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

fresenius kabi usa, llc - icatibant acetate (unii: 325o8467xk) (icatibant - unii:7pg89g35q7) - icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (hae) in adults 18 years of age and older. risk summary available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (mrhd) and higher. decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the mrhd. in a pre- and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the mrhd and higher, which resulted in deaths of dams at doses 2 times the mrhd and higher. fetal death and early pup deaths were observed with doses 2 times the mrhd (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. data animal data in an embryo-fetal development study with rats that received icatibant from gestation days 7 to 18, there was no evidence of any treatment-related structural abnormalities or effects on embryo-fetal survival with maternal doses up to 2.7 times the mrhd (on a mg/m2 basis with maternal subcutaneous doses up to 25 mg/kg/day). in a fertility and early embryonic development study with rats, icatibant increased pre-implantation loss at a dose that was 7 times the mrhd (on an auc basis at a maternal dose of 10 mg/kg/day). in an embryo-fetal development study with rabbits that received icatibant from gestation days 7 to 18, premature birth and abortion rates increased at doses approximately 0.025 times the mrhd and higher (on a mg/m2 basis at maternal subcutaneous doses of 0.1 mg/kg and higher). icatibant treatment resulted in dose-related decreases of total implantations and total number of live fetuses as well as dose-related increases of percent pre-implantation loss at a dose that was 13 times the mrhd (on an auc basis with a maternal subcutaneous dose of 10 mg/kg/day). there was no evidence of any treatment-related structural abnormalities with maternal doses up to 13 times the mrhd (on an auc basis with maternal subcutaneous doses up to 10 mg/kg/day). in a pre- and post-natal development study in the rat, dams received icatibant by the subcutaneous route at doses of 1, 3, and 10 mg/kg/day from gestation day 6 to post-partum (ppd) day 20. delayed parturition was observed at doses 0.5 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 1 mg/kg/day and higher), which resulted in deaths of dams at doses 2 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 3 mg/kg/day and higher). fetal death and increased pup deaths through ppd 4 were observed with doses 2 times the mrhd (on an auc with a maternal subcutaneous dose of 3 mg/kg/day and higher). impairment of pup righting reflex and decreased pup hair growth were also observed at 7 times the mrhd (on an auc basis with a maternal dose of 10 mg/kg). icatibant and the m2 metabolite were found in maternal milk following subcutaneous administration of icatibant. the no effect dose for f1 pups was identified at a dose 0.5 times the mrhd (on an auc basis with a maternal subcutaneous dose of 1 mg/kg/day). a no effect dose was not identified for f0 maternal toxicity. risk summary there are no data on the presence of icatibant in human milk, the effects on the breastfed infant, or the effects on milk production. icatibant and the m2 metabolite were found in rat milk following subcutaneous administration of icatibant (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. however, systemic absorption of icatibant in infants is not expected after oral exposure through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for icatibant injection and any potential adverse effects on the breastfed child from icatibant injection or from the underlying maternal condition. data animal data icatibant is excreted into the milk of lactating rats at concentrations that sometimes slightly exceeded those measured in the maternal plasma. safety and effectiveness in pediatric patients below the age of 18 years have not been established. juvenile toxicity data subcutaneous daily administration of icatibant to young rats during the juvenile period of development (postnatal days 22-70) delayed the sexual maturation of male reproductive tissues (atrophy of testes and epididymides) at exposures approximating one-third or greater the mrhd on a mg/m2 basis. impaired fertility and reproductive performance were also observed in male rats at the end of the postnatal treatment period at exposures approximating the mrhd or greater on a mg/m2 basis. no effects were observed in females at exposures approximating 3-fold the mrhd on a mg/m2 basis. the observed tissue findings in males were consistent with those seen in sexually mature rats and dogs and are attributed to antagonism of the bradykinin b2 receptor and subsequent effects on gonadotropins. the