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

leo pharma inc. - tralokinumab (unii: gk1lyb375a) (tralokinumab - unii:gk1lyb375a) - adbry is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. adbry can be used with or without topical corticosteroids. adbry is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in adbry [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adbry during pregnancy. healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. risk summary there are limited data from the use of adbry in pregnant women to inform a drug-associated risk of adverse developmental outcomes. human igg antibodies are known to cross the placental barrier; therefore, adbry may be transmitted from the mother to the developing fetus. in an enhanced pre-and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after intravenous administration of tralokinumab-ldrm during organogenesis through parturition at doses up to 10 times the maximum recommended human dose (mrhd). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in a pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys once every week from gestation day 20 to parturition. no maternal or developmental toxicity was observed at doses up to 100 mg/kg/week (10 times the mrhd on a mg/kg basis of 10 mg/kg/week). in an enhanced pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm (10 times the mrhd on a mg/kg basis of 10 mg/kg/week) were administered to pregnant cynomolgus monkeys once every week from the beginning of organogenesis to parturition. no treatment-related adverse effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age. risk summary there are no data on the presence of tralokinumab-ldrm in human milk, the effects on the breastfed infant, or the effects on milk production. maternal igg is present in breast milk. the effects of local gastrointestinal exposure and limited systemic exposure to adbry on the breastfed infant are unknown. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for adbry and any potential adverse effects on the breastfed child from adbry or from the underlying maternal condition. the safety and effectiveness of adbry have been established for the treatment of moderate-to-severe atopic dermatitis in pediatric patients 12 to 17 years of age whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable . use of adbry in this age group is supported by a multicenter, randomized, double-blind, placebo-controlled study (ecztra 6) in 289 pediatric subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis. the safety and effectiveness were consistent between pediatric subjects 12 to 17 years of age and adult subjects [see adverse reactions (6.1) and clinical studies (14)] . safety and effectiveness of adbry have not been established in pediatric patients younger than 12 years of age. of the 1605 subjects exposed to adbry in 5 atopic dermatitis trials in the initial treatment period of up to 16 weeks, 77 subjects were 65 years or older. clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see clinical pharmacology (12.3)]. adbry® [ad'-bree] (tralokinumab-ldrm) injection, for subcutaneous use this instructions for use contains information on how to inject adbry. read this instructions for use before you start using the adbry prefilled syringe and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. keep this instructions for use and refer to it as needed. each single-dose prefilled syringe contains 150 mg of adbry. the adbry prefilled syringes are for one time use only. important information you need to know before injecting adbry: - your healthcare provider should show you or your caregiver how to prepare and inject a dose of adbry using the prefilled syringe before you inject adbry for the first time. talk to your healthcare provider if you have any questions about how to inject adbry the right way. - adbry is given as an injection under the skin (subcutaneous injection). - do not inject yourself or someone else until you have been shown how to inject adbry the right way. - in children 12 years of age and older, it is recommended that adbry be given by or under supervision of an adult. - talk to your healthcare provider about your prescribed dose before injecting adbry. - rotate the injection site each time you give an injection. - the adbry prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. - do not remove the needle cover until just before you give the injection. - do not share or reuse your adbry prefilled syringe. - do not inject through clothes. - store adbry prefilled syringes in a refrigerator between 36°f to 46°f (2°c to 8°c). - store adbry prefilled syringes in the original carton to protect from light until you are ready to use them. - adbry can be stored in the original carton at room temperature up to 86°f (30°c) for up to 14 days. - if left out of the refrigerator for more than 14 days, throw away (dispose of) the adbry prefilled syringes. - do not freeze adbry prefilled syringes. do not use if they have been frozen. - do not shake the adbry prefilled syringes. - do not heat the adbry prefilled syringes. - do not put the adbry prefilled syringes into direct sunlight. - keep adbry prefilled syringes and all medicines out of the reach of children. adbry prefilled syringe parts (see figure a): figure a step 1: setting up adbry injection figure b 1a: gather the supplies needed for your injection. for each adbry dose you will need (see figure b): - a clean, flat, well-lit work surface, like a table - prescribed number of adbry prefilled syringe(s) - an alcohol swab (not included in the carton) - clean cotton balls or gauze pads (not included in the carton) - a puncture-resistant sharps disposal container (not included in the carton). see step 5 "disposing of adbry" at the end of this instructions for use. figure c 1b: take the adbry prefilled syringe carton out of the refrigerator - check the expiration