Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corporation - vitex negundo l. (lagundi leaf) - tablet - 600mg

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corporation - vitex negundo l. (lagundi leaf) - tablet - 300 mg

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corporation; distributor: metro drug inc. - human coagulation factor ix - lyophilized powder for injection - 500iu

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corporation - human tetanus immunoglobulin - solution for injection (im.) - 250 i.u. / ml

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corporation; distributor: metro drug, inc. - propiverine hydrochloride - sugar-coated tablet - 15 mg

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corporation - vitamin b6 , folic acid , vitamin b12 - capsule - 10 mg/1 mg 400 mcg

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

novartis pharmaceuticals corporation - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - reclast is indicated for treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, diagnosed by bone mineral density (bmd) or prevalent vertebral fracture, reclast reduces the incidence of fractures (hip, vertebral, and non-vertebral osteoporosis-related fractures). in patients at high risk of fracture, defined as a recent low-trauma hip fracture, reclast reduces the incidence of new clinical fractures [see clinical studies (14.1) ]. reclast is indicated for prevention of osteoporosis in postmenopausal women [see clinical studies (14.2) ]. reclast is indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3 ) ]. reclast is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [s ee clinical

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

novartis pharmaceuticals corporation - nilotinib (unii: f41401512x) (nilotinib - unii:f41401512x) - nilotinib 200 mg - tasigna is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. tasigna is indicated for the treatment of adult patients with chronic phase and accelerated phase philadelphia chromosome positive chronic myelogenous leukemia (ph+ cml) resistant or intolerant to prior therapy that included imatinib. tasigna is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) with resistance or intolerance to prior tyrosine-kinase inhibitor (tki) therapy. tasigna is contraindicated in patients with hypokalemia, hypomagnesemia, or long qt syndrome [see boxed warning]. risk summary based on findings from animal studies and the mechanism of action, tasigna can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of nilotinib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryo-fetal lethality, fetal effects, and fetal variations in rats and rabbits at maternal exposures (auc) approximately 2 and 0.5 times, respectively, the exposures in patients at the recommended dose (see data ). advise pregnant women of the potential risk to a fetus. 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 are 2% to 4% and 15% to 20%, respectively. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of nilotinib up to 100 mg/kg/day and 300 mg/kg/day, respectively, during the period of organogenesis. in rats, oral administration of nilotinib produced embryo-lethality/fetal effects at doses ≥ 30 mg/kg/day. at ≥ 30 mg/kg/day, skeletal variations of incomplete ossification of the frontals and misshapen sternebra were noted, and there was an increased incidence of small renal papilla and fetal edema. at 100 mg/kg/day, nilotinib was associated with maternal toxicity (decreased gestation weight, gravid uterine weight, net weight gain, and food consumption) and resulted in a single incidence of cleft palate and two incidences of pale skin were noted in the fetuses. a single incidence of dilated ureters was noted in a fetus also displaying small renal papilla at 100 mg/kg/day. additional variations of forepaw and hindpaw phalanx unossified, fused sternebra, bipartite sternebra ossification, and incomplete ossification of the cervical vertebra were noted at 100 mg/kg/day. in rabbits, oral administration of nilotinib resulted in the early sacrifice of two females, maternal toxicity and increased resorption of fetuses at 300 mg/kg/day. fetal skeletal variations (incomplete ossification of the hyoid, bent hyoid, supernumerary short detached ribs and the presence of additional ossification sites near the nasals, frontals and in the sternebral column) were also increased at this dose in the presence of maternal toxicity. slight maternal toxicity was evident at 100 mg/kg/day but there were no reproductive or embryo-fetal effects at this dose. at 30 mg/kg/day in rats and 300 mg/kg/day in rabbits, the maternal systemic exposure (auc) were 72700 ng*hr/ml and 17100 ng*hr/ml, respectively, representing approximately 2 and 0.5 times the exposure in humans at the highest recommended dose 400 mg twice daily. when pregnant rats were dosed with nilotinib during organogenesis and through lactation, the adverse effects included a longer gestational period, lower pup body weights until weaning and decreased fertility indices in the pups when they reached maturity, all at a maternal dose of 60 mg/kg (i.e., 360 mg/m2 , approximately 0.7 times the clinical dose of 400 mg twice daily based on body surface area). at doses up to 20 mg/kg (i.e., 120 mg/m2 , approximately 0.25 times the clinical dose of 400 mg twice daily based on body surface area) no adverse effects were seen in the maternal animals or the pups. risk summary there are no data on the presence of nilotinib or its metabolites in human milk or its effects on a breastfed child or on milk production. however, nilotinib is present in the milk of lactating rats. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with tasigna and for 14 days after the last dose. animal data after a single 20 mg/kg of [14 c] nilotinib dose to lactating rats, the transfer of parent drug and its metabolites into milk was observed. the overall milk-to-plasma exposure ratio of total radioactivity was approximately 2, based on the auc0-24h or auc0-inf values. no rat metabolites of nilotinib were detected that were unique to milk. based on animal studies, tasigna can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing females of reproductive potential should have a pregnancy test prior to starting treatment with tasigna. contraception females advise females of reproductive potential to use effective contraception during treatment with tasigna and for 14 days after the last dose. infertility the risk of infertility in females or males of reproductive potential has not been studied in humans. in studies in rats and rabbits, the fertility in males and females was not affected [see nonclinical toxicology (13.1)] . the safety and effectiveness of tasigna have been established in pediatric patients greater than or equal to 1 year of age with newly diagnosed and resistant or intolerant ph+ cml in chronic phase [see clinical studies (14.5)] . there are no data for pediatric patients under 2 years of age. use of tasigna in pediatric patients 1 year to less than 2 years of age with newly diagnosed or resistant or intolerant ph+ cml in chronic phase is supported by efficacy in pediatric patients 2 to 6 years of age for these indications. the safety and effectiveness of tasigna have been established in pediatric patients greater than or equal to 1 year of age with resistant or intolerant ph+ cml in accelerated phase based on evidence of effectiveness from an adequate and well-controlled single-arm study in adults [see clinical studies (14.2)] with safety data from two pediatric studies as described in the next paragraph. use of tasigna in pediatric patients 1 to less than 18 years of age is supported by evidence from two clinical trials [see clinical studies (14.5)] . the 25 patients with newly diagnosed ph+ cml-cp were in the following age groups: 6 children (age 2 to less than 12 years) and 19 adolescents (age 12 to less than 18 years). the 44 patients with resistant or intolerant ph+ cml-cp included 18 children (age 2 to less than 12 years) and 26 adolescents (age 12 to less than 18 years). all pediatric patients received tasigna treatment at a dose of 230 mg/m2 twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg). no differences in efficacy or safety were observed between the different age subgroups in the two trials. the frequency, type, and severity of adverse reactions observed were generally consistent with those observed in adults, with the exception of the laboratory abnormalities of hyperbilirubinemia (grade 3/4: 16%) and transaminase elevation (ast grade 3/4: 2.9%, alt grade 3/4: 10%), which were reported at a higher frequency in pediatric patients than in adults [see adverse reactions (6.1)] . for pediatric growth and development, growth retardation has been reported in pediatric patients with ph+ cml-cp treated with tasigna [see warnings and precautions (5.14), adverse reactions (6.1)] . the safety and effectiveness of tasigna in pediatric patients below the age of 1 year with newly diagnosed, or resistant or intolerant ph+ cml in chronic phase and accelerated phase, have not been established. in the clinical trials of tasigna (patients with newly diagnosed ph+ cml-cp and resistant or intolerant ph+ cml-cp and cml-ap), approximately 12% and 30% of patients were 65 years or over, respectively. - patients with newly diagnosed ph+ cml-cp: there was no difference in major molecular response between patients aged less than 65 years and those greater than or equal to 65 years. - patients with resistant or intolerant cml-cp: there was no difference in major cytogenetic response rate between patients aged less than 65 years and those greater than or equal to 65 years. - patients with resistant or intolerant cml-ap: the hematologic response rate was 44% in patients less than 65 years of age and 29% in patients greater than or equal to 65 years. no major differences for safety were observed in patients greater than or equal to 65 years of age as compared to patients less than 65 years. in the clinical trials, patients with a history of uncontrolled or significant cardiovascular disease, including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia, were excluded. caution should be exercised in patients with relevant cardiac disorders [see boxed warning, warnings and precautions (5.2)]. reduce the tasigna dosage in patients with hepatic impairment and monitor the qt interval closely in these patients [see dosage and administration (2.7), clinical pharmacology (12.3)] .

