Takhzyro

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

 

This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

TAKHZYRO 300 mg solution for injection  

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  

 

One unit (vial or pre-filled syringe) contains 300 mg of lanadelumab* in 2 mL solution. 

 

*Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.  

 

For the full list of excipients, see section 6.1.  

 

 

3. PHARMACEUTICAL FORM  

 

Solution for injection  

Solution for injection in pre-filled syringe. 

 

The solution is colourless to slightly yellow, appearing either clear or slightly opalescent.  

 

The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg.  

 

 

4. CLINICAL PARTICULARS  

 

4.1 Therapeutic indications  

 

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) 

in patients aged 12 years and older.  

 

4.2 Posology and method of administration  

 

This medicinal product should be initiated under the supervision of a physician experienced in the 

management of patients with hereditary angioedema (HAE).  

 

Posology  

 

The recommended starting dose is 300 mg lanadelumab every 2 weeks. In patients who are stably 

attack free on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, 

especially in patients with low weight. 

 

TAKHZYRO is not intended for treatment of acute HAE attacks (see section 4.4)  

 

Missed doses  

 

If a dose of TAKHZYRO is missed, the patient should be instructed to administer the dose as soon as 

possible ensuring at least 10 days between doses.  



3 

 

Special populations  

 

Elderly 

 

Age is not expected to affect exposure to lanadelumab. No dose adjustment is required for patients 

above 65 years of age (see section 5.2).  

 

Hepatic impairment  

 

No studies have been conducted in patients with hepatic impairment. Hepatic impairment is not 

expected to affect exposure to lanadelumab. No dose adjustment is required in patients with hepatic 

impairment (see section 5.2).  

 

Renal impairment  

 

No studies have been conducted in patients with severe renal impairment. Renal impairment is not 

expected to affect exposure to lanadelumab or the safety profile. No dose adjustment is required in 

patients with renal impairment. (see section 5.2).  

 

Paediatric population  

 

The safety and efficacy of TAKHZYRO in children aged less than 12 years have not been established. 

No data are available.  

 

Method of administration  

 

TAKHZYRO is intended for subcutaneous (SC) administration only.  

 

Each TAKHZYRO unit (vial or pre-filled syringe) is intended for single use only (see section 6.6).  

 

The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the 

upper outer arms (see section 5.2). Rotation of the injection site is recommended. 

 

TAKHZYRO may be self-administered or administered by a caregiver only after training on SC 

injection technique by a healthcare professional.  

 

4.3 Contraindications  

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  

 

4.4 Special warnings and precautions for use  

 

Traceability  

 

In order to improve the traceability of biological medicinal products, the name and the batch number 

of the administered product should be clearly recorded.  

 

Hypersensitivity reactions  

 

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, 

administration of TAKHZYRO must be stopped immediately and appropriate treatment must be 

initiated.  

 

General 

 



4 

TAKHZYRO is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE 

attack, individualized treatment should be initiated with an approved rescue medication.  

 

There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH 

activity. 

 

Interference with coagulation test  

 

Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of 

lanadelumab with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic 

coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma 

kallikrein by lanadelumab can increase aPTT in this assay. None of the increases in aPTT in patients 

treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no 

differences in international normalised ratio (INR) between treatment groups.  

 

Sodium content  

 

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 

'sodium-free'.  

 

4.5 Interaction with other medicinal products and other forms of interaction  

 

No dedicated drug-drug interaction studies have been conducted. Based on the characteristics of 

lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. 

 

As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive 

effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab 

and C1 esterase inhibitor (see section 5.1).  

 

4.6 Fertility, pregnancy and lactation  

 

Pregnancy  

 

There are no or limited data from the use of lanadelumab in pregnant women. Animal studies do not 

indicate direct or indirect harmful effects with respect to reproductive or developmental toxicity (see 

section 5.3). As a precautionary measure, it is preferable to avoid the use of lanadelumab during 

pregnancy.  

 

Breast-feeding  

 

It is unknown whether lanadelumab is excreted in human milk. Human IgGs are known to be excreted 

in breast milk during the first few days after birth, which is decreasing to low concentrations soon 

afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. 

Afterwards, lanadelumab could be used during breast-feeding if clinically needed. 

 

Fertility  

 

Lanadelumab’s effect on fertility has not been evaluated in humans. Lanadelumab had no effect on 

male or female fertility in cynomolgus monkeys (see section 5.3).  

 

4.7 Effects on ability to drive and use machines  

 

TAKHZYRO has negligible influence on the ability to drive or use machines.  

 



5 

4.8 Undesirable effects  

 

Summary of the safety profile  

 

The most commonly (52.4%) observed adverse reaction associated with TAKHZYRO was injection 

site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of 

these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration 

of 6 minutes.  