date (exp) on the carton (see figure c). do not use if the expiration date on the carton has passed. - when using the first prefilled syringe, check to make sure the seal on the adbry carton is intact. - do not use the adbry prefilled syringes if the seal on the carton is broken. figure d 1c: determine how many adbry prefilled syringes you need for your dose if you have been prescribed a 300 mg dose, you will need 2 syringes. if you have been prescribed a 150 mg dose, you will only need 1 syringe and the remaining syringe should be returned to the refrigerator in its carton. - remove the adbry prefilled syringe(s) by grasping the body (not the plunger rod) of the adbry prefilled syringe (see figure d ). - do not touch the needle guard clips to keep from activating the safety device (needle guard) too soon. - do not remove the needle cover on the prefilled syringe until you have reached step 3 and are ready to inject. figure e 1d: let the adbry prefilled syringe(s) warm up to room temperature (see figure e) place the adbry prefilled syringe(s) on the flat surface and wait 30 minutes before you inject adbry to let the prefilled syringe(s) warm up to room temperature 68°f to 86°f (20°c to 30°c). this will help to reduce discomfort. - do not microwave the prefilled syringes, run hot water over them, or leave them in direct sunlight. - do not shake the syringes. - do not remove the needle cover on the prefilled syringes until you have reached step 3 and are ready to inject. - do not put the syringes back in the refrigerator after they have reached room temperature. figure f 1e: inspect the adbry prefilled syringe(s) (see figure f) - make sure adbry appears on the label. - check the expiration date printed on the syringe. - check the medicine through the viewing window. the medicine inside should be clear to slightly pearly and colorless to pale yellow. - do not use the adbry prefilled syringe, throw away and get a new one if: the expiration date printed on the syringe has passed the medicine is cloudy, discolored, or has particles in it looks damaged or has been dropped - the expiration date printed on the syringe has passed - the medicine is cloudy, discolored, or has particles in it - looks damaged or has been dropped - you may see small air bubbles in the liquid. this is normal. you do not need to do anything about it. step 2: choosing and preparing injection area figure g 2a: choose the area for your injection (see figure g) - you may inject into your thighs or your stomach area (abdomen), but not within 2 inches (5 cm) of your belly button (navel). - the upper arm can also be used if a caregiver gives the injection. - inject your dose into a different body area each time you inject adbry. - if you need more than 1 injection for your dose, inject into the same body area, but at least 1 inch (3 cm) apart from each other. - do not inject where the skin is tender, damaged, bruised or scarred. figure h 2b: wash your hands and prepare your skin - wash your hands with soap and water. - clean the injection area with an alcohol swab using a circular motion (see figure h ). let the area dry completely. do not blow or touch the cleaned area before injecting. - let the area dry completely. - do not blow or touch the cleaned area before injecting. step 3: injecting adbry figure i 3a: pull off the adbry needle cover hold the adbry prefilled syringe body with one hand, pull the needle cover straight off with your other hand (see figure i ) and throw it away in the sharps container. - do not try to recap the adbry prefilled syringe. - do not hold the plunger rod or plunger head while removing the needle cover. - you may see a drop of liquid at the end of the needle. this is normal. - do not touch the needle, or let it touch any surface. if either of these occur, throw away the syringe and get a new one. figure j 3b: insert the needle with one hand, gently pinch and hold a fold of skin where you cleaned the injection area. with the other hand, insert the needle completely at about a 45-degree angle into your skin (see figure j ). figure k 3c: inject the medicine use your thumb to firmly push down the plunger head all the way down (see figure k ). all the medicine is injected when you cannot push the plunger head any further. figure l 3d: release and remove lift your thumb off the plunger head. the needle will automatically move back inside the syringe body and lock into place (see figure l ). - place a dry cotton ball or gauze pad over the injection site for a few seconds. do not rub the injection site. if needed, cover the injection site with a small bandage. - there may be a small amount of blood or liquid where you injected. this is normal. throw away the used adbry prefilled syringe in the sharps disposal container. see step 5 "disposing of adbry". step 4: repeating for multiple injections figure m if you need to give multiple injections for your prescribed dose, repeat step 3. the other injection(s) should be given into the same body area, but at least 1 inch (3 cm) away from each other. step 5: disposing of adbry syringe(s) figure n - put the used adbry prefilled syringe(s) in an fda-cleared sharps disposal container right away after use (see figure n ). do not throw away the adbry prefilled syringe(s) 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 sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. 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 recycle your used sharps disposal container. for more information go to www.adbry.com or call 1-844-692-3279. if you still have questions, call your healthcare provider. manufactured by: leo pharma a/s industriparken 55, dk-2750 ballerup, denmark distributed by: leo pharma inc., madison, nj 07940, usa u.s. license no. 2169 adbry® is a registered trademark of leo pharma a/s. © 2023 leo pharma inc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised 12/2023