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

novartis pharmaceuticals corporation - dabrafenib mesylate (unii: b6dc89i63e) (dabrafenib - unii:qgp4ha4g1b) - dabrafenib 50 mg - tafinlar®  is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test. tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test [see dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection [see dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test [see dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options [see dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see dosage and administration (2.1)] . this indication is approved under accelerated approval based on overall response rate (orr) and duration of response (dor) [see clinical studies (14.6)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). tafinlar is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy [see dosage and administration (2.1)] . - tafinlar is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibition [see indications and usage (1.6), clinical pharmacology (12.1)] . - tafinlar is not indicated for treatment of patients with wild-type braf solid tumors [see warnings and precautions (5.2)] . none. risk summary based on findings from animal reproduction studies and its mechanism of action [see clinical pharmacology (12.1)] , tafinlar can cause fetal harm when administered to a pregnant woman. there is insufficient data in pregnant women exposed to tafinlar to assess the risks. dabrafenib was teratogenic and embryotoxic in rats at doses three times greater than the human exposure at the recommended adult clinical dose of 150 mg twice daily (see data) . advise pregnant women 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 is 2% to 4% and 15% to 20%, respectively. data animal data in a combined female fertility and embryo-fetal development study in rats conducted during the period of organogenesis, developmental toxicity consisted of embryo-lethality, ventricular septal defects, and variation in thymic shape at a dabrafenib dose of 300 mg/kg/day [approximately three times the human exposure at the recommended adult dose based on area under the curve (auc)]. at doses of 20 mg/kg/day or greater (equivalent to the human exposure at the recommended adult dose based on auc), rats demonstrated delays in skeletal development and reduced fetal body weight. risk summary there are no data on the presence of dabrafenib in human milk, or the effects of dabrafenib on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with tafinlar and for 2 weeks following the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating tafinlar. contraception based on data from animal studies and its mechanism of action, tafinlar can cause fetal harm when administered to pregnant women [see use in specific populations (8.1 )]. females advise female patients of reproductive potential to use effective contraception during treatment with tafinlar and for 2 weeks after the last dose. counsel patients to use a non-hormonal method of contraception since tafinlar can render hormonal contraceptives ineffective [see drug interactions (7.2)] . males to avoid potential drug exposure to pregnant partners and female partners of reproductive potential, advise male patients (including those who have had vasectomies) with female partners of reproductive potential to use condoms during treatment with tafinlar and for 2 weeks after the last dose. infertility females advise female patients of reproductive potential that tafinlar may impair fertility. a reduction in fertility was observed in female rats at dose exposures equivalent to the human exposure at the recommended adult dose. a reduction in the number of corpora lutea was noted in pregnant rats at dose exposures approximately three times the human exposure at the recommended adult dose [see nonclinical toxicology (13.1)]. males advise male patients of the potential risk for impaired spermatogenesis which may be irreversible. effects on spermatogenesis have been observed in animals treated with dabrafenib at dose exposures up to three times the human exposure at the recommended adult dose [see nonclinical toxicology (13.1)]. braf v600e mutation-positive unresectable or metastatic solid tumors and lgg the safety and effectiveness of tafinlar in combination with trametinib have been established in pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options; or with lgg with braf v600e mutation who require systemic therapy. use of tafinlar in combination with trametinib for these indications is supported by evidence from studies x2101 and g2201 that enrolled 171 patients (1 to < 18 years) with braf v600 mutation-positive advanced solid tumors, of which 4 (2.3%) patients were 1 to < 2 years of age, 39 (23%) patients were 2 to < 6 years of age, 54 (32%) patients were 6 to < 12 years of age, and 74 (43%) patients were 12 to < 18 years of age [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.6, 14.7)] . the safety and effectiveness of tafinlar in combination with trametinib have not been established for these indications in pediatric patients less than 1 year old. the safety and effectiveness of tafinlar as a single agent in pediatric patients have not been established. juvenile animal toxicity data in a repeat-dose toxicity study in juvenile rats, an increased incidence of kidney cysts and tubular deposits were noted at doses as low as 0.2 times the human exposure at the recommended adult dose based on auc. additionally, forestomach hyperplasia, decreased bone length, and early vaginal opening were noted at doses as low as 0.8 times the human exposure at the recommended adult dose based on auc. of the 586 patients with various solid tumors who received single agent tafinlar, 22% were aged 65 years and older. of the 187 patients with melanoma who received single-agent tafinlar in the break-3 study, 21% were aged 65 years or older [see clinical studies (14.1)] . no overall differences in the effectiveness or safety of tafinlar were observed between geriatric patients as compared to younger adults in the break-3 study. of the 994 patients with melanoma who received tafinlar plus trametinib in the combi-d, combi-v, and combi-ad studies [see clinical studies (14.2, 14.3)] , 21% were aged 65 years and older and 5% were aged 75 years and older. no overall differences in the effectiveness of tafinlar plus trametinib were observed in geriatric patients