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takeda pharmaceuticals america, inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 100 mg - carbatrol is indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:      - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvements than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general ). carbatrol is indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marrow depression, hyper

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takeda pharmaceuticals america, inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 15 mg - prevacid and prevacid solutab are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)] . triple therapy: prevacid or prevacid solutab/amoxicillin/clarithromycin prevacid or prevacid solutab in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)] . please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: prevacid or prevacid solutab/amoxicillin prevacid or prevacid solutab in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulc

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takeda pharmaceuticals america, inc. - teduglutide (unii: 7m19191ikg) (teduglutide - unii:7m19191ikg) - teduglutide 5 mg in 0.5 ml - gattex® is indicated for the treatment of adults and pediatric patients 1 year of age and older with short bowel syndrome (sbs) who are dependent on parenteral support. none. risk summary available data from case reports with gattex use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. pregnant women with short bowel syndrome are at risk for malnutrition, which is associated with adverse maternal and fetal outcomes (see clinical considerations) . in animal reproduction studies, no effects on embryo-fetal development were observed with the subcutaneous administration of teduglutide to pregnant rats and rabbits during organogenesis at exposures up to 686 and 657 times, respectively, the clinical exposure at the recommended human dose (based on auc) (see data ). 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. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with short bowel syndrome are at risk for malnutrition. severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. data animal data reproduction studies have been performed in pregnant rats at subcutaneous doses of teduglutide up to 25 mg/kg twice daily (50 mg/kg/day) (about 686 times the clinical exposure (auc) at the recommended daily human dose of 0.05 mg/kg) and in pregnant rabbits at subcutaneous doses up to 25 mg/kg twice daily (50 mg/kg/day) (about 657 times the clinical exposure (auc) at the recommended daily human dose of 0.05 mg/kg) during the period of organogenesis. these studies did not reveal any evidence of impaired fertility or harm to the fetus due to teduglutide. in a pre- and postnatal development study in rats (gestation day 7 to lactation day 20), teduglutide did not show any significant adverse effects on pre- and postnatal development at doses up to 25 mg/kg twice daily (50 mg/kg/day) (about 343 times the clinical exposure (auc) at the recommended daily human dose of 0.05 mg/kg). risk summary there is no information regarding the presence of gattex in human milk, the effects of gattex on the breastfed infant, or the effects of gattex on milk production. teduglutide is present in the milk of lactating rats (see data ). systemic exposure of teduglutide to a breastfed infant is expected to be low. however, because of the potential for serious adverse reactions in a breastfed infant, including tumorigenicity [see nonclinical toxicology (13.1)] , advise patients that breastfeeding is not recommended during treatment with gattex. data in a milk excretion study in the rat, a single subcutaneous dose of 25 mg/kg of teduglutide (81 times the recommended daily human dose of 0.05 mg/kg based on body surface area) was administered to lactating female rats at day 12 postpartum. the maximum concentration of teduglutide in the milk corresponded to 0.9% and 2.9% of the plasma concentration at 1.5 and 4 hours after dosing, respectively. the safety and effectiveness in pediatric patients less than 1 year of age have not been established. the safety and effectiveness of gattex have been established in pediatric patients 1 year to less than 17 years of age who are dependent on parenteral support for the treatment of sbs. use of gattex in this population is supported by evidence from adequate and well-controlled studies in adults, with additional efficacy, safety, pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see dosage and administration (2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.2)] . these data were derived from two studies of 24-week (study 5) and 12-week (nct01952080) duration in which 41 pediatric patients were treated with gattex in the following groups: 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years) and 3 adolescents (12 years to less than 17 years). in these 2 studies and the corresponding extension studies (study 6 and nct02949362), 29 pediatric patients were administered gattex prospectively for up to 94 weeks [see clinical studies (14.2)] . adverse reactions in pediatric patients were similar to those seen in adults [see adverse reactions (6.1)] . juvenile animal toxicity data in a juvenile toxicity study, teduglutide was administered to juvenile minipigs at subcutaneous doses of 0.5, 2.5 and 12.5 mg/kg twice daily (1, 5, and 25 mg/kg/day) from post-natal day 7 and continuing for 90 days). exposures (auc) at these doses were at least 12-, 25-, and 170-fold the pediatric clinical exposure for ages 1 year to 11 years at 0.05 mg/kg, respectively, and 10-, 21-, and 141-fold the pediatric clinical exposure for ages 12 years to 17 years at 0.05 mg/kg, respectively. in juvenile minipigs, subcutaneous teduglutide caused intestinotrophic effects, gall bladder mucosal hyperplasia, bile duct mucosal hyperplasia, and injection site reactions, similar to those observed in adult animals. of the 134 patients with sbs that were treated with gattex at the recommended dosage of 0.05 mg/kg/day in the clinical studies, 19 patients were 65 years or older while 5 patients were 75 years of age or older. no overall differences in safety or efficacy 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, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . in adult subjects with moderate to severe renal impairment or end-stage renal disease (esrd) (creatinine clearance <60 ml/min), the exposure to teduglutide increased with the degree of renal impairment [see clinical pharmacology (12.3)] . reduce the dosage of gattex by half in both pediatric and adult patients with egfr less than 60 ml/min/1.73 m2  [see dosage and administration (2.3)] . gattex has not been studied in patients with severe hepatic impairment (child-pugh grade c). no dosage adjustment is recommended for patients with mild and moderate hepatic impairment (child-pugh grade a and b) [see clinical pharmacology (12.3)] . read this instructions for use before you start using gattex and each time you get a refill. there may be new information. your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of gattex the right way. if you cannot give yourself the injection: - ask your healthcare provider or nurse to help you, or - ask someone who has been trained by a healthcare provider or nurse to give your injections self-administration is not recommended in pediatric patients. in pediatric patients, gattex should be injected by: - a healthcare provider or nurse, or - a parent or adult caregiver who has been trained by a healthcare provider or nurse to give injections of gattex to pediatric patients important information: - use of the gattex 5 mg kit is not recommended in pediatric patients weighing less than 22 pounds (10 kg). - before you start, check the "use by" date on your gattex kit. make sure that the "use by" date has not passed. do not use anything in the gattex kit after the "use by" date on the kit. - give gattex within 3 hours after you mix the powder with the diluent (sterile water for injection). - use the syringes and needles provided in the gattex kit. - do not use a gattex vial more than 1 time, even if there is medicine left in the vial. - throw away (dispose of) any unused gattex after you give your injection. - safely throw away gattex vials after use. - do not re-use syringes or needles. see "step 7: dispose of syringes and needles" for information about how to safely throw away needles and syringes. - to help avoid needle-stick injuries, do not recap needles. gather the supplies you will need to prepare gattex and to give your injection (see figure a). figure a - 5-mg vial of gattex with green cap. your healthcare provider will tell you how many vials of gattex you will need for your injection. - 2 alcohol swab pads - diluent syringe with a white snap-off cap - needle for reconstitution (23g, 1½ inch) - plastic dosing syringe (1 ml) with needle attached (27g, 1/2 inch) - a sharps disposal container (not included in the gattex kit). see "step 7: dispose of needles and syringes." step 1: prepare the injection. - choose a well-lit, clean, flat work surface. - wash your hands with soap and water. step 2: preparing the diluent syringe. - put the diluent syringe (see figure b1) and the 23g, 1½ inch needle in front of you on your work surface. - hold the diluent syringe by the barrel. snap off the white cap (bend the cap sideways until the cap comes off). only the top portion of the white cap should be snapped off. the lower portion of the cap will remain in place (see figure b2) . throw the cap away. - remove the 23g, 1½ inch needle from the package. use the fold in the package to peel back the plastic cover (see figure c) . leave the plastic cap on the needle. - push the open end of the needle onto the end of the diluent syringe (see figure d) . twist the needle clockwise (to the right) until it stops turning. - when the needle is tightly in place, put the diluent syringe and needle on your work surface. step 3: mix gattex powder with diluent. - remove the green cap from the gattex vial. throw away the green cap. - find the gray rubber seal on top of the gattex vial (see figure e) . - use an alcohol swab pad to clean the gray rubber seal (see figure f) . - do not touch the gray rubber seal after you clean it. - pick up the diluent syringe with the needle attached. - remove the plastic cap that covers the needle (see figure g) . throw the cap away. - hold the gattex vial between your thumb and index (pointer) finger (see figure h) . be careful not to touch the gray rubber seal. - push the needle down through the center of the gray rubber seal. - slowly push down on the plunger of the diluent syringe. empty all the diluent into the gattex vial. - leave the needle and diluent syringe in place. - gently tap the barrel of the diluent syringe with a finger (see figure i) . - make sure all the diluent has gone into the gattex vial. - remove the diluent syringe and needle from