observed effects may be a consequence of daily icatibant administration. toxicity to the testis did not occur in dogs treated twice a week for 9 months [see carcinogenesis, mutagenesis, impairment of fertility (13.1)] . clinical studies of icatibant injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients [see clinical pharmacology (12.3)] . since other reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients, no dose adjustment is recommended. icatibant injection was studied in patients with mild to moderate (child pugh scores of 5 to 8) hepatic impairment. no change in systemic exposure is noted in these patient populations. no dose adjustment is required in patients with hepatic impairment [see clinical pharmacology (12.3)] . although a formal renal impairment study has not been conducted, 10 of 37 patients treated with icatibant injection had hepatorenal syndrome with glomerular filtration rate (gfr) below 60 ml/min. icatibant injection is cleared non-renally and hence it is not expected to show any change in systemic exposure in patients with impaired renal function. no dose adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] . step-by-step instructions for your icatibant injection step 1. preparing your dose of icatibant injection - wash your hands with soap and water. - you will need the following supplies: your icatibant injection carton that includes 1 single-dose icatibant injection prefilled syringe and 1 needle. an alcohol wipe - your icatibant injection carton that includes 1 single-dose icatibant injection prefilled syringe and 1 needle. - an alcohol wipe - the medicine inside your icatibant injection prefilled syringe should be clear and colorless. do not use your icatibant injection prefilled syringe if the solution contains particles, is cloudy, or an unusual color. figure a step 2. remove the prefilled syringe and needle from the carton. see figure b. figure b step 3. remove the seal from the needle cap (the needle should remain inside the protective needle cap until ready to use). see figure c. figure c step 4. remove the protective cap from the end of the pre-filled syringe by unscrewing the cap. hold the syringe firmly. carefully attach the needle to the prefilled syringe containing the colorless icatibant injection solution. see figure d. figure d step 5. firmly screw the needle on the prefilled syringe. be careful not to remove the needle from the needle cap. see figure e. figure e preparing the injection site step 6. choose the injection site. the injection site should be a fold of skin on your stomach, about 2 to 4 inches (5 to 10 cm) below your belly button on either side. see figure f. the area you choose for injection should be at least 2 inches (5 cm) away from any scars. do not choose an area that is bruised, swollen, or painful. figure f step 7. clean your icatibant injection site with an alcohol wipe and allow it to dry. see figure g. figure g injecting your icatibant step 8. remove the needle from the needle cap by holding the needle cap and carefully pulling the syringe. do not pull up on the plunger. see figure h. figure h step 9. hold the icatibant injection prefilled syringe in 1 hand, between your fingers and thumb. see figure i. figure i step 10. use your other hand to gently pinch the fold of skin you cleaned with the alcohol wipe between your thumb and fingers for your injection. see figure j. figure j step 11. hold the syringe between a 45 to 90 degree angle to your skin with the needle facing the fold of skin you are holding. see figure k. figure k step 12. hold the fold of skin. bring the syringe to the skin and quickly insert the needle into the skin fold. see figure l. figure l step 13. push the plunger, at the top of the syringe, over at least 30 seconds until no icatibant injection is in the syringe. see figure m. figure m step 14. release the skin fold and gently pull the needle out. see figure n. figure n disposal of your used icatibant injection prefilled syringe step 15. place the used icatibant injection syringe, with the needle attached, in a sharps container (such as a red biohazard container), a hard plastic container, (such as a detergent bottle), or a metal container (such as an empty coffee can). seal the container and throw it away the right way. there may be state and local laws about the right way to throw away used syringes and needles. ask your healthcare provider or pharmacist how to throw away used syringes and needles. see figure o. figure o this patient package insert and instructions for use have been approved by the u.s. food and drug administration. manufactured by: lake zurich, il 60047 made in austria www.fresenius-kabi.com/us 451496b revised: september 2023