 

Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was 

observed (1.2%), see section 4.4.  

 

Tabulated list of adverse reactions  

 

Table 1 summarises adverse reactions observed in the HELP study that included 84 subjects with 

HAE, who received at least one dose of TAKHZYRO.  

 

The frequency of adverse reactions listed in Table 1 is defined using the following convention: 

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare 

(≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).  

 

Table 1: Adverse reactions reported with lanadelumab  

 

System organ class  Adverse drug reaction  Frequency  

Immune system disorders  Hypersensitivity*  Common  

Nervous system disorders  Dizziness  Common  

Skin and subcutaneous tissue disorders  Rash maculo-papular  Common  

Musculoskeletal and connective tissue 

disorders  
Myalgia  Common  

General disorders and administration 

site conditions  
Injection site reactions**  Very common  

Investigations  
Alanine aminotransferase increased Common  

Aspartate aminotransferase increased Common  

*Hypersensitivity includes: pruritus, discomfort and tingling of tongue.  

**Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, 

pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.  

 

Paediatric population  

 

The safety of TAKHZYRO was evaluated in a subgroup of 23 subjects aged 12 to <18 years old. 

Results of the subgroup analysis were consistent with overall study results for all subjects.  

 

Immunogenicity  

 

Treatment with lanadelumab has been associated with development of treatment emergent anti-drug 

antibodies (ADA) in 11.9% (10/84) of subjects. All antibody titres were low. The ADA response was 

transient in 20% (2/10) of ADA positive subjects. 2.4% (2/84) of lanadelumab-treated subjects tested 

positive for neutralising antibodies.  



6 

 

The development of ADA including neutralising antibodies against TAKHZYRO did not appear to 

adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.  

 

Reporting of suspected adverse reactions  

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V.  

 

4.9 Overdose  

 

No case of overdose has been reported. There is no available information to identify potential signs 

and symptoms of overdose. If symptoms should occur, symptomatic treatment is recommended. There 

is no antidote available.  

 

 

5. PHARMACOLOGICAL PROPERTIES  

 

5.1  Pharmacodynamic properties  

 

Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC 

code: B06AC05 

  

Mechanism of action  

 

Lanadelumab is a fully human, monoclonal antibody (IgG1/ κ-light chain). Lanadelumab inhibits 

active plasma kallikrein proteolytic activity. Increased plasma kallikrein activity leads to angioedema 

attacks in patients with HAE through the proteolysis of high-molecular-weight-kininogen (HMWK) to 

generate cleaved HMWK (cHMWK) and bradykinin. Lanadelumab provides sustained control of 

plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE.  

 

Pharmacodynamic effects  

 

Concentration-dependent inhibition of plasma kallikrein, measured as reduction of cHMWK levels, 

was demonstrated after SC administration of TAKHZYRO 150 mg every 4 weeks, 300 mg every 

4 weeks or 300 mg every 2 weeks in subjects with HAE.  

 

The PK-PD relationship between TAKHZYRO and cHMWK is described by an indirect exposure-

response pharmacological model. The cHMWK formation rate was maximally reduced by 53.7% with 

an IC50 of 5705 ng/ml.  

 

Clinical efficacy and safety  

 

HELP study  

 

The HELP study was a multicenter, randomised, double-blind, placebo-controlled parallel-group study 

in 125 (115 adults and 10 adolescents) subjects with symptomatic type I or II HAE. Subjects were 

randomised into 1 of 4 parallel treatment arms, stratified by baseline attack rate, in a 3:2:2:2 ratio 

(placebo, lanadelumab 150 mg every 4 weeks [q4wks], lanadelumab 300 mg every 4 weeks [q4wks], 

or lanadelumab 300 mg every 2 weeks [q2wks] by SC injection) for the 26-week treatment period.  

 

The median (range) age of the study population was 42 (12 to 73) years with 88 female subjects 

(70%). A history of laryngeal angioedema attacks was reported in 65% (81/125) of subjects and 

56% (70/125) were on prior long-term prophylaxis (LTP). During the study run-in period, the mean 

attack rate was 3.7 attacks/month with 52% (65/125) of subjects experiencing ≥3 attacks/month.  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


7 

 

All TAKHZYRO treatment arms produced 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) (Table 2).  

