Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab emtansine, quantity: 106 mg - injection, powder for - excipient ingredients: sucrose; polysorbate 20; succinic acid; sodium hydroxide - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ranibizumab, quantity: 2.3 mg - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; trehalose dihydrate; polysorbate 20; water for injections - lucentis (ranibizumab) 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), ? treatment of proliferative diabetic retinopathy (pdr), ? the treatment of visual impairment due to choroidal neovascularisation, ? 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 (rvo).,lucentis is indicated in preterm infants for:,? the treatment of retinopathy of prematurity (rop) with zone i (stage 1+, 2+, 3 or 3+), zone ii (stage 3+) or ap-rop (aggressive posterior rop) disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

biogen australia pty ltd - natalizumab, quantity: 300 mg - injection, concentrated - excipient ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - tysabri (natalizumab) is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (ms) to delay the progression of physical disability and to reduce the frequency of relapse.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - pertuzumab, quantity: 420 mg - injection, intravenous infusion - excipient ingredients: histidine; sucrose; glacial acetic acid; water for injections; polysorbate 20 - early breast cancer perjeta is indicated in combination with trastuzumab and chemotherapy for:,- the neoadjuvant treatment of patients with her2-positive inflammatory or locally advanced, or early stage (either > 2 cm in diameter or node positive) breast cancer as part of a complete treatment regimen for early breast cancer,-the adjuvant treatment of patients with her2-positive early breast cancer at high risk of recurrence.,metastatic breast cancer,perjeta is indicated in combination with trastuzumab and docetaxel for patients with metastatic her2-positive breast cancer who have not received prior anti-her2 therapy or chemotherapy for their metastatic disease.

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - gemtuzumab ozogamicin (unii: 8gzg754x6m) (gemtuzumab ozogamicin - unii:8gzg754x6m) - gemtuzumab ozogamicin 5 mg in 5 ml - mylotarg is indicated for the treatment of newly-diagnosed cd33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. mylotarg is indicated for the treatment of relapsed or refractory cd33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older. mylotarg is contraindicated in patients with a history of hypersensitivity to the active substance in mylotarg or any of its components or to any of the excipients. reactions have included anaphylaxis [see warnings and precautions (5.2), adverse reactions (6)] . risk summary based on its mechanism of action and findings from animal studies [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] , mylotarg can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on mylotarg use in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alteration

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - inotuzumab ozogamicin (unii: p93ruu11p7) (inotuzumab ozogamicin - unii:p93ruu11p7) - inotuzumab ozogamicin 0.25 mg in 1 ml - besponsa is indicated for the treatment of relapsed or refractory cd22-positive b-cell precursor acute lymphoblastic leukemia (all) in adult and pediatric patients 1 year and older . none. risk summary based on its mechanism of action and findings from animal studies [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] , besponsa can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on besponsa use in pregnant women to inform a drug-associated risk. in rat embryo-fetal development studies, inotuzumab ozogamicin caused embryo-fetal toxicity at maternal systemic exposures that were ≥ 0.4 times the exposure in patients at the maximum recommended dose, based on auc [see data] . advise patients of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2–4% and 15–20%, respectively. data animal data in embryo-fetal development studies in rats, pregnant animals received daily intravenous doses of inotuzumab ozogamicin up to 0.36 mg/m2 during the period of organogenesis. embryo-fetal toxicities including increased resorptions and fetal growth retardation as evidenced by decreased live fetal weights and delayed skeletal ossification were observed at ≥ 0.11 mg/m2 (approximately 2 times the exposure in patients at the maximum recommended dose, based on auc). fetal growth retardation also occurred at 0.04 mg/m2 (approximately 0.4 times the exposure in patients at the maximum recommended dose, based on auc). in an embryo-fetal development study in rabbits, pregnant animals received daily intravenous doses up to 0.15 mg/m2 (approximately 3 times the exposure in patients at the maximum recommended dose, based on auc) during the period of organogenesis. at a dose of 0.15 mg/m2 , slight maternal toxicity was observed in the absence of any effects on embryo‑fetal development. risk summary there are no data on the presence of inotuzumab ozogamicin or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with besponsa and for 2 months after the last dose. based on its mechanism of action and findings from animal studies, besponsa can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating besponsa. contraception females advise females of reproductive potential to use effective contraception during treatment with besponsa and for 8 months after the last dose [see nonclinical toxicology (13.1)] . males advise males with female partners of reproductive potential to use effective contraception during treatment with besponsa and for 5 months after the last dose [see nonclinical toxicology (13.1)] . infertility females based on findings in animals, besponsa may impair fertility in females of reproductive potential [see nonclinical toxicology (13.1)] . males based on findings in animals, besponsa may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and effectiveness of besponsa in pediatric patients 1 year and older with relapsed or refractory cd22-positive b-cell precursor all have been established. the use of besponsa for this indication is supported by evidence of safety and effectiveness in study wi203581 (itcc-059) [see adverse reactions (6.1), clinical studies (14.1)] . the study included patients in the following age groups: 2 patients 1 year to < 2 years old, 10 patients 2 years to < 6 years old, 20 patients 6 years to < 12 years old, and 20 patients 12 years to < 17 years old. compared to adults, pediatric patients had a higher incidence of liver test abnormalities; with grade 3-4 increases in ast, alt, and total bilirubin in 21%, 21%, and 9%, respectively, in pediatric patients treated with besponsa compared to 4%, 4%, and 5% in adults. the safety and effectiveness of besponsa in patients < 1 year of age with relapsed or refractory cd22-positive b-cell precursor all have not been established. in the ino-vate all trial, 30/164 patients (18%) treated with besponsa were ≥ 65 years of age. no differences in responses were identified between older and younger patients. based on a population pharmacokinetic analysis in 765 patients, no adjustment to the starting dose is required based on age [see clinical pharmacology (12.3)] . based on a population pharmacokinetic analysis, the clearance of inotuzumab ozogamicin in patients with mild hepatic impairment (total bilirubin less than or equal to uln and ast greater than uln, or total bilirubin greater than 1.0–1.5 × uln and ast any level; n=150) was similar to patients with normal hepatic function (total bilirubin/ast less than or equal to uln; n=611). in patients with moderate (total bilirubin greater than 1.5–3 × uln and ast any level; n=3) and severe hepatic impairment (total bilirubin greater than 3 × uln and ast any level; n=1), inotuzumab ozogamicin clearance did not appear to be reduced [see clinical pharmacology (12.3)]. no adjustment to the starting dose is required when administering besponsa to patients with total bilirubin less than or equal to 1.5 × uln and ast/alt less than or equal to 2.5 × uln [see dosage and administration (2.3)]. there is limited safety information available in patients with total bilirubin greater than 1.5 × uln and/or ast/alt greater than 2.5 × uln prior to dosing. interrupt dosing until recovery of total bilirubin to less than or equal to 1.5 × uln and ast/alt to less than or equal to 2.5 × uln prior to each dose unless due to gilbert's syndrome or hemolysis. permanently discontinue treatment if total bilirubin does not recover to less than or equal to 1.5 × uln or ast/alt does not recover to less than or equal to 2.5 × uln [see dosage and administration (2.3), warnings and precautions (5.1)] .

