United States - English - NLM (National Library of Medicine)

viela bio, inc. - inebilizumab (unii: 74t7185bmm) (inebilizumab - unii:74t7185bmm) - uplizna is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. uplizna is contraindicated in patients with: - a history of a life-threatening infusion reaction to uplizna [see warnings and precautions ( 5.1 )] - active hepatitis b infection [see warnings and precautions ( 5.2 )] - active or untreated latent tuberculosis [see warnings and precautions ( 5.2 )] risk summary uplizna is a humanized igg1 monoclonal antibody and immunoglobulins are known to cross the placental barrier. there are no adequate data on the developmental risk associated with the use of uplizna in pregnant women. however, transient peripheral b-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other b-cell depleting antibodies during pregnancy. b-cell levels in infants following maternal exposure to uplizna have not been studied in clinical trials. the potential duration of b-cell depletion in such infan

United States - English - NLM (National Library of Medicine)

horizon therapeutics usa, inc. - inebilizumab (unii: 74t7185bmm) (inebilizumab - unii:74t7185bmm) - uplizna is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. uplizna is contraindicated in patients with: - a history of a life-threatening infusion reaction to uplizna [see warnings and precautions ( 5.1 )] - active hepatitis b infection [see warnings and precautions ( 5.2 )] - active or untreated latent tuberculosis [see warnings and precautions ( 5.2 )] risk summary uplizna is a humanized igg1 monoclonal antibody and immunoglobulins are known to cross the placental barrier. there are no adequate data on the developmental risk associated with the use of uplizna in pregnant women. however, transient peripheral b-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other b-cell depleting antibodies during pregnancy. b-cell levels in infants following maternal exposure to uplizna have not been studied in clinical trials. the potential duration of b-cell depletion in such infants, and the impact of b-cell depletion on vaccine safety and effectiveness, is unknown [see   warnings and precautions ( 5.2 )]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg/week) to human cd19 transgenic (hucd19 tg) male and female mice prior to and during mating and continuing in females through gestation day 15 resulted in no adverse effects on embryofetal development; however, there was a marked reduction in b cells in fetal blood and liver at both doses tested. these results demonstrate that inebilizumab-cdon crosses the placenta and depletes b cells in the fetus. intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg) to hucd19 tg mice every three days throughout organogenesis and lactation resulted in depletion of b cells and persistent reductions in immune function (even following repletion of b cells and lasting into adulthood) in offspring at both doses tested. at the end of the lactation period, plasma inebilizumab-cdon levels in offspring were only slightly lower than those in maternal plasma. a no-effect level for immunotoxicity in the offspring was not identified. risk summary there are no data on the presence of inebilizumab-cdon in human milk, the effects on a breastfed infant, or the effects on milk production. human igg is excreted in human milk, and the potential for absorption of uplizna to lead to b-cell depletion in the breastfed infant is unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for uplizna and any potential adverse effects on the breastfed infant from uplizna or from the underlying maternal condition. contraception women of childbearing potential should use contraception while receiving uplizna and for 6 months after the last infusion of uplizna [see clinical pharmacology ( 12.3 )] . safety and effectiveness in pediatric patients have not been established. clinical studies of uplizna did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nihon generic co.,ltd - suplatast tosilate - white opaque capsule, length: 15.9 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nihon generic co.,ltd - suplatast tosilate - white opaque capsule, length: 14.5 mm

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

upl australia pty ltd - mcpa present as the dimethylamine salt - water miscible liquid - mcpa present as the dimethylamine salt phenoxy acids-mcpa-amine active 500.0 g/l - herbicide - barley | cereal rye | commercial/industrial land | fallow crop land weed control | flax | grass pasture | grass seed crop | lins - amsinckia,yellow burrweed or burr grass | annual thistle | artichoke thistle | ball mustard | bathurst burr | bellvine | bifora, carrot weed or bird's eye | bindweed | blue top - ageratum/heliotropium spp. | californian burr | caltrop or yellow vine | cape tulip | capeweed | cat's ear or flatweed | charlock | chinese burr | common iceplant | common storksbill | corn gromwell, ironweed or sheepweed | cutleaf mignonette | dandelion - taraxacum officinale | deadnettle | denseflower fumitory (red) | dock | dock - seedling | erodium, crowfoot or storksbill | fat hen | fennel | field bindweed | field cress | flannel weed - abutilon oxycarpum | gambia pea | geranium | hedge or wild mustard | hoary cress or whiteweed | horehound | horehound - seedling | lesser swinecress or bittercress | lincoln weed, sand rocket or mustard | london rocket | melilotus or hexham scent | merremia vine | mintweed | morning glory - ipomoea spp. | mustard | nodding thistle | noogoora burr | opium poppy | paterson's curse | pimpernels | pi

European Union - English - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - immunosuppressants - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.1).

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

towa pharmaceutical co., ltd. - suplatast tosilate - white capsule, length: approx. 15.8 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

towa pharmaceutical co., ltd. - suplatast tosilate - white capsule, length: approx. 14.2 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sawai pharmaceutical co.,ltd. - suplatast tosilate - white opaque capsule, length: 15.8 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sawai pharmaceutical co.,ltd. - suplatast tosilate - white opaque capsule, length: 14.2 mm