REVLIMID®
(lenalidomide) may cause birth defects or death to an unborn baby if taken during
pregnancy. Do not take REVLIMID®
if you are pregnant or plan on becoming pregnant.
Female patients must not get pregnant.
Female patients who are pregnant or who plan to become pregnant must not take REVLIMID®. Female patients who can get pregnant
will get regular pregnancy testing. Female patients who can become pregnant must
agree to use 2 separate forms of effective birth control at the same time, 4 weeks
before, while taking, and for 4 weeks after stopping REVLIMID®.
It is not known if REVLIMID®
passes into semen.
Male patients, including those who have had a vasectomy, must use a latex condom
during any sexual contact with a pregnant female or a female that can become pregnant
while taking REVLIMID® and for
4 weeks after stopping REVLIMID®.
If you get pregnant while taking REVLIMID®, stop taking it right away and call
your healthcare professional. Female partners of males taking REVLIMID® should call their healthcare professional
right away if they get pregnant. Healthcare professionals and patients should
report all cases of pregnancy to:
FDA MedWatch at 1-800-FDA-1088, and
Celgene Corporation at 1-888-423-5436
To avoid fetal exposure, REVLIMID® is only available under a special restricted
distribution program called RevAssist®.
To receive REVLIMID® you must
be registered with and do everything required in the RevAssist®
program.
REVLIMID®
is associated with low neutrophils (a type of white blood cell) and platelets (which
help stop bleeding). You should have your blood counts monitored weekly for the
first 8 weeks of therapy and at least monthly thereafter.
In patients with certain medical conditions, REVLIMID® has shown an increased chance for
blood clots in the veins and in the lungs. Contact your healthcare professional
immediately if you experience any of the following: shortness of breath, chest pain,
or swelling in the arms or legs.
Breastfeeding
It is not known if REVLIMID®
is passed into breast milk.
If you are breastfeeding, please talk to your healthcare
professional to decide if you should stop nursing or stop taking REVLIMID®.
Taking other medications
Medications taken together can interact and lead
to serious side effects.
Always let your healthcare professional know which
medications you are taking.
This includes prescription and non-prescription medicine,
vitamins, and herbal supplements.
Talk to your healthcare professional if you have a history of kidney problems
REVLIMID®
is mostly eliminated from your body through your kidneys.
Your healthcare professional may monitor your kidney
function and may adjust your dose of REVLIMID®,
if necessary.
Elderly patients may be at greater risk for kidney
problems, so please consult your healthcare professional.
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.
