n patients treated with takhzyro were associated with abnormal bleeding adverse events. there were no differences in inr values between treatment groups.

nt is well-controlled (e.g., attack free) for more than 6 months. 2.2 recommended dosage for pediatric patients 2 to less than 12 years of age pediatric patients 6 to less than 12 years of age the recommended starting dosage in pediatric patients 6 to less than 12 years of age is 150 mg administered subcutaneously q2wks. a dosing interval of 150 mg q4wks may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months. pediatric patients 2 to less than 6 years of age the recommended dosage in pediatric patients 2 to less than 6 years of age is 150 mg administered subcutaneously q4wks. 2.3 preparation and administration instructions takhzyro is administered subcutaneously only. takhzyro is intended for administration by a healthcare provider, patient or caregiver. the patient or caregiver should be trained in subcutaneous injection technique by a healthcare professional. adult and pediatric patients 12 years of age and older: takhzyro may be administered by the patient or caregiver. pediatric patients 2 to less than 12 years of age: takhzyro should be administered by a healthcare provider or caregiver. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. do not use takhzyro if the solution appears discolored or contains visible particles. takhzyro is a clear to slightly opalescent, colorless to slightly yellow solution. administration instructions for single-dose prefilled syringes instruct patients and/or caregiver on proper use of the takhzyro prefilled syringe and assess that they are well trained in subcutaneous injection technique prior to administration by patient and/or caregiver. avoid vigorous agitation of the prefilled syringe. take the takhzyro prefilled syringe out of the refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature using aseptic technique, inject takhzyro subcutaneously into the abdomen, thigh, or upper arm. discard any unused portion of drug remaining in the prefilled syringe. for detailed instructions on the preparation and administration of takhzyro see instructions for use for either single-dose 1 ml prefilled syringe or single-dose 2 ml prefilled syringe. administration instructions for single-dose vial takhzyro vial is provided as a ready-to-use solution that does not require additional reconstitution or dilution for administration. instruct patients and/or caregivers on proper use of takhzyro from a vial and assess that they are well trained in subcutaneous injection technique prior to administration by patient and/or caregiver. avoid vigorous agitation of the vial. take the takhzyro vial out of the refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature. using aseptic technique, withdraw the prescribed dose of takhzyro from the vial using an 18-gauge needle. change the needle on the syringe to a 27-gauge, ½-inch needle or other needle suitable for subcutaneous injection. inject takhzyro subcutaneously into the abdomen, thigh, or upper arm. in clinical studies, the majority of patients self-administered takhzyro over 10 to 60 seconds. takhzyro should be administered within 2 hours of preparing the dosing syringe. after the dosing syringe is prepared, it can be refrigerated at 36°f to 46°f (2°c to 8°c) and must be used within 8 hours. discard any unused portions of drug remaining in the vial and dosing syringe. for detailed instructions on the preparation and administration of takhzyro see single-dose vial instructions for use .

atients with hae aged 12 years and older received at least one dose of takhzyro. overall, 70% of patients were female and 90% of patients were caucasian with a mean age of 41 years. the proportion of patients who discontinued study drug prematurely due to adverse events was 1.2% for takhzyro-treated patients and 4.9% for placebo-treated patients. no deaths occurred in the trial. the safety profile of takhzyro was generally similar across all subgroups of patients, including analysis by age, sex, and geographic region. table 1 shows adverse reactions occurring in ≥10% of patients in any takhzyro treatment group that also occurred at a higher rate than in the placebo treatment group in trial 1. table 1 adverse reactions observed in ≥10% of patients treated with takhzyro in trial 1 adverse reaction placebo (n=41) takhzyro 150 mg q4wks (n=28) 300 mg q4wks (n=29) 300 mg q2wks (n=27) total (n=84) n (%) n (%) n (%) n (%) n (%) n= number of patients; n =number of patients experiencing the event; q2wks = every 2 weeks; q4wks = every 4 weeks injection site reactions injection site reactions include: pain, erythema, bruising, hematoma, hemorrhage, pruritus, swelling, induration, paresthesia, reaction, warmth, edema and rash. 14 (34) 16 (57) 13 (45) 15 (56) 44 (52) upper respiratory infection includes upper respiratory infection, viral upper respiratory infection 13 (32) 3 (11) 9 (31) 12 (44) 24 (29) headache includes headache, tension headache, sinus headache 9 (22) 3 (11) 6 (21) 9 (33) 18 (21) rash includes rash, rash maculopapular, rash erythematous 2(5) 2 (7) 3 (10) 1 (4) 6 (7) dizziness 0 1 (4) 3 (10) 1 (4) 5 (6) diarrhea 2 (5) 3 (11) 0 1 (4) 4 (5) myalgia 0 1 (4) 0 3 (11) 4 (5) injection site reactions primarily consisted mainly of pain, erythema, and bruising at the injection site. there