Revlimid Dosage

Generic name: lenalidomide
Dosage form: capsule

This dosage information does not include all the information needed to use Revlimid safely and effectively. See full prescribing information for Revlimid.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

​REVLIMIDshould be taken orally at about the same time each day, either with or without food. REVLIMID capsules should be swallowed whole with water. The capsules should not be opened, broken, or chewed.

Multiple Myeloma

​The recommended starting dose of REVLIMID is 25 mg once daily on Days 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg once daily on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on Days 1-4 every 28 days. Treatment is continued or modified based upon clinical and laboratory findings.

Dose Adjustments for Hematologic Toxicities During Multiple Myeloma Treatment

Dose modification guidelines, as summarized below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to lenalidomide.

Platelet counts

Thrombocytopenia in MM

When Platelets Recommended Course
Fall to <30,000/mcL Interrupt REVLIMID treatment, follow CBC
weekly
Return to ≥30,000/mcL Restart REVLIMID at 15 mg daily
For each subsequent drop <30,000/mcL Interrupt REVLIMID treatment
Return to ≥30,000/mcL Resume REVLIMID at 5 mg less than the
previous dose. Do not dose below 5 mg daily

Absolute Neutrophil counts (ANC)

Neutropenia in MM

When Neutrophils Recommended Course
Fall to <1000/mcL Interrupt REVLIMID treatment, add G-CSF,
follow CBC weekly
Return to ≥1,000/mcL and neutropenia is the only toxicity Resume REVLIMID at 25 mg daily
Return to ≥1,000/mcL and if other toxicity Resume REVLIMID at 15 mg daily
For each subsequent drop <1,000/mcL Interrupt REVLIMID treatment
Return to ≥1,000/mcL Resume REVLIMID at 5 mg less than the
previous dose. Do not dose below 5 mg daily

Other Grade 3 / 4 Toxicities in MM

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

Starting Dose Adjustment for Renal Impairment in MM
Since REVLIMID is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to nonmalignant conditions, REVLIMID starting dose adjustment is recommended for patients with CLcr < 60 mL/min. Non-dialysis patients with creatinine clearances less than 11 mL/min and dialysis patients with creatinine clearances less than 7 mL/min have not been studied. The recommendations for initial starting doses for patients with multiple myeloma (MM) are as follows:

Table 1: Starting Dose Adjustment for Renal Impairment in Multiple Myeloma (Days 1 – 21 of each 28 day cycle)
Category Renal Function
(Cockcroft-Gault)
                        Dose
Moderate Renal
Impairment
CLcr 30-60 mL/min 10 mg
Every 24 hours
Severe Renal
Impairment
CLcr < 30 mL/min (not
requiring dialysis)
15 mg
Every 48 hours
End Stage Renal
Disease
CLcr < 30 mL/min (requiring
dialysis)
5 mg
Once daily. On dialysis days, administer
the dose following dialysis.

After initiation of REVLIMID therapy, subsequent REVLIMID dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section.

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 every other day

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
Return to ≥500/mcL Resume REVLIMID at 2.5 mg every other day

Other Grade 3 / 4 Toxicities in MDS
For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at next lower dose level when toxicity has resolved to ≤ Grade 2.

Starting Dose Adjustment for Renal Impairment in MDS:
Since REVLIMID is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to nonmalignant conditions, REVLIMID starting dose adjustment is recommended for patients with CLcr < 60 mL/min. Non-dialysis patients with creatinine clearances less than 11 mL/min and dialysis patients with creatinine clearances less than 7 mL/min have not been studied. The recommendations for initial starting doses for patients with myelodysplastic syndromes (MDS) are as follows:

Table 2: Starting Dose Adjustment for Renal Impairment in Myelodysplastic Syndromes (Days 1 – 28 of each 28 day cycle)
Category Renal Function
(Cockcroft-Gault)
Dose
Moderate Renal
Impairment
CLcr 30-60 mL/min 5 mg
Every 24 hours
Severe Renal
Impairment
CLcr < 30 mL/min (not requiring dialysis) 2.5 mg
Every 24 hours
End Stage Renal
Disease
CLcr < 30 mL/min (requiring dialysis) 2.5 mg once daily. On dialysis days,
administer the dose following dialysis.

After initiation of REVLIMID therapy, subsequent REVLIMID dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section.

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