Presentation of two evaluation studies
Presentation of two evaluation studies of the combination of REVLIMID® and rituximab in lymphomas not hodgkiniens at the international conference on malignant lymphoma
Patients with untreated follicular Lymphoma who received the combination of REVLIMID and rituximab (R2) showed an overall response rate of 92.6% and 72.2% of the patients presented a complete answer
The combination of R2CHOP showed a rate of survival without progression of the disease by 73% in the patients with non Hodgkin Lymphoma diffuse large cell B
"The volume growing clinical evidence in the evaluation of the combination of REVLIMID and rituximab we provide significant guidance on the potential of cellular cytotoxicity antibody-dependent in lymphomas and the potential of these. innovative combinations of patients in subtypes with a bad prognosis,"said Jean-Pierre Bizzari, M.D., Vice President in hematology and Oncology for Celgene Corporation. "We look forward to the prospect of additional data from the studies presented at the conference this year ICML."
Combination of lenalidomide and rituximab in patients with previously untreated follicular Lymphoma
In this preliminary report of a study of phase II, which was developed by the Alliance for Clinical Trials in Oncology and presented by Peter Martin, M.D., Assistant Professor in medicine at the Weill Cornell Medical College, patients suffering from Lymphoma Follicular untreated, including those where the disease has reached a level of 1 to 3 a, step 3 to 4 or step 2 of bulky disease and predictive index prognosis international follicular Lymphoma (FLIPI) of 0-2, have been administering the len alidomide (20 mg/day from the 1st to the 21st day on each 28-day cycle) for 12 cycles and rituximab (four weekly doses of 375 mg/m2 during cycle 1 and the 1st day of the cycles 4,6,8 and 10). Sixty-six patients were initially enrolled. The main results indicated a response rate and survival without progression of the disease.
On the 54 evaluable patients, the overall response rate was 92.6% (50/54), including 72.2% (39/54) of patients who experienced a complete response, 20.4% (11/54) received a partial response, 3.7% (2/54) who presented a stable disease and 3.7% (2/54) did not answer.
During the study, adverse events of level 3 to 4 commonly observed in at least 5% of patients have included neutropenia (20%), lymphopenia (8%), rash (8%), fatigue (6%) and Leucopenia (5%).
Combination of lenalidomide with the multidrug R - CHOP (R2CHOP) in diffuse Lymphoma large cell B
Another study of phase II, presented by Grzegorz Nowakowski, M.D., Assistant Professor in medicine at the Mayo Clinic clinic, has evaluated the combination of lenalidomide and rituximab, of cyclophosphamide, of the hydroxydaunorubicine of the oncovin and the prednisone (R2CHOP) in patients suffering from diffuse large cell B (DLBCL) or level 3B follicular Lymphoma lymphoma.
During this study, 63 patients with DLBCL and four patients with follicular Lymphoma level 3B met administer six cycles of R2CHOP and their response was assessed using PET/CT scans at the end of the treatment cycle. The main results were the response rate and survival without progression of the disease.
The 63 evaluable patients, the overall response rate was 98%, with 74% of patients with a complete answer. After 18 months, the rate of survival without progression of the disease for these patients was 66% (95% CI: 55 to 80%).
Hematologic adverse events of levels 3 and 4 the most common during the study were thrombocytopenia (respectively 21% and 18%) and neutropenia (15% and 73). The most frequent non-haematological toxicities were febrile neutropenia (8%) and fatigue (5%). There was one death (2%) following an intestinal perforation.
Additional analysis of survival without progression of the disease was conducted to compare the results of the study of 87 patients with DLBCL consecutive group in the database of the Mayo Clinic treated by combination chemotherapy RCHOP standard. Each group included both of the patients with and without subtypes of B cells in germinal Center (GCB).
Survival without progression of the disease at the end of 18 months for all patients included in the Group of multidrug RCHOP was 57% (95% CI: 48 to 69%). Without BCG patients treated with combination chemotherapy RCHOP presented a survival without disease progression considerably worse compared to patients with BCG, with respective rates of progression of the disease-free survival at 18 months from 32% (95% CI: 19 in) 55%) and 70% (95% CI: 59 to 82%) (p = 0, 002). For patients treated with R2CHOP, patients without GCB had a rate of survival without progression of the disease to 18 months by 73% (95% CI: 55 to 97%), which was not very different from the rate of survival without progression of the disease to 18 months in 5 5% (IC 95%: 37 at 83%) in patients with GCB (p = 0, 78).
