Introduction
Revlixen 10 mg is a high‑potency immunomodulatory and antineoplastic agent used in the treatment of multiple hematologic malignancies. Manufactured under WHO‑GMP standards by Everest Pharmaceuticals and distributed globally by Saif Pharma, it is indicated for Multiple Myeloma (MM) (including post‑auto‑HSCT maintenance), Myelodysplastic Syndromes (MDS) with deletion 5q, Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), and Marginal Zone Lymphoma (MZL). This capsule form enables precise dose adjustments, particularly in elderly or comorbid populations.
Indications
- Multiple Myeloma (MM) – Combined with Dexamethasone; also for maintenance after autologous stem cell transplant.
- Myelodysplastic Syndromes (MDS) – For transfusion‑dependent anemia in low- to intermediate-risk patients with del(5q).
- Mantle Cell Lymphoma (MCL) – For relapsed/refractory disease after ≥2 prior therapies including Bortezomib.
- Follicular and Marginal Zone Lymphomas (FL/MZL) – In combination with Rituximab in previously treated adult patients.
Revlixen is not indicated for CLL outside clinical trials.
Pharmacology & Mechanism of Action
Lenalidomide is a thalidomide analog with multiple mechanisms:
- Immunomodulatory: Enhances T- and NK-cell functions and increases ADCC.
- Antineoplastic: Targets cereblon-E3 ligase, leading to degradation of tumor survival proteins (Aiolos, Ikaros, CK1α), inducing apoptosis.
- Antiangiogenic: Inhibits tumor blood vessel growth.
- Better tolerability than thalidomide, with lower neuropathy risk.
Pharmacokinetics
- Absorption: Rapid (Tmax 0.5–6 hours); high-fat meals reduce bioavailability by ~20–50%.
- Distribution: ~30% plasma protein binding; present in semen.
- Metabolism: Minimal; main circulating form is unchanged drug.
- Elimination: Predominantly renal; half-life 3–5 hours.
Dosage & Administration
- MM (with Dexamethasone): 25 mg daily, Days 1–21 of 28-day cycle (even if cap is 10 mg, combination dosing applies).
- Post‑HSCT Maintenance: Start 10 mg daily, increase to 15 mg after 3 cycles if tolerated.
- MDS (del5q): 10 mg once daily until progression/toxicity.
- MCL: 25 mg daily, Days 1–21.
- FL/MZL: 20 mg daily, Days 1–21, up to 12 cycles with Rituximab.
Take at same time daily, with/without food; swallow whole without crushing.
Drug Interactions
- Digoxin: Increases exposure by ~14% – monitor plasma levels.
- Warfarin: No PK interaction but monitor PT/INR.
- Thrombosis-risk drugs: ESA or estrogen risk greater – use with caution and thromboprophylaxis.
Contraindications
- Pregnancy: teratogenic—strict REMS program applies.
- Hypersensitivity reactions: angioedema, SJS/TEN.
- Use in women of childbearing potential is contraindicated unless REMS compliance.
Warnings & Precautions
- REMS Program: Mandatory for prescribers, pharmacists, and patients.
- Hematologic Toxicity: Neutropenia/thrombocytopenia—weekly CBCs initially, then monthly.
- Thromboembolism: Increased risk – venous and arterial events; prophylaxis advised.
- Hepatotoxicity: Monitor liver enzymes; discontinue if elevated.
- Severe Skin Reactions: Discontinue for SJS, TEN, DRESS, etc.
- Thyroid Disorders: Baseline and periodic monitoring recommended.
- Stem Cell Mobilization: Early transplant referral advised due to reduced CD34+ yield.
- Secondary Cancers: Monitor for second malignancies.
Pregnancy & Lactation
- Do not use during pregnancy or breastfeeding.
- Women must avoid pregnancy and confirm non-pregnant status before and during therapy.
- Male contraception required due to excretion in semen.
Special Populations
- Pediatrics: Not studied/effective.
- Renal Impairment: Adjust dose—minimal change.
- Elderly: Consider reduced dexamethasone dose.
Overdose Management
No specific antidote—supportive treatment only with close monitoring for hematologic, renal, cardiac effects.
Therapeutic Class
Cytotoxic Chemotherapy – Immunomodulatory Drug (Imi
Storage & Handling
Store at ≤ 30 °C in dry conditions; protect from light and moisture; keep out of reach of children.
Why Choose Revlixen 10 mg from Saif Pharma?
Saif Pharma, a trusted global oncology distributor present in 60+ countries, partners with Everest Pharmaceuticals Ltd—a WHO-GMP certified manufacturer—to ensure high-quality, accessible, and authentic Revlixen 10 mg Capsules. Competitive pricing, robust global logistics, and regulatory compliance make it an ideal option for hospitals, cancer centers, and procurement agencies worldwide.
Clinical Benefits
- Effective across multiple hematologic cancers
- Synergistic with Dexamethasone and Rituximab
- Oral administration for outpatient convenience
- Strong safety and tolerability data