European Union - English - EMA (European Medicines Agency)

leo pharma a/s - tralokinumab - dermatitis, atopic - other dermatological preparations - adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Canada - English - Health Canada

leo pharma inc - tralokinumab - solution - 150mg - tralokinumab 150mg - misc. skin and mucous membrane agents

Canada - English - Health Canada

leo pharma inc - tralokinumab - solution - 300mg - tralokinumab 300mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

pharmaceutical products, denmark - tralokinumab - solution for injection - 150 mg,

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

leo pharma k.k. - tralokinumab(genetical recombination) - injection

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

novartis pharmaceuticals corporation - canakinumab (unii: 37cq2c7x93) (canakinumab - unii:37cq2c7x93) - canakinumab 150 mg in 1 ml - ilaris® (canakinumab) is an interleukin-1β (il-1β) blocker indicated for the treatment of the following autoinflammatory periodic fever syndromes: cryopyrin-associated periodic syndromes (caps) ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps), in adults and pediatric patients 4 years of age and older, including: - familial cold autoinflammatory syndrome (fcas) - muckle-wells syndrome (mws) tumor necrosis factor receptor (tnf) associated periodic syndrome (traps) ilaris is indicated for the treatment of tumor necrosis factor (tnf) receptor associated periodic syndrome (traps) in adult and pediatric patients. hyperimmunoglobulin d syndrome (hids)/mevalonate kinase deficiency (mkd) ilaris is indicated for the treatment of hyperimmunoglobulin d (hyper-igd) syndrome (hids)/mevalonate kinase deficiency (mkd) in adult and pediatric patients. familial mediterranean fever (fmf) ilaris is indicated for the treatment of familial mediterranean fever (fmf) in adult and pediatric pat

Israel - English - Ministry of Health

novartis israel ltd - canakinumab - powder for solution for injection - canakinumab 150 mg / 1 ml - canakinumab - canakinumab - ►periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromes (caps)ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:• muckle-wells syndrome (mws),• neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),• severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.►tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).►hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd)ilaris is i

Israel - English - Ministry of Health

novartis israel ltd - canakinumab - solution for injection - canakinumab 150 mg / 1 ml - canakinumab - ►periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromes (caps)ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:• muckle-wells syndrome (mws),• neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),• severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.►tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).►hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd)ilaris is indicated for the treatment of hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd).►familial mediterranean fever (fmf)ilaris is indicated for the treatment of familial mediterranean fever (fmf) in patients in whom colchicine is contraindicated, is not tolerated, or does not provide an adequate response despite the highest tolerable dose of colchicine.ilaris can be given as monotherapy or in combination with colchicine.ilaris is also indicated for the treatment of:►still’s diseaseilaris is indicated for the treatment of active still’s disease including adult-onset still’s disease (aosd) and systemic juvenile idiopathic arthritis (sjia) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (nsaids) and systemic corticosteroids. ilaris can be given as monotherapy or in combination with methotrexate.►gouty arthritisilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (nsaids) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate

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

novartis pharmaceuticals australia pty ltd - canakinumab -