Marekani - Kiingereza - NLM (National Library of Medicine)

regeneron pharmaceuticals, inc - aflibercept (unii: 15c2vl427d) (aflibercept - unii:15c2vl427d) - eylea hd is indicated for the treatment of: eylea hd is contraindicated in patients with ocular or periocular infections. eylea hd is contraindicated in patients with active intraocular inflammation. eylea hd is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in eylea hd. hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation. risk summary adequate and well-controlled studies with eylea hd have not been conducted in pregnant women. aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. a fetal no observed adverse effect level (noael) was not identified. at the lowest dose shown to produce adverse embryofetal effects, systemic exposure (based on auc for free aflibercept) was approximately 0.9 -fold of the population pharmacokinetic estimated exposure in humans after an intravitreal dose of 8 mg (see data) . animal reproduction studies are not always predictive of human response, and it is not known whether eylea hd can cause fetal harm when administered to a pregnant woman. based on the anti-vegf mechanism of action for aflibercept [see clinical pharmacology (12.1)] , treatment with eylea hd may pose a risk to human embryofetal development. eylea hd should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in two embryofetal development studies, aflibercept produced adverse embryofetal effects when administered every three days during organogenesis to pregnant rabbits at intravenous doses ≥3 mg per kg, or every six days during organogenesis at subcutaneous doses ≥0.1 mg per kg. adverse embryofetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). the maternal no observed adverse effect level (noael) in these studies was 3 mg per kg. aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal noael was not identified. at the lowest dose shown to produce adverse embryofetal effects in rabbits (0.1 mg per kg), systemic exposure (auc) of free aflibercept was approximately 0.9-fold of the population pharmacokinetic estimated systemic exposure (auc) in humans after an intravitreal dose of 8 mg. risk summary there is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, eylea hd is not recommended during breastfeeding. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eylea hd and any potential adverse effects on the breastfed child from eylea hd. contraception females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 4 months after the last intravitreal injection of eylea hd. infertility there are no data regarding the effects of eylea hd on human fertility. aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose 91 times higher (based on auc of free aflibercept) than the corresponding systemic level estimated based on population pharmacokinetic analysis in humans following an intravitreal dose of 8 mg. a no observed adverse effect level (noael) was not identified. these findings were reversible within 20 weeks after cessation of treatment [see nonclinical toxicology (13.1)]. the safety and effectiveness of eylea hd in pediatric patients have not been established. in pulsar, approximately 90% (604/673) of the patients in the hdq12 and hdq16 groups were 65 years of age or older and approximately 51% (343/673) were 75 years of age or older. in photon, approximately 44% (214/491) of the patients in the hdq12 and hdq16 groups were 65 years of age or older and approximately 10% (50/491) were 75 years of age or older.

Marekani - Kiingereza - NLM (National Library of Medicine)

regeneron pharmaceuticals, inc. - aflibercept (unii: 15c2vl427d) (aflibercept - unii:15c2vl427d) - aflibercept 40 mg in 1 ml - eylea is indicated for the treatment of: eylea is contraindicated in patients with ocular or periocular infections. eylea is contraindicated in patients with active intraocular inflammation. eylea is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in eylea. hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation. risk summary adequate and well-controlled studies with eylea have not been conducted in pregnant women. aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. a fetal no observed adverse effect level (noael) was not identified. at the lowest dose shown to produce adverse embryofetal effects, systemic exposures (based on auc for free aflibercept) were approximately 6 times higher than auc values observed in humans after a single intravitreal treatment at the recommended clinical dose [see animal data]. animal reproduction studies are not always predictive of human response, and it is not known whether eylea can cause fetal harm when administered to a pregnant woman. based on the anti-vegf mechanism of action for aflibercept [see clinical pharmacology (12.1)], treatment with eylea may pose a risk to human embryofetal development. eylea should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in two embryofetal development studies, aflibercept produced adverse embryofetal effects when administered every three days during organogenesis to pregnant rabbits at intravenous doses ≥3 mg per kg, or every six days during organogenesis at subcutaneous doses ≥0.1 mg per kg. adverse embryofetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). the maternal no observed adverse effect level (noael) in these studies was 3 mg per kg. aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal noael was not identified. at the lowest dose shown to produce adverse embryofetal effects in rabbits (0.1 mg per kg), systemic exposure (auc) of free aflibercept was approximately 6 times higher than systemic exposure (auc) observed in adult patients after a single intravitreal dose of 2 mg. risk summary there is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, eylea is not recommended during breastfeeding. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eylea and any potential adverse effects on the breastfed child from eylea. contraception females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of eylea. infertility there are no data regarding the effects of eylea on human fertility. aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose approximately 1500 times higher than the systemic level observed in adult patients with an intravitreal dose of 2 mg. a no observed adverse effect level (noael) was not identified. these findings were reversible within 20 weeks after cessation of treatment [see nonclinical toxicology (13.1)]. the safety and effectiveness of eylea have been demonstrated in two clinical studies of pre-term infants with rop. these two studies randomized pre-term infants between initial treatment with eylea or laser. efficacy of each treatment is supported by the demonstration of a clinical course which was better than would have been expected without treatment [see dosage and administration (2.9), adverse reactions (6.1), clinical pharmacology (12.3) and clinical studies (14.6)] . in the clinical studies, approximately 76% (2049/2701) of patients randomized to treatment with eylea were ≥65 years of age and approximately 46% (1250/2701) were ≥75 years of age. no significant differences in efficacy or safety were seen with increasing age in these studies.