 

Table 2. Results of primary and secondary efficacy measures-ITT population  

 

Endpoint statisticsa 
Placebo 

(N=41) 

Lanadelumab 

150mg 

q4wks 

(N=28) 

300 mg 

q4wks 

(N=29) 

300 mg 

q2wks 

(N=27) 

Primary endpoint - Number of HAE attacks from Day 0 to 182 

LS Mean (95% CI) monthly attack 

rateb 

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)c 

 76 (61, 85) 73 (59, 82) 87 (76, 93) 

Adjusted p-valuesd  <0.001 <0.001 <0.001 

Secondary endpoint - Number of HAE attacks requiring acute treatment from Day 0 to 182  

LS Mean (95% CI) monthly attack 

rateb 

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)c 

 81 (66, 89) 74 (59, 84) 87 (75, 93) 

Adjusted p-valuesd  <0.001 <0.001 <0.001 

Secondary endpoint - Number of moderate or severe HAE attacks from Day 0 to 182  

LS Mean (95% CI) monthly attack 

rateb 

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)c 

 70 (50, 83) 73 (54, 84) 83 (67, 92) 

Adjusted p-valuesd  <0.001 <0.001 <0.001 

Note: CI=confidence interval; LS=least squares.  
a 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 subject was observed during the treatment period as an offset variable in the model.  

b Model-based treatment period HAE attack rate (attacks/4 weeks).  
c % reduction relative to placebo corresponds to 100% * (1-rate ratio). The rate ratio is ratio of the 

model-based treatment period HAE attack rates.  
d Adjusted p-values for multiple testing.  

 

The mean reduction in HAE attack rate was consistently higher across the TAKHZYRO treatment 

arms compared to placebo regardless of the baseline history of LTP, laryngeal attacks, or attack rate 

during the run-in period. The percentage of subjects who were attack free is provided in Table 3.  



8 

 

Table 3. Percentage of subjects who were attack free through treatment  

 

Criteria Placebo 

Lanadelumab 

150 mg 

q4wks 

300 mg 

q4wks 

300 mg 

q2wks 

Treatment period (Day 0 to Day 182, 26 weeks) 

N 41 28 29 27 

Attack free 2% 39% 31% 44% 

 

The percentage of patients who were attack free for the last 16-weeks (Day 70 to Day 182) of the 

study was 77% in the 300 mg q2wks group, compared to 3% of patients in the placebo group. 

 

100% of the subjects on 300 mg q2wks or q4wks and 89% on 150 mg q4wks achieved at least a 

50% reduction in HAE attack rate compared to the run-in period. 

 

Health related Quality of Life  

 

All TAKHZYRO treatment groups observed an improvement in Angioedema Quality of Life 

Questionnaire (AE-QoL) total and domain (functioning, fatigue/mood, fear/shame, and nutrition) 

scores compared to the placebo group; the largest improvement was observed in the functioning score 

as shown in Table 4. A reduction of 6 points is considered a clinically meaningful improvement. The 

percentage of patients who achieved a clinically meaningful improvement in AE-QoL total score was 

65% (Odds ratio vs placebo, [95% CI]= 3.2 [1.1, 9.2]), 63% (2.9 [1.1, 8.1]), and 81% (7.2 [2.2, 23.4]), 

in TAKHZYRO 150 mg q4 wks, 300 mg q4 wks, and 300 mg q2 wks groups, respectively, compared 

to 37% of patients in the placebo group.  

 

Table 4 Change in AE-QoL scorea - placebo vs TAKHZYRO at week 26 in HELP study  

 

LS mean change (SD) from baseline at week 26 Placebo 
TAKHZYRO 

total 

AE-QoL Total score -4.7 (18.8) -19.5 (18.6) 

Functioning score -5.4 (22.7) -29.3 (22.9) 

Fatigue/Mood score -1.8 (23.3) -13.0 (23.1) 

Fear/Shame score -9.0 (24.0) -18.8 (23.7) 

Nutrition score 0.5 (22.5) -17.0 (22.3) 

Note: AE-QoL= Angioedema Quality of Life; LS=least squares; SD=standard deviation.  
a Lower scores indicate lower impairment (or better health-related quality of life).  

 
HELP study extension  

 

Long-term safety and efficacy of TAKHZYRO for prophylaxis to prevent HAE attacks was evaluated 

in an open-label HELP study extension.  

A total of 212 adult and adolescent subjects with symptomatic type I or II HAE received at least one 

dose of lanadelumab in this study, including 109 subjects who entered as rollover subjects from the 

HELP study and 103 new or non-rollover subjects (including 19 subjects from Phase1b study) who 



9 

had an historical baseline attack rate of ≥1 attack per 12 weeks Subjects were allowed to initiate 

self-administration after receiving the first 2 doses from a health care professional in clinic and 

completing appropriate training. Interim analysis indicates that the effect was sustained up to one year 

of treatment.  

Paediatric population  

 

The European Medicines Agency has deferred the obligation to submit the results of studies with 

TAKHZYRO in one or more subsets of the paediatric population in the prevention of hereditary 

angioedema attacks.  

