European Union - English - EMA (European Medicines Agency)

serono europe limited - efalizumab - psoriasis - immunosuppressants - treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and puva (see section 5.1 - clinical efficacy).

Canada - English - Health Canada

emd serono, a division of emd inc., canada - efalizumab - powder for solution - 150mg - efalizumab 150mg - misc. skin and mucous membrane agents

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efalizumab 125mg - injection with diluent - 125 mg - active: efalizumab 125mg excipient: histidine histidine hydrochloride polysorbate 20 sucrose water for injection

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck serono ltd - efalizumab - powder and solvent for solution for injection - 125mg

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasis - immunosuppressants - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

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

genentech, inc. - omalizumab (unii: 2p471x1z11) (omalizumab - unii:2p471x1z11) - omalizumab 202.5 mg in 1.4 ml - xolair is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. limitations of use: xolair is not indicated for the relief of acute bronchospasm or status asthmaticus. xolair is indicated for 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. xolair is indicated for the reduction of allergic reactions (type i), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with ige-mediated food allergy. xolair is to be used in conjunction with food allergen avoidance. limitations of use: xolair is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. xolair is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (csu) who remain symptomatic despite h1 antihistamine treatment. limitations of use: xolair is not indicated for treatment of other forms of urticaria. xolair is contraindicated in patients with severe hypersensitivity reaction to xolair or any ingredient of xolair [see warnings and precautions (5.1)] . risk summary a registry study of xolair exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. there was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking xolair during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity [see data] . there are risks associated with poorly or moderately controlled asthma in pregnancy [see clinical considerations ] . human igg antibodies are known to cross the placental barrier; therefore, xolair may be transmitted from the mother to the developing fetus. in animal reproduction studies, no evidence of fetal harm was observed in cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (mrhd) [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the us 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 in women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. the level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. data human data a prospective cohort pregnancy exposure registry study conducted in the us from 2006 to 2018, included 250 pregnant women with asthma treated with xolair. of these, 246 patients were exposed to xolair in the first trimester of pregnancy, and the median exposure duration was 8.7 months. the registry findings for applicable mother and infant subgroups were compared to age-adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to xolair) identified from healthcare databases of residents in the canadian province of quebec, and referred to as the quebec external comparator cohort ("comparator cohort"). among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%). among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. there was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking xolair during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity. the registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort. animal data reproductive studies have been performed in cynomolgus monkeys. there was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the mrhd (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing. risk summary there is no information regarding the presence of omalizumab in human milk, or the effects on milk production. however, omalizumab is a human monoclonal antibody (igg1 kappa), and immunoglobulin (igg) is present in human milk in small amounts. the majority of infants (80.9%, 186/230) in the pregnancy exposure registry were breastfed. events categorized as "infections and infestations" were not significantly increased in infants who were exposed to xolair through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposure to xolair. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for xolair and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition. asthma safety and effectiveness of xolair for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older. use of xolair for this indication is supported by evidence from adequate and well-controlled studies. xolair was evaluated in 2 trials in 926 (xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen. one trial was a pivotal trial of similar design and conduct to that of adult and adolescent asthma trials 1 and 2. the other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. in the pivotal trial, xolair-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ics dose) [see clinical studies (14.1)] . safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. chronic rhinosinusitis with nasal polyps safety and effectiveness in pediatric patients with chronic rhinosinusitis with nasal polyps (crswnp) below 18 years of age have not been established. ige-mediated food allergy the safety and effectiveness of xolair for the reduction of allergic reactions (type i), including anaphylaxis, that may occur with accidental exposure to one or more foods have been established in pediatric patients aged 1 year and older with ige-mediated food allergy. use of xolair for this indication is supported by evidence from an adequate and well-controlled study that included a total of 165 pediatric patients; 61 patients aged 1 year to less than 6 years of age and 104 patients aged 6 to less than 18 years of age. a significantly greater percentage of xolair-treated patients compared to placebo-treated patients was able to consume a single dose of food (peanut, cashew, milk, egg) without dose- limiting symptoms [see clinical studies (14.3)]. safety and effectiveness in pediatric patients with ige-mediated food allergy below 1 year of age have not