{"id":586,"date":"2026-04-12T15:26:00","date_gmt":"2026-04-12T15:26:00","guid":{"rendered":"https:\/\/luciuspharmacy.com\/?post_type=product&p=586"},"modified":"2026-08-30T03:53:25","modified_gmt":"2026-08-30T03:53:25","slug":"lucilena-lenalidomide-10-mgx30-capsules","status":"publish","type":"product","link":"https:\/\/luciuspharmacy.com\/es\/product\/lucilena-lenalidomide-10-mgx30-capsules\/","title":{"rendered":"LuciLena 10mg"},"content":{"rendered":"

HIGHLIGHTS OF PRESCRIBING INFORMATION <\/span><\/strong><\/span><\/p>\n

These highlights do not include all the information needed to use LuciLena safely and effectively. See full prescribing information for LuciLena.<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

INDICATIONS AND USAGE<\/strong><\/strong><\/span><\/p>\n

LuciLena is a thalidomide analogue indicated for the treatment of adult patients with: <\/span><\/p>\n

\u2022 Multiple myeloma (MM), in combination with dexamethasone. <\/span><\/p>\n

\u2022MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) . <\/span><\/p>\n

\u2022 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. <\/span><\/p>\n

\u2022 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib . <\/span><\/p>\n

\u2022 Previously treated follicular lymphoma (FL), in combination with a rituximab product . <\/span><\/p>\n

\u2022 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product. <\/span><\/p>\n

Limitations of Use: <\/span><\/p>\n

\u2022 LuciLena is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.<\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE AND ADMINISTRATION<\/strong><\/strong><\/span><\/p>\n

\u2022  MM combination therapy: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. <\/span><\/p>\n

\u2022 MM maintenance therapy following auto-HSCT: 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles. <\/span><\/p>\n

\u2022 MDS: 10 mg once daily . <\/span><\/p>\n

\u2022 MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. <\/span><\/p>\n

\u2022 FL or MZL: 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles.<\/span><\/p>\n

\u2022 Renal impairment: Adjust starting dose based on the creatinine clearance value. <\/span><\/p>\n

\u2022 For concomitant therapy doses, see Full Prescribing Information.<\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE FORMS AND STRENGTHS <\/strong><\/strong><\/span><\/p>\n

Capsules: 10 mg\u00d730 capsules<\/span><\/p>\n

 <\/span><\/p>\n

CONTRAINDICATIONS <\/strong><\/strong><\/span><\/p>\n

\u2022  Pregnancy. <\/span><\/p>\n

\u2022  Demonstrated severe hypersensitivity to lenalidomide.<\/span><\/p>\n

 <\/span><\/p>\n

WARNINGS AND PRECAUTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Increased Mortality: serious and fatal cardiac adverse reactions occurred in patients with CLL treated with LuciLena (lenalidomide) . <\/span><\/p>\n

\u2022 Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with MM receiving LuciLena . <\/span><\/p>\n

\u2022 Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue . <\/span><\/p>\n

\u2022 Hepatotoxicity: Hepatic failure including fatalities; monitor liver function. Stop LuciLena and evaluate if hepatotoxicity is suspected . <\/span><\/p>\n

\u2022 Severe Cutaneous Reactions: Discontinue LuciLena for severe reactions . <\/span><\/p>\n

\u2022 Tumor lysis syndrome (TLS) including fatalities: Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions. <\/span><\/p>\n

\u2022 Tumor fare reaction: Serious tumor fare reactions, including fatal reactions, have occurred during investigational use of LuciLena for chronic lymphocytic leukemia and lymphoma. <\/span><\/p>\n

\u2022 Impaired Stem Cell mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with LuciLena has been reported. Consider early referral to transplant center . <\/span><\/p>\n

\u2022 Early mortality in MCL: Higher rate of early deaths have occurred in patients with MCL . <\/span><\/p>\n

\u2022 Hypersensitivity: Monitor patients for potential hypersensitivity. Discontinue LuciLena for angioedema and anaphylaxis.<\/span><\/p>\n

 <\/span><\/p>\n

ADVERSE REACTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 MM: Most common adverse reactions (\u226520%) include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp\/ spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor. <\/span><\/p>\n

\u2022 MDS: Most common adverse reactions (>15%) include thrombocytopenia, neutropenia, diarrhea, pruritus, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, pharyngitis, and epistaxis. <\/span><\/p>\n

\u2022 Non-Hodgkin\u2019s Lymphoma (NHL: MCL, FL or MZL): Most common adverse reactions (\u226515%) included neutropenia, thrombocytopenia, anemia, leukopenia, diarrhea, constipation, nausea, fatigue, pyrexia, cough, upper respiratory tract infection, and rash .<\/span><\/p>\n

 <\/span><\/p>\n

DRUG INTERACTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Digoxin: Monitor digoxin plasma levels periodically due to increased Cmax and AUC with <\/span><\/p>\n

concomitant LuciLena therapy. <\/span><\/p>\n

\u2022 Concomitant use of erythropoietin stimulating agents or estrogen containing therapies <\/span><\/p>\n

with LuciLena may increase the risk of thrombosis.<\/span><\/p>\n

 <\/span><\/p>\n

USE IN SPECIFIC POPULATIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Lactation: Advise not to breastfeed.<\/span><\/p>\n

 <\/span><\/p>\n

Storage <\/strong><\/strong><\/span><\/p>\n

Store at 20\u2103 to 25\u2103 (68\u2109 to 77\u2109), excursions permitted between 15\u2103 and 30\u2103 (59\u2109 and 86\u2109) [see USP Controlled Room Temperature]. Protect from moisture. <\/span><\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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