was no meaningful difference in injection site reactions with self-administration. less common adverse reactions other adverse reactions that occurred at a higher incidence in takhzyro-treated patients compared to placebo include hypersensitivity (1% vs 0%), increased aspartate transaminase (2% vs 0%), and increased alanine transaminase (2% vs 0%). safety data from the open-label extension study, consisting of 109 rollover patients from trial 1 and 103 non-rollover hae patients, is consistent with controlled safety data from trial 1. laboratory abnormalities transaminase elevations during the placebo-controlled treatment period in trial 1, the number of takhzyro-treated patients with maximum transaminase (alt or ast) levels >8, >5, or >3 times the upper limit of normal (uln) was 1 (1.2%), 0 (0%), or 3 (3.6%) respectively, compared to 0 in the placebo-treated patients. these transaminase elevations were asymptomatic and transient. no patients had elevated total bilirubin >2× uln. one takhzyro-treated patient permanently discontinued treatment due to elevated transaminases (4.1× uln ast). none of the patients were reported to have serious adverse reactions of elevated transaminases. pediatric patients 2 to less than 12 years of age the safety of takhzyro was evaluated at 150 mg/ml (150 mg q4wks for patients 2 to <6 years or 150 mg q2wks with the option for 150 mg q4wks if the patient is well-controlled for 6 months for patients 6 to <12 years) in an open-label, multicenter study with 21 patients aged 2 to less than 12 years. no new safety signals were observed in these patients.

n patients treated with takhzyro were associated with abnormal bleeding adverse events. there were no differences in inr values between treatment groups.

eys were administered lanadelumab-flyo once weekly at subcutaneous doses resulting in up to 33 times the exposure at the mrhd (on an auc basis with maternal subcutaneous doses up to 50 mg/kg/week) from gestation day 20, at the beginning of organogenesis, through to parturition. there were no lanadelumab-flyo-related effects on maintenance of pregnancy or parturition. maternal lanadelumab-flyo treatment had no effects on embryo-fetal development, survival, growth, or postnatal development of offspring through 3 months of age. lanadelumab-flyo crossed the placenta in monkeys. offspring were exposed to lanadelumab-flyo at approximately 50% of the maternal plasma concentration out to postnatal day 21 (pnd 21). lanadelumab-flyo concentrations were approximately equivalent in maternal and offspring plasma at pnd 90. 8.2 lactation risk summary there are no data on the presence of lanadelumab-flyo in human milk, its effects on the breastfed infant, or its effects on milk production. lanadelumab-flyo was detected in the milk of lactating cynomolgus monkeys at approximately 0.2% of the maternal plasma concentration. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for takhzyro and any potential adverse effects on the breastfed infant from takhzyro or from the underlying maternal condition. data animal data available pharmacokinetic data in cynomolgus monkeys have shown excretion of lanadelumab-flyo in milk at approximately 0.2% of the maternal plasma level. 8.4 pediatric use the safety and effectiveness of takhzyro for prophylaxis to prevent attacks of hereditary angioedema (hae) have been established in pediatric patients 2 years of age and older. use of takhzyro for this indication in patients 12 years of age and older was supported by a subgroup analysis by age of 10 patients aged 12 to <18 years in trial 1 (a randomized, double-blind, placebo-controlled parallel-group study in adult and pediatric patients 12 years of age and older with hae). results of the subgroup analysis by age were consistent with overall study results. an additional 13 pediatric patients aged 12 to <18 years were enrolled in the open-label extension study [see adverse reactions (6.1) , clinical pharmacology (12.3) and clinical studies (14) ]. use of takhzyro for this indication in patients 2 to less than 12 years of age was supported by extrapolation of efficacy data from trial 1, an adequate and well controlled study in adult and pediatric (12 to less than 18 years of age) patients, with additional pharmacokinetic analyses showing similar drug exposures between adults (>18 years of age) and pediatric patients (2 to less than 12 years of age), and safety and pharmacodynamic data from an open-label, multicenter study in pediatric patients with hae aged 2 to less than 12 years that enrolled 21 patients (4 patients were aged 2 to less than 6 years and 17 patients were 6 to less than 12 years of age) [see adverse reactions (6.1) and clinical pharmacology (12.3) ] . the pharmacodynamic response observed in this trial for pediatric patients 2 to less than 12 years of age was similar to that seen in adult and pediatric patients 12 years of age and older [see clinical pharmacology (12.2) ] . the safety and effectiveness of takhzyro in pediatric patients less than 2 years of age have not been established. 8.5 geriatric use the safety and effectiveness of takhzyro were evaluated in a subgroup of patients (n=5) aged ≥65 years in trial 1. results of the subgroup analysis by age were consistent with overall study results [see adverse reactions (6.1) , clinical pharmacology (12.3) and clinical studies (14) ] .