been established. chronic spontaneous urticaria the safety and effectiveness of xolair for chronic spontaneous urticaria (csu) who remain symptomatic despite h1 antihistamine treatment have been established in pediatric patients aged 12 years and older. use of xolair in this population is supported by evidence from adequate and well-controlled studies. adolescent patients with csu were evaluated in 39 patients 12 to 17 years of age (xolair 29, placebo 10) included in three randomized, placebo-controlled csu trials. a numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older. safety and effectiveness in pediatric patients with csu below 12 years of age have not been established. in clinical studies, 134 asthma patients, 20 crswnp patients, 37 csu patients and no ige-mediated food allergy patients 65 years of age or older were treated with xolair. although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients. - xolair prefilled syringes (you may need more than 1 prefilled syringe for your prescribed dose). see "choose the correct prefilled syringe or combination of prefilled syringes" for more information. each xolair carton contains 1 prefilled syringe. - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 14 "after the injection" ) choose the correct prefilled syringe or combination of prefilled syringes xolair prefilled syringes are available in 2 dose strengths. these instructions are to be used for both dose strengths. your prescribed dose may require more than 1 injection. the table below shows the combination of prefilled syringes needed to give your full dose. check the label on the xolair carton to make sure you have received the correct prefilled syringe or combination of prefilled syringes for your prescribed dose. if your dose requires more than 1 injection, inject the medicine from all of your prescribed prefilled syringes, immediately one after another. contact your healthcare provider if you have any questions. - keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). do not remove the prefilled syringe from its original carton during storage. - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not exceed 2 days. if the prefilled syringe is exposed to temperatures above 77 °f (25 °c), do not use it and throw away in a sharps disposal container. - keep your xolair prefilled syringes out of direct sunlight. - do not freeze. do not use if the prefilled syringe has been frozen. - the needle cap contains a type of natural rubber latex. tell your healthcare provider if you have a latex allergy. - do not open the sealed carton until you are ready to inject xolair. - do not take the needle cap off until you are ready to inject xolair. - do not try to take the prefilled syringe apart at any time. - do not reuse the same prefilled syringe. - do not leave the prefilled syringe unattended. - if your dose requires you to give more than 1 injection, take all cartons out of the refrigerator at the same time. the following steps must be followed for each prefilled syringe. - do not use if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - set aside the carton for at least 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature. leave the prefilled syringe in the carton to protect it from light. - if the prefilled syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the blister pack out of the carton. - check the expiration date on the blister pack. - do not use it if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - peel off the blister pack cover fully. be careful when taking out the prefilled syringe. - do not flip the blister pack upside down to take out the prefilled syringe. this may damage the prefilled syringe. - take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe. when holding the prefilled syringe, make sure you always hold the prefilled syringe as shown. do not touch the needle-shield wings (see "prefilled syringe parts" ). - do not handle the prefilled syringe by holding the plunger or needle cap. - check the prefilled syringe. the medicine in the prefilled syringe should be clear and colorless to pale brownish-yellow. do not use the prefilled syringe if the medicine is cloudy, discolored, or contains particles. - check the expiration date on the prefilled syringe. do not use the prefilled syringe if the expiration date has passed. - if the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - do not use if the packaging or prefilled syringe appears damaged, tampered with, or has been dropped. - if you are giving yourself the injection, you can inject into the front and middle of the thighs and the stomach area (abdomen). the outer area of the upper arms may also be used if the injection is being given by a caregiver. do not try to inject into the upper arm area by yourself. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be exposed, clean skin. - if your prescribed dose requires more than 1 injection, choose a different injection site for each new injection, at least 1 inch from other injection sites. - do not touch the injection site again before giving the injection. - do not fan or blow on the cleaned skin. - do not twist the needle cap. - do not hold, push or pull the plunger while you remove the needle cap. - do not touch the needle or let it touch any surfaces after removing the needle cap. - throw away the needle cap in regular household trash. do not recap the needle. - there may be 1 or more small air bubbles in the prefilled syringe. this is normal, and you should not try to remove the air bubbles. - you may also see a drop of liquid at the end of the needle. this is also normal and will not affect the dose. - pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). - it is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work. - do not touch the plunger while inserting the needle into the skin. - do not insert the needle through clothing. - hold the prefilled syringe tightly in place and do not change the angle of injection or insert the needle again after the needle is inserted. - you should not move and should avoid sudden movements when giving the injection. - you must press the plunger all the way down to make sure that the full dose of medicine gets injected. if the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed. - if the needle is not covered by the needle-shield, carefully remove the prefilled syringe from the skin and throw away the prefilled syringe in a sharps disposal container (see step 14 ). - do not rub the injection site. - if needed, cover the injection site with a small bandage. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - throw away the used prefilled syringe as described in step 14 . - repeat step 2 through step 13 for the next injection using a new prefilled syringe. - choose a different injection site for each new injection at least 1 inch from other injection sites. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. 14 throw away (dispose of) your used xolair prefilled syringes in an fda-cleared sharps disposal container right away after use. - the xolair prefilled syringe is a single-dose prefilled syringe and should not be used again. - do not throw away prefilled syringes in your household trash. - do not recap the needle. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used prefilled 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 dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. - do not recycle your used sharps disposal container. prefilled syringe parts - xolair prefilled syringe . - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 14) - keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). do not remove the prefilled syringe from its original carton during storage. - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not be more than 2 days. if the prefilled syringe is left at temperatures above 77°f (25°c), do not use it and throw away in a sharps disposal container. - keep your prefilled syringes out of direct light. - do not freeze. do not use if the prefilled syringe has been frozen. - do not use if the carton is damaged or appears to be tampered with. - do not open the carton until you are ready to inject. - do not use if the prefilled syringe is damaged or appears to be tampered with. - do not take the needle cap off until you are ready to inject. - do not use if the prefilled syringe has been dropped on a hard surface or dropped after removing the needle cap. - do not try to take apart the prefilled syringe at any time. - if you need more than 1 prefilled syringe to deliver your full dose (see dosing table ), take all cartons out of the refrigerator at the same time (each carton contains 1 prefilled syringe). the following steps must be followed for each prefilled syringe. - do not use if the expiration date has passed. - if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - set aside the carton on a clean, flat surface for at least 30 to 45 minutes so the prefilled syringe can warm up on its own to room temperature. leave the prefilled syringe in the carton to protect it from light. - if the prefilled syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the blister pack out of the carton. - check the expiration date on the blister pack. - do not use it if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - peel off the blister pack cover fully. be careful when taking out the prefilled syringe. - do not flip the blister pack upside down to take out the prefilled syringe. - take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe, as shown. - do not handle the prefilled syringe by holding the plunger or needle cap. - check the prefilled syringe. the medicine inside should be clear and colorless to pale brownish-yellow. you may see air bubbles in the medicine, which is normal. do not try to remove the air bubbles. - do not use the prefilled syringe if the medicine contains particles, or if the medicine looks cloudy or brown. - check the expiration date on the prefilled syringe. do not use the prefilled syringe if the expiration date has passed. - do not use if the prefilled syringe appears to be damaged or tampered with. - if the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - if giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). if a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh, or the stomach area (abdomen). do not try to inject yourself in the upper arm. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be uncovered, clean skin. - if your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other. - wipe the injection site with an alcohol swab in a circular motion and let air dry for 10 seconds. - do not fan or blow on the cleaned skin. - do not touch the injection site again before giving the injection. - hold the prefilled syringe firmly with 1 hand and pull the needle cap straight off with your other hand as shown. do not twist the cap. - do not hold, push or pull the plunger while you remove the needle cap. - do not touch the needle or let it touch any surfaces after removing the needle cap. - do not put the cap back on the prefilled syringe. throw away the needle cap in regular household trash. - you may see a drop of liquid at the end of the needle. this is normal. - use your other hand and gently pinch the area of skin that was cleaned. hold the pinched skin tightly until the injection is complete. - pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). - while holding the prefilled syringe by the center, insert the needle all the way into the pinched skin at an angle of about 45 degrees as shown. - it is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work. - do not touch the plunger while inserting the needle into the skin. - hold the prefilled syringe tightly in place and do not change the angle of injection or insert the needle again after the needle is inserted. - you should not move and should avoid sudden movements when giving the injection. - gently push the plunger all the way down until the plunger head is between the safety guard wings as shown. - you must press the plunger all the way down to make sure that the full dose of medicine is injected. if the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed. - release the plunger and allow the needle to be covered by the needle-shield. - if the needle is not covered by the needle-shield, carefully remove the prefilled syringe from the skin and throw away the prefilled syringe in a sharps disposal container (see step 14 ). - do not rub the injection site. - there may be a little bleeding or drop of liquid at the injection site. you can press a cotton ball or gauze over the injection site until the bleeding stops. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - if needed, cover the injection site with a small bandage. - throw away the used prefilled syringe as described in step 14 . - repeat step 2 through step 13 for the next injection using a new prefilled syringe. - make sure each injection is at least 1 inch apart from each other. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. - put your used prefilled syringes in an fda-cleared sharps disposal container right away after use. - the xolair prefilled syringe is a single-dose prefilled syringe and should not be used again. - do not throw away the prefilled syringes in your household trash. - do not recap the needle. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used prefilled 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 dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. - do not recycle your used sharps disposal container. - xolair autoinjector - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 15 ) - keep your unused autoinjectors in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not be more than 2 days. if the autoinjector is left at temperatures above 77°f (25°c), do not use it and throw away in a sharps disposal container. - do not remove the autoinjector from its original carton during storage. - keep your autoinjectors out of direct light. - do not freeze. do not use if the autoinjector has been frozen. - do not use if the carton is damaged or appears to be tampered with. - do not open the carton until you are ready to inject. - do not use if the autoinjector has been damaged or appears to be tampered with. - do not take the cap off the autoinjector until you are ready to inject. - do not use if the autoinjector has been dropped on a hard surface or dropped after removing the needle cap. - do not take apart the autoinjector at any time. - do not clean or touch the needle guard. - if you need more than 1 autoinjector to deliver your prescribed dose (see dosing table ), take all cartons out of the refrigerator at the same time (each carton contains 1 autoinjector). the following steps must be followed for each autoinjector. - do not use if the expiration date has passed. - if the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see step 15 ) and contact your healthcare provider. - set aside the carton on a clean, flat surface for at least 30 to 45 minutes so the autoinjector can warm up on its own to room temperature. leave the autoinjector in the carton to protect it from light. - if the autoinjector does not reach room temperature, this could cause the injection to feel uncomfortable. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the autoinjector out of the carton as shown. - do not turn the carton upside down to take out the autoinjector, as this may damage the autoinjector. - do not hold the autoinjector by the cap. make sure you hold the autoinjector by the middle as shown. - do not remove the cap until you are ready to inject. - look through the viewing window of the autoinjector. the medicine in the autoinjector viewing window should be clear and colorless to pale brownish-yellow. you may see air bubbles in the medicine, which is normal. - do not use the autoinjector if the medicine contains particles, or if the medicine looks cloudy or brown. - check the expiration date on the autoinjector. do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if it appears to be damaged or tampered with. - if the medicine does not look as described or if the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see step 15 ) and contact your healthcare provider. - if giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). if a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh or stomach area (abdomen). do not try to inject yourself in the upper arm. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be uncovered, clean skin. - if your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other. - wipe the injection site with an alcohol swab in a circular motion and let it air dry for 10 seconds. - do not fan or blow on the cleaned skin. - do not touch the injection site again before giving the injection. - hold the autoinjector firmly with 1 hand and pull the cap straight off with your other hand as shown. do not twist the cap. - do not put the cap back on the autoinjector. throw away the cap in regular household trash. - do not clean or touch the needle guard of the device. - hold the autoinjector comfortably with the needle guard directly against the skin. - the autoinjector should be at a 90-degree angle against the skin, as shown. - press straight down and hold the autoinjector firmly against the skin. the 1st click indicates that the injection has started. - hold the autoinjector tightly in place. do not change the angle of injection or remove the autoinjector until the injection is completed. - keep holding the autoinjector against the skin. the green indicator will move within the viewing window. - listen for the 2nd click . this indicates that the injection is almost complete. - hold the autoinjector in position until the green indicator has stopped moving and completely fills the viewing window to make sure the injection is complete. - after the green indicator has stopped moving and has completely filled the viewing window, lift the autoinjector straight up from the skin. the needle guard will automatically extend and lock over the needle. - if the green indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist. - do not rub the injection site. - there may be a little bleeding or a drop of liquid at the injection site. you can press a cotton ball or gauze pad over the injection site until any bleeding stops. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - if needed, cover the injection site with a small bandage. - throw away the used autoinjector as described in step 15 . - repeat step 2 through step 14 for the next injection using a new autoinjector. - make sure each injection is at least 1 inch apart from each other. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. - put your used autoinjectors in an fda-cleared sharps disposal container right away after use. - the xolair autoinjector is a single-dose autoinjector and should not be used again. - do not throw away (dispose of) the autoinjectors in your household trash. - do not recap the autoinjector. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used autoinjectors. 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 used sharps disposal container in your household trash unless your community guidelines permit this. - do not recycle your used sharps disposal container.