the gattex vial. let the vial sit for about 30 seconds. - do not put the needle cap back on the needle. - throw away (dispose of) the diluent syringe and needle in your sharps disposal container. - after 30 seconds, place the gattex vial between the palms of your hands. gently roll the vial for about 15 seconds (see figure j) . - do not shake the gattex vial. - do not touch the gray rubber seal. if you do, clean it again with a new alcohol pad. - let the gattex vial stand on your work surface for about 2 minutes. step 4: check the mixed gattex. - after 2 minutes, look at the vial of gattex. the liquid in the vial should be clear and colorless to pale yellow, and should not have any particles in it. - if there is any powder in the gattex vial that did not dissolve, gently roll the vial between your hands for 15 seconds more. - do not shake the gattex vial. - check the gattex vial again for anything that did not dissolve. - do not use the gattex vial if there is anything in it that did not dissolve. start from the beginning of this instructions for use to prepare a new vial. use a new gattex vial, new diluent syringe, and a new needle. step 5: draw up your dose of gattex. - remove the plastic dosing syringe from the package. use the fold in the package to peel back the plastic cover (see figure k) . - remove the needle cap from the plastic dosing syringe (see figure l ). - throw the needle cap away. do not touch the needle or allow it to touch anything. - carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider. - use 1 hand to hold the gattex vial steady. use your other hand to insert the needle straight down into the middle of the gray rubber seal on the gattex vial (see figure m) . you may feel some resistance as the needle passes through the rubber seal. - gently push down the plunger until all of the air has gone from the plastic dosing syringe into the gattex vial. - turn the gattex vial and plastic dosing syringe upside down (see figure n) . - hold the gattex vial with 1 hand. - slowly pull back the plunger of the plastic dosing syringe with your other hand. - fill the plastic dosing syringe until the black tip of the plunger lines up with the mark that matches your prescribed dose (see figure o) . - keep the plastic dosing syringe and needle in the gattex vial. - you may see some bubbles inside the gattex vial when the plastic dosing syringe is filled. this is normal. with the needle still in the vial, gently tap the side of the plastic dosing syringe with a finger to make any air bubbles rise to the top (see figure p) . - slowly push the plunger up until all air bubbles are out of the plastic dosing syringe. make sure the tip of the needle is in the fluid. slowly pull back the plunger to draw up the right dose of gattex into the plastic dosing syringe. - remove the plastic dosing syringe and needle from the gattex vial (see figure q) . do not touch the needle or allow it to touch anything. step 6: inject gattex. - choose an injection site on the stomach area (abdomen), thighs, or upper arms. - choose a different site to give the injection each day. do not inject into areas where the skin is tender, bruised, red, or hard. (see figure r and figure s) figure s - clean the skin where you plan to give the injection with a new alcohol swab pad. do not touch this area again before giving the injection. - use 1 hand to gently pinch up a fold of skin around the injection site (see figure t) . - use your other hand to hold the plastic dosing syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick, "dart-like" motion (see figure u) . - let go of the skin. hold the syringe barrel with 1 hand while you slowly push down the plunger until the plastic dosing syringe is empty (see figure v) . - when the plastic dosing syringe is empty, quickly pull the needle out of your skin. there may be a little bleeding at the injection site. apply an adhesive bandage to the injection site if needed. step 7: dispose of syringes and needles. - do not re-use a syringe or needle. - to help avoid needle-stick injuries, do not recap a needle. - put your needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes 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 heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharp items 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 heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharp items 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 to throw away syringes and needles. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal . - do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your sharps disposal container. - throw away the gattex vial into the container where you put the syringes and needles. - if you have any questions, talk to your healthcare provider or pharmacist. how should i store gattex? - store gattex powder at room temperature up to 77°f (25°c). - do not freeze gattex. - use the gattex powder by the expiration date on the "use by" sticker on the kit. - use gattex within 3 hours after mixing it. - throw away any unused gattex that has been mixed, even if there is medicine left in the vial. - do not store any gattex you have mixed. keep gattex and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. distributed by: takeda pharmaceuticals america, inc. lexington, ma 02421 usa 1-877-825-3327 gattex® and the gattex® logo are registered trademarks of takeda pharmaceuticals u.s.a., inc. ©2024 takeda pharmaceuticals u.s.a., inc. all rights reserved. revised: 02/2024

