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Lymphoid Hyperplasia

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181. Stivarga - regorafenib

, ? GLDH, TSH and fibrinogen, ? urine GGT, ? kidney, pancreas weight (F), ? mandibular gland weight, ? thymus weight, glomerulosclerosis (F), hyperplasia in Bowmanns Capsule and cortical mineralization (M), interstit. Fibrosis, vacuolar degener in adrenal cortex (M), cystic Corpora Lutea, follicular cyst, ? devel. Follicles, peri-/folliculitis (skin), lymphoid hyperplasia in spleen, mineralization of tonsils alb: albumin, ALT: alanine aminotransferase, ALP: alkaline phosphatase AST: aspartate (...) , ? ALP (M), ? kidney, pancreas weight (M), mononuclear infiltration in liver, epithelial hyperplasia in gall bladder, glomerulosclerosis (M), hyperplasia in Bowmanns Capsule and cortical mineralization (F), tub degen/regen, glomerulopathy, ? foll. Degener, cystic gld. dilatation, pigment clumping in skin, ? haematopoiesis and pigment deposit in spleen =16: articular muscle atrophy, stomatitis, pustules, ? monocytes (F), ? Relative alb, ? Alb/globulin quotient, ? ALP (F), ? AST, initially ? ALT

2013 European Medicines Agency - EPARs

182. Lonquex - lipegfilgrastim

-4), cervical lymph node (gp3-4), ? extramed haematopoiesis in liver, ? haematopoietic and giant cells in spleen, ? follicular lymphoid hyperplasia in spleen. Recovery: Effects on haematology, macroscopy, organ weights: incompletely recovered. In addition (macroscopy): Increased lobular pattern of liver. Histopathology: Minimal myeloid hyperplasia in liver and spleen (1 male) + bone marrow (3 males). Assessment report EMA/371234/2013 Page 23/108 CD Rat Main study: 10/sex/dose; Recovery phase: 5 (...) , ? myeloid : erythroid ratio. Histopathology (only gps 1 and 4 investigated): Dose related myeloid hyperplasia in spleen, bone marrow, liver with ? erythropoiesis and granulopoiesis. ? follicular lymphoid hyperplasia in spleen. Reduction and atrophy of amount and density of trabecular bone near the cartilaginous growth plate of gp 4 male os femoris. Recovery: Hind leg paralysis was incompletely recovered. Increased rel and abs spleen weight gp 4 incompletely recovered. Effect on trabecular bone in gp 4

2013 European Medicines Agency - EPARs

183. Imnovid (previously Pomalidomide Celgene)

differentiation. In an in vivo knockout transgenic mouse model of SCD, pomalidomide (10 mg/kg; 5 QD/week x 8) stimulated erythropoiesis as indicated by bone marrow hyperplasia and increased extramedullary hematopoiesis, a trend toward higher reticulocytes and significantly higher red blood cell (RBC) levels. Pomalidomide significantly increased HbF expression with a trend toward higher gamma-globin chain A (A?) levels. The pomalidomide responder rate, defined as the percentage of animals that exceeded (...) systems. The major findings were decreased RBC parameters (red blood cell count, haemoglobin, and haematocrit), decreased white blood cell (WBC) counts (neutrophils, lymphocytes, and monocytes), and histologic lymphoid depletion (lymph nodes, spleen, thymus, and GALT). In addition, increased incidence of loose and watery stool leading to weight loss were often observed and contributed to poor clinical conditions. In the 28 day study, administration of pomalidomide to monkeys at 30, 100, and 300 mg/kg

2013 European Medicines Agency - EPARs

184. Kynamro - mipomersen sodium

as inflammatory effects. These effects were typically mild, reversible, and evident mostly in mice treated with = 44 mg/kg/week mipomersen for 13 weeks. Plasma MCP-1 was transiently increased from control levels at doses of 10 or 75 mg/kg/week on Day 1. These data demonstrated the limited scope of the inflammatory effects associated with chronic mipomersen treatment. Toxicology studies in rats showed treatment-related increased spleen weight, lymphoid hyperplasia in spleen and multiorgan lymphohistiocytic (...) /week in the 5 month study were observed. In monkeys, there was a presence of basophilic granules in Kupffer cells and hyperplasia/hypertrophy in Kupffer cells at doses = 3 mg/kg/week. In the absence of associated changes in hepatic function, Kupffer cell hyperplasia/ hypertrophy is of uncertain toxicological significance. In hyperlipidemic monkeys there were no increases in serum transaminases, indicating that there were no adverse effects of apoB inhibition on the liver. In these monkeys fed

