What is lenalidomide (Revlimid)? What is lenalidomide used for?
Lenalidomide (Revlimid) is an oral anti-cancer
medication. Lenalidomide is similar to thalidomide (Thalomid), an older cancer
medicine that, although effective, was associated with serious side effects. The
exact mechanism through which lenalidomide stops the growth of cancer cells is
not understood. Lenalidomide stimulates or regulates the body’s immune system to
attack and kill cancer cells, reduces the formation of new blood vessels that
supply nutrients to the cancer cells, and prevents or stops growth of the
cancer. Laboratory studies have shown that lenalidomide inhibits cancer growth
and causes programmed cell death in certain types of cancers, including multiple
myeloma, mantle cell lymphoma, and del (5q) myelodysplastic syndromes.
Lenalidomide was approved by the FDA Dec. 27, 2005.
What brand names are available for lenalidomide?
Revlimid
Is lenalidomide available as a generic drug?
No
Do I need a prescription for lenalidomide Revlimid?
Yes
What are the side effects of lenalidomide?
Common side effects of lenalidomide are:
- diarrhea,
- itching,
- rash,
- tiredness,
- fatigue,
- neutropenia (a drop in white blood cell count),
- constipation,
- diarrhea,
- muscle cramp,
- anemia,
- fever,
- peripheral edema (swelling in the ankles, feet, or legs),
- nausea,
- back pain,
- upper respiratory tract infection,
- shortness of breath,
- dizziness,
- thrombocytopenia ( a drop in the platelet count),
- tremor, and
- rash.
Lenalidomide may cause some other rare but serious side effects. These include:
- increase risk of death in patients who have chronic lymphocytic leukemia (CLL);
- risk of new cancers;
- severe liver problems;
- serious skin reactions;
- tumor lysis syndrome, or TLS (caused by the fast breakdown of cancer cells);
- formation of blood clots in the arteries, veins, and lungs;
- serious birth defects or death of an unborn baby;
- and worsening of tumors.
What is the dosage for lenalidomide?
Lenalidomide capsules should be swallowed whole with water around the
same time each day.
Multiple myeloma (MM): the recommended starting dose of lenalidomide is 25 mg
by mouth once a day on day 1-21 of repeated 28-day cycles. The recommended dose
of dexamethasone is 40 mg once daily on day 1-4, 9-12, and 17-20 of each 28-day
cycle for the first 4 cycles of therapy, followed by 40 mg once daily on day 1-4
every 28 days thereafter.
Myelodysplastic syndrome (MDS): the recommended starting dose of lenalidomide
is 10 mg by mouth once a day.
Mantle cell lymphoma (MCL): the recommended starting dose of lenalidomide is
25 mg by mouth once a day on days 1-21 of repeated 28 cycles.
As lenalidomide is primarily cleared from the body via the kidneys, dose
adjustments are recommended in patients with moderate or severe kidney disease
and in patients on dialysis.
Which drugs or supplements interact with lenalidomide?
When multiple doses of lenalidomide were administered with digoxin, the blood
levels of digoxin were increased. Patients receiving both medications should be
closely monitored to minimize the occurrence of unwanted side effects.
Due to the increased risk of forming blood clots in the arteries, veins, or
lungs, lenalidomide should be used cautiously in patients using erythropoietin-stimulating agents and estrogen-containing therapies.
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Is lenalidomide safe to take if I’m pregnant or breastfeeding?
Lenalidomide is similar to thalidomide which is a known human
teratogen that causes life-threatening human birth defects or embryo-fetal
death. It should not be used during pregnancy. Lenalidomide is classified as FDA
pregnancy risk category X (animal and human studies have demonstrated harm to
the fetus). A program called Revlimid REMS was developed to prevent fetal
exposure to lenalidomide. Patients, prescribers, and pharmacies must be
registered in the Revlimid REMS programs to receive, prescribe, and dispense
lenalidomide.
Females must not get pregnant for 4 weeks before starting lenalidomide, while
taking lenalidomide, during any breaks in treatment, and for 4 weeks after
stopping lenalidomide.
As lenalidomide may pass into human semen, all males taking lenalidomide must
use a latex or synthetic condom during any sexual contact with a pregnant female
or a female who can become pregnant. Male patients should not donate sperm while
taking lenalidomide, during any breaks in treatment, and for 4 weeks after
stopping lenalidomide.
Lenalidomide should not be used by females who are
breastfeeding. It is not known whether lenalidomide is excreted in breast milk
and its effect on the nursing infant.
What else should I know about lenalidomide?
What preparations of lenalidomide are available?
Oral capsules: 2.5, 5, 10, 15, 20, and 25 mg.
How should I keep lenalidomide stored?
Capsules should be stored at room temperature, between 15 C and 30 C
(59 F to 86 F). It is extremely important to keep this medication away from
children, pets, and pregnant females due to the high risk of serious side
effects associated with accidental exposure.