as compared to younger adults across these melanoma studies. the incidences of peripheral edema (26% vs. 12%) and anorexia (21% vs. 9%) were increased in geriatric patients as compared to younger adults in these studies. of the 171 patients with nsclc who received tafinlar in study brf113928, there were insufficient numbers of geriatric patients to determine whether they respond differently from younger adults [see clinical studies (14.4)] . of the 26 patients with atc who received tafinlar in study brf117019, 77% were aged 65 years and older, and 31% were aged 75 years and older [see clinical studies (14.5)] . this study in atc did not include sufficient numbers of younger adults to determine whether they respond differently compared to geriatric patients. dose adjustment is not recommended for patients with mild (bilirubin ≤ upper limit of normal (uln) and aspartate aminotransferase (ast) > uln or bilirubin > 1x to 1.5x uln and any ast) hepatic impairment. as hepatic metabolism and biliary secretion are the primary routes of elimination of dabrafenib and its metabolites, patients with moderate (bilirubin > 1.5x to 3x uln and any ast) to severe (bilirubin > 3x to 10x uln and any ast) hepatic impairment may have increased exposure. an appropriate dosage has not been established for patients with moderate to severe hepatic impairment [see clinical pharmacology (12.3)] . - read this “instructions for use” carefully before you prepare and take or give tafinlar oral suspension for the first time and each time you get a refill. there may be new information. - this “instructions for use” does not take the place of talking with your healthcare provider about your or your child’s medical condition and treatment. - your healthcare provider or pharmacist should show you how to prepare and take or give a dose of tafinlar oral suspension correctly. always take or give tafinlar exactly as your healthcare provider tells you to. - if you have any questions about how to prepare and take or give a dose of tafinlar oral suspension, talk to your healthcare provider or pharmacist. - always use the dosing cup that comes with your tafinlar pack. if your pack does not contain a dosing cup, contact your healthcare provider or pharmacist. - use only clean water to rinse. do not use soap or dishwashing liquid to clean the dosing cup. - if at any time tafinlar oral suspension gets on your or your child’s skin, wash the area well with soap and water. - if at any time tafinlar oral suspension gets in your or your child’s eyes, rinse the eyes well with cool water. - if you spill any tafinlar oral suspension, follow the instructions at the end of this “instructions for use” in section e. “how to clean up any spilled tafinlar oral suspension”. - you will receive the tafinlar tablets in a sealed bottle. the tafinlar tablets must be mixed in water before taking or giving a dose of tafinlar oral suspension. the tablets break apart (disperse) in the water and may not fully dissolve. follow the instructions below to mix the tablets in water. - the prescribed number of tablets - 1 dosing cup - 1 teaspoon - drinking water - add cool drinking water up to the markings on the dosing cup, as follows: - if the prescribed dose is 1 to 4 tablets, you will need about 5 ml of water. - if the prescribed dose is 5 to 15 tablets, you will need about 10 ml of water. - do not throw away (dispose of) the cap. - if you are opening the bottle for the first time, remove the seal from the bottle. - add the prescribed number of tablets into the water in your dosing cup. - the bottle contains 2 plastic canisters to keep the tablets dry. if either canister falls out when you are taking out the tablets, re-insert it back into the bottle. - with your other hand, gently stir the water and tablets with the handle of a teaspoon until the tablets break apart (disperse). - it may take 3 minutes or more for the tablets to disperse. after the tablets disperse, the tafinlar oral suspension should be cloudy white, but may contain small pieces. - take or give the tafinlar oral suspension no later than 30 minutes after the tablets have been dispersed in water. - if more than 30 minutes have passed, throw away the tafinlar oral suspension following the instructions in section d and restart from the beginning of section a. if you are not sure how to throw away the tafinlar oral suspension, ask your healthcare provider or pharmacist. - if the prescribed dose is 1 to 4 tablets: do steps 7 through 9 one time. - if the prescribed dose is 5 to 15 tablets: do steps 7 through 9 two times. - if the prescribed dose is 1 to 3 tablets, the feeding tube size that may be used is 10 french gauge or larger. - if the prescribed dose is 4 to 15 tablets, the feeding tube size that may be used is 12 french gauge or larger. - if any of the tafinlar oral suspension comes into contact with your skin or eyes when you are following the steps below, follow the instructions in the section “important information you need to know before taking or giving tafinlar tablets for oral suspension”. - if any of the tafinlar oral suspension spills, follow the instruction in section e. “how to clean up any spilled tafinlar oral suspension”. - wash and dry your hands before giving a dose of tafinlar oral suspension. - it is important to give all of the medicine residue that is left in the oral syringe and feeding tube. repeat steps 4 through 7 three times to make sure that you give a full dose of tafinlar. - shake off excess water then wipe dry using clean paper towels. - you can also wash the teaspoon in a dishwasher. - throw away unused tafinlar tablets or oral suspension, or old dosing cups into the trash. do not pour tafinlar oral suspension down the drain. - ask your healthcare provider or pharmacist about how to safely throw away tafinlar tablets or oral suspension if you are not sure. - store the bottle of tafinlar tablets for oral suspension at room temperature between 68°f to 77°f (20°c to 25°c). - store the bottle of tafinlar tablets for oral suspension, along with the two plastic canisters inside the original packaging, with the cap tightly closed. the canisters contain a drying agent (desiccant) to help keep your medicine dry. - tafinlar tablets for oral suspension come in a bottle with a child-resistant cap. - throw away any tafinlar oral suspension if it is not taken or given within 30 minutes after it is prepared. t2024-24

