Vientiane, Laos, August 12, 2024 - BigBear Pharma, a leading biopharmaceutical company focused on developing and commercializing innovative cancer treatments, today announced that Pralsetinib oral capsules have been approved by the Lao Ministry of Health. The approved trade name is PRASEDX; Lao registration number: 07L1157/24.
Pralsetinib is an oral, once-daily RET kinase inhibitor that inhibits RET and the phosphorylation of its downstream molecules, effectively suppressing cell proliferation in cells expressing RET gene variants.
Indications
Pralsetinib is approved for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), patients with advanced or metastatic RET mutant medullary thyroid cancer, and patients with advanced or metastatic RET fusion-positive thyroid cancer.
Dosage and Administration
1. Recommended Dosage
Adults and children ≥12 years: 400 mg orally once daily on an empty stomach (fasting for at least 2 hours before and after taking the dose).
2. Dosage Modifications
Withhold, reduce dose, or permanently discontinue based on the severity of adverse reactions.
First dose reduction to 300 mg, second to 200 mg, third to 100 mg; discontinue if 100 mg cannot be tolerated.
Adverse Reactions
1. Common Adverse Reactions (≥25%)
Musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, fever, cough.
2. Laboratory Abnormalities (≥2% Grade 3-4)
Lymphopenia, neutropenia, decreased hemoglobin, hypophosphatemia, elevated transaminases, etc.
3. Serious Adverse Reactions
Interstitial lung disease/pneumonitis, hypertensive crisis, hepatotoxicity, hemorrhagic events.
Warnings and Precautions
Interstitial lung disease/pneumonitis: Monitor for respiratory symptoms. If acute worsening occurs, withhold and evaluate. Permanently discontinue in severe cases.
Hypertension: Control blood pressure before treatment and monitor regularly during treatment. Withhold and reduce dose for Grade 3 persistent hypertension; discontinue for Grade 4.
Hepatotoxicity: Monitor ALT/AST before and during treatment. Withhold and reduce dose for Grade 3-4 abnormalities.
Hemorrhagic risk: Permanently discontinue for serious bleeding events.
Wound healing: Withhold for at least 5 days before elective surgery, and resume at least 2 weeks after surgery.
Embryo-fetal toxicity: Females of reproductive potential should use non-hormonal contraception.
About BigBear Pharma
BigBear Pharmaceuticals is headquartered in Vientiane, the capital of Laos. The company is committed to drug research and development, production, and sales, providing high-quality, safe, and effective medicines. BigBear Pharmaceuticals has established a good reputation in the Lao pharmaceutical market with its outstanding expertise and innovation capabilities, and actively participates in international pharmaceutical cooperation and exchanges.