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

alexion pharmaceuticals inc. - eculizumab (unii: a3ulp0f556) (eculizumab - unii:a3ulp0f556) - eculizumab 300 mg in 30 ml - soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (pnh) to reduce hemolysis. soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (ahus) to inhibit complement-mediated thrombotic microangiopathy. limitation of use soliris is not indicated for the treatment of patients with shiga toxin e. coli related hemolytic uremic syndrome (stec-hus). soliris is indicated for the treatment of generalized myasthenia gravis (gmg) in adult patients who are anti-acetylcholine receptor (achr) antibody positive. soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. soliris is contraindicated for initiation in patients with unresolved serious neisseria meningitidis infection [see warnings and precautions (5.1)] . risk summary limited data on outcomes of pregnancies that have occurred following soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes (see data ). there are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) in pregnancy (see clinical considerations ). animal studies using a mouse analogue of the soliris molecule (murine anti-c5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose (see data ). the estimated 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 defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or fetal/neonatal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. ahus in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (iugr), fetal death and low birth weight. data human data a pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to soliris have not suggested safety concerns. however, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. animal data animal reproduction studies were conducted in mice using doses of a murine anti-c5 antibody that approximated 2-4 times (low dose) and 4-8 times (high dose) the recommended human soliris dose, based on a body weight comparison. when animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. when maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose; however, the exposure did not increase fetal loss or neonatal death. when maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group). surviving offspring had normal development and reproductive function. risk summary although limited published data does not report detectable levels of eculizumab in human milk, maternal igg is known to be present in human milk. available information is insufficient to inform the effect of eculizumab on the breastfed infant. there are no data on the effects of eculizumab on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for soliris and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition. safety and effectiveness of soliris for the treatment of pnh, gmg, or nmosd in pediatric patients have not been established. the safety and effectiveness of soliris for the treatment of ahus have been established in pediatric patients. use of soliris in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effectiveness of soliris for the treatment of ahus. the studies included a total of 47 pediatric patients (ages 2 months to 17 years). the safety and effectiveness of soliris for the treatment of ahus appear similar in pediatric and adult patients [see adverse reactions (6.1), and clinical studies (14.2) ]. administer vaccinations for the prevention of infection due to neisseria meningitidis , streptococcus pneumoniae and haemophilus influenzae type b (hib) according to acip guidelines [see warnings and precautions (5.1, 5.3)] . fifty-one patients 65 years of age or older (15 with pnh, 4 with ahus, 26 with gmg, and 6 with nmosd) were treated with soliris in clinical trials in the approved indications. although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