mab-flyo once weekly at subcutaneous doses resulting in up to 33 times the exposure at the mrhd (on an auc basis with maternal subcutaneous doses up to 50 mg/kg/week) from gestation day 20, at the beginning of organogenesis, through to parturition. there were no lanadelumab-flyo-related effects on maintenance of pregnancy or parturition. maternal lanadelumab-flyo treatment had no effects on embryo-fetal development, survival, growth, or postnatal development of offspring through 3 months of age. lanadelumab-flyo crossed the placenta in monkeys. offspring were exposed to lanadelumab-flyo at approximately 50% of the maternal plasma concentration out to postnatal day 21 (pnd 21). lanadelumab-flyo concentrations were approximately equivalent in maternal and offspring plasma at pnd 90.

ars of age) patients, with additional pharmacokinetic analyses showing similar drug exposures between adults (>18 years of age) and pediatric patients (2 to less than 12 years of age), and safety and pharmacodynamic data from an open-label, multicenter study in pediatric patients with hae aged 2 to less than 12 years that enrolled 21 patients (4 patients were aged 2 to less than 6 years and 17 patients were 6 to less than 12 years of age) [see adverse reactions (6.1) and clinical pharmacology (12.3) ] . the pharmacodynamic response observed in this trial for pediatric patients 2 to less than 12 years of age was similar to that seen in adult and pediatric patients 12 years of age and older [see clinical pharmacology (12.2) ] . the safety and effectiveness of takhzyro in pediatric patients less than 2 years of age have not been established.

subcutaneous administration of takhzyro 150 mg q4wks, 300 mg q4wks or 300 mg q2wks in patients with hae. for pediatric patients 2 to less than 6 years (150 mg q4wks) and 6 to less than 12 years (150 mg q2wks), the observed mean percent change from baseline chmwk levels was similar to that observed in adult and pediatric (12 to less than 18 years) patients (300 mg q2wks or 300 mg q4wks). cardiac electrophysiology takhzyro did not prolong the qt/qtc interval. 12.3 pharmacokinetics following subcutaneous administration, the pharmacokinetics of lanadelumab-flyo was approximately dose-proportional in the therapeutic dose range in patients with hae (table 2). the pharmacokinetic properties and exposure (steady state) of lanadelumab-flyo in hae patients, following subcutaneous administration of 150 mg q4wks, 300 mg q4wks and 300 mg q2wks, are provided in table 2 . following subcutaneous administration of takhzyro, peak plasma concentrations are reached within 5 days, and terminal elimination half-life is ~ 2 weeks. the anticipated time to reach steady state concentration was approximately 70 days. at steady-state, the mean accumulation ratio is approximately 1.44, 1.42, and 2.43 for dosing regimen of 150 mg q4wks, 300 mg q4wks and 300 mg q2wks, respectively. table 2 mean (sd) pharmacokinetic parameters of lanadelumab-flyo following subcutaneous administration (trial 1) pharmacokinetic parameters lanadelumab-flyo 150 mg q4wks (n=28) 300 mg q4wks (n=29) 300 mg q2wks (n=27) cl/f: apparent clearance; vc/f: apparent volume of distribution; auc tau,ss : area under the curve over the dosing interval at steady-state; c max,ss : maximum concentration at steady-state; c min,ss : minimum concentration at steady state; t max : time to maximum concentration; t 1/2 terminal elimination half-life. cl/f (l/day) 0.667 (0.162) 0.742 (0.239) 0.809 (0.370) vc/f (l) 14.1 (2.93) 14.9 (4.45) 16.6 (4.79) auc tau,ss (µg*day/ml) 233 (56.6) 441(137) 408 (138) c max,ss (µg/ml) 12.0 (3.01) 23.3 (7.94) 34.4 (11.2) c min,ss (µg/ml) 4.81 (1.40) 8.77 (2.80) 25.4 (9.18) t max (day) 5.17 (1.09) 5.17 (1.12) 4.11 (0.377) t 1/2 (day) 14.9 (2.00) 