Leavdo

Leavdo

lenalidomide

Manufacturer:

TTY Biopharm

Distributor:

American Taiwan Biopharm

Marketer:

American Taiwan Biopharm
Concise Prescribing Info
Contents
Lenalidomide
Indications/Uses
As monotherapy for the maintenance treatment of adults w/ newly diagnosed multiple myeloma (NDMM) who have undergone autologous stem cell transplantation (ASCT); w/ transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated w/ an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate; w/ relapsed or refractory mantle cell lymphoma (MCL). As combination therapy for adults w/ previously untreated multiple myeloma who are not eligible for transplant. In combination w/ dexamethasone for multiple myeloma in adults who have received at least 1 prior therapy. In combination w/ rituximab for adults w/ previously treated follicular lymphoma (FL).
Dosage/Direction for Use
Adult NDMM Patients who are not eligible for transplant In combination w/ dexamethasone: Initially lenalidomide 25 mg once daily on days 1-21 of repeated 28-day cycles w/ dexamethasone 40 mg once daily on days 1, 8, 15 & 22 of repeated 28-day cycles. In combination w/ bortezomib & dexamethasone: Initially lenalidomide 25 mg once daily on days 1-14 of each 21-day cycle w/ bortezomib 1.3 mg/m2 SC inj twice wkly on days 1, 4, 8 & 11 of each 21-day & combine w/ dexamethasone until progression. In combination w/ melphalan & prednisone followed by lenalidomide maintenance: Initially lenalidomide 10 mg once daily on days 1-21 of repeated 28-day cycles for up to 9 cycles w/ melphalan 0.18 mg/kg on days 1-4 of repeated 28-day cycles, & w/ prednisone 2 mg/kg on days 1-4 repeated 28-day cycles. Patients who complete 9 cycles or who are unable to complete the combination therapy due to intolerance 10 mg once daily on days 1-21 of repeated 28-day cycles given until disease progression. Patients >75 yr In combination w/ dexamethasone: Initially 20 mg once daily on days 1, 8, 15, & 22 of each 28-day treatment cycle. ASCT Initially 10 mg once daily continuously (on days 1-28 of repeated 28-day cycles) given until disease progression or intolerance. May be increased to 15 mg once daily after 3 cycles of lenalidomide maintenance. Multiple myeloma w/ at least 1 prior therapy In combination w/ dexamethasone: Initially lenalidomide 25 mg once daily for days 1-21 of repeated 28-day cycles w/ dexamethasone 40 mg once daily on days 1-4, 9-12 & 17-20 each 28-day cycle for the first 4 cycles of therapy, & then 40 mg once daily on days 1-4 every 28 days. End-stage renal disease CrCl <30 mL/min (requiring dialysis) 5 mg once daily. On dialysis days, the dose should be administered following dialysis. Severe renal impairment CrCl <30 mL/min (not requiring dialysis) 7.5 mg once daily; 15 mg every other day. Moderate renal impairment CrCl 30-50 mL/min 10 mg once daily. May be escalated to 15 mg once daily after 2 cycles if patient is not responding to treatment & is tolerating the treatment. MDS Initially 10 mg once daily on days 1-21 of repeated 28-day cycles. End-stage renal disease CrCl <30 mL/min (requiring dialysis) Dose should be administered following dialysis. Initially 2.5 mg once daily on days 1-21 of repeated 28-day cycles. Dose level -1: 2.5 mg once daily on days 1-28 of repeated 28-day cycles. Dose level -2: 2.5 mg twice a wk on days 1-28 of repeated 28-day cycles. Severe renal impairment CrCl <30 mL/min (not requiring dialysis) Initially 2.5 mg once daily on days 1-21 of repeated 28-day cycles. Dose level -1: 2.5 mg every other day on days 1-28 of repeated 28-day cycles. Dose level -2: 2.5 mg twice a wk on days 1-28 of repeated 28-day cycles. Moderate renal impairment CrCl 30-50 mL/min Initially 5 mg once daily on days 1-21 of repeated 28-day cycles. Dose level -1: 2.5 mg once daily on days 1-28 of repeated 28-day cycles. Dose level -2: 2.5 mg once every other day on days 1-28 of repeated 28-day cycles. MCL Initially 25 mg once daily for days 1-21 of repeated 28-day cycles. End-stage renal disease CrCl <30 mL/min (requiring dialysis) 5 mg once daily on days 1-21 of repeated 28-day cycles. On dialysis days, administer dose following dialysis. Severe renal impairment CrCl <30 mL/min (not requiring dialysis) 7.5 mg once daily on days 1-21 of repeated 28-day cycles; 15 mg every other day. Moderate renal impairment CrCl 30-50 mL/min 10 mg once daily. Dose may be escalated 15 mg once daily after 2 cycles if patient is not responding to treatment & is tolerating the treatment. FL In combination w/ rituximab: Initially lenalidomide 20 mg once daily for days 1-21 of repeated 28-day cycles for up to 12 cycles of treatment w/ rituximab initially 375 mg/m2 IV every wk in cycle 1 (days 1, 8, 15, & 22) & day 1 of every 28-day cycle for cycles 2 through 5. Moderate renal impairment CrCl 30-60 mL/min 10 mg once daily on days 1-21 of repeated 28-day cycles. Dose may be escalated to 15 mg once daily after 2 cycles if patient is not responding to treatment & is tolerating the treatment.