These data come from experimental studies. REVLIMID® and the combination of REVLIMID and rituximab are not approved for the treatment of follicular Lymphoma or DLBCL.
About REVLIMID®
The REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma of bone who received at least one prior treatment, nearly 70 countries in Europe, the Americas, the Middle East in Asia and, and in combination with dexamethasone for the treatment of patients whose disease has progressed following treatment in Australia and New Zealand.
The REVLIMID is approved in the United States, to the Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as in Malaysia and Israel, for anemia, transfusion due to a low or intermediate risk 1 SMD-dependent associated with an abnormal cytogenetic deletion 5q with or without additional cytogenetic abnormalities. Applications for authorisation of placing on the market are currently being investigated in a number other countries.
The REVLIMID is approved in the United States for the treatment of patients achieved (LCM) mantle cell lymphoma whose disease is in relapse or progressed after two prior treatments, which included one bortezomib.
Regulatory information for Revlimid in the United States
REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma of bone who received at least one prior treatment
REVLIMID® (lenalidomide) is indicated for the treatment of patients with dependent anemia of transfusion due to syndromes MDS (MDS) of intermediate or low risk 1 a cytogenetic deletion 5 q abnormality associated with or without additional cytogenetic abnormalities
REVLIMID® (lenalidomide) is indicated for the treatment of patients with lymphoma cells of the mantle (LCM) whose disease is in relapse or progressed after two prior treatments, which included one bortezomib
Important safety information
WARNING: FŒTALE EMBRYO TOXICITY, HAEMATOLOGICAL TOXICITY AND VENOUS THROMBO-EMBOLISM
Embryo-fetal toxicity
Do not use the treatment during pregnancy. Lenalidomide, a thalidomide analog, resulted in abnormalities of the members during a development study conducted on monkeys. Thalidomide's teratogenic human known to generate serious and potentially fatal defects on humans. If lenalidomide is taken during pregnancy, it may generate an embryo-fetal death or congenital abnormalities. Among women of childbearing age, get 2 negative pregnancy tests before starting the treatment under REVLIMID. Women of childbearing age must use 2 forms of birth control or continually refrain of all heterosexual report and during the treatment under REVLIMID and 4 weeks after the end of the treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is available only through a restricted distribution program, REVLIMID REMS™ program (formerly the program "RevAssist®").
Hematologic toxicity (neutropenia and thrombocytopenia)
The REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with MDS with del 5q took a report / a reduction in dosage during the major study. Thirty percent of patients required a second postponement / dosage reduction. Events of hematologic of level 3 or 4 toxicity have been observed in 80% of patients participating in the study. Patients under treatment for the SMD with del 5q should have their complete blood count every week during the first 8 weeks of treatment and at least once a month then. Patients may require an interruption or reduction in dosage. Patients may require the use of blood products and growth factors.
The REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma of bone who received at least one prior treatment, nearly 70 countries in Europe, the Americas, the Middle East in Asia and, and in combination with dexamethasone for the treatment of patients whose disease has progressed following treatment in Australia and New Zealand.
The REVLIMID is approved in the United States, to the Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as in Malaysia and Israel, for anemia, transfusion due to a low or intermediate risk 1 SMD-dependent associated with an abnormal cytogenetic deletion 5q with or without additional cytogenetic abnormalities. Applications for authorisation of placing on the market are currently being investigated in a number other countries.
The REVLIMID is approved in the United States for the treatment of patients achieved (LCM) mantle cell lymphoma whose disease is in relapse or progressed after two prior treatments, which included one bortezomib.
Regulatory information for Revlimid in the United States
REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma of bone who received at least one prior treatment
REVLIMID® (lenalidomide) is indicated for the treatment of patients with dependent anemia of transfusion due to syndromes MDS (MDS) of intermediate or low risk 1 a cytogenetic deletion 5 q abnormality associated with or without additional cytogenetic abnormalities
REVLIMID® (lenalidomide) is indicated for the treatment of patients with lymphoma cells of the mantle (LCM) whose disease is in relapse or progressed after two prior treatments, which included one bortezomib
Important safety information
WARNING: FŒTALE EMBRYO TOXICITY, HAEMATOLOGICAL TOXICITY AND VENOUS THROMBO-EMBOLISM
Embryo-fetal toxicity
Do not use the treatment during pregnancy. Lenalidomide, a thalidomide analog, resulted in abnormalities of the members during a development study conducted on monkeys. Thalidomide's teratogenic human known to generate serious and potentially fatal defects on humans. If lenalidomide is taken during pregnancy, it may generate an embryo-fetal death or congenital abnormalities. Among women of childbearing age, get 2 negative pregnancy tests before starting the treatment under REVLIMID. Women of childbearing age must use 2 forms of birth control or continually refrain of all heterosexual report and during the treatment under REVLIMID and 4 weeks after the end of the treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is available only through a restricted distribution program, REVLIMID REMS™ program (formerly the program "RevAssist®").
