The FDA ( U.S. Food and Drug Administration ) has approved the drug Revlimid ( Lenalidomide ) for the treatment of patients with a subtype of myelodysplastic syndrome ( MSD ).
The subtype is MDS patients with deletion 5q cytogenetic abnormality.

Myelodysplastic syndrome is a collection of disorders in which the bone marrow does not function normally and the body does not make enough normal blood cells.
Patients with myelodysplastic syndrome may need blood and platelet transfusions and antibiotic therapy for infections.

In clinical trials, patients treated with Revlimid no longer needed transfusions, with most patients becoming independent of transfusion by three months.
The transfusion-free period lasted for an average of 44 weeks.

Myelodysplastic syndrome can develop following treatment with drugs or radiation therapy for other diseases, or it can develop without any known cause.
Some forms of myelodysplastic syndrome can progress to acute myeloid leukemia ( AML ), a type of cancer in which too many white blood cells are made.

An estimated 7,000 to12,000 new cases of myelodysplastic syndrome are diagnosed yearly in the United States.
Although myelodysplastic syndrome occurs in all age groups, the highest prevalence is in people over 60 years of age.
Typical symptoms include weakness, fatigue, infections, easy bruising, bleeding, and fever.

Revlimid is structurally similar to Thalidomide, a drug known to cause severe birth defects.

Additional studies are ongoing in animals to address whether there is a risk that Revlimid will also cause birth defects when taken during pregnancy.
While these studies are under way, Celgene is marketing Revlimid under a risk management plan called RevAssist, designed to prevent fetal exposure.

Under RevAssist, only pharmacists and prescribers registered with the program will prescribe and dispense Revlimid.
The program requires patients, including female patients undergoing mandatory pregnancy testing, to give informed consent before starting Revlimid.
Physicians are to check pregnancy tests, limit prescriptions to a one-month mail supply, and report any pregnancies to FDA.

FDA and the manufacturer will re-evaluate the risk management plan when results of further animal testing for birth defects are completed.

The labeling for Revlimid will include a Black Box Warning and a Medication Guide regarding the prevention of fetal exposure.
Additional Black Box Warnings include the potential need to lower the dose due to suppressed blood counts and increased risk of blood clots.
Common side effects reported with Revlimid include thrombocytopenia, neutropenia, diarrhea, pruritis, rash, and fatigue.

Source: FDA, 2005


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