LuciLena Lenalidomide Capsule 10mg/25mg

Lenalidomide: Key Points from the Prescribing Information

Drug Name

Generic Name: Lenalidomide

Brand Name: Revlimid®

Specifications: 10 mg × 30 capsules/box; 25 mg × 30 capsules/box

Manufacturer: Lucius Pharmaceutical (Laos) Co., Ltd.

Indications

1.  Multiple Myeloma (MM): Used in combination with dexamethasone for the treatment of newly diagnosed and relapsed/refractory MM.

2.  Myelodysplastic Syndromes (MDS): Indicated for MDS with an isolated del(5q) cytogenetic abnormality and transfusion-dependent anemia.

3.  Mantle Cell Lymphoma (MCL): Used as second-line therapy for relapsed/refractory MCL (in combination with rituximab).

Dosage and Administration

1.  Recommended Dosage

Multiple Myeloma: 25 mg orally once daily on Days 1–21 of a 28-day cycle, in combination with dexamethasone. 

Myelodysplastic Syndromes: 10 mg orally once daily, administered continuously until disease progression or unacceptable toxicity occurs. 

Mantle Cell Lymphoma: 25 mg orally once daily on Days 1–21 of a 28-day cycle, in combination with rituximab.

May be taken with or without food. Capsules should be swallowed whole; do not crush or chew.

2.  Dosage Adjustment

Hematologic Toxicity: Suspend treatment in cases of neutropenia (ANC < 1 × 10⁹/L) or thrombocytopenia (PLT < 50 × 10⁹/L); upon recovery, reduce the dose to 10 mg/day. 

Hepatic and Renal Impairment: Adjust dosage based on creatinine clearance; use with caution in patients with severe hepatic impairment.

3.  Duration of Treatment

Treatment should generally be continued until disease progression or the occurrence of unacceptable toxicity. Precautions

1. Serious Side Effects

Teratogenicity: Contraindicated in pregnant women; may cause fetal birth defects. Strict contraception is required (starting 4 weeks prior to treatment, throughout the treatment period, and for 4 weeks after discontinuation).

Hematologic Toxicity: May cause neutropenia and thrombocytopenia; regular monitoring of complete blood counts (CBC) is required.

Thrombotic Risk: The risk of thrombosis increases when used in combination with chemotherapy or corticosteroids; prophylactic anticoagulation therapy is required.

Tumor Lysis Syndrome: High-risk patients require preventive measures (e.g., hydration, uric acid-lowering therapy).

2. Drug Interactions

Avoid concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole), as this may increase toxicity; concomitant use with inducers (e.g., rifampin) may reduce efficacy.

Monitor INR when used concomitantly with warfarin.

3. Special Populations

Pregnant/Lactating Women: Contraindicated; lactating women must discontinue breastfeeding.

Elderly Patients: No dose adjustment is required, but close monitoring for side effects is necessary.

Common Side Effects

Hematologic: Neutropenia, thrombocytopenia, anemia.

Non-hematologic: Fatigue, constipation, nausea, diarrhea, rash, upper respiratory tract infection.

Important Notes

Strict Contraception: Female patients must use highly effective contraceptive measures throughout the treatment period and for 4 weeks after discontinuation.

Monitoring and Follow-up: Regularly monitor complete blood counts (CBC), as well as liver and kidney function; remain alert for symptoms of thrombosis (e.g., chest pain, difficulty breathing).

Missed Doses: If a dose is missed, take it as soon as possible; however, if it is close to the time for the next scheduled dose, skip the missed dose—do not take a double dose to make up for it.

It is recommended to consult with an oncologist or pharmacist in detail prior to using lenalidomide to ensure safe and effective use of the medication.