LuciAlpe 150mg, Alpelisib Tablets

LuciAlpe 150mg, generically known as alpelisib, is a targeted oral medication approved for specific oncological and genetic conditions. It functions as a selective inhibitor of the phosphatidylinositol-3-kinase alpha (PI3Kα) isoform, a key component in cell proliferation and survival pathways. By inhibiting this pathway, LuciAlpe 150mg disrupts abnormal cell growth associated with certain cancers and genetic disorders.

What is LuciAlpe 150mg Alpelisib?

LuciAlpe 150mg is a prescription oral medication that contains Alpelisib as its active ingredient. It is classified as a PI3K inhibitor, specifically targeting the PI3K-alpha isoform, a part of the PI3K/AKT/mTOR signaling pathway that regulates cell growth, survival, and metabolism.

Mechanism of Action

Alpelisib targets and inhibits the PI3Kα isoform, a critical enzyme in the PI3K/AKT/mTOR signaling pathway. By inhibiting PI3Kα, alpelisib disrupts these processes, leading to reduced tumor growth and improved clinical outcomes in patients with PIK3CA mutations.

• Target: PI3K-α (Phosphatidylinositol-3-Kinase Alpha)
  

• • • PI3K enzymes are involved in transmitting signals inside cells from receptors on the surface to promote survival and growth.
      
    • Mutations in this gene are common in certain cancers, especially breast cancer, and in rare disorders like PIK3CA-Related Overgrowth Spectrum (PROS).
      

• Mutation Activation

• Uncontrolled cell proliferation
• Inhibition of programmed cell death (apoptosis)
• Tissue overgrowth (in non-cancer disorders like PROS)
  

• Alpelisib Binding

Alpelisib selectively binds to the mutant PI3K-α isoform and inhibits its activity.

This inhibition blocks downstream signaling through:

• AKT (Protein Kinase B)
• mTOR (Mammalian Target of Rapamycin)
  

• Cellular Outcomes
  

• In cancer cells: Inhibition leads to slowed tumor growth and increased cell death.
  

• In PROS: Reduces excessive cell and tissue growth, minimizing physical symptoms and complications.

Indications

1. Breast cancer that has progressed or spread after an endocrine-based regimen:
   Used in conjunction with fulvestrant to treat postmenopausal women and men with PIK3CA-mutant hormone receptor-positive, HER2-negative breast cancer.
   

2. PIK3CA-Related Overgrowth Spectrum (PROS):
   Licensed to treat adults and children two years of age and up who have severe PROS symptoms and need systemic treatment. 

Dosage 

• Take with food: Food increases absorption and reduces the risk of side effects like nausea or diarrhea.

Side Effects

Common side effects include:

• Hyperglycemia: Elevated blood sugar levels are frequent and may require dose adjustments.
  Diarrhea: May be severe and necessitate medical intervention.
• Rash: Skin reactions can occur and should be monitored.
• Nausea and Vomiting: Gastrointestinal symptoms are possible.

Serious side effects:

• Hyperglycemia: Elevated blood sugar levels; monitor regularly.
• Severe Diarrhea: Can lead to dehydration; initiate antidiarrheal treatment promptly.
• Skin Reactions: Such as Stevens-Johnson syndrome; discontinue if such reactions occur.
• Lung Toxicity: Monitor for signs of pneumonitis; discontinue if confirmed.

• Severe Hypersensitivity Reactions: Including anaphylaxis.
• Severe Cutaneous Reactions: Such as Stevens-Johnson syndrome.

Patients should be monitored regularly for these adverse effects.

Monitoring Parameters

• Blood sugar levels (because of the possibility of hyperglycemia)
• Liver function tests
• Renal function
• Electrolytes
• Body weight and symptoms (especially in PROS)

Storage

• Store LuciAlpe 150mg at room temperature, between 20°C to 25°C (68°F to 77°F). 
• The medication should be kept out of reach of children and should not be used after the expiration date.
• Keep in original packaging: Protects from moisture and light
• Do not refrigerate or freeze
• Keep away from children and pets
• Avoid storing in humid places (e.g., bathroom)
• Dispose of expired or unused medication properly

Benefits

• Clinical Efficacy: Demonstrated improved progression-free survival in clinical trials for breast cancer patients with PIK3CA mutations.
• Targeted Therapy: Alpelisib offers a targeted approach to cancer treatment, focusing on specific genetic mutations.
• Combination Therapy: When used with fulvestrant, it provides an effective treatment option for certain types of breast cancer.
• Treatment for PROS: Provides a therapeutic option for individuals with PIK3CA-related overgrowth spectrum, a rare genetic condition.

Prescription 

LuciAlpe 150mg is a prescription medication and should be administered under the supervision of a healthcare provider experienced in the use of anticancer therapies. Regular monitoring of blood glucose levels, liver function, and other relevant parameters is essential during treatment.

Drug Interactions

Alpelisib is metabolized by the CYP3A4 enzyme.Conversely, CYP3A4 inhibitors may increase alpelisib levels, raising the risk of adverse effects. 

Alpelisib may interact with other medications, including:

• CYP3A4 Inhibitors: Such as ketoconazole, which may increase alpelisib levels.
• CYP3A4 Inducers: Such as rifampin, which may decrease alpelisib levels.
• Other Anticancer Agents: Concomitant use with certain chemotherapeutic agents may require dose adjustments.

FAQs

1. Common side effects?
   Diarrhea, nausea, rash, fatigue, mouth sores, high blood sugar.
   

2. Serious side effects?
   Severe hyperglycemia, skin reactions, pneumonitis, diarrhea.
   

3. Should I avoid anything?
   Yes – avoid alcohol, pregnancy, and certain medications. Tell your doctor everything you’re taking.
   

4. How should it be stored?
   In a cool, dry place at 20–25°C. Keep out of children’s reach.

Conclusion

LuciAlpe 150mg (alpelisib) represents a significant advancement in targeted therapy for patients with specific genetic mutations. Its role in treating PIK3CA-related overgrowth spectrum and hormone receptor-positive, HER2-negative breast cancer underscores the importance of personalized medicine. 

LuciAlpe 150 mg is an effective targeted therapy for treating specific types of advanced breast cancer (HR+, HER2-, PIK3CA-mutated). It works by blocking the PI3K pathway that fuels cancer growth. While it can significantly help control cancer progression, it may cause side effects—especially high blood sugar, diarrhea, and rash—that need careful monitoring. It’s not safe during pregnancy or breastfeeding, and patients with diabetes or other chronic conditions should take extra precautions.