Lemide (Lenalidomide) 25mg

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Poster
  • Details
  • Description
  • Packaging Size
    25mg*21capsules/box
  • Strength
    25mg
  • Compositon
    Lenalinomide
  • Treatment
    Treatment of multiple myeloma (MM)
  • Form
    Capsule
  • Brand
    Lemide
  • Quantity Unit
    21capsules/box
  • Manufacturer
    TLPH

Generic name: Lenalidomide

Brand name: Lemide

Dosage form: Capsules.

Strength: 25mg.


Oral administration

  • around the same time every day
  • Swallow capsule whole with water; do not open capsule, chew or break
  • with or without food
  • Monitoring: CBC, Hgb, Hct, pregnancy test, kidney and liver function

myelodysplastic syndrome

Indicates transfusion-dependent anemia associated with deletion 5q cytogenetic abnormalities due to myelodysplastic syndromes (MDS) at low or intermediate 1 risk, with or without other cytogenetic abnormalities

10 mg orally once daily; modify treatment regimen based on clinical and laboratory findings

Continue treatment until disease progression or unacceptable toxicity

multiple myeloma

treat

  • In combination with dexamethasone for the treatment of multiple myeloma (MM)
  • Repeat 28-day cycle Days 1-21 of 25 mg orally once daily (with dexamethasone)
  • Not eligible for autologous HSCT: continue until disease progression or unacceptable toxicity
  • Dexamethasone Timeline
    • On Days 1-4, Days 9-12 and Days 17-20 of the first 28 cycles, 40 mg orally once daily for the first 4 cycles, then
    • 40 mg orally once daily on Days 1-4 every 28 days
    • Age > 75 years: 20 mg orally once daily on days 1, 8, 15 and 22 of each 28-day cycle

maintenance

  • Indicated maintenance therapy for MM after autologous hematopoietic stem cell transplantation (auto-HSCT)
  • Begin after adequate hematologic recovery (ie, ANC ≥ 1000/mcL and/or platelet count ≥ 75,000/mcL)
  • Starting dose: 10 mg orally once daily continuously (ie, repeating Days 1-28 of a 28-day cycle) until disease progression or unacceptable toxicity
  • After 3 cycles: If tolerated, increase dose to 15 mg orally once daily
  • Hematopoietic stem cell mobilization should occur within 4 cycles of lenalidomide-containing therapy

mantle cell lymphoma

MCL for 2 patients with disease recurrence or progression after prior therapy, 1 of which included bortezomib

Repeat 25 mg orally once daily on days 1-21 of a 28-day cycle; modify regimen based on clinical or laboratory findings

Continue until disease progression or unacceptable toxicity

follicular lymphoma or marginal zone lymphoma

In combination with rituximab for the treatment of previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL)

Rituximab 375mg/m2 IV cycle 1 cycle (days 1, 8, 15 and 22) on day 28 of each cycle for cycles 2-5 

Lenalidomide 20 mg orally once daily on days 1-22 every 28 days for up to 12 cycles (Leonard 2019)

Dose Modification (MDS)

Starting dose of 10 mg/day, thrombocytopenia within 4 weeks

  • Baseline ≥ 100,000/mcL
    • Platelet count falls to <50,000/mcL: Interrupt treatment
    • Platelet recovery to ≥50,000/mcL: recovery to 5 mg/day
  • Baseline <100,000/mcL
    • Platelet count falls to 50% of baseline: Interrupt treatment
    • If baseline platelets ≥ 60,000/mcL and recover to ≥ 50,000/mcL: revert to 5 mg/day
    • If baseline platelets <60,000/mcL and recover to ≥30,000/mcL: recover to 5 mg/day

Thrombocytopenia after 4 weeks

  • The starting dose is 5 mg/day
    • Platelet count <30,000/mcL or <50,000/mcL, platelet transfusion: Interrupt treatment
    • Platelet recovery to ≥30,000/mcL (without hemostasis failure): recovery 2.5 mg/day
  • The starting dose is 10 mg/day
    • Platelet count <30,000/mcL or <50,000/mcL, platelet transfusion: Interrupt treatment
    • Platelet count recovery to ≥30,000/mcL (without hemostasis failure): 5 mg/day recovery