Hematologic toxicity (neutropenia and thrombocytopenia)
The REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with MDS with del 5q took a report / a reduction in dosage during the major study. Thirty percent of patients required a second postponement / dosage reduction. Events of hematologic of level 3 or 4 toxicity have been observed in 80% of patients participating in the study. Patients under treatment for the SMD with del 5q should have their complete blood count every week during the first 8 weeks of treatment and at least once a month then. Patients may require an interruption or reduction in dosage. Patients may require the use of blood products and growth factors.
Venous thrombosis
It has been shown that the REVLIMID greatly increases the risk of deep vein thrombosis (DVT) and pulmonary embolism (EP) in patients with multiple myeloma of bone that have been treated to the REVLIMID and dexamethasone. It is advisable for patients and doctors to monitor the signs and symptoms of thrombo-embolism. To recommend patients to go to a doctor if they develop symptoms like the breathlessness, chest pain, or swelling of the arms or legs. It is not known if anticoagulation, prophylactic or antiplatelet therapy prescribed in conjunction with the REVLIMID may or may not reduce the potential for venous thrombo-embolism. The decision to take prophylactic measures should be taken with caution after an assessment of the factors of individual underlying risks of a patient.
CONTRAINDICATIONS
Pregnancy:
the REVLIMID can harm the fetus when administered to a pregnant woman. Lenalidomide is contraindicated in pregnant women. If this drug is used during pregnancy, or if the patient falls pregnant during treatment, the patient must be informed of potential hazards to the fetus
Allergic reactions:
the treatment is contraindicated in patients who have experienced a hypersensitivity (e.g.: angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) to lenalidomide
WARNINGS AND CAUTIONS
Embryo-fetal toxicity:
the REVLIMID is an analogue of thalidomide, a teratogen human known to generate potentially fatal human congenital anomalies or embryo-fetal death. A study on embryo-fetal development in monkeys indicates that lenalidomide generates malformations in the offspring of the monkeys who received the drug during pregnancy, similar to congenital anomalies observed in humans following exposure to thalidomide during pregnancy
Women of childbearing age: they should avoid becoming pregnant for at least 4 weeks before starting treatment with REVLIMID, processing, during periods of interruption of dosing and for at least 4 weeks after the end of the treatment. They must commit to continually refrain from heterosexual intercourse or use two reliable methods of contraception from the period of 4 weeks prior to treatment REVLIMID, being processed, in the course of downtime of dosage and for 4 weeks after the end of the treatment to the REVLIMID. They must have 2 negative pregnancy tests before starting the treatment
Men: lenalidomide is present in the sperm of patients receiving the drug. Men should always use a condom LaTeX or synthetic during sexual contacts with women in age to procreate during treatment under REVLIMID and during a period of up to 28 days after discontinuation of the treatment, even if they a successful vasectomy. Men treated in the REVLIMID patients should not donate sperm
Blood donation: patients must not be blood processing under REVLIMID and for 1 month after stopping the medication, since the blood might be given to a pregnant patient whose fetus must not be exposed to the REVLIMID
REVLIMID REMS™ program
Because of embryo-fetal risk, the REVLIMID is available only through a restricted as part of a strategy assessment and mitigation of risk (Risk Evaluation and Mitigation Strategy - REMS), REVLIMID REMS) formerly the program "RevAssist®"). Prescribers and pharmacies must be approved by the program and patients must sign an agreement and to comply with the requirements.
It has been shown that the REVLIMID greatly increases the risk of deep vein thrombosis (DVT) and pulmonary embolism (EP) in patients with multiple myeloma of bone that have been treated to the REVLIMID and dexamethasone. It is advisable for patients and doctors to monitor the signs and symptoms of thrombo-embolism. To recommend patients to go to a doctor if they develop symptoms like the breathlessness, chest pain, or swelling of the arms or legs. It is not known if anticoagulation, prophylactic or antiplatelet therapy prescribed in conjunction with the REVLIMID may or may not reduce the potential for venous thrombo-embolism. The decision to take prophylactic measures should be taken with caution after an assessment of the factors of individual underlying risks of a patient.
