Other Toxicities in MM

For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.

Starting Dose Adjustment for Renal Impairment in MM

[see Dosage and Administration (2.4)].

2.2 Myelodysplastic Syndromes
 
The recommended starting dose of REVLIMID is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings.

Dose Adjustments for Hematologic Toxicities During MDS Treatment

Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:

Platelet counts

If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS

If baseline ≥100,000/mcL 
When Platelets Recommended Course
Fall to <50,000/mcL Interrupt REVLIMID treatment
Return to ≥50,000/mcL Resume REVLIMID at 5 mg daily
If baseline <100,000/mcL 
When Platelets Recommended Course
Fall to 50% of the baseline value Interrupt REVLIMID treatment
If baseline ≥60,000/mcL and
returns to ≥50,000/mcL Resume REVLIMID at 5 mg daily
If baseline <60,000/mcL and
returns to ≥30,000/mcL Resume REVLIMID at 5 mg daily

If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS

When Platelets Recommended Course
<30,000/mcL or <50,000/mcL
with platelet transfusions Interrupt REVLIMID treatment
Return to ≥30,000/mcL
(without hemostatic failure) Resume REVLIMID at 5 mg daily

Patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows:

If thrombocytopenia develops during treatment at 5 mg daily in MDS

When Platelets Recommended Course
<30,000/mcL or <50,000/mcL
with platelet transfusions Interrupt REVLIMID treatment
Return to ≥30,000/mcL
(without hemostatic failure) Resume REVLIMID at 2.5 mg daily

Patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted as follows:

Absolute Neutrophil counts (ANC)

If neutropenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS

If baseline ANC ≥1,000/mcL 
When Neutrophils Recommended Course
Fall to <750/mcL Interrupt REVLIMID treatment
Return to ≥1,000/mcL Resume REVLIMID at 5 mg daily
If baseline ANC <1,000/mcL 
When Neutrophils Recommended Course
Fall to <500/mcL Interrupt REVLIMID treatment
Return to ≥500/mcL Resume REVLIMID at 5 mg daily

If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS

When Neutrophils Recommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C) Interrupt REVLIMID treatment
Return to ≥500/mcL Resume REVLIMID at 5 mg daily

Patients who experience neutropenia at 5 mg daily should have their dosage adjusted as follows:

If neutropenia develops during treatment at 5 mg daily in MDS

When Neutrophils Recommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C) Interrupt REVLIMID treatment