Administration
May be taken with or without food: Take at the same time each day. Swallow whole, do not open/break/chew.
Contraindications
Hypersensitivity. Women of childbearing potential. Pregnancy.
Special Precautions
Allergic/hypersensitivity reactions; discontinue for exfoliative or bullous rash or if Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction w/ eosinophilia & systemic symptoms (DRESS). Perform pregnancy test prior initiation of therapy & repeated at least every 4 wk including at least 4 wk after the end of treatment. Do not donate blood during therapy or for at least 7 days following discontinuation. Closely monitor patients w/ known risk factors of MI including prior thrombosis, & should minimize all modifiable risk factors eg, smoking, HTN & hyperlipidemia. Increased risk of venous & arterial thromboembolic events. Concomitant use w/ erythropoeitic agents or other agents that increase risk of thrombosis eg, hormone replacement therapy; myelosuppressive agents. Perform CBC including WBC w/ differential count, platelet count, Hb & haematocrit every wk for the first 8 wk of treatment & mthly thereafter. Promptly report febrile episodes. Observe signs & symptoms of bleeding including petechiae & epistaxes, especially in patients in concomitant use w/ medicinal products susceptible to induce bleeding. Grade 4 neutropenia & febrile neutropenia; grade 3 & 4 thrombocytopenia. Optimal control of comorbid conditions influencing thyroid function prior to start of treatment & baseline & ongoing monitoring is recommended. Peripheral neuropathy. Closely monitor patients at risk of tumour lysis syndrome & tumour flare reaction especially during the 1st cycle or dose-escalation. Not recommended in patients w/ high tumour burden. Patients w/ galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Carefully evaluate for occurrence of hematologic secondary primary malignancies prior to initiating & during treatment. Hepatic disorders; monitor liver function, particularly when there is history of or concurrent viral liver infection or when combined w/ medicinal products known to be associated w/ liver dysfunction. Closely monitor patients w/ known risk factors to develop infections including pneumonia; for signs & symptoms of active HBV infection throughout therapy. Patients previously infected w/ HBV, including anti-HBc positive but HBsAg negative. Permanently discontinue if progressive multifocal leukoencephalopathy is confirmed. Regular monitoring of visual ability is recommended due to risk of cataract in prolonged use. Minor or moderate influence on the ability to drive or use machines. Women of childbearing potential must use at least 1 effective method of contraception at least 4 wk before therapy, during therapy & until 4 wk after therapy. Discontinue breast-feeding during therapy. Patients >75 yr, ISS stage III, ECOG PS 2 or CrCl <60 mL/min.
Adverse Reactions
Pneumonia, lung infection; hypotension, dehydration; renal failure (including acute); febrile neutropenia, anemia; venous thromboembolism, grade 4 neutropenia; grade 3 or 4 neutropenia, febrile neutropenia & grade 3 or 4 thrombocytopenia; neutropenia, pulmonary embolism, diarrhea. Neutropenia, bronchitis, diarrhea, nasopharyngitis, muscle spasms, leucopenia, asthenia, cough, thrombocytopenia, gastroenteritis, pyrexia; fatigue, peripheral neuropathy, constipation, hypocalcaemia; back pain, insomnia, rash, decreased appetite; anemia, peripheral oedema; muscle cramp; nausea, pruritus.
Drug Interactions
Increased risk of thrombosis w/ erythropoietic agents, or other agents eg, hormone replacement therapy. Increase plasma exposure of digoxin. Increased risk of rhabdomyolysis w/ statins.
ATC Classification
L04AX04 - lenalidomide ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Leavdo cap 25 mg
Packing/Price
3 × 7's
Form
Leavdo cap 5 mg
Packing/Price
3 × 7's
Form
Leavdo cap 10 mg
Packing/Price
3 × 7's
Form
Leavdo cap 15 mg
Packing/Price
3 × 7's
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