2013 European Medicines Agency - EPARs

186. Iclusig - ponatinib

, and can last over 10 years in some patients (Padmanabhan et al, 2008). However, if transition to AP-CML occurs, median survival is typically limited to under a year, while patients in BP-CML (which resembles acute leukaemia) usually live for only a few months. Most patients are diagnosed in CP-CML and may be asymptomatic or present with fatigue, anaemia, weight loss, night sweats, or splenomegaly. Acute lymphoblastic leukaemia (ALL) is a malignant proliferation of lymphoid cells. The majority of cases (...) . Three (1 male, 2 females) of 30 animals at 3 mg/kg/day in the toxicology portion of the study were found dead/sacrificed in moribund condition between Days 9 and 13. One animal (a male) of 30 animals at 1.5 mg/kg/day in the toxicology portion of the study was found dead on Day 28. 6 mg/kg: Hyperplasia of bone marrow. Minimal to marked necrosis of thymus. Sporadic necrosis of the glandular and non-glandular mucosa of the stomach. =3mg/kg: rough hair coats; inappetance; thinness; lethargy; hunched

2013 European Medicines Agency - EPARs

187. Istodax - romidepsin

2.3 3.0 Adult T cell leukaemia/lymphoma 1.0 2.0 Subcutaneous panniculitis-like T-cell lymphoma 0.5 1.3 Of the approximately 65,000 new cases of non-Hodgkin’s lymphoma (NHL) diagnosed in the US each year, with a similar incidence reported in the EU, PTCLs comprise between 5% and 10% of the cases (Armitage and Weisenburger, 1998; Jemal et al, 2007; Groves et al, 2000). These T-cell neoplasms account for approximately 10% to 15% of all lymphoid neoplasms (Armitage, 2006; Jaffe et al, 2001

2013 European Medicines Agency - EPARs

189. Inflectra - infliximab

forms. It is mainly produced by macrophages, as well as by a broad variety of other cell types including lymphoid cells, mast cells, endothelial cells, cardiac myocytes, adipose tissue, fibroblasts and neural tissue. TNFa exhibits a wide spectrum of activity, including coordinating host immune and inflammatory response to infectious, malignant and autoimmune conditions. Large amounts of TNFa have been shown to be released in response to liposaccharide, other bacterial components and interleukin-1

2013 European Medicines Agency - EPARs

190. Childhood Hodgkin Lymphoma Treatment (PDQ®): Health Professional Version

. [ ] Skinnider BF, Mak TW: The role of cytokines in classical Hodgkin lymphoma. Blood 99 (12): 4283-97, 2002. [ ] Steidl C, Shah SP, Woolcock BW, et al.: MHC class II transactivator CIITA is a recurrent gene fusion partner in lymphoid cancers. Nature 471 (7338): 377-81, 2011. [ ] [ ] Green MR, Monti S, Rodig SJ, et al.: Integrative analysis reveals selective 9p24.1 amplification, increased PD-1 ligand expression, and further induction via JAK2 in nodular sclerosing Hodgkin lymphoma and primary mediastinal (...) Defining strict CT or MRI size criteria for lymphomatous nodal involvement is complicated by several factors, such as size overlap between what proves to be benign reactive hyperplasia versus malignant lymphadenopathy, the implication of nodal clusters, and obliquity of node orientation to the scan plane. Additional difficulties more specific to children include greater variability of normal nodal size and the frequent occurrence of reactive hyperplasia. General concepts to consider in regard

