Revlimid- high dose dex dosage schedule (high-dose dexamethasone): Month* 1-4
Day 1

Rev + dex
Day 2

Rev + dex
Day 3

Rev + dex
Day 4

Rev + dex
Day 5

Rev
Day 6

Rev
Day 7

Rev
Day 8

Rev
Day 9

Rev + dex
Day 10

Rev + dex
Day 11

Rev + dex
Day 12

Rev + dex
Day 13

Rev
Day 14

Rev
Day 15

Rev
Day 16

Rev
Day 17

Rev + dex
Day 18

Rev + dex
Day 19

Rev + dex
Day 20

Rev + dex
Day 21

Rev
Day 22 - 28: Rest

Rev + dex = Revlimid plus dexamethasone (Revlimid-dex)
* 28 day treatment cycle

 

Revlimid- high dose dex dosage schedule: Month* 5 and beyond
Day 1

Rev + dex
Day 2

Rev + dex
Day 3

Rev + dex
Day 4

Rev + dex
Day 5

Rev
Day 6

Rev
Day 7

Rev
Day 8

Rev
Day 9

Rev
Day 10

Rev
Day 11

Rev
Day 12

Rev
Day 13

Rev
Day 14

Rev
Day 15

Rev
Day 16

Rev
Day 17

Rev
Day 18

Rev
Day 19

Rev
Day 20

Rev
Day 21

Rev
Day 22 - 28: Rest

Rev + dex = Revlimid plus dexamethasone (Revlimid-dex)
* 28 day treatment cycle

 

 

 

Revlimid-low dex dose schedule: Monthly schedule
Day 1

Rev + dex
Day 2

Rev
Day 3

Rev
Day 4

Rev
Day 5

Rev
Day 6

Rev
Day 7

Rev
Day 8

Rev + dex
Day 9

Rev
Day 10

Rev
Day 11

Rev
Day 12

Rev
Day 13

Rev
Day 14

Rev
Day 15

Rev + dex
Day 16

Rev
Day 17

Rev
Day 18

Rev
Day 19

Rev
Day 20

Rev
Day 21

Rev
Day 22 - 28: Rest

Rev + dex = Revlimid plus dexamethasone (Revlimid-dex)
* 28 day treatment cycle

 

 

Common Side Effects: Large Revlimid/Dex Studies (Phase III Trials)
Side Effect Revlimid/Dex(n=346) Placebo/Dex(n=345)
Mild or Moderate (grade 1-2) Severe (grade 3-4) Mild or Moderate (grade 1-2) Severe (grade 3-4)
Constipation 37% 2% 19% 0%
Fatigue 32% 6% 33% 4%
Insomnia 32% 0% 37% 0%
Muscle cramp 30% 0% 21% 0%
Diarrhea 27% 2% 24% 0.6%
Low white blood cell count (neutropenia)* 7% 21% 2% 3%
Anemia* 17% 8% 14% 3%
Weakness/loss of strength (asthenia) 19% 4% 20% 5%
Fever 22% 1% 17% 2%
Nausea 22% 0% 19% 0%
Headache 21% 0% 21% 0%
Swelling of arms/legs 21% 0% 19% 0%
Dizziness 21% 0% 15% 0%
Shortness of breath 17% 3% 13% 2%
Tremor (involuntary movements/shakiness) 20% 0% 7% 0%
Decreased weight 18% 0% 14% 0%
Low platelet counts (thrombocytopenia)* 7% 10% 4% 6%
Rash** 16% 0% 8% 0%
Back pain 15% 0% 14% 0%
Elevated blood sugar 8% 7%* 6% 8%
Muscle weakness 10% 5% 12% 3%
Blood clots* | Vein (Deep Vein Thrombosis, DVT) 1% 7% 0% 3%
Lung (Pulmonary Embolism) 0% 3% 0% 1%

* Includes life-threatening side effect (grade 4) in >1% of patients
** Another study did not show an increase in rash

 

Starting Dose for Patients with Renal Impairment
Degree of Renal Impairment: Revlimid Dose:
Moderate* 10mg every 24 hours
Severe+ 15mg every 48 hours
End Stage, requiring dialysis++ 5 mg once daily. On the dialysis days, Revlimid should be given after dialysis.

*Moderate: 30 < CLcr < 60mL/min
+Severe: CLcr < 30 mL/min; dialysis not required
++End Stage, requiring dialysis: CLcr < 30 mL/min

 

Guidelines for Additional Revlimid Dose Changes for Serious Side Effects*

 

Low Platelet Counts
When Platelet Counts: Recommendation:
Fall to <30,000/mcL

Return to ≥30,000/mcL
  • Interrupt Revlimid treatment.
  • Check platelet counts with weekly blood tests
  • Restart Revlimid at a lower dose, usually 15 mg daily*
For each subsequent drop <30,000/mcL

Return to ≥30,000/mcL
  • Interrupt Revlimid treatment.
  • Resume Revlimid at 5 mg less than the previous dose.
  • Do not go below a 5 mg daily dose

*Typical starting dose of Revlimid is 25mg/day, Minimum dose: 5 mg/day

 

 

Low White Blood Cell Counts
When White Blood Cells: Recommendation:
Fall to <1000/mcL

Return to ≥1000/mcL and low white blood cells is the only side effect
  • Interrupt Revlimid treatment
  • Add white blood cell growth factor (granulocyte colony-stimulating factor known as G-CSF)
  • Check white blood cell counts weekly (blood tests )
  • Resume Revlimid at 25 mg daily
Return to ≥1000/mcL , but the patient is experiencing other side effects
  • Resume Revlimid at 15 mg daily
For each subsequent drop <1000/mcL

Return to ≥1000/mcL
  • Interrupt Revlimid treatment
  • Resume Revlimid at 5 mg less than the previous dose.
  • Do not go below a 5 mg daily dose

 

Other Serious Side Effects (Potentially life-threatening, grade 3 or 4)

For other serious side effects considered to be related to Revlimid, your doctor will temporarily stop treatment. After the side effect has significantly improved (to a mild or moderate level or ≤ grade 2) Revlimid can be re-started at a lower dose.