 

5.2 Pharmacokinetic properties  

 

The single and multiple dose pharmacokinetics of lanadelumab have been studied in patients with 

HAE. Pharmacokinetics of lanadelumab showed linear dose-exposure response with doses up to 

400 mg and reproducible exposure following subcutaneous administration up to 12 months. The 

absolute bioavailability of lanadelumab after subcutaneous administration has not been determined. In 

the HELP study, patients treated with 300 mg q2 wks presented mean (SD) area under the curve over 

the dosing interval at steady-state (AUCtau,ss), maximum concentration at steady-state (Cmax,ss) and 

minimum concentration at steady-state (Cmin,ss) of 408 µg*day/ml (138), 34.4 µg/mL (11.2), and 

25.4 µg/mL (9.18), respectively. The anticipated time to reach steady state concentration was 

approximately 70 days.  

 

Absorption  

 

Following SC administration, the time to maximum concentration is approximately 5 days. The site of 

SC injection (thigh, arm, or abdomen) and self-administration did not affect the absorption of 

lanadelumab.  

 

Distribution  

 

The mean (SD) volume of distribution of lanadelumab in patients with HAE is 14.5 litres (4.53). 

Lanadelumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins.  

 

Elimination  

 

Lanadelumab has a mean (SD) total body clearance of 0.0297 L/h (0.0124) and a terminal elimination 

half-life of approximately 14 days.  

 

Special populations  

 

No dedicated studies have been conducted to evaluate the pharmacokinetics of lanadelumab in special 

patient populations including gender, age, pregnant women or the presence of renal or hepatic 

impairment.  

 

In a population pharmacokinetic analysis, after correcting for body weight, no influence of gender or 

age (12 to 75 years) was apparent on the clearance or volume of distribution of lanadelumab.  

 

Although body weight was identified as an important covariate describing the variability of clearance, 

a 300 mg q2wks dose regimen provided sufficient exposure for the indication (see section 5.1).  

 

Renal and hepatic impairment  

 

As IgG monoclonal antibodies are mainly eliminated via intracellular catabolism, renal impairment or 

hepatic impairment is not expected to influence clearance of lanadelumab.  



10 

Accordingly, in a population pharmacokinetic analysis, renal impairment (estimated GFR: 

60 to 89 ml/min/1.73 m2 [mild, N=98] and 30 to 59 ml/min/1.73m2 [moderate, N=9]) had no effect on 

the clearance or volume of distribution of lanadelumab.  

 

5.3 Preclinical safety data  

 

In repeat-dose studies evaluating once weekly SC injection in both rats (up to 28 days) and 

cynomolgus monkeys (up to 6 months) lanadelumab was well-tolerated at doses of up to and including 

50 mg/kg (highest dose tested) with no organs of toxicity identified. Exposures in cynomolgus 

monkeys following 6 months of administration were approximately 23-fold greater than that noted at 

300 mg q2 wks based on AUC. 

 

Lanadelumab is not expected to interact directly with DNA or other chromosomal material, as it is 

made up entirely of naturally occurring amino acids and contains no inorganic or synthetic linkers or 

other nonprotein portions; therefore no genotoxicity evaluation has been conducted. 

Carcinogenicity has not been evaluated in animals as based on the weight of evidence approach, 

lanadelumab is considered to have a low risk for carcinogenicity.  

 

The effects of lanadelumab on fertility were evaluated in sexually mature cynomolgus monkeys. In a 

13-week study, once weekly SC administration of lanadelumab had no effects on male or female 

fertility at doses of 10 or 50 mg/kg (highest dose tested). Exposures in sexually mature cynomolgus 

monkeys in the fertility study were approximately 20-and 22-fold greater than that noted at 

300 mg q2 wks based on Cmax and AUC, respectively.  

 

In the ePPND study in pregnant cynomolgus monkeys administered once weekly doses of 10 or 50 mg/kg 

(highest dose tested), there were no lanadelumab-related effects on pregnancy and parturition, 

embryo-foetal development, survival, growth, and/or postnatal development of offspring. Exposures in 

the ePPND study were approximately 32-fold greater than that noted at 300 mg q2 wks based on 

AUC.  

 

 

6. PHARMACEUTICAL PARTICULARS  

 

6.1 List of excipients  

 

Disodium phosphate dihydrate  

Citric acid monohydrate  

Histidine  

Sodium chloride  

Polysorbate 80  

Water for injections  

 

6.2 Incompatibilities  

 

Not applicable.  

 

6.3 Shelf life  

  

TAKHZYRO 300 mg solution for injection in vial 

2 years  

 

The injection should be administered within 2 hours of preparing the dosing syringe. If not 

administered immediately after preparation, the syringe may be stored in the refrigerator (2C to 8C), 

protected from light and administered within 8 hours.  

 

Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C and for 8 hours at 

2°C to 8°C. From a microbiological point of view, unless the method of preparation precludes the 



11 

risks of microbial contamination, the product should be used immediately. If not used immediately, 

in-use storage times and conditions are the responsibility of the user. 