Marekani - Kiingereza - NLM (National Library of Medicine)

apellis pharmaceuticals, inc. - pegcetacoplan (unii: to3jyr3bou) (pegcetacoplan - unii:to3jyr3bou) - syfovre is indicated for the treatment of geographic atrophy (ga) secondary to age-related macular degeneration (amd). syfovre is contraindicated in patients with ocular or periocular infections [see warnings and precautions (5.1)] . syfovre is contraindicated in patients with active intraocular inflammation. risk summary there are no adequate and well-controlled studies of syfovre administration in pregnant women to inform a drug-associated risk. the use of syfovre may be considered following an assessment of the risks and benefits. systemic exposure of syfovre following ocular administration is low [see clinical pharmacology (12.3)] . subcutaneous administration of pegcetacoplan to pregnant monkeys from the mid gestation period through birth resulted in increased incidences of abortions and stillbirths at systemic exposures 1040-fold higher than that observed in humans at the maximum recommended human ophthalmic dose (mrhod) of syfovre (based on the area under the curve (auc) systemically measured levels). no adverse maternal or fetal effects were observed in monkeys at systemic exposures approximately 470-fold higher than that observed in humans at the mrhod (see data) . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in embryofetal development studies, subcutaneous administration of pegcetacoplan to pregnant cynomolgus monkeys from the mid gestation period through birth produced increased incidences of abortions and stillbirths at doses of 28 mg/kg/day [approximately 1040-fold higher than the mrhod based on exposure (auc)]. pegcetacoplan was not maternally toxic and did not produce adverse embryofetal effects in the monkey at subcutaneous doses of 7 mg/kg/day. (approximately 470-fold higher than the mrhod). no developmental effects were observed in infants up to 6 months postpartum. minimal systemic exposure to pegcetacoplan (less than 1%, not pharmacologically significant) was detected in fetuses from monkeys treated subcutaneously with 28 mg/kg/day from the period of organogenesis through the second trimester. risk summary it is not known whether intravitreal administered pegcetacoplan is secreted in human milk or whether there is potential for absorption and harm to the infant. animal data suggest that the risk of clinically relevant exposure to the infant following maternal intravitreal treatment is minimal (see data) . because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when syfovre is administered to a nursing woman. data animal data pegcetacoplan was detectable in milk of lactating monkeys after subcutaneous administration at less than 1% concentration of serum levels but was not detectable in the serum of nursing infants. contraception females it is recommended that women of childbearing potential use effective contraception methods to prevent pregnancy during treatment with intravitreal pegcetacoplan. advise female patients of reproductive potential to use effective contraception during treatment with syfovre and for 40 days after the last dose. for women planning to become pregnant, the use of syfovre may be considered following an assessment of the risks and benefits. the safety and effectiveness of syfovre in pediatric patients have not been established. in clinical studies, approximately 97% (813/839) of patients randomized to treatment with syfovre were ≥ 65 years of age and approximately 72% (607/839) were ≥ 75 years of age. no significant differences in efficacy or safety were seen with increasing age in these studies. no dosage regimen adjustment is recommended based on age.

Marekani - Kiingereza - NLM (National Library of Medicine)

