Description

Lenalidomide Capsules

Healthy Inc is a specialized global supplier and exporter of advanced oncology, hematology, and immunomodulatory therapeutics. We provide ultra-high-purity Lenalidomide Capsules (5 mg / 10 mg / 15 mg / 25 mg), manufactured in WHO–GMP certified, dedicated Highly Potent API (HPAPI) negative-pressure oncology facilities. This “Immunomodulatory Imide Drug (IMiD)” is a massive-value, premium export to comprehensive cancer centers, hematology wards, and government health ministries in LATAM, the Middle East, Southeast Asia, and Africa, serving as the definitive, life-prolonging intervention for Multiple Myeloma and Myelodysplastic Syndromes.

Product Overview

This formulation contains Lenalidomide, a highly potent analogue of thalidomide with vastly superior anti-tumor efficacy and an optimized toxicity profile.

The “Tumor Apoptosis & Immune Activation” Specialist:

• Mechanism 1 (Direct Tumor Apoptosis via Cereblon): Lenalidomide binds directly to cereblon (CRBN), a component of the cullin-RING E3 ubiquitin ligase complex. This binding alters the complex’s substrate specificity, forcing it to rapidly tag two critical transcription factors (Ikaros and Aiolos) for destruction. Because Multiple Myeloma cells rely entirely on these factors to survive, their sudden destruction triggers rapid, targeted apoptosis (cell death) of the cancer cells.
• Mechanism 2 (Immune System Modulation): Lenalidomide acts as a profound immunomodulator. It aggressively stimulates the proliferation and activation of the patient’s own T-cells and Natural Killer (NK) cells, weaponizing the immune system to hunt down and destroy residual myeloma cells in the bone marrow.
• Mechanism 3 (Anti-Angiogenesis): It physically alters the bone marrow microenvironment, starving tumors by inhibiting angiogenesis (the formation of new blood vessels that tumors need to grow) and blocking crucial cellular adhesion pathways.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in specialized, highly secure Alu-Alu blister strips. Due to strict handling protocols, packaging frequently incorporates child-resistant, peel-push foil technologies.

*Pack Sizes: 1×21 or 3×7 Alu-Alu Blisters (Specifically optimized for the standard 21-day “On” / 7-day “Off” oncology dosing cycle).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Oncology Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified oncology units.

• OEB-5 HPAPI Containment: Lenalidomide is extremely hazardous to handle. Our manufacturing is executed within strictly isolated, completely dedicated Oncology blocks operating under severe negative pressure with multi-stage HEPA filtration. Powders are handled inside closed-loop barrier isolators (glove boxes) to guarantee absolute operator safety and zero cross-contamination with other drug lines.
• Cleaning Validation (Swab Testing): Rigorous swab testing and HPLC residual analysis are conducted between batches to ensure equipment meets ultra-trace limits (parts per billion) for clearance of this potent teratogen.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe hematological malignancies:

• Multiple Myeloma (MM): In combination with Dexamethasone, for the treatment of adult patients with previously untreated multiple myeloma, as well as those who have received at least one prior therapy. Also used as maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT).
• Myelodysplastic Syndromes (MDS): Treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality.
• Mantle Cell Lymphoma (MCL): Treatment of patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

Dosage & Administration

Recommended Dosage (Strictly as per Board-Certified Oncologist/Hematologist):

• Administration: Taken orally, once daily, at about the same time each day, with or without food.
• Handling Protocol (CRITICAL HAZARD): Capsules MUST NOT be opened, broken, or chewed. If powder from a broken capsule makes contact with the skin, wash the area immediately and thoroughly with soap and water. Healthcare providers and caregivers must wear gloves when handling the blister packs.
• Renal Adjustment: Because Lenalidomide is excreted primarily by the kidneys, the dose must be heavily adjusted downwards in patients with moderate to severe renal impairment.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Severe Teratogenicity): Lenalidomide is a thalidomide analogue. It causes catastrophic, life-threatening birth defects (phocomelia) and fetal death. It is strictly contraindicated in pregnant women. Females of reproductive potential must use two forms of reliable contraception and undergo regular pregnancy testing. Males receiving the drug must use a condom, even with a pregnant partner, as the drug is present in semen.
• BLACK BOX WARNING (Hematologic Toxicity): Can cause significant, life-threatening neutropenia (loss of white blood cells) and thrombocytopenia (loss of platelets). Complete blood counts (CBC) must be monitored every 7 days for the first 8 weeks, and monthly thereafter.
• BLACK BOX WARNING (Venous & Arterial Thromboembolism): Massively increases the risk of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke. Patients are almost always concurrently prescribed prophylactic blood thinners (e.g., Aspirin, Apixaban, or Enoxaparin).

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Oncology Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government cancer institutes in LATAM or a B2B Pharma Marketplace partner for the Middle East, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Specialty Medicine Wholesaler receives WHO-GMP certified products at competitive rates.