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

cipla usa inc. - icatibant acetate (unii: 325o8467xk) (icatibant - unii:7pg89g35q7) - icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (hae) in adults 18 years of age and older. none. risk summary available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (mrhd) and higher. decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the mrhd. in a pre-and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the mrhd and higher, which resulted in deaths of dams at doses 2 times the mrhd and higher. fetal death and early pup deaths were observed with doses 2 times the mrhd (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. data animal data in an embryo-fetal development study with rats that received icatibant from gestation days 7 to 18, there was no evidence of any treatment-related structural abnormalities or effects on embryo-fetal survival with maternal doses up to 2.7 times the mrhd (on a mg/m2 basis with maternal subcutaneous doses up to 25 mg/kg/day). in a fertility and early embryonic development study with rats, icatibant increased pre-implantation loss at a dose that was 7 times the mrhd (on an auc basis at a maternal dose of 10 mg/kg/day). in an embryo-fetal development study with rabbits that received icatibant from gestation days 7 to 18, premature birth and abortion rates increased at doses approximately 0.025 times the mrhd and higher (on a mg/m2 basis at maternal subcutaneous doses of 0.1 mg/kg and higher). icatibant treatment resulted in dose-related decreases of total implantations and total number of live fetuses as well as dose-related increases of percent pre-implantation loss at a dose that was 13 times the mrhd (on an auc basis with a maternal subcutaneous dose of 10 mg/kg/day). there was no evidence of any treatment-related structural abnormalities with maternal doses up to 13 times the mrhd (on an auc basis with maternal subcutaneous doses up to 10 mg/kg/day). in a pre- and post-natal development study in the rat, dams received icatibant by the subcutaneous route at doses of 1, 3, and 10 mg/kg/day from gestation day 6 to post-partum (ppd) day 20. delayed parturition was observed at doses 0.5 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 1 mg/kg/day and higher), which resulted in deaths of dams at doses 2 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 3 mg/kg/day and higher). fetal death and increased pup deaths through ppd 4 were observed with doses 2 times the mrhd (on an auc with a maternal subcutaneous dose of 3 mg/kg/day and higher). impairment of pup righting reflex and decreased pup hair growth were also observed at 7 times the mrhd (on an auc basis with a maternal dose of 10 mg/kg). icatibant and the m2 metabolite were found in maternal milk following subcutaneous administration of icatibant. the no effect dose for f1 pups was identified at a dose 0.5 times the mrhd (on an auc basis with a maternal subcutaneous dose of 1 mg/kg/day). a no effect dose was not identified for f0 maternal toxicity. risk summary there are no data on the presence of icatibant in human milk, the effects on the breastfed infant, or the effects on milk production. icatibant and the m2 metabolite were found in rat milk following subcutaneous administration of icatibant (see data ). when a drug is present in animal milk, it is likely that the drug will be present in human milk. however, systemic absorption of icatibant in infants is not expected after oral exposure through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for icatibant and any potential adverse effects on the breastfed child from icatibant or from the underlying maternal condition. data animal data icatibant is excreted into the milk of lactating rats at concentrations that sometimes slightly exceeded those measured in the maternal plasma. safety and effectiveness in pediatric patients below the age of 18 years have not been established. juvenile toxicity data subcutaneous daily administration of icatibant to young rats during the juvenile period of development (postnatal days 22-70) delayed the sexual maturation of male reproductive tissues (atrophy of testes and epididymides) at exposures approximating one-third or greater the mrhd on a mg/m2 basis. impaired fertility and reproductive performance were also observed in male rats at the end of the postnatal treatment period at exposures approximating the mrhd or greater on a mg/m2 basis. no effects were observed in females at exposures approximating 3-fold the mrhd on a mg/m2 basis. the observed tissue findings in males were consistent with those seen in sexually mature rats and dogs and are attributed to antagonism of the bradykinin b2 receptor and subsequent effects on gonadotropins. the observed effects may be a consequence of daily icatibant administration. toxicity to the testis did not occur in dogs treated twice a week for 9 months [see carcinogenesis, mutagenesis, impairment of fertility (13.1)] . clinical studies of icatibant injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients [see clinical pharmacology (12.3)] . since other reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients, no dose adjustment is recommended. icatibant injection was studied in patients with mild to moderate (child pugh scores of 5 to 8) hepatic impairment. no change in systemic exposure is noted in these patient populations. no dose adjustment is required in patients with hepatic impairment [see clinical pharmacology (12.3)] . although a formal renal impairment study has not been conducted, 10 of 37 patients treated with icatibant injection had hepatorenal syndrome with glomerular filtration rate (gfr) below 60 ml/min. icatibant injection is cleared non-renally and hence it is not expected to show any change in systemic exposure in patients with impaired renal function. no dose adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] .

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - icatibant acetate - solution for injection in pre-filled syringe - icatibant

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

bryant ranch prepack - icatibant acetate (unii: 325o8467xk) (icatibant - unii:7pg89g35q7) - icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (hae) in adults 18 years of age and older. none. risk summary available data from published literature and the pharmacovigilance database with icatibant injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (mrhd) and higher. decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the mrhd. in a pre- and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the mrhd and higher, which resulted in deaths of da

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

generic health pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: glacial acetic acid; sodium hydroxide; sodium chloride; water for injections - icatibant gh is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.

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

generic health pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: water for injections; glacial acetic acid; sodium hydroxide; sodium chloride - icatibant lapl is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva b.v. - icatibant acetate 31,38 mg - eq. icatibant 30 mg - solution for injection in pre-filled syringe - 30 mg - icatibant acetate 31.38 mg - icatibant

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoire aguettant - icatibant acetate - eq. icatibant 10 mg/ml - solution for injection in pre-filled syringe - 30 mg - icatibant acetate - icatibant

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - icatibant acetate 12 mg/ml - eq. icatibant 10 mg/ml - solution for injection in pre-filled syringe - 30 mg - icatibant acetate 12 mg/ml - icatibant

Canada - English - Health Canada

mint pharmaceuticals inc - icatibant (icatibant acetate) - solution - 10mg - icatibant (icatibant acetate) 10mg