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Revlimid (Lenalidomide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Multiple Myeloma

REVLIMID in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy.

Myelodysplastic Syndromes

REVLIMID is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Mantle Cell Lymphoma

REVLIMID is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

Limitations of Use

REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5)].

DOSAGE AND ADMINISTRATION

REVLIMID should 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 REVLIMID.

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 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 Section 2.4

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
Return to ≥500/mcL Resume REVLIMID at 2.5 mg daily

Other Grade 3 / 4 Toxicities in MDS

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 MDS:

See Section 2.4.

Mantle Cell Lymphoma

The recommended starting dose of REVLIMID is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.

Treatment is continued, modified or discontinued based upon clinical and laboratory findings.

Dose Adjustments for Hematologic Toxicities During MCL Treatment

Dose modification guidelines as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicities considered to be related to REVLIMID.

Platelet counts

Thrombocytopenia during treatment in MCL

When Platelets Recommended Course
Fall to <50,000/mcL Interrupt REVLIMID treatment and follow
CBC weekly
Return to ≥50,000/mcL Resume REVLIMID at 5 mg less than the
previous dose. Do not dose below 5 mg daily

Absolute Neutrophil counts (ANC)

Neutropenia during treatment in MCL

When Neutrophils Recommended Course
Fall to <1000/mcL for at least 7 days
OR
Falls to < 1,000/mcL with an associated temperature ≥ 38.5°C
OR
Falls to < 500 /mcL
Interrupt REVLIMID treatment and follow
CBC weekly
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 MCL

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 MCL:

See Section 2.4.

Starting Dose for Renal Impairment in MM, MDS or MCL

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 non-malignant 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 MM, MDS or MCL are as follows:

Table 1: Starting Dose Adjustments for Patients with Renal Impairment in MM, MDS or MCL
Category Renal Function (Cockcroft-
Gault)
Dose in MM or MCL Dose in MDS
Moderate Renal
Impairment
CLcr 30-60 mL/min 10 mg
Every 24 hours
5 mg
Every 24 hours
Severe Renal Impairment CLcr < 30 mL/min (not
requiring dialysis)
15 mg
Every 48 hours
2.5 mg
Every 24 hours
End Stage Renal Disease CLcr < 30 mL/min (requiring
dialysis)
5 mg
Once daily. On dialysis
days, administer the dose
following dialysis.
2.5 mg
Once daily. On dialysis days,
administer the dose following
dialysis.

After initiation of REVLIMID therapy, subsequent REVLIMID dose modification is based on individual patient treatment tolerance, as described elsewhere (see section 2).

DOSAGE FORMS AND STRENGTHS

REVLIMID 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules will be supplied through the REVLIMID REMS™ program.

REVLIMID is available in the following capsule strengths:

2.5 mg: White and blue-green opaque hard capsules imprinted “REV” on one half and “2.5 mg” on the other half in black ink
5 mg: White opaque capsules imprinted “REV” on one half and “5 mg” on the other half in black ink
10 mg: Blue/green and pale yellow opaque capsules imprinted “REV” on one half and “10 mg” on the other half in black ink
15 mg: Powder blue and white opaque capsules imprinted “REV” on one half and “15 mg” on the other half in black ink
20 mg: Powder blue and blue-green opaque hard capsules imprinted “REV” on one half and “20 mg” on the other half in black ink
25 mg: White opaque capsules imprinted “REV” on one half and “25 mg” on the other half in black ink

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

White and blue-green opaque hard capsules imprinted “REV” on one half and “2.5 mg” on the other half in black ink:

     2.5 mg bottles of 28 (NDC 59572-402-28)

     2.5 mg bottles of 100 (NDC 59572-402-00)

White opaque capsules imprinted “REV” on one half and “5 mg” on the other half in black ink:

     5 mg bottles of 28 (NDC 59572-405-28)

     5 mg bottles of 100 (NDC 59572-405-00)

Blue/green and pale yellow opaque capsules imprinted “REV” on one half and “10 mg” on the other half in black ink:

     10 mg bottles of 28 (NDC 59572-410-28)

     10 mg bottles of 100 (NDC 59572-410-00)

Powder blue and white opaque capsules imprinted “REV” on one half and “15 mg” on the other half in black ink:

     15 mg bottles of 21 (NDC 59572-415-21)

     15 mg bottles of 100 (NDC 59572-415-00)

Powder blue and blue-green opaque hard capsules imprinted “REV” on one half and “20 mg” on the other half in black ink.

     20 mg bottles of 21 (NDC 59572-420-21)

     20 mg bottles of 100 (NDC 59572-420-00)

White opaque capsules imprinted “REV” on one half and “25 mg” on the other half in black ink:

     25 mg bottles of 21 (NDC 59572-425-21)

     25 mg bottles of 100 (NDC 59572-425-00)

Storage

Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature].

Handling and Disposal

Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or crushed. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.

Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.1

Dispense no more than a 28-day supply.

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