LuciLena 10mg

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciLena safely and effectively. See full prescribing information for LuciLena.

 

INDICATIONS AND USAGE

LuciLena is a thalidomide analogue indicated for the treatment of adult patients with:

• Multiple myeloma (MM), in combination with dexamethasone.

•MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) .

• 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.

• Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib .

• Previously treated follicular lymphoma (FL), in combination with a rituximab product .

• Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Limitations of Use:

• LuciLena is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

 

DOSAGE AND ADMINISTRATION

•  MM combination therapy: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles.

• MM maintenance therapy following auto-HSCT: 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles.

• MDS: 10 mg once daily .

• MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles.

• FL or MZL: 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles.

• Renal impairment: Adjust starting dose based on the creatinine clearance value.

• For concomitant therapy doses, see Full Prescribing Information.

 

DOSAGE FORMS AND STRENGTHS

Capsules: 10 mg×30 capsules

 

CONTRAINDICATIONS

•  Pregnancy.

•  Demonstrated severe hypersensitivity to lenalidomide.

 

WARNINGS AND PRECAUTIONS

• Increased Mortality: serious and fatal cardiac adverse reactions occurred in patients with CLL treated with LuciLena (lenalidomide) .

• Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with MM receiving LuciLena .

• Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue .

• Hepatotoxicity: Hepatic failure including fatalities; monitor liver function. Stop LuciLena and evaluate if hepatotoxicity is suspected .

• Severe Cutaneous Reactions: Discontinue LuciLena for severe reactions .

• Tumor lysis syndrome (TLS) including fatalities: Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions.

• Tumor fare reaction: Serious tumor fare reactions, including fatal reactions, have occurred during investigational use of LuciLena for chronic lymphocytic leukemia and lymphoma.

• 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 .

• Early mortality in MCL: Higher rate of early deaths have occurred in patients with MCL .

• Hypersensitivity: Monitor patients for potential hypersensitivity. Discontinue LuciLena for angioedema and anaphylaxis.

 

ADVERSE REACTIONS

• MM: Most common adverse reactions (≥20%) 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.

• 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.

• Non-Hodgkin’s Lymphoma (NHL: MCL, FL or MZL): Most common adverse reactions (≥15%) included neutropenia, thrombocytopenia, anemia, leukopenia, diarrhea, constipation, nausea, fatigue, pyrexia, cough, upper respiratory tract infection, and rash .

 

DRUG INTERACTIONS

• Digoxin: Monitor digoxin plasma levels periodically due to increased Cmax and AUC with

concomitant LuciLena therapy.

• Concomitant use of erythropoietin stimulating agents or estrogen containing therapies

with LuciLena may increase the risk of thrombosis.

 

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

 

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.