Description

Alpelisib Film-Coated Tablets (50 mg / 150 mg / 200 mg)

Healthy Inc is a specialized global supplier and exporter of advanced oncology, precision medicine, and targeted high-containment therapeutics. We provide ultra-high-purity, kinetically optimized Alpelisib Tablets, manufactured in WHO–GMP certified, strictly segregated high-containment oncology facilities. This “alpha-specific PI3K inhibitor” is a premium strategic export to cancer research hospitals, specialized oncology clinics, and government health ministries, serving as the globally mandated intervention for HR+/HER2- Advanced Breast Cancer with a PIK3CA mutation.

Product Overview

This formulation operates as a “Signal Jammer.” In cancers with a PIK3CA mutation, the PI3K pathway is stuck in the “ON” position, causing cells to grow uncontrollably. Alpelisib physically blocks this signal.

• Mechanism 1 (Alpha-Specific PI3K Inhibition): Alpelisib targets the alpha-isoform of phosphatidylinositol 3-kinase (PI3K$\alpha$). This isoform is specifically mutated in many breast cancers, making Alpelisib far more precise than older, non-selective inhibitors.

• Mechanism 2 (Overcoming Endocrine Resistance): Often, breast cancer becomes resistant to standard hormone therapies (like Fulvestrant). By blocking the PI3K pathway, Alpelisib “resensitizes” the tumor, allowing combination therapy to be effective again.

• Mechanism 3 (Cell Cycle Arrest): By inhibiting this pathway, the drug induces G1-phase cell cycle arrest and increases apoptosis (programmed cell death) in the tumor, physically shrinking the mass.

Technical & Logistics Specifications

• HS Code: 3004.90.99 (Medicaments containing other active substances – Oncology/Targeted Therapy)

• CAS Number: 1217486-61-7 (Alpelisib)

• Dosage Form: Film-Coated Tablet

• Packaging: Alu-Alu Blisters. Protects the API from light and environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

• OEB 5 High-Containment: Alpelisib is a highly potent antineoplastic. Our facility utilizes Dedicated Oncology Blocks with isolator technology and negative pressure to ensure zero cross-contamination and maximum safety for the production team.

• Mutation-Specific Precision: Our manufacturing process focuses on absolute chemical purity to ensure the PI3K$\alpha$ selectivity remains exact, providing the predictable clinical response required for genomic-based therapy.

Primary Indications

• Oncology: Treatment of post-menopausal women (and men) with Hormone Receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer.

• Combination Therapy: Strictly indicated for use in combination with Fulvestrant following progression on or after an endocrine-based regimen.

Dosage & Administration

• Standard Adult Dosing: 300 mg (two 150 mg tablets) once daily.

• Administration: Must be taken with food. This is critical for the absorption and pharmacokinetic profile of the drug.

• Prerequisite: Patients must be confirmed to have a PIK3CA mutation via a validated companion diagnostic test before starting treatment.

Safety Warning: Severe Hyperglycemia. Alpelisib significantly impacts glucose metabolism. Monitor blood glucose and HbA1c regularly. Severe Skin Reactions: Monitor for Stevens-Johnson Syndrome (SJS). Use with extreme caution in patients with a history of Type 2 Diabetes.

Global Export & Contract Manufacturing

Healthy Inc is a premier Oncology Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-end Targeted Antineoplastics. Whether you are a Precision Oncology Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.