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

2 years 

 

 

6.4 Special precautions for storage  

 

Store in a refrigerator (2C to 8C).  

 

Do not freeze.  

 

Keep the solution (vial or pre-filled syringe) in the outer carton in order to protect from light.  

 

The solution (vial or pre-filled syringe) may be stored below 25°C for a single period of 14 days, but 

not beyond the expiry date. Do not return TAKHZYRO to refrigerated storage after storage at room 

temperature. 

 

For storage conditions after first opening of the product in vial, see section 6.3. 

 

6.5 Nature and contents of container  

 

TAKHZYRO 300 mg solution for injection in vial 

2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with 

violet flip-off cap. TAKHZYRO is available as a single pack containing one 2 ml vial and in 

multipacks comprising 2 or 6 cartons, each carton containing 1 vial.  

 

Each pack also contains the following items:  

• Empty 3 ml syringe  
• 18G vial access needle  
• 27G x 13 mm injection needle  

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

2 ml of solution in pre-filled syringe with a bromobutyl stopper, 27G x 13 mm staked needle and rigid 

needle cap. TAKHZYRO is available as unit packs containing 1 or 2 pre-filled syringes and in 

multipacks containing 6 (3 packs of 2) pre-filled syringes. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling  

 

Lanadelumab is provided in single use vials and pre-filled syringes. 

 

Before use, TAKHZYRO solution should be visually inspected for appearance. The solution should be 

clear or slightly yellow. Solutions that are discoloured or contain particles should not be used.  

 

Avoid vigorous agitation.  

 

Administration steps  

 

TAKHZYRO 300 mg solution for injection in vial 

Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe 

using an 18 gauge needle.  

 

Change the needle on the syringe to a 27 gauge needle or other needle suitable for SC injection. Inject 

TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2). 



12 

 

Discard the vial with any unused contents.  

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

After removing the pre-filled syringe from the refrigerator, wait 15-30 minutes before injecting to 

allow the solution to reach room temperature. Inject TAKHZYRO subcutaneously into the abdomen, 

thigh, or upper arm (see section 4.2). 

 

Each pre-filled syringe is for single use only. Discard the pre-filled syringe after injection is 

completed. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

All needles and syringes should be disposed of in a sharps container.  

 

 

7. MARKETING AUTHORISATION HOLDER  

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland  

Tel: +80066838470 

E-mail: medinfoEMEA@shire.com  

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1340/001 

EU/1/18/1340/002 

EU/1/18/1340/003 

EU/1/18/1340/004 

EU/1/18/1340/005 

EU/1/18/1340/006 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  

 

Date of first authorisation: 22 November 2018 

 

 

10. DATE OF REVISION OF THE TEXT  

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu.  

mailto:medinfoEMEA@shire.com
http://www.ema.europa.eu/


13 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A.  MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) 

RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING 

SUPPLY AND USE 

C. OTHER CONDITIONS AND REQUIREMENTS OF 

THE MARKETING AUTHORISATION 

D. CONDITIONS OR RESTRICTIONS WITH REGARD 

TO THE SAFE AND EFFECTIVE USE OF THE 

MEDICINAL PRODUCT 

 



14 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 

MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) of the biological active substance(s)  

Rentschler Biopharma SE 

Erwin-Rentschler-Strasse 21 

D-88471 Laupheim 

GERMANY 

 

Name and address of the manufacturer(s) responsible for batch release 

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 and 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

IRELAND  

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  

 

• Periodic safety update reports (PSURs)  

 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal. 

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 

months following authorisation. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

• Risk management plan (RMP) 

 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 

and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 

authorisation and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached.  



15 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING  



17 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

VIAL - UNIT PACK CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

TAKHZYRO 300 mg solution for injection  

lanadelumab  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each vial contains 300 mg lanadelumab. 

 

 

3. LIST OF EXCIPIENTS  

 

Disodium phosphate, dihydrate  

Citric acid monohydrate  

Histidine  

Sodium chloride  

Polysorbate 80  

Water for injections  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection  

1 vial of 2 ml  

 

This pack also contains:  

3 ml syringe  

18 gauge access needle  

Injection needle  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use  

Read the package leaflet before use  

For single use only  

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

 



18 

8. EXPIRY DATE  

 

EXP  

 

 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  

Do not freeze.  

Keep in the outer carton in order to protect from light.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1340/001 

 

 

13. BATCH NUMBER  

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

16. INFORMATION IN BRAILLE  

 

TAKHZYRO 300 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included.  

 

 



19 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA  

 

PC  

SN  

NN  



20 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

VIAL - MULTIPACK INNER CARTON (NO BLUE-BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

TAKHZYRO 300 mg solution for injection  

lanadelumab  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each vial contains 300 mg lanadelumab. 