14.2 (1.89) 15.0 (2.48) specific populations population pharmacokinetic analyses showed that age, gender and race did not meaningfully influence the pharmacokinetics of lanadelumab-flyo after correcting for body weight. body weight was identified as an important covariate describing the variability of clearance and volume of distribution, resulting in higher exposure (auc and c max ) in lighter patients. however, this difference is not considered to be clinically relevant and no dose adjustments are recommended for any of these demographics. pediatric population based on population pharmacokinetics (pk) analyses, the geometric mean lanadelumab-flyo average concentration at steady state (c ave ) was approximately 25% higher following subcutaneous administration of takhzyro 300 mg q2wks in pediatric patients 12 to less than 18 years of age than the mean c ave in adult patients under the same dosing regimen, due to lower body weight in pediatric patients. lanadelumab-flyo exposures in pediatric patients 2 to less than 12 years of age receiving takhzyro 150 mg q2wks or q4wks are comparable to those in adult patients receiving takhzyro 300 mg q2wks. the geometric mean lanadelumab-flyo c ave was approximately 7% higher following subcutaneous administration of takhzyro 150 mg q2wks in pediatric patients 6 to less than 12 years of age compared to the mean c ave in adult patients receiving 300 mg q2wks. the mean lanadelumab-flyo c ave was approximately 14% lower following subcutaneous administration of takhzyro 150 mg q4wks in pediatric patients 2 to less than 6 years of age compared to the mean c ave in adult patients receiving 300 mg q2wks. renal impairment no dedicated studies have been conducted to evaluate the pk of lanadelumab-flyo in renal impairment patients. based on population pharmacokinetic analysis, renal impairment (estimated gfr: 60 to 89 ml/min/1.73m 2 , [mild, n=98] and 30 to 59 ml/min/1.73m 2 , [moderate, n=9]) had no effect on the clearance or volume of distribution of lanadelumab-flyo. concomitant medications the use of analgesic, antibacterial, antihistamine, anti-inflammatory and anti-rheumatic medications had no effect on clearance and volume of distribution of lanadelumab-flyo. for breakthrough hae attacks, use of rescue medications such as plasma-derived and recombinant c1-inh, icatibant or ecallantide had no effects on clearance and volume of distribution of lanadelumab-flyo. 12.6 immunogenicity the observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of lanadelumab-flyo or of other lanadelumab products. in trial 1 with adult and pediatric patients 12 years of age and older, 10 (12%) lanadelumab-flyo-treated and 2 (5%) placebo-treated patients had at least 1 anti-drug antibody (ada)-positive sample during the 26-week treatment period; antibody titers were low (range: 20 to 1280). the ada response observed was transient in 2/10 lanadelumab-flyo and 1/2 placebo-treated patients. pre-existing low titer antibodies were observed in 3 lanadelumab-flyo-treated patients and 1 placebo-treated patient with adas. two patients receiving 150 mg q4wks had low titer antibodies classified as neutralizing. in an open-label, multicenter study in pediatric patients 2 to less than 12 years of age, 3/20 (15%) lanadelumab-treated patients who completed the study developed adas during the 52-week treatment period; all of whom were in the 6 to less than 12 years age group. the ada response observed was transient in all 3 patients. none of these patients had pre-existing antibodies. one patient had neutralizing antibodies. the development of ada including neutralizing antibodies against lanadelumab-flyo did not appear to adversely affect pharmacokinetics (pk), pharmacodynamics (pd), safety or clinical response.