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

novartis pharmaceuticals corporation - secukinumab (unii: dlg4eml025) (secukinumab - unii:dlg4eml025) - secukinumab 150 mg in 1 ml - cosentyx® is indicated for the treatment of moderate to severe plaque psoriasis (pso) in patients 6 years and older who are candidates for systemic therapy or phototherapy. cosentyx is indicated for the treatment of active psoriatic arthritis (psa) in patients 2 years of age and older. cosentyx is indicated for the treatment of adult patients with active ankylosing spondylitis (as). cosentyx is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation. cosentyx is indicated for the treatment of active enthesitis-related arthritis (era) in pediatric patients 4 years of age and older. cosentyx is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (hs). cosentyx is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in cosentyx. cases of anaphylaxis have been reported during treatment with cosentyx [see warnings and precautions (5.2)] . risk summary limited available human data with cosentyx use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose (mrhd) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown; however, the 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 an embryo-fetal development study was performed in cynomolgus monkeys with secukinumab. no malformations or embryo-fetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the mrhd (on a mg/kg basis at a maternal dose of 150 mg/kg). a pre- and post-natal development toxicity study was performed in mice with a murine analog of secukinumab. no treatment-related effects on functional, morphological, or immunological development were observed in fetuses from pregnant mice that were administered the murine analog of secukinumab on gestation days 6, 11, and 17 and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose. risk summary it is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. there are no data on the effects of cosentyx on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cosentyx and any potential adverse effects on the breastfed child from cosentyx or from the underlying maternal condition. subcutaneous administration pediatric plaque psoriasis the safety and effectiveness of cosentyx have been established for the treatment of moderate to severe pso in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy [see adverse reactions (6.1) and clinical studies (14.2)] . safety and effectiveness of cosentyx in pediatric patients with pso below the age of 6 years have not been established. juvenile psoriatic arthritis the safety and effectiveness of cosentyx have been established for the treatment of active jpsa in pediatric patients aged 2 years and older who weigh 15 kg or more [see adverse reactions (6.1) and clinical studies (14.6)] . the safety and effectiveness of cosentyx in pediatric patients less than 2 years of age with jpsa or with a body weight less than 15 kg has not been established. enthesitis-related arthritis the safety and effectiveness of cosentyx for the treatment of active era in pediatric patients aged 4 years and older who weigh 15 kg or more has been established [see adverse reactions (6.1) and clinical studies (14.6)] . the safety and effectiveness of cosentyx in pediatric patients below the age of 4 years old or with body weight less than 15 kg have not been established. hidradenitis suppurativa the safety and effectiveness of cosentyx in pediatric patients with hs have not been established. intravenous administration the safety and effectiveness of intravenous cosentyx in pediatric patients have not been established. of the 3,430 pso subjects exposed to subcutaneous cosentyx in clinical trials, a total of 230 (7%) were 65 years of age or older, and 32 (1%) subjects were 75 years of age or older. although no differences in safety or efficacy were observed between subjects 65 years of age or older and younger adult subjects, the number of subjects 65 years of age and older was not sufficient to determine whether they respond differently from younger adult subjects. of the 1,060 subjects with hs exposed to cosentyx in clinical trials, a total of 14 (1.3%) were 65 years of age and older. clinical trials in hs did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 300 mg/2 ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. the needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe. - do not remove the needle cap until just before you give the injection. - avoid touching the syringe guard wings before use. touching them may cause the syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe . see “how should i dispose of the used cosentyx prefilled syringe?” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringe in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringe in the original carton until ready to use to protect from light. - do not freeze the cosentyx prefilled syringe. - throw away (dispose of) any expired or unused cosentyx prefilled syringes. keep cosentyx and all medicines out of the reach of children. cosentyx prefilled syringe parts (see figure a): - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-42 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 150 mg/ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. children should not inject cosentyx themselves using the prefilled syringe. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the needle caps of the prefilled syringes contain latex. do not handle the prefilled syringes if you are sensitive to latex. - the prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. the needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe. - do not remove the needle cap until just before you give the injection. - avoid touching the syringe guard wings before use. touching them may cause the syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe. see “how should i dispose of used cosentyx prefilled syringes?” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringes in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringes in the original carton until ready to use to protect from light. - the cosentyx prefilled syringes may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date the cosentyx prefilled syringes were removed from and returned to the refrigerator in the space provided on the carton. - throw away the cosentyx prefilled syringe if it has been kept outside of the refrigerator over 4 days. - cosentyx prefilled syringe may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx prefilled syringes. - throw away (dispose of) any expired or unused cosentyx prefilled syringes. keep cosentyx and all medicines out of the reach of children. - if your prescribed dose of cosentyx is 150 mg , you must give 1 injection . - if your prescribed dose of cosentyx is 300 mg , you must give 2 injections . - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-43 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 75 mg/0.5 ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. children should not inject cosentyx themselves using the prefilled syringe. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the needle cap of the prefilled syringe contains latex. do not handle the prefilled syringe if you are sensitive to latex. - the prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. the needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe. - do not remove the needle cap until just before you give the injection. - avoid touching the syringe guard wings before use. touching them may cause the syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe. see “how should i dispose of the used cosentyx prefilled syringe? ” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringe in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringe in the original carton until ready to use to protect from light. - cosentyx prefilled syringe may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date cosentyx prefilled syringe was removed from and returned to the refrigerator in the space provided on the carton. - throw away cosentyx prefilled syringe if it has been kept outside of the refrigerator over 4 days. - cosentyx prefilled syringe may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx prefilled syringe. - throw away (dispose of) any expired or unused cosentyx prefilled syringe. keep cosentyx and all medicines out of the reach of children. - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-44 - do not use the cosentyx unoready pen if the seal on the outer carton is broken. keep the cosentyx unoready pen in the sealed outer carton until you are ready to use it. - do not shake the cosentyx unoready pen. - if you drop your cosentyx unoready pen, do not use it if it looks damaged, or if you dropped it with the cap removed. - the needle is covered by the needle guard and the needle will not be seen. do not touch or push the needle guard because you could get a needle stick. - throw away (dispose of) the used cosentyx unoready pen right away after use. - do not re-use the cosentyx unoready pen. see “step 9. disposing of the used cosentyx unoready pen ” at the end of this instructions for use. - store your carton of cosentyx unoready pen in a refrigerator between 36°f and 46°f (2°c and 8°c). - keep the cosentyx unoready pen in the original carton until ready to use to protect from light. - do not freeze the cosentyx unoready pen. - throw away (dispose of) any expired or unused cosentyx unoready pen. - a new cosentyx unoready pen each cosentyx unoready pen contains 300 mg of cosentyx. check to make sure that you have the correct medicine and dose. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container. see “step 9. disposing of the used cosentyx unoready pen ” at the end of this instructions for use. - look at the expiration date (exp) on your cosentyx unoready pen. do not use the cosentyx unoready pen if the expiration date has passed. - look through the viewing window. the liquid should be clear. its color may vary from colorless to slightly yellow. - do not use if the liquid contains visible particles, is cloudy or is discolored. you may see air bubbles, which is normal. - the recommended site is the front of the thighs. you may also use the lower abdomen, but not the area 2 inches around the navel (belly button) (see figure f) . - choose a different site each time you give an injection. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - if a caregiver or healthcare provider is giving you your injection, they may also inject into your outer upper arm (see figure g) . - wash your hands well with soap and water. - using a circular motion, clean the injection site with the alcohol wipe (see figure h) . leave it to dry before injecting. - do not touch the cleaned area again before injecting. - only remove the cap when you are ready to use the cosentyx unoready pen. - pull the cap straight off (see figure i) . do not twist the cap. - throw away the cap. do not try to re-attach the cap. - use the cosentyx unoready pen within 5 minutes of removing the cap. - this means the medicine has been delivered. contact your healthcare provider or pharmacist if the green indicator is not visible or does not fill the window. - there may be a small amount of blood at the injection site. you can press a cotton ball or gauze over the injection site and hold it for a few seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. - put your used cosentyx unoready pen in an fda-cleared sharps disposal container right away after use (see figure m) . do not throw away (dispose of) the cosentyx unoready pen in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles, syringes, and cosentyx unoready pens. t2023-45 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 150 mg/ml single-dose sensoready® pen be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the sensoready pen before you use it for the first time. children should not inject cosentyx themselves using the sensoready pen. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx sensoready pen if either the seal on the outer carton or the seal on the pen is broken. keep the cosentyx sensoready pen in the sealed outer carton until you are ready to use it. - do not shake the cosentyx sensoready pen. - the caps of the sensoready pens contain latex. do not handle the sensoready pens if you are sensitive to latex. - if you drop your cosentyx sensoready pen, do not use it if the sensoready pen looks damaged, or if you dropped it with the cap removed. - throw away (dispose of) the used cosentyx sensoready pen right away after use. do not re-use the cosentyx sensoready pen. see “how should i dispose of used cosentyx sensoready pens? ” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx sensoready pens in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx sensoready pens in the original carton until ready to use to protect from light. - the cosentyx sensoready pens may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date the cosentyx sensoready pens were removed from and returned to the refrigerator in the space provided on the carton. - throw away the cosentyx sensoready pen if it has been kept outside of the refrigerator over 4 days. - cosentyx sensoready pen may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx sensoready pens. - throw away (dispose of) any expired or unused cosentyx sensoready pens. keep cosentyx and all medicines out of the reach of children. - if your prescribed dose of cosentyx is 150 mg, you must give 1 injection. - if your prescribed dose of cosentyx is 300 mg, you must give 2 injections. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container. - look through the viewing window. the liquid should be clear. its color may vary from colorless to slightly yellow. do not use if the liquid contains visible particles, is cloudy or is discolored. you may see a small air bubble, which is normal. - look at the expiration date (exp) on your sensoready pen. do not use your cosentyx sensoready pen if the expiration date has passed. - the recommended site is the front of the thighs. you may also use the lower abdomen, but not the area 2 inches around the navel (belly button) (see figure e). - choose a different site each time you give an injection. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - if a caregiver or healthcare provider is giving you your injection, they may also inject into your outer upper arm (see figure f) . - wash your hands well with soap and water. - using a circular motion, clean the injection site with the alcohol wipe. leave it to dry before injecting (see figure g). - do not touch the cleaned area again before injecting. - only remove the cap when you are ready to use the cosentyx sensoready pen. - twist off the cap in the direction of the arrow (see figure h). - throw away the cap. do not try to re-attach the cap. - use the cosentyx sensoready pen within 5 minutes of removing the cap. - hold the cosentyx sensoready pen at 90 degrees to the cleaned injection site (see figure i) . - the 1st click indicates that the injection has started. - several seconds later a 2nd click will indicate that the injection is almost finished. - press the cosentyx sensoready pen firmly against the skin to start the injection (see figure j) . - the 1st click indicates the injection has started. - keep holding the cosentyx sensoready pen firmly against the skin. - the green indicator shows the progress of the injection. - listen for the 2nd click. this indicates the injection is almost complete. - check the green indicator fills the window and has stopped moving (see figure k) . - the cosentyx sensoready pen can now be removed. - this means the medicine has been delivered. contact your healthcare provider if the green indicator is not visible. - there may be a small amount of blood at the injection site. you can press a cotton ball or gauze over the injection site and hold it for 10 seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-46