 

 

3. LIST OF EXCIPIENTS  

 

Disodium phosphate, dihydrate  

Citric acid monohydrate  

Histidine  

Sodium chloride  

Polysorbate 80  

Water for injections  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection  

1 vial of 2 ml component of a multipack, can’t be sold separately. 

 

This pack also contains:  

3 ml syringe  

18 gauge access needle  

Injection needle  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use  

Read the package leaflet before use  

For single use only  

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

 



21 

8. EXPIRY DATE  

 

EXP  

 

 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  

Do not freeze.  

Keep in the outer carton in order to protect from light.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1340/002  

EU/1/18/1340/003  

 

 

13. BATCH NUMBER  

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

16. INFORMATION IN BRAILLE  

 

TAKHZYRO 300 mg  



22 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

VIAL - MULTIPACK OUTER CARTON (INCLUDING BLUE-BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

TAKHZYRO 300 mg solution for injection  

lanadelumab  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each vial contains 300 mg lanadelumab. 

 

 

3. LIST OF EXCIPIENTS  

 

Disodium phosphate, dihydrate  

Citric acid monohydrate  

Histidine  

Sodium chloride  

Polysorbate 80  

Water for injections  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection  

 

Multipack: 2 vials (2 packs of 1 vial) of 2 ml. 

Multipack: 6 vials (6 packs of 1 vial) of 2 ml. 

 

Each Single pack also contains:  

3 ml syringe  

18 gauge access needle  

Injection needle  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use  

Read the package leaflet before use  

For single use only  

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 



23 

 

8. EXPIRY DATE  

 

EXP  

 

 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  

Do not freeze.  

Keep in the outer carton in order to protect from light.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland   

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1340/002  

EU/1/18/1340/003  

 

 

13. BATCH NUMBER  

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

16. INFORMATION IN BRAILLE  

 

TAKHZYRO 300 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included.  



24 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA  

 

PC  

SN  

NN  

 



25 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  

 

VIAL LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION  

 

TAKHZYRO 300 mg solution for injection 

lanadelumab  

Subcutaneous use  

 

 

2. METHOD OF ADMINISTRATION  

 

Read the package leaflet before use  

 

 

3. EXPIRY DATE  

 

EXP  

 

 

4. BATCH NUMBER  

 

Lot  

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT  

 

2 ml  

 

 

6. OTHER  

 

 



26 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

PRE-FILLED SYRINGE- UNIT PACK CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

lanadelumab  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each pre-filled syringe contains 300 mg lanadelumab. 

 

 

3. LIST OF EXCIPIENTS  

 

Disodium phosphate, dihydrate  

Citric acid monohydrate  

Histidine  

Sodium chloride  

Polysorbate 80  

Water for injections  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection  

1 pre-filled syringe of 2 ml  

2 pre-filled syringes of 2 ml  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use  

Read the package leaflet before use  

For single use only  

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

 

8. EXPIRY DATE  

 

EXP  

 



27 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  

Do not freeze.  

Keep in the outer carton in order to protect from light.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1340/004 

EU/1/18/1340/005 

 

 

13. BATCH NUMBER  

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

16. INFORMATION IN BRAILLE  

 

TAKHZYRO 300 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included.  

 

 



28 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA  

 

PC  

SN  

NN  

 

 



29 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

PRE-FILLED SYRINGE MULTIPACK INNER CARTON (NO BLUE-BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

lanadelumab  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each pre-filled syringe contains 300 mg lanadelumab. 

 

 

3. LIST OF EXCIPIENTS  

 

Disodium phosphate, dihydrate  

Citric acid monohydrate  

Histidine  

Sodium chloride  

Polysorbate 80  

Water for injections  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection  

1 unit pack of 2 pre-filled syringes (2 ml each), can’t be sold separately.  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use  

Read the package leaflet before use  

For single use only  

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

 

8. EXPIRY DATE  

 

EXP  

 

 



30 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  

Do not freeze.  

Keep in the outer carton in order to protect from light.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1340/006 

 

 

13. BATCH NUMBER  

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

16. INFORMATION IN BRAILLE  

 

TAKHZYRO 300 mg  



31 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

PRE-FILLED SYRINGE MULTIPACK OUTER CARTON (INCLUDING BLUE-BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

lanadelumab  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each pre-filled syringe contains 300 mg lanadelumab. 

 

 

3. LIST OF EXCIPIENTS  

 

Disodium phosphate, dihydrate  

Citric acid monohydrate  

Histidine  

Sodium chloride  

Polysorbate 80  

Water for injections  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection Multipack of 6: 3 unit packs of 2 pre-filled syringes (2 ml each)  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use  

Read the package leaflet before use  

For single use only  

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

 

8. EXPIRY DATE  

 

EXP  

 

 



32 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  

Do not freeze.  

