Tables

Revlimid- high dose dex dosage schedule: Month* 1-4

D1 Rev + dex	D2 Rev + dex	D3 Rev + dex	D4 Rev + dex	D5 Rev	D6 Rev	D7 Rev
D8 Rev	D9 Rev + dex	D10 Rev + dex	D11 Rev + dex	D12 Rev + dex	D13 Rev	D14 Rev
D15 Rev	D16 Rev	D17 Rev + dex	D18 Rev + dex	D19 Rev + dex	D20 Rev + dex	D21 Rev
D22 – D28: Rest period

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

D1 Rev + dex	D2 Rev + dex	D3 Rev + dex	D4 Rev + dex	D5 Rev	D6 Rev	D7 Rev
D8 Rev	D9 Rev	D10 Rev	D11 Rev	D12 Rev	D13 Rev	D14 Rev
D15 Rev	D16 Rev	D17 Rev	D18 Rev	D19 Rev	D20 Rev	D21 Rev
D22 – D28: Rest period

D = Day; Rev + dex = Revlimid plus dexamethasone (Revlimid-dex)

* 28 day treatment cycle

Revlimid-low dex dose schedule: Monthly schedule

D1 Rev + dex	D2 Rev	D3 Rev	D4 Rev	D5 Rev	D6 Rev	D7 Rev
D8 Rev + dex	D9 Rev	D10 Rev	D11 Rev	D12 Rev	D13 Rev	D14 Rev
D15 Rev + dex	D16 Rev	D17 Rev	D18 Rev	D19 Rev	D20 Rev	D21 Rev
D22 dex (No Rev)
D23 – D28: Rest period

D23 – D28: Rest period

D = Day; 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) Lung (Pulmonary Embolism)	1% 0%	7% 3%	0% 0%	3% 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.