Lemide (Lenalidomide) 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

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

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

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

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

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

usage restrictions

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

Adverse reactions