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Lenalidomide 10 mg Lenalidomide capsules 10 mg/capsule, 30 capsules/box
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- Contraindications
- Warnings and Precautions
• Increased mortality: Serious and fatal cardiac adverse reactions occurred in patients with CLL treated with LuciLena (lenalidomide).
• Second primary malignancy (SPM): A higher incidence of SPM was observed in a controlled trial of MM patients treated with LuciLena.
• Increased mortality: Increased mortality was observed in patients with MM following the addition of pembrolizumab to dexamethasone and thalidomide analogues.
• Hepatotoxicity: liver failure including death; monitoring of liver function. Discontinue use of LuciLena and evaluate for suspected hepatotoxicity.
• Severe skin reaction: In case of severe reaction, discontinue LuciLena.
• Tumor Lysis Syndrome (TLS) includes death: Monitor patients at risk for TLS (i.e., patients with a high tumor burden) and take appropriate precautions.
• Tumor response: Serious tumor reactions, including fatal reactions, have occurred during the experimental use of LuciLena for the treatment of chronic lymphocytic leukemia and lymphoma.
• Impaired stem cell mobilization: A decrease in the Quantity of CD34 + cells collected after treatment with LuciLena (> 4 cycles) was reported. Consider referring to a transplant center as soon as possible.
• Early mortality in MCL: Patients with MCL have a higher early mortality rate.
• Hypersensitivity: Monitor the patient for potential hypersensitivity reactions. LuciLena should be discontinued in case of angioedema and anaphylaxis. - Medication risks
- Adverse Reactions
• MM: The most common adverse reactions (≥ 20%) include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle spasms/cramps, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infections, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, loss of appetite, thrombocytopenia, and tremorrhea.
• MDS: The most common adverse reactions (> 15%) include thrombocytopenia, neutropenia, diarrhea, itching, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, fever, back pain, peripheral edema, cough, dizziness, headache, muscle spasms, dyspnea, pharyngitis, and nasal bleeding.
• Non-Hodgkin lymphoma (NHL: MCL, FL, or MZL): The most common adverse effects (≥ 15%) include neutropenia, thrombocytopenia, anemia, leukopenia, diarrhea, constipation, nausea, fatigue, pyrexia, cough, upper respiratory tract infection, and rash.
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