Stany Zjednoczone - angielski - NLM (National Library of Medicine)

cipla usa inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm).    lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult 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. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, is indicated

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

cipla usa inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult 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. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, is indi

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

teva pharmaceuticals, inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated for the treatment of adult 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. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules are not indicated and are not recommended for the treatment of patients with cll outside of controlled clinical trials [see warnings and precautions (5.5)] . lenalidomide capsules can cause fetal harm when administered to a pregnant female. limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. this effect was seen at all doses tested. due to the results of this developmental monkey study, and lenalidomide’s structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [see boxed warning] . if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus [see warnings and precautions (5.1, 5.2), use in special populations (8.1, 8.3)] . lenalidomide capsules are contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, stevens-johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see warnings and precautions (5.9, 5.15)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide capsules during pregnancy as well as female partners of male patients who are exposed to lenalidomide capsules. this registry is also used to understand the root cause for the pregnancy. report any suspected fetal exposure to lenalidomide capsules to the fda via the medwatch program at 1-800-fda-1088 and also to the rems call center at 1‐888‐423‐5436. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies [see data] , lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see boxed warning, contraindications (4.1), and use in specific populations (5.1)] . lenalidomide is a thalidomide analogue. thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. alimentary tract, urinary tract, and genital malformations have also been documented and mortality at or shortly after birth has been reported in about 40% of infants. lenalidomide caused thalidomide-type limb defects in monkey offspring. lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats [see data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. if pregnancy does occur during treatment, immediately discontinue the drug. under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. report any suspected fetal exposure to lenalidomide capsules to the fda via the medwatch program at 1-800-fda-1088 and also to the rems call center at 1‐888‐423‐5436. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in an embryo-fetal developmental toxicity study in monkeys, teratogenicity, including thalidomide-like limb defects, occurred in offspring when pregnant monkeys received oral lenalidomide during organogenesis. exposure (auc) in monkeys at the lowest dose was 0.17 times the human exposure at the maximum recommended human dose (mrhd) of 25 mg. similar studies in pregnant rabbits and rats at 20 times and 200 times the mrhd respectively, produced embryo lethality in rabbits and no adverse reproductive effects in rats. in a pre- and post-natal development study in rats, animals received lenalidomide from organogenesis through lactation. the study revealed a few adverse effects on the offspring of female rats treated with lenalidomide at doses up to 500 mg/kg (approximately 200 times the human dose of 25 mg based on body surface area). the male offspring exhibited slightly delayed sexual maturation and the female offspring had slightly lower body weight gains during gestation when bred to male offspring. as with thalidomide, the rat model may not adequately address the full spectrum of potential human embryo-fetal developmental effects for lenalidomide. following daily oral administration of lenalidomide from gestation day 7 through gestation day 20 in pregnant rabbits, fetal plasma lenalidomide concentrations were approximately 20% to 40% of the maternal cmax . following a single oral dose to pregnant rats, lenalidomide was detected in fetal plasma and tissues; concentrations of radioactivity in fetal tissues were generally lower than those in maternal tissues. these data indicated that lenalidomide crossed the placenta. risk summary there is no information regarding the presence of lenalidomide in human milk, the effects of lenalidomide capsules on the breastfed child, or the effects of lenalidomide on milk production. because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children from lenalidomide capsules, advise women not to breastfeed during treatment with lenalidomide capsules. pregnancy testing lenalidomide capsules can cause fetal harm when administered during pregnancy [see use in specific populations (8.1)] . verify the pregnancy status of females of reproductive potential prior to initiating lenalidomide capsules therapy and during therapy. advise females of reproductive potential that they must avoid