is revlimid fda approved

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NCI's gateway for information about multiple myeloma and other plasma cell neoplasms.NCI's drug information summaries provide consumer-friendly information about certain drugs that are approved by the U.S.

U.S. Food & Drug Administration [5-07-2012] The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo.

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    • U.S. Food & Drug Administration Revlimid (lenalidomide) is approved to treat a subgroup of patients with Myelodysplastic Syndrome (MDS).MDS is a collection of disorders in which the bone marrow does not function normally and not enough normal blood cells are made. MDS may develop following treatment with drugs or radiation therapy for other diseases or it may develop without any known cause. Some forms of MDS can progress to acute myeloid leukemia (AML), a type of cancer in which too many white blood cells are made.Yes. The sponsor, Celgene Corporation, submitted a Risk Management Program to prevent pregnancy exposures to this drug. This program is called RevAssist.Because of the potential for birth defects, exposure of a developing fetus to this product must be avoided.

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    • U.S. Food & Drug Administration [04-08-2011] The U.S. Food and Drug Administration (FDA) is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug.FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their healthcare provider. The benefits and the risks of Revlimid should be carefully weighed when prescribing this drug. Healthcare professionals should be aware that Revlimid may increase the risk of developing another type of cancer.Revlimid is used to treat a type of blood disorder known as myelodysplastic syndrome.

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    • U.S. Food & Drug Administration The Food and Drug Administration (FDA) has approved the drug Revlimid (lenalidomide) for the treatment of patients with a subtype of Myelodysplastic Syndrome (MDS). The subtype is MDS patients with deletion 5q cytogenetic abnormality.MDS 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 MDS 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.

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    SUMMIT, N.J., Dec. 28 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced that the U.S. Food and Drug Administration (FDA) granted approval of REVLIMID (lenalidomide) which is indicated for the treatment of 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.

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    Our portfolio of services and pharmaceutical products in the U.S. include: are registered trademarks of Celgene Corporation. These products may not be approved and/or licensed in all countries where this website is accessible.

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    NewYork-Presbyterian. The University Hospital of Columbia and Cornell.One Hosptial affiliated with two Ivy League Medical Schools: Columbia University College of Physicians & Surgeons and Weill Cornell Medical College.

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    Independent, up-to-date news and information for multiple myeloma patients and their families.The U.S. Food and Drug Administration (FDA) announced last week that it is investigating the safety of the multiple myeloma drugs Revlimid and thalidomide.

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    Independent, up-to-date news and information for multiple myeloma patients and their families.The U.S. Food and Drug Administration earlier today issued an extensive update regarding the risk of developing a second cancer while being treated with Revlimid.

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    Revlimid FDA Approval History - Drugs.comDrugs.com Blog (lenalidomide) is an immunomodulatory drug indicated for the treatment of 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.See also...Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect.

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    . Independent, up-to-date news and information for MDS patients and their families.The U.S. Food and Drug Administration (FDA) announced last week that it is investigating the safety of Revlimid and the chemically similar drug thalidomide.

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    The U.S. Food and Drug Administration (FDA) has approved REVLIMID® (lenalidomide) as a treatment for multiple myeloma, a type of blood cancer.

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    Revlimid (lenalidomide) is an orally available thalidomide analog, exerting both anti-angiogenic and immunomodulatory/anti-inflammatory properties.Revlimid is specifically indicated for the treatment of 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.Revlimid is supplied as an opaque capsule for oral administration.

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