Revlixen 25 mg (Lenalidomide) Capsule

Introduction

Revlixen 25 mg (Lenalidomide) Capsule is an advanced immunomodulatory and antineoplastic agent used in the treatment of multiple hematologic malignancies. Manufactured by Everest Pharmaceuticals Ltd and globally supplied by Saif Pharma, Revlixen is clinically validated for conditions such as Multiple Myeloma (MM), Myelodysplastic Syndromes (MDS), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), and Marginal Zone Lymphoma (MZL). With immunomodulatory, antiangiogenic, and direct cytotoxic effects, Revlixen is a cornerstone in targeted chemotherapy regimens across various cancer stages.

Key Indications

Revlixen 25 mg is approved for the treatment of:

• Multiple Myeloma (MM): In combination with Dexamethasone or as maintenance therapy post autologous stem cell transplantation (auto-HSCT).
• Myelodysplastic Syndromes (MDS): For transfusion-dependent anemia with deletion 5q cytogenetic abnormality.
• Mantle Cell Lymphoma (MCL): For patients with relapsed or refractory disease following two prior therapies including Bortezomib.
• Follicular Lymphoma (FL) & Marginal Zone Lymphoma (MZL): In combination with Rituximab in previously treated patients.

Mechanism of Action

Lenalidomide, the active component of Revlixen, is an analog of thalidomide and functions through multiple pathways:

• Cereblon Binding: Modulates substrate degradation (Aiolos, Ikaros, CK1α) via the ubiquitin ligase complex.
• Cytotoxicity: Induces apoptosis and inhibits tumor proliferation.
• Immunomodulation: Enhances NK and T-cell activity, promotes ADCC, and reduces inflammatory cytokines (e.g., TNF-α, IL-6).
• Antiangiogenic Effects: Inhibits formation of new blood vessels within tumor microenvironments.

Pharmacokinetics

• Absorption: Rapid, with peak plasma concentration between 0.5–6 hours. Food may reduce absorption by 20–50%.
• Distribution: 30% plasma protein binding. Detected in semen up to 24 hours post-dose.
• Metabolism: Undergoes limited hepatic metabolism; primarily excreted unchanged.
• Excretion: ~90% via urine; renal clearance exceeds GFR. Mean half-life: 3–5 hours.

Dosage and Administration

Multiple Myeloma:

• Induction: 25 mg orally once daily (Days 1–21 of a 28-day cycle) with Dexamethasone.
• Maintenance Post-HSCT: Start with 10 mg daily, increase to 15 mg after 3 cycles if tolerated.

MDS (Del 5q):

• 10 mg once daily until disease progression or unacceptable toxicity.

MCL:

• 25 mg orally once daily (Days 1–21 of a 28-day cycle).

FL/MZL:

• 20 mg orally once daily (Days 1–21 of a 28-day cycle) up to 12 cycles with Rituximab.

Administration Instructions:

• Take at the same time daily, with or without food.
• Swallow whole; do not crush, chew, or open capsules.

Drug Interactions

• Digoxin: Slight increase in Cmax and AUC. Monitor plasma levels.
• Warfarin: No significant PK changes, but monitor PT/INR closely.
• Thrombosis Risk Agents: Caution with estrogens and ESAs due to increased thrombotic risk.

Contraindications

• Known hypersensitivity to Lenalidomide or formulation components.
• Pregnancy: Teratogenic. Strict contraception and pregnancy testing required under REMS program.

Warnings and Precautions

• REVLIXEN REMS Program: Mandatory certification for prescribers, patients, and pharmacies.
• Hematologic Toxicity: Risk of neutropenia and thrombocytopenia. Regular CBC monitoring is essential.
• Thromboembolism: VTE and ATE risks are elevated. Use thromboprophylaxis.
• Second Primary Malignancies: Monitor for secondary cancers during therapy.
• Hepatotoxicity: Monitor liver function and adjust dosing as necessary.
• Severe Cutaneous Reactions: Discontinue immediately if SJS, TEN, or DRESS is suspected.
• Thyroid Dysfunction: Monitor thyroid function periodically.
• Stem Cell Mobilization: Early transplant referral recommended due to risk of impaired mobilization.

Pregnancy and Lactation

Lenalidomide is strictly contraindicated in pregnancy due to teratogenic risks. It is unknown if the drug is excreted in breast milk; therefore, breastfeeding is not recommended during treatment.

Use in Special Populations

• Pediatric Use: Safety and efficacy not established.
• Renal Impairment: Dose adjustment may be necessary.
• Elderly Patients: May require dose modification of co-administered drugs like Dexamethasone.

Overdose Management

No specific antidote. In case of overdose, initiate symptomatic management, including cardiovascular and hepatic monitoring.

Therapeutic Class

Cytotoxic Chemotherapy – Immunomodulatory Antineoplastic Agent

Storage and Handling

• Store below 30°C in a dry environment.
• Protect from light and moisture.
• Keep out of reach of children.

Why Choose Revlixen 25 mg from Saif Pharma?

Saif Pharma is a trusted global oncology medicine supplier, delivering quality-assured anticancer medications to 60+ countries. With a commitment to affordability, accessibility, and authenticity, Saif Pharma sources products only from WHO-GMP certified manufacturers like Everest Pharmaceuticals Ltd. Revlixen 25 mg is crafted under strict quality control protocols, ensuring safety, efficacy, and global regulatory compliance.

Clinical Benefits Summary

• Effective across multiple hematologic malignancies.
• Proven synergy with Dexamethasone and Rituximab.
• Dual immunomodulatory and antineoplastic actions.
• Available through Saif Pharma’s global distribution channels.