Starting dose of 10 mg/day, neutropenia within 4 weeks

  • Baseline ANC <1,000/mcL
    • ANC drops to <750/mcL: interrupt handling
    • ANC recovery to ≥1,000/mcL: recovery to 5 mg/day
  • Baseline ANC > 1,000/mcL
    • ANC drops to <500/mcL: interrupt handling
    • ANC recovery to ≥500/mc/L: recovery to 5 mg/day

Neutropenia after 4 weeks

  • The starting dose is 5 mg/day
    • ANC <500/mcL ≥7 days or fever (≥38.5°C): Interrupt treatment
    • ANC recovery to ≥500/mcL: recovery to 2.5 mg/day
  • The starting dose is 10 mg/day
    • ANC <500/mcL ≥7 days or fever (≥38.5°C): Interrupt treatment
    • Recovery of ANC to ≥500/mcL: Recovery to 5 mg/day

Other grade 3-4 toxicity

  • When toxicity has decreased to ≤ Grade 2, interrupt treatment and at next lower dose at physician's discretion

renal insufficiency

  • CrCl > 60 mL/min: No dose adjustment required
  • CrCl 30-60mL/min: 5mg orally once a day
  • CrCl <30mL/min (non-dialysis dependent): 2.5mg orally once daily
  • CrCl <30 mL/min (dialysis-dependent): 2.5 mg orally once daily; on dialysis days, after dialysis

Dose Modification (MM)

renal insufficiency

  • MM treatment starting dose
    • Follow the same cycle but reduce the dose as listed below
    • CrCl > 60 mL/min: No dose adjustment required
    • CrCl 30-60 mL/min: 10 mg PO qDay; if patient tolerates 10 mg dose without dose-limiting toxicity, consider dose escalation to 15 mg/day after 2 cycles
    • CrCl <30 mL/min (dialysis not required): 15 mg orally every other day
    • CrCl <30 mL/min (dialysis required): 5 mg orally once daily; on dialysis days, after dialysis
  • MM maintenance dose
    • Follow the same cycle, but decrease or increase according to patient tolerance
    • CrCl > 60 mL/min: No dose adjustment required
    • CrCl 30-60mL/min: 5mg orally once a day
    • CrCl <30 mL/min (dialysis not required): 2.5 mg orally every other day
    • CrCl <30 mL/min (dialysis required): 2.5 mg PO qDay; on dialysis days, after dialysis

thrombocytopenia

  • During treatment
    • Platelet count drops to <30,000/mcL: Interrupt treatment and weekly CBC
    • Platelet recovery to ≥30,000/mcL: restart at next lower dose, but not <2.5 mg/day
    • For each subsequent drop <30,000/mcL: Interrupt treatment, then resume at next lower dose when ≥30,000/mcL, but not <2.5 mg/day
  • during maintenance
    • Platelets down to <30,000/mcL: Interrupt treatment and weekly CBC
    • Platelet recovery to ≥30,000/mcL: recovery at next lower dose for days 1-28 of repeat 28-day cycle
  • 5 mg/day during maintenance
    • Platelets drop to <30,000/mcL: Interrupt treatment; do not <5 mg/day for days 1-21 of 28-day cycle
    • Platelet recovery to ≥30,000/mcL: resume 5 mg/day on Days 1-21 of 28-day cycles; do not <5 mg/day per day for Days 1-21 of 28-day cycles

neutropenia

  • During treatment
    • ANC drops to <1,000/mcL: Interrupt treatment, add G-CSF, follow CBC weekly
    • Recovery of ANC to ≥1,000/mcL with neutropenia as only toxicity: return to 25 mg/day or initial dose
    • ANC recovery to ≥1,000/mcL with other toxicities: resume at next lower dose, but <2.5 mg/day mg/day
    • For each subsequent drop <1,000/mcL: Interrupt treatment, then resume at next lower dose when ≥1,000/mcL, but not <2.5 mg/day
  • during maintenance
    • ANC drops to <500/mcL: Interrupt processing; follow CBC weekly
    • Recovery of ANC to ≥500/mcL: Continue to resume next lower dose on Days 1-28 of repeating 28-day cycles
  • 5 mg/day during maintenance
    • ANC drops to <500/mcL: Interrupt treatment; do not <5 mg/day for days 1-21 of 28-day cycle
    • Recovery of ANC to ≥500/mcL: Return to 5 mg/day on Days 1-21 of 28-day cycles; do not <5 mg/day per day for Days 1-21 of 28-day cycles

