Approved indication for REVLIMID® (lenalidomide) offers a new option for European patients with relapsed/refractory MCL, one of the poorest prognoses among all lymphomas
MCL is a rare sub-type of aggressive non-Hodgkin's lymphoma (NHL), which
starts in the lymph nodes but can move to other organs, causing tumours
known as lymphomas. Between 3 and 6 percent of
"New treatment options are vitally needed in order to change the course
of MCL for patients, given the severity of the disease, and there are
still limited existing treatment options," said Prof. Marek Trneny,
In the study, the most frequently observed adverse reactions which occurred more frequently in the REVLIMID® arm compared with the IC arm were neutropenia (50.9%), anaemia (28.7%), diarrhoea (22.8%), fatigue (21.0%), constipation (17.4%), pyrexia (16.8%), and rash (16.2%).
In addition to the EU approval, REVLIMID® is indicated
for the treatment of patients with relapsed/refractory MCL in
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM
Do not use REVLIMID® during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID® treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID® treatment.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID® can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. 34% of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.
Venous and Arterial Thromboembolism
REVLIMID® has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID® and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient's underlying risks.
REVLIMID® is approved in
REVLIMID® is also approved in
In addition, REVLIMID® is approved in
Celgene International Sàrl, located in Boudry, in the
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3 Smedby KE, Hjalgrim H. Epidemiology and etiology of mantle
cell lymphoma and other non-Hodgkin lymphoma subtypes.
4 Trneny, M et al. Phase II Randomized, Multicenter Study of
Lenalidomide Vs Best Investigator's Choice in Relapsed/Refractory Mantle
Cell Lymphoma: Results of the MCL-002 (SPRINT) Study Blood
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