(n=29) 300 mg q2wks (n=27) cl/f: apparent clearance; vc/f: apparent volume of distribution; auc tau,ss : area under the curve over the dosing interval at steady-state; c max,ss : maximum concentration at steady-state; c min,ss : minimum concentration at steady state; t max : time to maximum concentration; t 1/2 terminal elimination half-life. cl/f (l/day) 0.667 (0.162) 0.742 (0.239) 0.809 (0.370) vc/f (l) 14.1 (2.93) 14.9 (4.45) 16.6 (4.79) auc tau,ss (µg*day/ml) 233 (56.6) 441(137) 408 (138) c max,ss (µg/ml) 12.0 (3.01) 23.3 (7.94) 34.4 (11.2) c min,ss (µg/ml) 4.81 (1.40) 8.77 (2.80) 25.4 (9.18) t max (day) 5.17 (1.09) 5.17 (1.12) 4.11 (0.377) t 1/2 (day) 14.9 (2.00) 14.2 (1.89) 15.0 (2.48) specific populations population pharmacokinetic analyses showed that age, gender and race did not meaningfully influence the pharmacokinetics of lanadelumab-flyo after correcting for body weight. body weight was identified as an important covariate describing the variability of clearance and volume of distribution, resulting in higher exposure (auc and c max ) in lighter patients. however, this difference is not considered to be clinically relevant and no dose adjustments are recommended for any of these demographics. pediatric population based on population pharmacokinetics (pk) analyses, the geometric mean lanadelumab-flyo average concentration at steady state (c ave ) was approximately 25% higher following subcutaneous administration of takhzyro 300 mg q2wks in pediatric patients 12 to less than 18 years of age than the mean c ave in adult patients under the same dosing regimen, due to lower body weight in pediatric patients. lanadelumab-flyo exposures in pediatric patients 2 to less than 12 years of age receiving takhzyro 150 mg q2wks or q4wks are comparable to those in adult patients receiving takhzyro 300 mg q2wks. the geometric mean lanadelumab-flyo c ave was approximately 7% higher following subcutaneous administration of takhzyro 150 mg q2wks in pediatric patients 6 to less than 12 years of age compared to the mean c ave in adult patients receiving 300 mg q2wks. the mean lanadelumab-flyo c ave was approximately 14% lower following subcutaneous administration of takhzyro 150 mg q4wks in pediatric patients 2 to less than 6 years of age compared to the mean c ave in adult patients receiving 300 mg q2wks. renal impairment no dedicated studies have been conducted to evaluate the pk of lanadelumab-flyo in renal impairment patients. based on population pharmacokinetic analysis, renal impairment (estimated gfr: 60 to 89 ml/min/1.73m 2 , [mild, n=98] and 30 to 59 ml/min/1.73m 2 , [moderate, n=9]) had no effect on the clearance or volume of distribution of lanadelumab-flyo. concomitant medications the use of analgesic, antibacterial, antihistamine, anti-inflammatory and anti-rheumatic medications had no effect on clearance and volume of distribution of lanadelumab-flyo. for breakthrough hae attacks, use of rescue medications such as plasma-derived and recombinant c1-inh, icatibant or ecallantide had no effects on clearance and volume of distribution of lanadelumab-flyo.

0% of patients had type i hae. a history of laryngeal angioedema attacks was reported in 65% of patients and 56% were on prior long-term prophylaxis. during the study run-in period, attack rates of ≥3 attacks/month were observed in 52% of patients overall. all takhzyro treatment arms produced clinically meaningful and statistically significant reductions in the mean hae attack rate compared to placebo across all primary and secondary endpoints in the intent-to-treat population (itt) as shown in table 3 . table 3 results of primary and secondary efficacy measures-itt population endpoint statistics placebo (n=41) takhzyro 150 mg q4wks (n=28) 300 mg q4wks (n=29) 300 mg q2wks (n=27) ci=confidence interval; ls=least squares. note: results are from a poisson regression model accounting for over dispersion with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and the logarithm of time in days each patient was observed during the treatment period as an offset variable in the model. number of hae attacks from day 0 to 182 primary efficacy endpoint. ls mean (95% ci) monthly attack rate model-based treatment period hae attack rate (attacks/4 weeks). 1.97 (1.64, 2.36) 0.48 (0.31, 0.73) 0.53 (0.36, 0.77) 0.26 (0.14, 0.46) % reduction relative to placebo (95% ci) calculated as the ratio of the model-based treatment period hae attack rates (lanadelumab/placebo) minus 1 multiplied by 100. 