2017 PDQ - NCI's Comprehensive Cancer Database

191. Zyclara - imiquimod

activity, i.e. hyperplasia of B- and T-cell lymphoid tissue, increased number of plasma cells, enlargement of spleen and lymph nodes, Kupffer cell hyperplasia, mononuclear/macrophage cell accumulation or proliferation. These included over-stimulation and in some animals subsequent down-regulation of lymphoid tissue. These effects were reversed during a recovery period during which animals were not dosed. There were no other target organs and a No Observed Adverse Effect Level (NOAEL) of 3 mg/kg (...) irritancy of 1% and 5% imiquimod creams has been assessed in rats and rabbits. In rabbits there was no vaginal irritation. In rats there was no histopathological evidence of vaginal irritation however there were monocytic infiltrates below the vaginal epithelium, increased spleen weight and lymphoid hyperplasia consistent with the pharmacological activity of the compound. 2.3.5. Ecotoxicity/environmental risk assessment Currently, the reference product is the only imiquimod-containing product

2012 European Medicines Agency - EPARs

192. Dacogen - decitabine

EBV+ lymphoblastic cells 0.026 Lavelle, 2003 RAJI lymphoid leukemia 0.054 Qin, 2007 ; Qin 2009 TF-1 leukemia 0.01 Qin, 2009 HAL leukemia 0.04 Qin, 2009 ML-1 leukemia 0.098 Qin, 2007 ; Qin, 2009 K562 leukemia 0.4 Qin, 2009 Jurkat leukemia 1.0 – 2 Qin 2007 ; Qin, 2009 Primary culture AML About 0.25 Motoji, 1985 OPM-2 EBV- myeloma 0.036 Lavelle, 2003 Primary culture CML 0.04-0.4 Limonta, 1993 Decitabine was also shown to induce morphological and functional differentiation in leukemia cell lines (see (...) , in the human lymphoid CCRF/CEM/0 line, decitabine decreased the methylation level to 47% of baseline at 0.3 µM, while the IC50 for cell survival attained 1 µM, suggesting a gap between the hypomethylating doses and the cytotoxic doses (Antonsson, 1987). • Solid tumor The activity of decitabine was assessed in different solid tumor models (breast, colon, prostate cancer). IC50 values varied from nM to the µM range (Qin, 2009). In HT-29 human colon cancer cells, the concentration of 1 µM of decitabine

2012 European Medicines Agency - EPARs

195. Signifor - pasireotide

no longer suppress ACTH production and release. The most common pathologic finding in Cushing’s disease patients is bilateral hyperplasia of the adrenal cortex due to excessive stimulation of the adrenal glands by uncontrolled ACTH secretion by the pituitary adenoma. The primary clinical symptoms of Cushing’s disease are due to hypercortisolism. As a result, patients with Cushing's disease have increased morbidity and a mortality rate 4 times higher than age- and gender-matched subjects. Pituitary (...) ), thyroid (monkeys), pancreas (mice and rats), bone (rodents), liver (mice and rats), female reproductive organs (mice and rats), lymphoid and hematopoietic organs (mice, rats and monkey), vasculature (rats and monkey) and large intestine (monkey). Page 16/90 Injection site Irritation of the skin at the injection site was evident in all species used in the repeated dose toxicity studies. These changes consisted of inflammation (chronic partially active dermatitis), fibrotic changes, hyperkeratosis

2012 European Medicines Agency - EPARs

199. NovoThirteen - catridecacog

daily 4 weeks 15 [2505] NN DS 5 [835] Initial manufacturing site DS Reversible lymphoid hyperplasia in the spleen SBI 1249-175 (GLP) Monkey 1-2M/0-1F IV 0, 12.5, 17.5 3 days 3 days No NOAEL All monkeys but one died or were sacrificed moribund after 2 repeat doses, DIC SBI 1394-175 (GLP) Monkey 3-5M/3-5F IV 0, 0.3, 3, 6 daily, 2 weeks 6 [1002] none SBI 1266-175 (GLP) Monkey 3-5M/3-5F IV 0, 5, 8, 12.5 2 weeks, 4 weeks 8 [1336] Reversible lymphoid hyperplasia in the spleen; Mild glomerulopathy (in one

2012 European Medicines Agency - EPARs

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