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

theratechnologies inc. - ibalizumab (unii: lt369u66ce) (ibalizumab - unii:lt369u66ce) - ibalizumab 150 mg in 1 ml - trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in heavily treatment-experienced adults with multidrug resistant hiv-1 infection failing their current antiretroviral regimen. trogarzo is contraindicated in patients with a prior hypersensitivity reaction to trogarzo or any components of the product [see warnings and precautions (5.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiretrovirals during pregnancy. this registry does not include trogarzo, but likely includes patients’ concomitant antiretroviral drugs.  healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1–800–258–4263. risk summary based on animal data, ibalizumab-uiyk use during pregnancy may cause reversible immunosuppression (cd4+ t cell and b cell lymphocytopenia) in infants exposed to ibalizumab-uiyk in utero. immunoglobulin g (igg) antibodies, such as ibalizumab-uiyk, are transported across the placenta in significant amounts, especially near term; therefore, ibalizumab-uiyk has the potential to be transferred from the mother to the developing fetus (see clinical considerations). there are no available data on ibalizumab-uiyk use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. 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 2-4% and 15-20%, respectively. in a reproductive study in monkeys, reversible decreases in cd4+ t cells and b cells and increases in cd8+ t cells were observed within the first 4 weeks after birth in infants born to pregnant monkeys receiving ibalizumab-uiyk intravenously (see data ). lymphocyte counts returned to near normal levels by 3 months of age. one infant monkey died from a systemic viral infection that may be related to ibalizumab-uiyk-induced immunosuppression. no malformations or premature births were observed in this study. clinical considerations fetal/neonatal adverse reactions immunoglobulin g (igg) antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. administration of trogarzo during pregnancy may affect immune responses in the in utero-exposed infant. for infants with perinatal exposure to trogarzo, immune phenotyping of the peripheral blood, including cd4+ t cell and b cell counts, is recommended. expert consultation is also recommended to provide guidance on monitoring and management (e.g., need for antibiotic or immunoprophylaxis) of exposed infants based on the degree of immunosuppression observed. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. data animal data in an enhanced pre- and post-natal development (eppnd) study, pregnant cynomolgus monkeys were administered intravenous doses of either vehicle or 110 mg/kg ibalizumab-uiyk every week from gestation day 20-22 (gd 20-22) until parturition on gd 160 ± 10. significant changes in infant monkey immune cell levels on postnatal day (pnd) 14 (mean decreases of 78% in cd4+ t cells and 46% in b cells and increases of 2.3-fold in cd8+ t cells) and pnd 28 (mean decreases of 73% in cd4+ t cells and increases of 2.2-fold in cd8+ t cells), attributed to in utero ibalizumab-uiyk exposure, were observed relative to concurrent controls. the lymphocyte changes correlated with infant ibalizumab-uiyk serum concentrations and appeared to return to near normal levels between pnd 28-91, when ibalizumab-uiyk concentrations were nearly undetectable. although ibalizumab-uiyk exposure in these infant monkeys may be significantly higher than in human infants following in utero exposure at the recommended human maintenance dose, the risk of ibalizumab-uiyk-induced immunosuppression in human infants is possible. no meaningful differences in infant monkey lymphocyte counts were observed on pnd 180. further, no differences in immune cell function were observed in a t cell-dependent response assay conducted on pnd 138 to 180 ± 2 following immunization of the infant monkeys with keyhole limpet hemocyanin. one treatment-group infant monkey died on pnd 24 from a systemic viral infection with secondary superficial bacterial infection which was acquired during the postnatal period. despite the low incidence (1 of 20 infants), the death may be related to ibalizumab-uiyk-induced immunosuppression. decreases in cd4+ t cells (93%), and b cells (92%) were observed in this infant on pnd 14, and decreased cellularity was observed in the spleen, thymus and mandibular lymph node. unlike the rest of the ibalizumab-exposed infant monkey population, this infant also exhibited a decrease in cd8+ t cells of 71% on pnd 14. body weight was also decreased in this infant between pnd 14 and 24. no structural abnormalities were observed among the ibalizumab-uiyk-exposed infants. in addition, no maternal toxicities, including no changes in maternal lymphocyte subsets or effects on embryo-fetal survival, were observed. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers in the united states not breastfeed their infants to avoid the risk of postnatal transmission of hiv-1 infection. no data are available regarding the presence of trogarzo in human milk, the effects on the breastfed child, or the effects on milk production. human igg is present in human milk, although published data indicate that antibodies in breast milk do not enter the neonatal or infant circulation system in substantial amounts. because of the potential for hiv-1 transmission, instruct mothers not to breastfeed if they are receiving trogarzo. the safety and effectiveness of trogarzo in pediatric patients have not been established. no studies have been conducted with trogarzo in geriatric patients.

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

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 150 mg - injection, solution - excipient ingredients: polysorbate 20; histidine; arginine hydrochloride; histidine hydrochloride monohydrate; water for injections - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

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

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 75 mg - injection, solution - excipient ingredients: arginine hydrochloride; water for injections; histidine; histidine hydrochloride monohydrate; polysorbate 20 - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.