pregnancy 4 weeks before therapy, while taking lenalidomide capsules, during dose interruptions and for at least 4 weeks after completing therapy. females of reproductive potential must have 2 negative pregnancy tests before initiating lenalidomide capsules. the first test should be performed within 10 to 14 days, and the second test within 24 hours prior to prescribing lenalidomide capsules. once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. if menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. lenalidomide treatment must be discontinued during this evaluation. contraception females females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, iud, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner’s vasectomy, and 1 additional effective contraceptive method – male latex or synthetic condom, diaphragm, or cervical cap. contraception must begin 4 weeks prior to initiating treatment with lenalidomide capsules, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of lenalidomide therapy. reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed. males lenalidomide is present in the semen of males who take lenalidomide capsules. therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide capsules and for up to 4 weeks after discontinuing lenalidomide capsules, even if they have undergone a successful vasectomy. male patients taking lenalidomide capsules must not donate sperm and for up to 4 weeks after discontinuing lenalidomide capsules. safety and effectiveness have not been established in pediatric patients. mm in combination : overall, of the 1613 patients in the ndmm study who received study treatment, 94% (1521/1613) were 65 years of age or older, while 35% (561/1613) were over 75 years of age. the percentage of patients over age 75 was similar between study arms (rd continuous: 33%; rd18: 34%; mpt: 33%). overall, across all treatment arms, the frequency in most of the adverse reaction categories (eg, all adverse reactions, grade 3/4 adverse reactions, serious adverse reactions) was higher in older (> 75 years of age) than in younger (≤ 75 years of age) subjects. grade 3 or 4 adverse reactions in the general disorders and administration site conditions body system were consistently reported at a higher frequency (with a difference of at least 5%) in older subjects than in younger subjects across all treatment arms. grade 3 or 4 adverse reactions in the infections and infestations, cardiac disorders (including cardiac failure and congestive cardiac failure), skin and subcutaneous tissue disorders, and renal and urinary disorders (including renal failure) body systems were also reported slightly, but consistently, more frequently (<5% difference), in older subjects than in younger subjects across all treatment arms. for other body systems (e.g., blood and lymphatic system disorders, infections and infestations, cardiac disorders, vascular disorders), there was a less consistent trend for increased frequency of grade 3/4 adverse reactions in older vs younger subjects across all treatment arms serious adverse reactions were generally reported at a higher frequency in the older subjects than in the younger subjects across all treatment arms. mm after at least one prior therapy : of the 703 mm patients who received study treatment in studies 1 and 2, 45% were age 65 or over while 12% of patients were age 75 and over. the percentage of patients age 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups. of the 353 patients who received lenalidomide/dexamethasone, 46% were age 65 and over. in both studies, patients > 65 years of age were more likely than patients ≤ 65 years of age to experience dvt, pulmonary embolism, atrial fibrillation, and renal failure following use of lenalidomide capsules. no differences in efficacy were observed between patients over 65 years of age and younger patients. of the 148 patients with del 5q mds enrolled in the major study, 38% were age 65 and over, while 33% were age 75 and over. although the overall frequency of adverse reactions (100%) was the same in patients over 65 years of age as in younger patients, the frequency of serious adverse reactions was higher in patients over 65 years of age than in younger patients (54% vs. 33%). a greater proportion of patients over 65 years of age discontinued from the clinical studies because of adverse reactions than the proportion of younger patients (27% vs.16%). no differences in efficacy were observed between patients over 65 years of age and younger patients. of the 134 patients with mcl enrolled in the mcl trial, 63% were age 65 and over, while 22% of patients were age 75 and over. the overall frequency of adverse reactions was similar in patients over 65 years of age and in younger patients (98% vs. 100%). the overall incidence of grade 3 and 4 adverse reactions was also similar in these 2 patient groups (79% vs. 78%, respectively). the frequency of serious adverse reactions was higher in patients over 65 years of age than in younger patients (55% vs. 41%). no differences in efficacy were observed between patients over 65 years of age and younger patients. since elderly patients are more likely to have decreased renal function, care should be taken in dose selection. monitor renal function. adjust the starting dose of lenalidomide capsules based on the creatinine clearance value and for patients on dialysis [see dosage and administration (2.6)] .