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takeda pharmaceuticals america, inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - alogliptin 12.5 mg - kazano is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use kazano is not recommended for use in patients with type 1 diabetes mellitus. kazano is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. - history of serious hypersensitivity reaction to alogliptin or metformin or any of the excipients in kazano, such as anaphylaxis, angioedema and severe cutaneous adverse reactions [see warnings and precautions (5.4), adverse reactions (6.2)]. risk summary limited available data with kazano or alogliptin in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [se

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takeda pharmaceuticals america, inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - vortioxetine 5 mg - trintellix is indicated for the treatment of major depressive disorder (mdd) in adults. - hypersensitivity to vortioxetine or any component of the formulation. hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with trintellix [see adverse reactions (6.2)] . - the use of maois intended to treat psychiatric disorders with trintellix or within 21 days of stopping treatment with trintellix is contraindicated because of an increased risk of serotonin syndrome. the use of trintellix within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.4), warnings and precautions (5.2)] . starting trintellix in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monit

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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.

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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)].

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takeda pharmaceuticals america, inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon 8 mg - rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with rozerem should not be rechallenged with the drug. patients should not take rozerem in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with rozerem use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the rec

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takeda pharmaceuticals america, inc. - dexlansoprazole (unii: uye4t5i70x) (dexlansoprazole - unii:uye4t5i70x) - dexlansoprazole 30 mg - dexilant is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (ee) for up to eight weeks. dexilant is indicated in patients 12 years of age and older to maintain healing of ee and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. dexilant is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (gerd) for four weeks. - dexilant is contraindicated in patients with known hypersensitivity to any component of the formulation [see description (11)] . hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria [see warnings and precautions (5.2), adverse reactions (6)] . - ppis, including dexilant, are contraindicated with rilpivirine-containing products [see drug interactions (7)] . risk summary there are no studies with dexlansoprazole us

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takeda pharmaceuticals america, inc. - naltrexone hydrochloride (unii: z6375yw9sf) (naltrexone - unii:5s6w795cqm), bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - naltrexone hydrochloride 8 mg - contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (bmi) of: limitations of use: pregnancy category x risk summary contrave is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus. clinical considerations a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. human data there are no adequate and well-controlled studies of contrave in pregnant women. in clinical studies, 21 (0.7%) of 3,024 women became pregnant while taking contrave: 11 carried to term and gave b