Keep in the outer carton in order to protect from light.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1340/006 

 

 

13. BATCH NUMBER  

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

16. INFORMATION IN BRAILLE  

 

TAKHZYRO 300 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included.  

 

 



33 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA  

 

PC  

SN  

NN  

 



34 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  

 

PRE-FILLED SYRINGE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION  

 

TAKHZYRO 300 mg solution for injection 

lanadelumab  

s.c. 

 

 

2. METHOD OF ADMINISTRATION  

 

Read the package leaflet before use  

 

 

3. EXPIRY DATE  

 

EXP  

 

 

4. BATCH NUMBER  

 

Lot  

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT  

 

2 ml  

 

 

6. OTHER  

 

 



35 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



36 

Package leaflet: Information for the user 

 

TAKHZYRO 300 mg solution for injection in vial 

lanadelumab  

This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how 

to report side effects.  

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you.  

 

• Keep this leaflet. You may need to read it again.  

• If you have any further questions, ask your doctor, pharmacist or nurse.  

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.  

 

What is in this leaflet  

 

1. What TAKHZYRO is and what it is used for  

2. What you need to know before you use TAKHZYRO  

3. How to use TAKHZYRO  

4. Possible side effects  

5. How to store TAKHZYRO  

6. Contents of the pack and other information  

7. Instructions for use  

 

 

1. What TAKHZYRO is and what it is used for  

 

TAKHZYRO contains the active substance lanadelumab.  

 

What TAKHZYRO is used for  

 

TAKHZYRO is a medicine used in adults,  and adolescents aged 12 years and older to prevent 

angioedema attacks, in patients with HAE.  

 

What hereditary angioedema (HAE) is  

 

HAE is a condition which runs in families. With this condition your blood does not have enough of a 

protein called ‘C1 inhibitor’, or C1 inhibitor does not work properly. This leads to too much ‘plasma 

kallikrein’, which in turn produces higher levels of ‘bradykinin’ in your bloodstream. Too much 

bradykinin leads to symptoms of HAE like swelling and pain on the, 

• hands and feet  

• face, eyelids, lips or tongue  

• voice-box (larynx), which may make breathing difficult  

• genitals  

 

How TAKHZYRO works  

 

TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein. This helps to reduce the 

amount of bradykinin in your bloodstream and prevents symptoms of HAE.  

 

 



37 

2. What you need to know before you use TAKHZYRO  

 

Do not use TAKHZYRO:  

 

If you are allergic to lanadelumab or any of the other ingredients of this medicine (listed in section 6).  

 

Warnings and precautions  

 

• Talk to your doctor, pharmacist or nurse before using TAKHZYRO.  

• If you have a severe allergic reaction to TAKHZYRO with symptoms such as a rash, a tight 

chest, wheezing, or a fast heart beat, tell your doctor, pharmacist or nurse immediately.  

 

Keeping a record  

 

It is strongly recommended that every time you have a dose of TAKHZYRO, you write down the 

name and batch number of the medicine. This is so that you keep a record of the batches used.  

 

Laboratory tests  

 

Tell your doctor if you are using TAKHZYRO before you have laboratory tests to measure how well 

your blood is clotting. This is because TAKHZYRO in the blood may interfere with some laboratory 

tests, leading to inaccurate results 

 

Children and adolescents  

 

TAKHZYRO is not recommended for use in children under 12 years of age. This is because it has not 

been studied in this age group.  

 

Other medicines and TAKHZYRO  

 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines.  

 

TAKHZYRO is not known to affect other medicines or be affected by other medicines.  

 

Pregnancy and breast-feeding  

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before starting to use TAKHZYRO. There is limited information 

on the safety of TAKHZYRO use during pregnancy and breast-feeding. As a precautionary measure, it 

is preferable to avoid the use of lanadelumab during pregnancy and breast-feeding. Your doctor will 

discuss with you the risks and benefits of taking this medicine.  

 

Driving and using machines  

 

This medicine has negligible influence on the ability to drive or use machines.  

 

TAKHZYRO contains sodium  

 

The medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially 

‘sodium-free’. 

 

 

3. How to use TAKHZYRO  

 

TAKHZYRO is provided in single-use vials as ready-to-use solution. Your treatment will be started 

and managed under the supervision of a doctor experienced in the care of patients with HAE.  



38 

 

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has 

told you. Check with your doctor, pharmacist or nurse if you are not sure or have any further questions 

on the use of this medicine.  

 

How much TAKHZYRO to use  

 

The recommended starting dose is 300 mg every 2 weeks. If you have not had an attack for a long 

period, your doctor may change the dose to 300 mg every 4 weeks, especially if you have a low body 

weight.  

