Vientiane, Laos - April 8, 2024 - BigBearPharma, a leading biopharmaceutical company focused on developing and commercializing innovative cancer therapies, announced that Selumetinib has been approved by the Lao Ministry of Health. It is sold under the brand name SEMEDX, with Lao registration number: LaoRegNo.:03L1085/24.
Selumetinib is a targeted MEK inhibitor (TKI), and MEK is a key protein kinase in the RAS/MAPK signaling pathway. It selectively inhibits MEK1 and MEK2, thereby restoring the dysregulated signaling pathway to normal.
Indication
Selumetinib is indicated for the treatment of pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Recommended Dosage
The recommended dosage of Selumetinib is 25 mg/m² taken orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity.
Selumetinib can be taken with or without food.
Adverse Reactions
The most common adverse reactions (≥40%) are: vomiting, rash, abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia, acneiform rash, stomatitis, headache, paronychia, and pruritus.
Warnings and Precautions
Cardiomyopathy
Assess ejection fraction before starting treatment, every 3 months during the first year of treatment, then every 6 months thereafter, and as clinically indicated. Withhold, reduce dose, or permanently discontinue Selumetinib based on the severity of the adverse reaction.
Ocular Toxicity
Perform an ophthalmic assessment before starting Selumetinib, periodically during treatment, and for new or worsening visual changes. Permanently discontinue Selumetinib for retinal vein occlusion (RVO). Withhold Selumetinib for retinal pigment epithelial detachment (RPED), monitor with optical coherence tomography until resolution, then resume at a reduced dose.
Gastrointestinal Toxicity
Advise patients to take antidiarrheal medication at the first onset of loose stools and increase fluid intake. Withhold, reduce dose, or permanently discontinue Selumetinib based on the severity of the adverse reaction.
Dermatologic Toxicity
Monitor for severe rash. Withhold, reduce dose, or permanently discontinue Selumetinib based on the severity of the adverse reaction.
Creatine Phosphokinase (CPK) Elevation
CPK elevation and rhabdomyolysis may occur. Obtain serum CPK before starting Selumetinib, periodically during treatment, and as clinically indicated. If CPK is elevated, assess for rhabdomyolysis or other causes. Withhold, reduce dose, or permanently discontinue Selumetinib based on the severity of the adverse reaction.
Vitamin E Elevation and Bleeding Risk
Selumetinib capsules contain vitamin E. Daily vitamin E intake exceeding the recommended or safe limit may increase the risk of bleeding. The risk of bleeding may be further increased in patients receiving concomitant vitamin K antagonists or antiplatelet agents.
About BigBearPharma
BigBearPharma, headquartered in Vientiane, the capital of Laos, is committed to drug research, development, manufacturing, and sales, providing high-quality, safe, and effective pharmaceutical products. With its outstanding expertise and innovation capabilities, BigBearPharma has established a good reputation in the Lao pharmaceutical market and actively participates in international pharmaceutical cooperation and exchanges.