CONTRAINDICATIONS
Pregnancy:
the REVLIMID can harm the fetus when administered to a pregnant woman. Lenalidomide is contraindicated in pregnant women. If this drug is used during pregnancy, or if the patient falls pregnant during treatment, the patient must be informed of potential hazards to the fetus
Allergic reactions:
the treatment is contraindicated in patients who have experienced a hypersensitivity (e.g.: angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) to lenalidomide
WARNINGS AND CAUTIONS
Embryo-fetal toxicity:
the REVLIMID is an analogue of thalidomide, a teratogen human known to generate potentially fatal human congenital anomalies or embryo-fetal death. A study on embryo-fetal development in monkeys indicates that lenalidomide generates malformations in the offspring of the monkeys who received the drug during pregnancy, similar to congenital anomalies observed in humans following exposure to thalidomide during pregnancy
Women of childbearing age: they should avoid becoming pregnant for at least 4 weeks before starting treatment with REVLIMID, processing, during periods of interruption of dosing and for at least 4 weeks after the end of the treatment. They must commit to continually refrain from heterosexual intercourse or use two reliable methods of contraception from the period of 4 weeks prior to treatment REVLIMID, being processed, in the course of downtime of dosage and for 4 weeks after the end of the treatment to the REVLIMID. They must have 2 negative pregnancy tests before starting the treatment
Men: lenalidomide is present in the sperm of patients receiving the drug. Men should always use a condom LaTeX or synthetic during sexual contacts with women in age to procreate during treatment under REVLIMID and during a period of up to 28 days after discontinuation of the treatment, even if they a successful vasectomy. Men treated in the REVLIMID patients should not donate sperm
Blood donation: patients must not be blood processing under REVLIMID and for 1 month after stopping the medication, since the blood might be given to a pregnant patient whose fetus must not be exposed to the REVLIMID
REVLIMID REMS™ program
Because of embryo-fetal risk, the REVLIMID is available only through a restricted as part of a strategy assessment and mitigation of risk (Risk Evaluation and Mitigation Strategy - REMS), REVLIMID REMS) formerly the program "RevAssist®"). Prescribers and pharmacies must be approved by the program and patients must sign an agreement and to comply with the requirements.
Hematologic toxicity: the REVLIMID can lead to significant neutropenia and thrombocytopenia. Multiple myeloma of the bone: patients on REVLIMID for the treatment of multiple myeloma of the bone must monitor their complete blood count every 2 weeks for the first 12 weeks, then once a month. In tests on multiple myeloma of the bone by group, haematological levels 3 and 4 toxicities were more frequent in patients treated with the combination of REVLIMID and dexamethasone than in patients treated with dexamethasone alone. LCM: patients on REVLIMID for the LCM must monitor their complete blood count every week during the first cycle (28 days), every 2 weeks during cycles 2 to 4, then once a month. During the test on the LCM, events of neutropenia in level 3 or 4 have been reported in 43% of the patients. Events of thrombocytopenia of level 3 or 4 have been reported in 28% of the patients. It may be necessary to interrupt or reduce the dosage given to patients
Venous thrombo-embolism: events of venous thrombo-embolism (mainly deep venous thrombosis and pulmonary embolism) have affected patients with multiple myeloma of bone treated under combination with lenalidomide and SMD or MCL patients treated under monotherapy to lenalidomide. It is not known if anticoagulation, prophylactic or antiplatelet therapy prescribed in conjunction with the REVLIMID may or may not reduce venous thrombo-embolism potential. The decision to take prophylactic measures should be taken with caution after an assessment of the factors of individual underlying risks of the patient
Allergic reactions: events of edema and angioedema serious dermatological reactions, including syndrome Stevens - Johnson (FS) and the (NET) Toxic Epidermal Necrolysis, have been reported. These events can be fatal. Patients with a history of level 4 rashes associated with Thalidomide treatment should not take the REVLIMID. The interruption of the treatment should be considered for skin rashes from level 2 to 3. The treatment should be interrupted in the event of edema of angioedema, of rashes of level 4, of rashes Exfoliating or bullous or if they are susceptible to the FS or the NET and should not be resumed even if these reactions disappear. REVLIMID capsules contain lactose. Risk/benefit of REVLIMID treatment must be evaluated for patients intolerant to lactose