Other grade 3-4 toxicity

  • during treatment or maintenance
    • When toxicity has decreased to ≤ Grade 2, interrupt treatment and at next lower dose at physician's discretion

Dose adjustment (MCL)

thrombocytopenia

  • Platelets fall to <50,000/mcL: Interrupt treatment
  • Platelet recovery to ≥50,000/mcL: recovery 5 mg/day less than previous dose; do not drop below 5 mg/day

neutropenia

  • ANC falls to <1,000/mcL for at least 7 days or <1,000/mcL with fever (≥38.5°C) or ANC <500/mcL: Interrupt treatment and follow weekly CBC
  • ANC recovery to ≥1,000/mcL: recovery 5 mg/day less than previous dose; do not drop below 5 mg/day

Other grade 3-4 toxicity

  • When toxicity has decreased to ≤ Grade 2, interrupt treatment and at next lower dose at physician's discretion

renal insufficiency

  • Follow the same cycle but reduce the dose as listed below
  • CrCl 30-60mL/min: 10mg orally once a day
  • CrCl <30mL/min: 15mg orally once every 48 hours
  • ESRD: 5 mg orally once daily; on dialysis days, after dialysis

Dose adjustment (FL or MZL)

thrombocytopenia

  • Thrombocytopenia <50,000/mcL: Interrupt dose and follow CBC weekly
  • Platelet recovery to ≥50,000/mcL: If starting dose of 20 mg orally once daily, reduce by 5 mg from previous dose; do not drop below 5 mg qDay dose; if starting dose of 10 mg orally once daily, then Resume 5 mg less than previous dose; do not drop below 2.5 mg orally once daily dose

neutropenia

  • ANC decreased to <1000/mcL ≥7 days, OR decreased to <1000/mcL, temperature ≥38.5°C, or OR decreased <500/mcL: Interrupt dose and follow CBC weekly
  • ANC recovery to ≥1,000/mcL: If starting dose of 20 mg orally once daily, reduce by 5 mg from previous dose; do not drop below 5 mg qDay dose; if starting dose of 10 mg orally once daily, then Resume 5 mg less than previous dose; do not drop below 2.5 mg orally once daily y dose

Other grade 3 or 4 toxicity

  • Other Grade 3 or 4 Toxicity: When toxicity has decreased to ≤ Grade 2, maintain dose and restart at next lower dose level at physician's discretion

renal insufficiency

  • CrCl 30-60mL/min: 10mg PO qDay; after 2 cycles, can be increased to 15mg PO qDay if the patient has tolerated treatment
  • CrCl <30mL/min: 5mg orally once daily
  • ESRD: 5 mg PO qDay; on dialysis days, after dialysis

Orphan Drug Designation

diffuse large cell B lymphoma

Chronic lymphocytic leukemia: In July 2013, FDA halted clinical trial due to significant safety concerns; ORIGIN trial (NCT00910910) showed more mortality in patients treated with lenalidomide compared to patients treated with chlorambucil high

Dosage Considerations

usage restrictions

  • Unspecified and not recommended for the treatment of patients with CLL outside of controlled clinical trials

Adverse reactions

> 10%

  • Thrombocytopenia (62%)
  • Neutropenia (59%)
  • Diarrhea (48%)
  • Pruritus (42%)
  • Nausea (35%)
  • Rash (35%)
  • Fatigue (31%)
  • Constipation (24%)
  • Joint pain (22%)
  • Back pain (21%)
  • Peripheral edema (21%)
  • Get angry (21%)
  • Dizziness (20%)
  • Headache (20%)
  • Cough (19%)
  • Muscle cramps (18%)
  • Difficulty breathing (17%)
  • URTIs (15%)
  • Anemia (12%)
  • Pneumonia (12%)
  • UTIs (11%)

1-10% (Key AE)

  • Tumor flare response – MCL (10%)
  • Abdominal pain (8%)
  • Leukopenia (8%)
  • Myalgia (8%)
  • pain (7%)
  • Bronchitis (6%)
  • Rhinitis (6%)
  • Febrile neutropenia (5%)
  • Peripheral neuropathy (5%)

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