76 (61, 85) 73 (59, 82) 87 (76, 93) adjusted p-values adjusted p-values for multiple testing. <0.001 <0.001 <0.001 number of hae attacks requiring acute treatment from day 0 to 182 ls mean (95% ci) monthly attack rate 1.64 (1.34, 2.00) 0.31 (0.18, 0.53) 0.42 (0.28, 0.65) 0.21 (0.11, 0.40) % reduction relative to placebo (95% ci) 81 (66, 89) 74 (59, 84) 87 (75, 93) adjusted p-values <0.001 <0.001 <0.001 number of moderate or severe hae attacks from day 0 to 182 ls mean (95% ci) monthly attack rate 1.22 (0.97, 1.52) 0.36 (0.22, 0.58) 0.32 (0.20, 0.53) 0.20 (0.11, 0.39) % reduction relative to placebo (95% ci) 70 (50, 83) 73 (54, 84) 83 (67, 92) adjusted p-values <0.001 <0.001 <0.001 the mean reduction in hae attack rate was consistently higher across the takhzyro treatment arms compared to placebo regardless of the baseline history of prior long-term prophylaxis, laryngeal attacks, or attack rate during the run-in period. additional pre-defined exploratory endpoints included the percentage of patients who were attack free for the entire 26-week treatment period and the percentage of patients achieving threshold (≥50%, ≥70%, ≥90%) reductions in hae attack rates compared to run-in during the 26-week treatment period. a ≥50% reduction in hae attack rate was observed in 100% of patients on 300 mg q2wks or q4wks and 89% on 150 mg q4wks compared to 32% of placebo patients. a ≥70% reduction in hae attack rates was observed in 89%, 76%, and 79% of patients on 300 mg q2wks, 300 mg q4wks, and 150 mg q4wks, respectively, compared to 10% of placebo patients. a ≥90% reduction in hae attack rates was observed 67%, 55%, and 64% of patients on 300 mg q2wks, 300 mg q4wks, and 150 mg q4wks, respectively, compared to 5% of placebo patients. the percentage of attack-free patients for the entire 26-week treatment period was 44%, 31%, and 39% in the takhzyro 300 mg q2wks, 300 mg q4wks, and 150 mg q4wks groups respectively, compared to 2% of placebo patients. trial 2 (nct02741596) patients who completed trial 1 were eligible to rollover into an open-label extension study. rollover patients, regardless of randomization group in trial 1, received a single dose of takhzyro 300 mg at study entry and were followed until the first hae attack occurred. all efficacy endpoints were exploratory in this uncontrolled, unblinded study. at week 4 post-dose, approximately 80% of patients who had been in the 300 mg q2wks treatment group (n=25) in trial 1 remained attack-free. after the first hae attack, all patients received open-label treatment with takhzyro 300 mg q2wks.

your healthcare provider about the best way to feed your baby while using takhzyro. tell your healthcare provider about all the medicines you take , including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. how should i use takhzyro? see the detailed instructions for use that comes with this patient information leaflet about the right way to prepare and inject takhzyro. use takhzyro exactly as your healthcare provider tells you to use it. takhzyro is given as an injection under your skin (subcutaneous) by you or a caregiver. your healthcare provider should show you or your caregiver how to prepare and inject your dose of takhzyro before you inject yourself for the first time. do not try to inject takhzyro unless you have been trained by your healthcare provider. self-injection is not recommended in children (2 to less than 12 years). what are the possible side effects of takhzyro? takhzyro may cause serious side effects, including allergic reactions. allergic reactions may happen with takhzyro. call your healthcare provider or get emergency help right away if you have any of the following symptoms: wheezing difficulty breathing chest tightness fast heartbeat faintness rash hives the most common side effects of takhzyro are: injection site reactions (pain, redness, and bruising) upper respiratory infections headache rash dizziness diarrhea muscle aches tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all the possible side effects of takhzyro. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. general information about the safe and effective use of takhzyro. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use takhzyro for a condition for which it is not prescribed. do not give takhzyro to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about takhzyro that is written for health professionals. what are the ingredients in takhzyro? active ingredient: lanadelumab inactive ingredients: citric acid monohydrate, l-histidine, sodium chloride, sodium phosphate dibasic dihydrate and water for injection. manufactured by: takeda pharmaceuticals u.s.a., inc. lexington, ma 02421 u.s. license no. 1898 takhzyro ® is a registered trademark of dyax corp., a takeda company. takeda ® and the takeda logo ® are registered trademarks of takeda pharmaceutical company limited. ©2023 takeda pharmaceuticals u.s.a., inc. all rights reserved. for more information, visit www.takhzyro.com or call 1-877-takeda-7 (1-877-825-3327).