ABD - İngilizce - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86), pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - alogliptin 12.5 mg - oseni is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use oseni should not be used in patients with type 1 diabetes mellitus. serious hypersensitivity reaction to alogliptin or pioglitazone or any of the excipients in oseni, such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see warnings and precautions (5.3), adverse reactions (6.2)] . do not initiate in patients with nyha class iii or iv heart failure [see boxed warning] . risk summary limited data with oseni in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. in animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5 and 35 times the 45 mg clinical dose, respectively, based on body surface area. no adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180 and 149 times the 25 mg clinical dose, respectively, based on plasma drug exposure (auc) [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of 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. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data animal data alogliptin and pioglitazone co-administration of 100 mg/kg alogliptin and 40 mg/kg pioglitazone (39 and 10 times the 25 mg and 45 mg clinical doses, respectively, based on body surface area) to pregnant rats during organogenesis slightly augmented pioglitazone-related fetal effects of delayed development and reduced fetal weights but did not result in embryofetal mortality or teratogenicity. alogliptin alogliptin administered to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at doses of up to 200 mg/kg and 500 mg/kg, or 149 times and 180 times, the 25 mg clinical dose, respectively, based on plasma drug exposure (auc). placental transfer of alogliptin into the fetus was observed following oral dosing to pregnant rats. no adverse developmental outcomes were observed in offspring when alogliptin was administered to pregnant rats during gestation and lactation at doses up to 250 mg/kg (~95 times the 25 mg clinical dose, based on auc). pioglitazone pioglitazone administered to pregnant rats during organogenesis did not cause adverse developmental effects at a dose of 20 mg/kg (~5-times the 45 mg clinical dose), but delayed parturition and reduced embryofetal viability at 40 and 80 mg/kg, or ≥9-times the 45 mg clinical dose, by body surface area. in pregnant rabbits administered pioglitazone during organogenesis, no adverse developmental effects were observed at 80 mg/kg (~35-times the 45 mg clinical dose), but reduced embryofetal viability at 160 mg/kg, or ~69-times the 45 mg clinical dose, by body surface area. when pregnant rats received pioglitazone during late gestation and lactation, delayed postnatal development, attributed to decreased body weight, occurred in offspring at maternal doses of 10 mg/kg and above or ≥2 times the 45 mg clinical dose, by body surface area. risk summary there is no information regarding the presence of pioglitazone or alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. pioglitazone and alogliptin are present in rat milk; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for oseni and any potential adverse effects on the breastfed infant from oseni or from the underlying maternal condition. discuss the potential for unintended pregnancy with premenopausal women as therapy with pioglitazone, like other thiazolidinediones, may result in ovulation in some anovulatory women. safety and effectiveness of oseni in pediatric patients have not been established. oseni is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention and congestive heart failure, fractures and urinary bladder tumors [see warnings and precautions (5.1, 5.5, 5.6, 5.7)] . alogliptin and pioglitazone of the total number of patients (n=1533) in clinical safety and efficacy studies treated with alogliptin and pioglitazone, 248 (16.2%) patients were 65 years and older and 15 (1%) patients were 75 years and older. no overall differences in safety or effectiveness were observed between these patients and younger patients. while this and other reported clinical experiences have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be excluded. alogliptin of the total number of patients (n=9052) in clinical safety and efficacy studies treated with alogliptin, 2257 (24.9%) patients were ≥65 years old and 386 (4.3%) patients were ≥75 years old. no overall differences in safety or effectiveness were observed between patients ≥65 years old and younger patients. pioglitazone a total of 92 patients (15.2%) treated with pioglitazone in the three pooled, 16 to 26 week, double-blind, placebo-controlled, monotherapy trials were ≥65 years old and two patients (0.3%) were ≥75 years old. in the two pooled 16 to 24 week add-on to sulfonylurea trials, 201 patients (18.7%) treated with pioglitazone were ≥65 years old and 19 (1.8%) were ≥75 years old. in the two pooled 16 to 24 week add-on to metformin trials, 155 patients (15.5%) treated with pioglitazone were ≥65 years old and 19 (1.9%) were ≥75 years old. in the two pooled 16 to 24 week add-on to insulin trials, 272 patients (25.4%) treated with pioglitazone were ≥65 years old and 22 (2.1%) were ≥75 years old. in proactive, 1068 patients (41%) treated with pioglitazone were ≥65 years old and 42 (1.6%) were ≥75 years old. in pharmacokinetic studies with pioglitazone, no significant differences were observed in pharmacokinetic parameters between elderly and younger patients. these clinical experiences have not identified differences in effectiveness and safety between the elderly (≥65 years) and younger patients although small sample sizes for patients ≥75 years old limit conclusions [see clinical pharmacology (12.3)] . alogliptin a total of 602 patients with moderate renal impairment (egfr ≥30 and <60 ml/min/1.73 m2 ) and four patients with severe renal impairment/end-stage renal disease (egfr <30 ml/min/1.73 m2 or <15 ml/min/1.73 m2 , respectively) at baseline were treated with alogliptin in clinical trials in patients with type 2 diabetes. reductions in hba1c were generally similar in this subgroup of patients. the overall incidence of adverse reactions was generally balanced between alogliptin and placebo treatments in this subgroup of patients. in the examine trial of high cv risk type 2 diabetes patients, 694 patients had moderate renal impairment and 78 patients had severe renal impairment or end-stage renal disease at baseline. the overall incidences of adverse reactions, serious adverse reactions and adverse reactions leading to study drug discontinuation were generally similar between the treatment groups. alogliptin no dose adjustments are required in patients with mild to moderate hepatic impairment (child-pugh grade a and b) based on insignificant change in systemic exposures (e.g., auc) compared to subjects with normal hepatic function in a pharmacokinetic study. alogliptin has not been studied in patients with severe hepatic impairment (child-pugh grade c). use caution when administering alogliptin to patients with liver disease [see warnings and precautions (5.4)]. pioglitazone no dose adjustments are required in patients with hepatic impairment (child-pugh grade b and c) based on insignificant change in systemic exposures (e.g., auc) compared to subjects with normal hepatic function in a pharmacokinetic study. however, use with caution in patients with liver disease [see warnings and precautions (5.4)].

ABD - İngilizce - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - ponatinib hydrochloride (unii: 96r6pu3d8j) (ponatinib - unii:4340891kfs) - ponatinib 15 mg - iclusig is indicated for the treatment of adult patients with: - chronic phase (cp) chronic myeloid leukemia (cml) with resistance or intolerance to at least two prior kinase inhibitors. - accelerated phase (ap) or blast phase (bp) cml or philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) for whom no other kinase inhibitors are indicated. - t315i-positive cml (chronic phase, accelerated phase, or blast phase) or t315i-positive ph+ all. limitations of use : iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed cp-cml [see warnings and precautions (5.7)] . none. risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)] , iclusig can cause fetal harm when administered to a pregnant woman. there are no available data on iclusig use in pregnant women. in animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower

ABD - İngilizce - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine 0.6 mg - colcrys (colchicine, usp) tablets are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares: colcrys is indicated for prophylaxis of gout flares. - treatment of gout flares: colcrys tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colcrys (colchicine, usp) tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colcrys in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colcrys (colchicine), published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range. the estimated 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 human data available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, behcet's disease, or familial mediterranean fever (fmf) treated with colchicine at therapeutic doses during pregnancy. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. risk summary colchicine is present in human milk (see data) . adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. there are no data on the effects of colchicine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for colcrys and any potential adverse effects on the breastfed child from colcrys or from the underlying maternal condition. data limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. a systematic review of literature reported no adverse effects in 149 breastfed children. in a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants. infertility case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. a case report indicated that azoospermia was reversed when therapy was stopped. case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility. however, since the progression of fmf without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see nonclinical toxicology (13.1)] . the safety and efficacy of colchicine in children of all ages with fmf has been evaluated in uncontrolled studies. there does not appear to be an adverse effect on growth in children with fmf treated long-term with colchicine. safety and effectiveness of colchicine in pediatric patients with gout has not been established. clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of fmf did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see dosage and administration (2.4), clinical pharmacology (12.3)] . colchicine is significantly excreted in urine in healthy subjects. clearance of colchicine is decreased in patients with impaired renal function. total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis. prophylaxis of gout flares for prophylaxis of gout flares in patients with mild (estimated creatinine clearance clcr 50 to 80 ml/min) to moderate (clcr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. however, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. for the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see dosage and administration (2.5)] . treatment of gout flares for treatment of gout flares in patients with mild (clcr 50 to 80 ml/min) to moderate (clcr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colcrys. however, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. for patients with gout flares requiring repeated courses, consideration should be given to alternate therapy. for patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet). for these patients, the treatment course should not be repeated more than once every two weeks [see dosage and administration (2.5)] . fmf although pharmacokinetics of colchicine in patients with mild (clcr 50 to 80 ml/min) and moderate (clcr 30 to 50 ml/min) renal impairment is not known, these patients should be monitored closely for adverse effects of colchicine. dose reduction may be necessary. in patients with severe renal failure (clcr less than 30 ml/min) and end-stage renal disease requiring dialysis, colcrys may be started at the dose of 0.3 mg/day. any increase in dose should be done with adequate monitoring of the patient for adverse effects of colcrys [see clinical pharmacology (12.3), dosage and administration (2.5)] . the clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment compared to healthy subjects [see clinical pharmacology (12.3)] . prophylaxis of gout flares for prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see dosage and administration (2.6)] . treatment of gout flares for treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended colcrys dose is not required, but patients should be monitored closely for adverse effects of colcrys. however, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, the treatment course should be repeated no more than once every two weeks. for these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see dosage and administration (2.6)] . fmf in patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see clinical pharmacology (12.3), dosage and administration (2.6)] . tolerance, abuse or dependence with colchicine has not been reported.

Singapur - İngilizce - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - policresulen - suppository - 90 mg - policresulen 90 mg

İsrail - İngilizce - Ministry of Health

takeda israel ltd - albumin human - solution for infusion - albumin human 200 mg / 1 ml - albumin - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

İsrail - İngilizce - Ministry of Health

takeda israel ltd - albumin human - solution for infusion - albumin human 50 mg / 1 ml - albumin - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

takeda pharma a/s - azilsartan medoxomil - hypertension - agents acting on the renin-angiotensin system - ipreziv is indicated for the treatment of essential hypertension in adults.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

takeda pharma a/s - ferumoxytol - anemia; kidney failure, chronic - other antianemic preparations - rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (ckd).the diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

takeda pharma a/s - azilsartan medoxomil - hypertension - agents acting on the renin-angiotensin system - edarbi is indicated for the treatment of essential hypertension in adults.

ABD - İngilizce - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - vedolizumab (unii: 9rv78q2002) (vedolizumab - unii:9rv78q2002) - vedolizumab 300 mg in 5 ml - entyvio is indicated in adults for the treatment of: - moderately to severely active ulcerative colitis (uc). - moderately to severely active crohn's disease (cd). entyvio is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to entyvio or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see warnings and precautions (5.1)] . risk summary available data from the organization of teratology information specialists (otis)/mothertobaby entyvio pregnancy registry, published literature and pharmacovigilance in pregnant women have not reliably identified an entyvio-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data) . there are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see clinical considerations) . no fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see data) . the background risk of major birth defects and miscarriage for the indicated populations 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 miscarriage is 15 to 20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions entyvio administered during pregnancy could affect immune responses in the in utero exposed newborn and infant. the clinical significance of low levels of entyvio in utero-exposed infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. data human data the vedolizumab pregnancy exposure registry conducted by otis/mothertobaby study in the united states and canada collected prospective observational data between 2015 and 2022 to assess the risk of major birth defects in live-born infants of women with ulcerative colitis (uc) or crohn’s disease (cd) treated with vedolizumab during pregnancy. the study compared pregnant patients with uc or cd exposed to vedolizumab with pregnant patients with uc or cd treated with other biological products. the registry included 99 women (58 with uc, 41 with cd) treated with vedolizumab during pregnancy, and 76 women (27 with uc, 49 with cd) exposed to other biological products during pregnancy. the proportion of major birth defects among live-born infants in patients with uc or cd treated with vedolizumab and patients with uc or cd treated with other biological products was 7.4% (7/94) and 5.6% (4/71), respectively. overall, there was no evidence of increased risk for major structural birth defects (adjusted rr 1.07, 95% ci: 0.33, 3.52). the methodological limitations of the registry, including small sample size and the non-randomized design, resulted in a limited ability to estimate the risk of major birth defects and other maternal and infant outcomes. the conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance. animal data a reproduction study has been performed in pregnant rabbits at single intravenous doses up to 100 mg/kg administered on gestation day 7 (about 20 times the recommended human dosage) and has revealed no evidence of impaired fertility or harm to the fetus due to vedolizumab. a pre- and post-natal development study in monkeys showed no evidence of any adverse effect on pre- and post-natal development at intravenous doses up to 100 mg/kg (about 20 times the recommended human dosage). risk summary data from a clinical lactation study show the presence of vedolizumab in human milk. the mean calculated daily infant dosage was 0.02 mg/kg/day orally (see data) . systemic exposure in a breastfed infant is expected to be low because monoclonal antibodies are largely degraded in the gastrointestinal tract. there are no data on the effects of vedolizumab on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for entyvio and any potential adverse effects on the breastfed infant from entyvio or from the underlying maternal condition. data a milk-only lactation study was conducted in 9 adult lactating women being treated for active ulcerative colitis or crohn's disease with intravenous entyvio every 8 weeks after reaching steady state and completing the induction phase (entyvio administration at 0, 2, and 6 weeks). mean concentrations of entyvio in human milk ranged from 0.03 to 0.26 mcg/ml. the mean calculated daily infant oral dosage was 0.02 mg/kg/day calculated as a product of the average concentration over the 8-week dosing interval and the standardized milk consumption of 150 ml/kg/day. safety and effectiveness of entyvio in pediatric patients have not been established. clinical trials of entyvio did not include sufficient numbers of subjects aged 65 and over (56 crohn's and ulcerative colitis patients aged 65 and over were treated with entyvio during controlled phase 3 trials) to determine whether they respond differently from younger subjects. however, no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. entyvio ® (en ti' vee oh) pen (vedolizumab) injection, for subcutaneous use single-dose prefilled pen this instructions for use contains information on how to inject entyvio. your entyvio single-dose prefilled pen - read and follow this instructions for use before you inject entyvio. - your healthcare provider should show you how to use the entyvio pen before you use it for the first time. - entyvio pen is for subcutaneous injection only (inject directly into fatty layer under the skin). - do not shake the prefilled pen. - do not remove the purple cap from the prefilled pen until you are ready to inject. - do not put or press your thumb, fingers, or hand over the yellow needle shield. the yellow needle shield is visible when the purple cap is removed. - do not use the prefilled pen if it is dropped or damaged. storing entyvio - store your prefilled pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - your prefilled pen can be left in its box at room temperature up to 77°f (25°c) for up to 7 days (for example, when traveling). do not use the prefilled pen if it is left out of the refrigerator for more than 7 days. - do not freeze the prefilled pen. - do not leave the prefilled pen in direct sunlight. - throw away the prefilled pen in a fda-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. see step 14 for instructions on how to throw away (dispose of) the prefilled pen. - always keep entyvio pens, the sharps disposal container, and all medicines out of the reach of children. - do not use the prefilled pen if any of the seals on the box are broken. - do not use the prefilled pen if the expiration date on the box has passed. - do not warm the prefilled pen any other way. - do not let the prefilled pen sit in direct sunlight. - do not take the prefilled pen out of its tray until you are ready to inject. - alcohol pad - cotton ball or gauze - sharps disposal container (see step 14 "throw away (dispose of) the prefilled pen") - do not shake the prefilled pen. - do not remove the purple cap from the prefilled pen until step 9 . - do not use the prefilled pen if the expiration date on the prefilled pen has passed. - do not use the prefilled pen if the medicine is cloudy or has particles floating in it. - do not use the prefilled pen if any part of it is damaged. - do not inject into the same spot you used for your last injection. - do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged. - do not touch or blow on the cleaned injection site before you inject. - the needle is inside the yellow needle shield (under purple cap). - do not put or press your thumb, fingers, or hand over the yellow needle shield. - do not put the purple cap back on. this could accidentally start the injection. - hold the prefilled pen so you can see the viewing window. - place the yellow end of the prefilled pen flat on your skin at 90 degrees to the injection site (see figure j ). - the needle is inside the yellow needle shield. - do not push down on the prefilled pen until you are ready to inject. - you may hear a first click when the injection starts. - you may hear a second click. this is not the end of the injection. - continue holding the prefilled pen with constant pressure and watch the window turn purple. - you will see a small amount of gray in the viewing window. this is normal. - if the viewing window did not fill with purple, you may not have received your full dose. call your pharmacy or healthcare provider. - when you remove the prefilled pen, if the window has not turned purple, or it looks like the medicine is still coming out of the prefilled pen, this means you have not received a full dose. call your pharmacy or healthcare provider right away. - you may see a small amount of blood at the injection site. if you do, press on your skin with a cotton ball or gauze. - throw away the remaining supplies in your household trash or sharps disposal container. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of 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 local or state laws about how you should throw away needles and syringes. - for more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. this instructions for use has been approved by the u.s. food and drug administration. approved: 9/2023 entyvio® (en ti' vee oh) (vedolizumab) injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject entyvio. your entyvio single-dose prefilled syringe - read and follow this instructions for use before you inject entyvio. - your healthcare provider should show you how to use the entyvio prefilled syringe before you use it for the first time. - entyvio prefilled syringe is for subcutaneous injection only (inject directly into fatty layer under the skin). - do not shake the prefilled syringe. - do not remove the needle cap from the prefilled syringe until you are ready to inject. - do not use the prefilled syringe if it is dropped or damaged. - each prefilled syringe has a needle guard. it will automatically cover the needle after the injection is completed to reduce the risk of accidental needle sticks. storing entyvio - store your prefilled syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - your prefilled syringe can be left in its box at room temperature up to 77°f (25°c) for up to 7 days (for example, when traveling). do not use the prefilled syringe if it is left out of the refrigerator for more than 7 days. - do not freeze the prefilled syringe. - do not leave the prefilled syringe in direct sunlight. - throw away the prefilled syringe in a fda-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. see step 14 for instructions on how to throw away (dispose of) the prefilled syringe. - always keep entyvio prefilled syringes, the sharps disposal container, and all medicines out of the reach of children. - do not use the prefilled syringe if any of the seals on the box are broken. - do not use the prefilled syringe if the expiration date on the box has passed. - do not warm the prefilled syringe any other way. - do not let the prefilled syringe sit in direct sunlight. - do not take the prefilled syringe out of its tray until you are ready to inject. - alcohol pad - cotton ball or gauze - sharps disposal container (see step 14 "throw away (dispose of) the prefilled syringe") - do not lift from the purple plunger. - do not shake the prefilled syringe. - do not remove the needle cap from the prefilled syringe until step 9 . - do not use the prefilled syringe if the expiration date on the prefilled syringe has passed. - do not use the prefilled syringe if the medicine is cloudy or has particles floating in it. - do not use the prefilled syringe if any part of it is damaged. - do not try to remove air bubbles from the prefilled syringe. - do not inject into the same spot you used for your last injection. - do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged. - do not touch or blow on the cleaned injection site before you inject. - do not touch or pull back the purple plunger. - do not touch or re-cap the needle. - do not use a prefilled syringe with a bent or broken needle. - hold the pinch until the injection is completed. - avoid touching the plunger until the needle is inserted. - keep pressure on the plunger and take the needle out of the skin. - if you are not able to start or cannot complete the injection by pushing the plunger all the way down, you may not have received your full dose. call your pharmacy or healthcare provider. - you may see a small amount of blood at the injection site. if you do, press on your skin with a cotton ball or gauze. - throw away the remaining supplies in your household trash or sharps disposal container. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of 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 local or state laws about how you should throw away needles and syringes. - for more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. this instructions for use has been approved by the u.s. food and drug administration. approved: 9/2023