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

e.r. squibb & sons, l.l.c. - elotuzumab (unii: 1351pe5ugs) (elotuzumab - unii:1351pe5ugs) - elotuzumab 300 mg - none. there are no available data on empliciti use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted with elotuzumab. empliciti is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. lenalidomide and pomalidomide are only available through a rems program. the 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. 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. there are no data on the presence of empliciti in hum

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

eli lilly and company - ixekizumab (unii: bty153760o) (ixekizumab - unii:bty153760o) - ixekizumab 80 mg in 1 ml - taltz® is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. taltz is indicated for the treatment of adult patients with active psoriatic arthritis. taltz is indicated for the treatment of adult patients with active ankylosing spondylitis. taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation. taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see warnings and precautions (5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to taltz during pregnancy. pregnant women exposed to taltz are encouraged to enroll in the taltz pregnancy registry by calling 1-800-284-1695. contact information for the registry is also available on http://www.pregnancyregistry.lilly.com. risk summary available data from the published literature and the pharmacovigilance database with taltz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. human igg is known to cross the placental barrier; therefore, taltz may be transmitted from the mother to the developing fetus. an embryofetal development study conducted in pregnant monkeys during organogenesis at doses up to 19 times the maximum recommended human dose (mrhd) revealed no evidence of harm to the developing fetus. when dosing was continued until parturition, neonatal deaths were observed at 1.9 times the mrhd [see data] . the clinical significance of these nonclinical findings is unknown. the 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. 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 an embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab. no malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the mrhd (on a mg/kg basis of 50 mg/kg/week). ixekizumab crossed the placenta in monkeys. in a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the mrhd from the beginning of organogenesis to parturition. neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the mrhd (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the mrhd (on a mg/kg basis of 50 mg/kg/week). these neonatal deaths were attributed to early delivery, trauma, or congenital defect. the clinical significance of these findings is unknown. no ixekizumab-related effects on functional or immunological development were observed in the surviving infants from birth through 6 months of age. risk summary there are no available data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. ixekizumab was detected in the milk of lactating cynomolgus monkeys. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for taltz and any potential adverse effects on the breastfed infant from taltz or from the underlying maternal condition. the safety and effectiveness of taltz have been established in pediatric subjects aged 6 years to less than 18 years with moderate-to-severe plaque psoriasis. the safety and effectiveness of taltz in other pediatric indications and for pediatric subjects less than 6 years of age have not been established. of the 4204 adult psoriasis subjects exposed to taltz, a total of 301 were 65 years or older, and 36 subjects were 75 years or older. although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects [see clinical pharmacology (12.3)] .

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

astrazeneca pharmaceuticals lp - benralizumab (unii: 71492ge1fx) (benralizumab - unii:71492ge1fx) - benralizumab 30 mg in 1 ml - fasenra is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see clinical studies (14)] . limitations of use: fasenra is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fasenra during pregnancy. healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/fasenra. risk summary the data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. in a prenatal and postnatal devel

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

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 30 mg in 1 ml - campath is indicated as a single agent for the treatment of b-cell chronic lymphocytic leukemia (b-cll). none. risk summary based on findings from animal studies, campath may cause fetal harm when administered to a pregnant woman. available data from published cohort studies in pregnant women are insufficient to establish a campath-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. alemtuzumab was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis (see data) . human igg antibodies are known to cross the placental barrier; therefore, campath may be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. infants born to pregnant women treated with campath may be at increased risk of infection (see clinical considerations) . the 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