diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, headache, etc.
2. Serious Adverse Reactions
If any of these occur, seek immediate medical attention:
(1) Liver injury;
(2) Hypertension;
(3) Interstitial lung disease / non-infectious pneumonitis: symptoms may include hypoxia, cough, dyspnea, etc.
(4) QT prolongation: an abnormality that may affect heart rhythm.
(5) Hypersensitivity reactions and bleeding events.
3. Laboratory Test Abnormalities
May present as elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), hyperglycemia, leukopenia, thrombocytopenia, elevated total cholesterol, and electrolyte abnormalities (e.g., decreased blood sodium, decreased blood calcium).
Selpercatinib (SEPADX) is a kinase inhibitor, which means it can block an enzyme (kinase) and help prevent cancer cell growth. Before starting treatment, laboratory testing to identify RET gene alterations must be performed.