Unia Europejska - angielski - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomide - multiple myeloma - immunosuppressants - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan ireland limited - lenalidomide - multiple myeloma - immunosuppressants - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Unia Europejska - angielski - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - immunosuppressants - multiple myelomalenalidomide krka d.d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide krka d.d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide krka d.d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.myelodysplastic syndromeslenalidomide krka d.d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.follicular lymphomalenalidomide krka d.d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide is indicated for the treatment of adult 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. lenalidomide is not indicated and is not recommended for the treatment of patients with cll outside of controlled clinical trials [see warnings and precautions (5.5)] . lenalidomide can cause fetal harm when administered to a pregnant female. limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. this effect was seen at all doses tested. due to the results of this developmental monkey study, and lenalidomide's structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [see boxed warning ]. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus [see warnings and precautions (5.1, 5.2), use in special populations (8.1, 8.3)] . lenalidomide is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, stevens-johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see warnings and precautions (5.9, 5.15)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide during pregnancy as well as female partners of male patients who are exposed to lenalidomide. this registry is also used to understand the root cause for the pregnancy. report any suspected fetal exposure to lenalidomide to the fda via the medwatch program at 1-800-fda-1088 and also to the rems call center at 1‐888‐423‐5436. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies [see data ], lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see boxed warning, contraindications (4.1), and use in specific populations (5.1)] . lenalidomide is a thalidomide analogue. thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. alimentary tract, urinary tract, and genital malformations have also been documented and mortality at or shortly after birth has been reported in about 40% of infants. lenalidomide caused thalidomide-type limb defects in monkey offspring. lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats [see data ]. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. if pregnancy does occur during treatment, immediately discontinue the drug. under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. report any suspected fetal exposure to lenalidomide to the fda via the medwatch program at 1-800-fda-1088 and also to rems call center at 1‐888‐423‐5436. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in an embryo-fetal developmental toxicity study in monkeys, teratogenicity, including thalidomide-like limb defects, occurred in offspring when pregnant monkeys received oral lenalidomide during organogenesis. exposure (auc) in monkeys at the lowest dose was 0.17 times the human exposure at the maximum recommended human dose (mrhd) of 25 mg. similar studies in pregnant rabbits and rats at 20 times and 200 times the mrhd respectively, produced embryo lethality in rabbits and no adverse reproductive effects in rats. in a pre- and post-natal development study in rats, animals received lenalidomide from organogenesis through lactation. the study revealed a few adverse effects on the offspring of female rats treated with lenalidomide at doses up to 500 mg/kg (approximately 200 times the human dose of 25 mg based on body surface area). the male offspring exhibited slightly delayed sexual maturation and the female offspring had slightly lower body weight gains during gestation when bred to male offspring. as with thalidomide, the rat model may not adequately address the full spectrum of potential human embryo-fetal developmental effects for lenalidomide. following daily oral administration of lenalidomide from gestation day 7 through gestation day 20 in pregnant rabbits, fetal plasma lenalidomide concentrations were approximately 20-40% of the maternal cmax . following a single oral dose to pregnant rats, lenalidomide was detected in fetal plasma and tissues; concentrations of radioactivity in fetal tissues were generally lower than those in maternal tissues. these data indicated that lenalidomide crossed the placenta. risk summary there is no information regarding the presence of lenalidomide in human milk, the effects of lenalidomide on the breastfed child, or the effects of lenalidomide on milk production. because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children from lenalidomide, advise women not to breastfeed during treatment with lenalidomide. pregnancy testing lenalidomide can cause fetal harm when administered during pregnancy [see use in specific populations (8.1)] . verify the pregnancy status of females of reproductive potential prior to initiating lenalidomide therapy and during therapy. advise females of reproductive potential that they must avoid pregnancy 4 weeks before therapy, while taking lenalidomide, during dose interruptions and for at least 4 weeks after completing therapy. females of reproductive potential must have 2 negative pregnancy tests before initiating lenalidomide. the first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing lenalidomide. once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. if menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. lenalidomide treatment must be discontinued during this evaluation. contraception females females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, iud, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and 1 additional effective contraceptive method – male latex or synthetic condom, diaphragm, or cervical cap. contraception must begin 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of lenalidomide therapy. reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed. males lenalidomide is present in the semen of males who take lenalidomide. therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide and for up to 4 weeks after discontinuing lenalidomide, even if they have undergone a successful vasectomy. male patients taking lenalidomide must not donate sperm and for up to 4 weeks after discontinuing lenalidomide. safety and effectiveness have not been established in pediatric patients. mm in combination : overall, of the 1613 patients in the ndmm study who received study treatment, 94% (1521 /1613) were 65 years of age or older, while 35% (561/1613) were over 75 years of age. the percentage of patients over age 75 was similar between study arms (rd continuous: 33%; rd18: 34%; mpt: 33%). overall, across all treatment arms, the frequency in most of the adverse reaction categories (e.g., all adverse reactions, grade 3/4 adverse reactions, serious adverse reactions) was higher in older (> 75 years of age) than in younger (≤ 75 years of age) subjects. grade 3 or 4 adverse reactions in the general disorders and administration site conditions body system were consistently reported at a higher frequency (with a difference of at least 5%) in older subjects than in younger subjects across all treatment arms. grade 3 or 4 adverse reactions in the infections and infestations, cardiac disorders (including cardiac failure and congestive cardiac failure), skin and subcutaneous tissue disorders, and renal and urinary disorders (including renal failure) body systems were also reported slightly, but consistently, more frequently (<5% difference), in older subjects than in younger subjects across all treatment arms. for other body systems (e.g., blood and lymphatic system disorders, infections and infestations, cardiac disorders, vascular disorders), there was a less consistent trend for increased frequency of grade 3/4 adverse reactions in older vs younger subjects across all treatment arms serious adverse reactions were generally reported at a higher frequency in the older subjects than in the younger subjects across all treatment arms. of the 703 mm patients who received study treatment in studies 1 and 2, 45% were age 65 or over while 12% of patients were age 75 and over. the percentage of patients age 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups. of the 353 patients who received lenalidomide/dexamethasone, 46% were age 65 and over. in both studies, patients > 65 years of age were more likely than patients ≤ 65 years of age to experience dvt, pulmonary embolism, atrial fibrillation, and renal failure following use of lenalidomide. no differences in efficacy were observed between patients over 65 years of age and younger patients. of the 148 patients with del 5q mds enrolled in the major study, 38% were age 65 and over, while 33% were age 75 and over. although the overall frequency of adverse reactions (100%) was the same in patients over 65 years of age as in younger patients, the frequency of serious adverse reactions was higher in patients over 65 years of age than in younger patients (54% vs. 33%). a greater proportion of patients over 65 years of age discontinued from the clinical studies because of adverse reactions than the proportion of younger patients (27% vs.16%). no differences in efficacy were observed between patients over 65 years of age and younger patients. since elderly patients are more likely to have decreased renal function, care should be taken in dose selection. monitor renal function. adjust the starting dose of lenalidomide based on the creatinine clearance value and for patients on dialysis [see dosage and administration (2.6)] .

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

devatis limited - lenalidomide 2.5mg - capsule - 2.5 mg - active: lenalidomide 2.5mg excipient: croscarmellose sodium gelatin indigo carmine iron oxide yellow lactose magnesium stearate microcrystalline cellulose titanium dioxide - lenalidomide devatis is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. lenalidomide devatis is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide devatis in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

dr. reddy's laboratories inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult 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. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, is indicated for the

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

alvogen, inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated for the treatment of adult 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. lenalidomide capsules are not indicated and are not recommended for the treatment of patients with cll outside of controlled clinical trials [see warnings and precautions (5.5)]. lenalidomide can cause fetal harm when administered to a pregnant female. limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. this effect was seen at all doses tested. due to the results of this developmental monkey study, and lenalidomide's structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [