United States - English - 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

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

ucb, inc. - certolizumab pegol (unii: umd07x179e) (certolizumab pegol - unii:umd07x179e) - certolizumab pegol 200 mg in 1 ml - cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (ra). cimzia is indicated for the treatment of adult patients with active psoriatic arthritis (psa). cimzia is indicated for the treatment of adults with active ankylosing spondylitis (as). [see clinical studies (14.4)] cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation [see clinical studies (14.5)]. cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (pso) who are candidates for systemic therapy or phototherapy [see clinical studies (14.6)] cimzia is con

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

glaxosmithkline llc - mepolizumab (unii: 90z2uf0e52) (mepolizumab - unii:90z2uf0e52) - mepolizumab 100 mg in 1 ml - nucala is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype [see use in specific populations (8.4), clinical studies (14.1)] . limitations of use nucala is not indicated for the relief of acute bronchospasm or status asthmaticus. nucala is indicated for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (crswnp) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa). nucala is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (hes) for ≥6 months without an identifiable non-hematologic secondary cause. nucala is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see warnings and precautions (5.1), descrip

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards.,psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards. psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 331.2 mg - injection, powder for - excipient ingredients: polysorbate 80; arginine hydrochloride; histidine; sucrose; histidine hydrochloride monohydrate - ulcerative colitis,treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,crohn?s disease,treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,pouchitis,entyvio is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

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

glaxosmithkline australia pty ltd - mepolizumab, quantity: 100 mg - injection, powder for - excipient ingredients: polysorbate 80; water for injections; dibasic sodium phosphate heptahydrate; sucrose - severe eosinophilic asthma,nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see section 5.1 pharmacodynamic properties, clinical trials).,chronic rhinosinusitis with nasal polyps (crswnp),nucala is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (crswnp) with an inadequate response to intranasal corticosteroids (see section 5.1 pharmacodynamic properties, clinical 2 trials).,relapsed or refractory egpa,nucala is indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (egpa) in adult patients aged 18 years and over (see section 5.1 pharmacodynamic properties, clinical trials).

Israel - English - Ministry of Health

neopharm ltd, israel - certolizumab pegol - solution for injection - certolizumab pegol 200 mg/ml - certolizumab pegol - rheumatoid arthritis:cimzia, in combination with methotrexate (mtx), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmards) including methotrexate, has been inadequate. cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.axial spondyloarthritis:cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: ankylosing spondylitis (as): adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). axial spondyloarthritis without radiographic evidence of as adults with severe active axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri), who have had an inadequate response to, or are intolerant to nsaids. crohn's disease :cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.plaque psoriasis:cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.

Israel - English - Ministry of Health

takeda israel ltd - vedolizumab - powder for concentrate for solution for infusion - vedolizumab 300 mg/vial - vedolizumab - ulcerative colitis:entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.crohn’s disease:entyvio is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - mepolizumab - powder for solution for injection - mepolizumab 100 mg - mepolizumab - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patientschronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with corticosteroids and surgery in the last 10 years do not provide adequate disease control.eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa).hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.