Click "OK" to proceed or "CANCEL" to return to REVLIMID.com.
Skin Disorders
People taking REVLIMID®
(lenalidomide) may experience skin problems or discomfort. Although these symptoms
may be mild, serious skin reactions have been reported.
Dry skin, itchiness, and rash
It is not unusual to experience patches of dry skin and
itchiness while you are taking REVLIMID®.
If you get any kind of rash, call your healthcare professional to discuss the best
way to treat it.
If you notice any changes in your body or in the way
you feel, it's very important that you tell your healthcare professional right away.
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
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
ADDITIONAL WARNINGS: HEMATOLOGIC
TOXICITY
Multiple Myeloma
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:
Pregnancy Category X:
Lenalidomide is contraindicated in pregnant women and women capable
of becoming pregnant. When there is no alternative, females of childbearing potential
may be treated with lenalidomide provided adequate precautions are taken to avoid
pregnancy
Hypersensitivity:
REVLIMID® (lenalidomide)
is contraindicated in any patients who have demonstrated hypersensitivity to the
drug or its components
PRECAUTIONS:
Angioedema, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis:
Angioedema and serious dermatologic reactions including Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events
can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide
treatment should not receive REVLIMID®
(lenalidomide). REVLIMID® (lenalidomide)
interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID® (lenalidomide) must be discontinued
for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected,
and should not be resumed following discontinuation for these reactions
Tumor Lysis Syndrome:
Lenalidomide has antineoplastic activity and therefore the complications
of tumor lysis syndrome may occur. The patients at risk of tumor lysis syndrome
are those with high tumor burden prior to treatment. These patients should be monitored
closely and appropriate precautions taken
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.