Tumor Lysis syndrome: tumor Lysis syndrome (SLT)-related deaths have been reported during lenalidomide therapy. Patients with a risk of HI are those who have a tumor burden high before treatment. These patients should be monitored closely and appropriate precautions should be taken
Tumor outbreak: tumor outbreak events were reported during the experimental use of lenalidomide for the treatment of chronic lymphocytic leukemia (LLC) and lymphoma and they are characterized by a swelling of the nodes tender lymph, a low fever, pain, and skin rashes. It is not recommended to properly controlled under lenalidomide against the LLC outside of a clinical trial treatment
The monitoring and evaluation of the tumour outbreak are recommended in patients of LCM. The tumor surge could simulate the progression of the disease. In patients with a tumor outbreak of level 3 or 4, it is advisable to suspend the treatment with lenalidomide until the resolution of the tumor outbreak at a level ≤ 1. In testing for the LCM, 10% of patients have contracted a tumor outbreak; all reports indicated a severity level 1 or 2. All of the events occurred during the cycle 1 and one patient developed a tumor outbreak during the cycle again 11. Lenalidomide can be continued in patients of a tumor outbreak of levels 1 and 2 without interruption or modification, at the discretion of the physician. Patients with a tumor outbreak of level 1 or 2 can also be treated on Corticosteroids, anti-inflammatory drugs without steroids and Narcotic analgesics for the management of symptoms of tumor outbreak. Patients suffering from a tumor outbreak of level 3 or 4 can be treated for the management of symptoms according to the treatment of tumor outbreak of levels 1 and 2
Hepatotoxicity: hepatic events, including fatal cases, have occurred in patients treated under lenalidomide in combination with dexamethasone. The mechanism of hepatoxicite of drug origin is unknown. A history of viral disease of the liver, liver of basic high enzymes and concomitant medications may be risk factors. Regularly monitor the liver enzymes. Stop the Revlimid in an elevation of liver enzymes. After a return to core values, a treatment at a lower dosage may be considered
Second primary malignancies: patients with multiple myeloma of bone treated under lenalidomide in studies, including melphalan and stem cell transplantation, showed a higher incidence of second primary malignancies,. in particular friend acute leukemia (AML) and the Hodgkin Lymphoma, compared to patients in control that groups similar treatment was administered, but who did not receive lenalidomide. Monitor the possible development of second malignancies in patients. Take into account the potential benefit of lenalidomide and the risk of second primary malignancies when treatment with lenalidomide is considered
SIDE EFFECTS
Multiple myeloma of bone
In the REVLIMID/dexamethasone treatment group, 269 patients (76%) had at least an interruption of the dosage with or without reduction in dosage of the REVLIMID compared with 199 patients (57%) in the placebo/dexamethasone treatment group
Among patients who had an interruption in dosing with or without reduction of the dosage, 76% (269/353) against 57% (199/350), 50% in the REVLIMID/dexamethasone treatment group had at least an additional interruption of dosing with or without reduction dosage compared to 21% of patients in the placebo/dexamethasone treatment group
Most of the adverse events and grade 3/4 adverse events were more frequent in patients with multiple myeloma of the bone to which the combination of REVLIMID/dexamethasone has been administered compared to patients under placebo/dexamethasone
Events of grade 3/4 neutropenia occurred in 33.4% compared to 3.4% of patients; 2.3% have been affected by a febrile neutropenia grade 3/4 against 0%
Events of thrombosis deep venous (DVT) have been reported as a side effect to the drug (7.4%) or level 3/4 (8.2%) compared to 3.1% and 3.4%. Interruptions due to PST have been reported at rates comparable between groups
Events of pulmonary embolism (EP) were reported as a side effect to the drug (3.7%) or level 3/4 (4.0%) compared to 0.9% and 0.9%. Interruptions due to the EP have been reported at rates comparable between groups