iveric bio, inc. - avacincaptad pegol sodium (unii: k86enl12i5) (avacincaptad pegol - unii:tt0v5jlg5b) - izervay™ is indicated for the treatment of geographic atrophy (ga) secondary to age-related macular degeneration (amd). izervay is contraindicated in patients with ocular or periocular infections. izervay is contraindicated in patients with active intraocular inflammation. risk summary there are no adequate and well-controlled studies of izervay administration in pregnant women. the use of izervay may be considered following an assessment of the risks and benefits. administration of avacincaptad pegol to pregnant rats and rabbits throughout the period of organogenesis resulted in no evidence of adverse effects to the fetus or pregnant female at intravenous (iv) doses 5.1 times and 3.2 times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 2 mg once monthly, respectively (see data) . in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15%-20%, respectively. data animal data an embryo fetal developmental toxicity study was conducted with pregnant rats. pregnant rats received daily intravenous (iv) injections of avacincaptad pegol from day 6 to day 17 of gestation at 0.1, 0.4, 1.2 mg/kg/day. no maternal or embryofetal adverse effects were observed at any dose evaluated. an increase in the incidence of a non-adverse skeletal variation, described as short thoracolumbar (ossification site without distal cartilage) supernumerary ribs, was observed at all doses evaluated. the clinical relevance of this finding is unknown. plasma exposures at the high dose were 5.1 times the mrhd, based on area under the curve (auc). an embryo fetal developmental toxicity study was conducted with pregnant rabbits. pregnant rabbits received daily iv injections of avacincaptad pegol from day 7 to day 19 of gestation at 0.12, 0.4, 1.2 mg/kg/day. no maternal or embryofetal adverse effects were observed at any dose evaluated. plasma exposure in pregnant rabbits at the highest dose of 1.2 mg/kg/day was 3.2 times the human exposure at the mrhd, based on auc. risk summary there is no information regarding the presence of avacincaptad pegol in human milk, the effects of the drug on the breastfed infant, or the effects of avacincaptad pegol on milk production. many drugs are transferred in human milk with the potential for absorption and adverse reactions in the breastfed child. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for izervay, and any potential adverse effects on the breastfed infant from izervay. safety and effectiveness of izervay in pediatric patients have not been established. of the total number of patients who received izervay in the two clinical trials, 90% (263/292) were ≥65 years and 61% (178/292) were ≥75 years of age. no significant differences in efficacy or safety of avacincaptad pegol were seen with increasing age in these studies. no dose adjustment is required in patients 65 years and above.

Marekani - Kiingereza - NLM (National Library of Medicine)

bausch & lomb incorporated - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.59 mg - retisert ® is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. surgical placement of retisert is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye. no adequate animal reproduction studies have been conducted with fluocinolone acetonide. corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. fluocinolone acetonide when administered subcutaneously at a dose of 0.13 mg/kg/day (approximately 10,000 times the daily clinical dose of retisert), during days 6 to 18 of pregnancy in the rabbit, induced abortion at the end of the third and at the beginning of the fourth gestational week. when administered subcutaneously to rats and rabbits during gestation at a maternal toxic dose of 50 mcg/kg/day (approximately 4,000 times the clinical dose of retisert), fluocinolone acetonide caused abortions and malformations in a few surviving fetuses. there are no adequate and well-controlled studies in pregnant women. retisert should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. caution should be exercised when retisert is implanted in a nursing woman. safety and effectiveness in pediatric patients below the age of 12 years have not been established. no overall differences in safety and effectiveness have been observed between elderly and younger patients.

Marekani - Kiingereza - NLM (National Library of Medicine)

alimera sciences, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - yutiq® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. yutiq is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. yutiq is contraindicated in patients with known hypersensitivity to any components of this product. risk summary adequate and well-controlled studies with yutiq have not been conducted in pregnant women to inform drug associated risk. animal reproduction studies have not been conducted with yutiq. it is not known whether yutiq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage leve

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

specialised therapeutics limited - fluocinolone acetonide 190ug - intraocular implant - 190 mcg - active: fluocinolone acetonide 190ug excipient: med-1137 rtv silicone adhesive polyvinyl alcohol   pyromellitic dianhydride, 4,4'-oxydianiline polymer - for the treatment of diabetic macular oedema (dme) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (iop).

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ranibizumab 10 mg/ml - solution for injection - 10 mg/ml - active: ranibizumab 10 mg/ml excipient: histidine histidine hydrochloride polysorbate 20 trehalose dihydrate water for injection - lucentis® is indicated for the treatment of neovascular (wet) age-related macular degeneration (amd).

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

samsung bioepis nz limited - ranibizumab 10 mg/ml - solution for injection - 10 mg/ml - active: ranibizumab 10 mg/ml excipient: histidine histidine hydrochloride monohydrate polysorbate 20 trehalose dihydrate water for injection - byooviz is indicated for: - the treatment of neovascular (wet) age-related macular degeneration (amd), - the treatment of visual impairment due to diabetic macular oedema (dme), - treatment of proliferative diabetic retinopathy (pdr), - the treatment of visual impairment due to choroidal neovascularisation (cnv), - the treatment of visual impairment due to choroidal neovascularisation (cnv) secondary to pathologic myopia (pm), - the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo).

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - ophthalmologicals - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv)