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Dosing and Administration
REVLIMID® (lenalidomide) + dex combination therapy: given in 28-day cycles
REVLIMID®-start at 25 mg/day orally with water for days 1-21 of repeated 28-day cycles.
Dex-start at 40 mg/day orally:
Days 1-4, 9-12, and 17-20 of each 28-day cycle for first 4 cycles
Days 1-4 of every 28-day cycle thereafter
Dosing is continued or modified based on clinical and laboratory findings.
Monitor complete blood counts every 2 weeks for the first 12 weeks, then monthly thereafter.
REVLIMID® is known to be substantially excreted by the kidney. Because the risk of toxic reactions may be greater in patients with impaired renal function, care should be taken in dose selection, and it would be prudent to monitor renal function.
REVLIMID® dose adjustment during treatment
In the 2 randomized, placebo-controlled Phase III clinical studies:
75% of patients remained at REVLIMID® 25-mg dose at the end of the study.
In the REVLIMID® + dex group, 45% of patients underwent at least one dose interruption with or without a dose reduction of REVLIMID® compared to 21% in the placebo + dex group. Of these patients, 50% in the REVLIMID® + dex group underwent at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo + dex group.
Median time to first dose reduction in REVLIMID® + dex groups was 67 days.
Dose modification for managing grade 3 or 4 neutropenia or thrombocytopenia in patients with multiple myeloma
Platelet Counts
When counts
Recommended course
Fall to <30,000/mcL
Interrupt REVLIMID® treatment, follow CBC weekly
Return to >30,000/mcL
Resume REVLIMID® at 15 mg daily
For each subsequent drop to <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
Neutrophil Counts (ANC)*
When counts
Recommended course
Fall to <1000/mcL
Interrupt REVLIMID® treatment, add G-CSF, and follow CBC weekly
Return to >1000/mcL and neutropenia is the only toxicity
Resume REVLIMID® at 25 mg daily
Return to >1000/mcL and if other toxicity
Resume REVLIMID® at 15 mg daily
For each subsequent drop to <1000/mcL
Interrupt REVLIMID® treatment
Return to >1000/mcL
Resume REVLIMID® at 5 mg less than the previous dose. Do not dose below 5 mg daily
*Absolute neutrophil count
For other Grade 3/4 toxicities judged to be related to lenalidomide, hold treatment and restart at next lower dose level when toxicity has resolved to < Grade 2.
REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
REVLIMID® (lenalidomide) is indicated for 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.
Important Safety Information
WARNINGS:
1. POTENTIAL FOR HUMAN BIRTH DEFECTS.
Lenalidomide is an analogue of thalidomide. Thalidomide is a known human teratogen
that causes severe life-threatening human birth defects. If lenalidomide is taken
during pregnancy, it may cause birth defects or death to an unborn baby. Females
should be advised to avoid pregnancy while taking REVLIMID®
(lenalidomide).
Special Prescribing Requirements
Because of this potential toxicity and to avoid fetal
exposure to REVLIMID® (lenalidomide),
REVLIMID® (lenalidomide) is only
available under a special restricted distribution program. This program is called
“RevAssist®”. Under this program,
only prescribers and pharmacists registered with the program can prescribe and dispense
the product. In addition, REVLIMID®
(lenalidomide) must only be dispensed to patients who are registered and meet all
the conditions of the RevAssist® program.
2. HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA).
This drug is associated with significant neutropenia and thrombocytopenia. Eighty
percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction
during the major study. Thirty-four percent of patients had to have a second dose
delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled
in the study. Patients on therapy for del 5q myelodysplastic syndromes should have
their complete blood counts monitored weekly for the first 8 weeks of therapy and
at least monthly thereafter. Patients may require dose interruption and/or reduction.
Patients may require use of blood product support and/or growth factors. (see DOSAGE
and ADMINISTRATION)
3. DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM.
This drug has demonstrated a significantly increased risk of deep venous thrombosis
(DVT) and pulmonary embolism (PE) in patients with multiple myeloma who were treated
with REVLIMID® (lenalidomide)
combination therapy. Patients and physicians are advised to be observant for the
signs and symptoms of thromboembolism. Patients should be instructed to seek medical
care if they develop symptoms such as shortness of breath, chest pain, or arm or
leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet
therapy prescribed in conjunction with REVLIMID®
(lenalidomide) may lessen the potential for venous thromboembolic events. The decision
to take prophylactic measures should be done carefully after an assessment of an
individual patient’s underlying risk factors.
You can get the information about REVLIMID®
(lenalidomide) and the RevAssist®
program on the Internet at www.REVLIMID.com or by calling the manufacturer's
toll-free number at
1-888-423-5436.
In the pooled multiple myeloma studies, Grade 3 and 4 hematologic toxicities were more frequent in patients treated with the combination of REVLIMID® (lenalidomide) and dexamethasone than in patients treated with dexamethasone alone
Patients on therapy should have their complete blood counts monitored every 2 weeks for the first 12 weeks and then monthly thereafter
Patients may require dose interruption and/or dose reduction
CONTRAINDICATIONS: Hypersensitivity:
REVLIMID®(lenalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components
PRECAUTIONS: Renal impairment:
Since lenalidomide is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID® (lenalidomide) are recommended to provide appropriate drug exposure in patients with moderate or severe (CLcr < 60 mL/min) renal impairment and in patients on dialysis
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it would be prudent to monitor renal function
Nursing mothers:
It is not known whether REVLIMID® (lenalidomide) is excreted in human milk
Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother
ADVERSE REACTIONS: Multiple Myeloma
In the REVLIMID® (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of REVLIMID® (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group
Of these patients who had one dose interruption with or without a dose reduction, 50% in the REVLIMID® (lenalidomide)/dexamethasone treatment group underwent at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group
Most adverse events and Grade 3/4 adverse events were more frequent in MM patients who received the combination of REVLIMID® (lenalidomide)/dexamethasone compared to placebo/dexamethasone
Other adverse events reported in multiple myeloma patients (REVLIMID® (lenalidomide)/dexamethasone vs dexamethasone/placebo): constipation (39% vs 19%), fatigue (38% vs 37%), insomnia (32% vs 37%), muscle cramp (30% vs 21%), diarrhea (29% vs 25%), neutropenia (28% vs 5%), anemia (24% vs 17%), asthenia (23% vs 25%), pyrexia (23% vs 19%), nausea (22% vs 19%), headache (21% vs 21%), peripheral edema (21% vs 19%), dizziness (21% vs 15%), dyspnea (20% vs 15%), tremor (20% vs 7%), decreased weight (18% vs 14%), thrombocytopenia (17% vs 10%), rash (16% vs 8%), back pain (15% vs 14%), hyperglycemia (15% vs 14%), and muscle weakness (15% vs 15%).
Myelodysplastic Syndromes
Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events observed in the del 5q MDS population
Other adverse reactions reported in del 5q MDS patients (REVLIMID® (lenalidomide)): diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%), dyspnea (17%), and pharyngitis (16%).
DOSAGE AND ADMINISTRATION:
Dosing is continued or modified based upon clinical and laboratory findings. Dosing modifications are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID® (lenalidomide)
For other Grade 3 or 4 toxicities judged to be related to REVLIMID® (lenalidomide), hold treatment and restart at next lower dose level when toxicity has resolved to less than or equal to Grade 2
Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and ADVERSE REACTIONS.