Adverse reactions reported in ≥15% of patients with multiple myeloma of the bone (REVLIMID/dexamethasone dexamethasone/placebo): fatigue (44% against 42%), neutropenia (42% compared to 6%), constipation (41% compared to 21%), diarrhea (39% against 27%), muscle cramps (33% compared to 21%), anemia (31% against 24%), pyrexia (28% compared to 23%), peripheral edema (26% against 21%), nausea (26% against 21%), back pain (26% against 19%), upper respiratory infection (25% against 16%), Dyspnea) 24% against 17%), dizziness (23% against 17%), thrombocytopenia (22% against 11%), rash (21% against 9%), earthquakes (21% versus 7%), weight loss (20% against 15%), nasopharyngite (18% against 9%), blurred vision (17% against 11%), anorexia (16% c) 10% against) and dysgeusia (15% against 10%)
MDS
Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events among those that have been observed in the population of MDS with del 5q
Adverse events of levels 3 and 4 reported in ≥ 5% of patients with MDS with del 5q were neutropenia (53%), thrombocytopenia (50%), pneumonia (7%), rash (7%), anemia (6%), Leucopenia (5%), fatigue (5%), the d yspnee (5%) and back pain (5%)
Other adverse events reported in ≥15% of SMD patients with del 5q (REVLIMID) included: diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngite (23%). arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%), Dyspnea (17%), pharyngitis (16%), epistaxis (15%), asthenia (15%), infection of the routes tract (15%)
The mantle cell lymphoma
Adverse events of levels 3 and 4 reported in ≥5% of patients treated in the REVLIMID in the essay on the LCM (N = 134) included neutropenia (43%), thrombocytopenia (28%), anemia (11%), pneumonia (9%), Leucopenia (7%), fatigue (7%), the diarrhea (6%), Dyspnea (6%) and febrile neutropenia (6%)
The serious adverse events reported in ≥2 of patients treated under the REVLIMID for the LCM monotherapy included chronic obstructive pulmonary disease, colitis to difficult Clostridium, sepsis, the Bcc and the supraventricular tachycardia
Adverse events reported in ≥15% of patients treated under REVLIMID in the essay on the LCM included neutropenia (49%), thrombocytopenia (36%), fatigue (34%), anemia (31%), diarrhea (31%), nausea (30%), cough (28%), the pyrexia (23%), rash (22%), Dyspnea (18%), pruritus (17%), peripheral edema (16%), constipation (16%) and Leucopenia (15%)
The adverse events in patients treated under REVLIMID in the essay on the LCM resulted in at least an interruption of the dosage at 76 (57%) patients, at least a reduction of the dosage at 51 (38%) patients and an interruption of treatment at 26 (19%) patients
DRUG INTERACTIONS
Regular monitoring of plasma levels of Digoxin, according to clinical judgment and based on clinical practice, patients treated with this drug is recommended during administration of the treatment. It is unclear whether or not there is an interaction between dexamethasone and the warfarin. Close PT and INR monitoring is recommended in patients with multiple myeloma of bone who take warfarin concomitantly. Erythropoietiques agents or other agents that may increase the risk of thrombosis, as estrogen-based treatments, should be used with caution in patients with multiple myeloma of the bone under lenalidomide with the dexamethasone
USE IN SPECIFIC GROUPS
Pregnancy: pregnancy during treatment, immediately stop taking the drug. In such conditions, send the patient home an obstetrician/gynecologist experienced in reproductive toxicity for evaluation and further advice. Any suspected exposure of a fetus in the REVLIMID should be reported to the FDA through MedWatch program at 1-800-332-1088 the to Celgene Corporation at 1-888-423-5436 the
Nursing mothers: it is unclear whether or not the REVLIMID is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed babies, must decide whether or not the continued breastfeeding or the drug is necessary, taking into account the importance of the drug to the mother
Pediatrics: safety and efficacy in children patients less than 18 years have not been established
Geriatrics: older patients were more likely to present a reduced renal function, be careful in the selection of the dosage. Monitor renal function
Kidney failure: the REVLIMID is mainly excreted intact by the kidney, adjustments to the dosage of REVLIMID initially are recommended in order to provide a patient exposure to the drug affected by kidney disease moderate (CLcr 30-60 mL/min) or severe (CLcr < 30 ml/min) and in patients on dialysis
Please see the full dosage, including warnings on the packaging, the contraindications, warnings and updates in custody, as well as the adverse effects.
About Celgene
Celgene Corporation, Summit in the State of New Jersey, is an integrated international pharmaceutical company that focuses on the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through the regulation of genes and proteins. Celgene International Sarl, located in Boudry in Switzerland, is a wholly-owned subsidiary and the international headquarters of Celgene Corporation. For more information, please visit the site: www.celgene.com.
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