 

How to inject TAKHZYRO  

 

If you inject TAKHZYRO yourself or if your caregiver injects it, you or your caregiver must 

carefully read and follow the instructions in section 7, “Instructions for use”.  

 

• TAKHZYRO is for injection under the skin (‘subcutaneous injection’).  

• The injection can be given either by yourself or a caregiver.  

• A doctor, pharmacist or nurse should show you how to prepare and inject TAKHZYRO 

properly before you use it for the first time. Do not inject yourself or someone else until you 

have been trained to inject the medicine.  

• Insert the needle into the fatty tissue in the tummy (abdomen), thigh or upper arm.  

• Inject the medicine in a different place each time.  

• Use each vial of TAKHZYRO only once.  

 

If you use more TAKHZYRO than you should  

 

Tell your doctor, pharmacist or nurse if you take too much TAKHZYRO.  

 

If you forget to use TAKHZYRO  

 

If you miss a dose of TAKHZYRO, inject your dose as soon as possible but there must be at least 

10 days between each dose. If you are not sure when to inject TAKHZYRO after a missed dose, ask 

your doctor, pharmacist or nurse.  

 

If you stop using TAKHZYRO  

 

It is important that you keep injecting TAKHZYRO as instructed by your doctor even if you feel 

better.  

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.  

 

 

4. Possible side effects  

 

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

 

If you have a severe allergic reaction to TAKHZYRO with symptoms such as a rash, tight chest, 

wheezing, or a fast heart beat, tell your doctor, pharmacist or nurse immediately.  

 

Tell your doctor, pharmacist or nurse if you notice any of the following side effects.  

 

Very common (may affect more than 1 in 10 people):  

 

• Reactions where the injection is given – symptoms include pain, skin redness, bruising, 

discomfort, swelling, bleeding, itching, hardening of skin, tingling, warmth and rash.  

 



39 

Common (may affect up to 1 in 10 people):  

 

• Allergic reactions including itching, discomfort and tingling of the tongue  

• Dizziness, feeling faint  

• Raised skin rash  

• Muscle pain  

• Blood tests showing liver changes  

 

Reporting of side effects  

 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine.  

 

 

5. How to store TAKHZYRO  

 

Keep this medicine out of the sight and reach of children.  

 

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date 

refers to the last day of that month.  

 

Store in a refrigerator (2C-8C). Do not freeze. Keep the vial in the outer carton in order to protect 

from light.  

 

Vials may be stored below 25°C for a single period of 14 days, but not beyond the expiry date.  

Do not return TAKHZYRO to refrigerated storage after storage at room temperature. 

 

Do not use this medicine if you notice signs of deterioration such as particles in the vial or changed 

colour of the injection solution.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment.  

 

 

6. Contents of the pack and other information  

 

What TAKHZYRO contains  

 

• The active substance is lanadelumab. Each vial contains 300 mg of lanadelumab in 2mL 

solution.  

• The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, 

sodium chloride, polysorbate 80 and water for injections – see section 2 “TAKHZYRO contains 

sodium”  

 

What TAKHZYRO looks like and contents of the pack  

 

TAKHZYRO is presented as a clear, colourless to slightly yellow solution for injection in a glass vial.  

 

TAKHZYRO is available as a single pack containing one 2 ml vial and in multipacks comprising 2 or 

6 cartons, each carton containing 1 vial.  

 

Not all pack sizes may be marketed.  

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


40 

Each pack also contains the following items:  

• Empty 3 ml syringe  

• 18 gauge blunt tip vial access needle  

• 27 gauge x 13 mm pointed tip administration (injection) needle.  

 

Marketing Authorisation Holder and Manufacturer  

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland 

Tel:  +80066838470 

E-mail: medinfoEMEA@shire.com  

 

This leaflet was last revised in MM/YYYY 

 

Other sources of information  

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

https://www.ema.europa.eu/ There are also links to other websites about rare diseases and treatments.  

 

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.  

 

 

7. Instructions for use  

 

Be sure that you read, understand and follow the step-by-step instructions for injecting TAKHZYRO. 

Contact your doctor, pharmacist or nurse if you have any questions.  

 

In addition to the vial, each TAKHZYRO pack also contains:  

 

• One empty 3 ml syringe.  

 

 
 

 

 

• One 18 gauge blunt tip vial access needle.  

Used to draw medicinal solution from the vial into the 

syringe.  

 

 
 

 

 

• One 27 gauge x 13 mm pointed tip injection needle.  

Used for injection under the skin (subcutaneous).  

 

 
 

 

Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles in this pack or 

which your doctor has prescribed.  

 

mailto:medinfoEMEA@shire.com
https://www.ema.europa.eu/


41 

Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles one time. Place 

all used syringes and needles in the sharps container.  

 

Do not use any syringes, blunt-tip vial access needles and pointed-tip injection needles that appear 

damaged.  

 

You will also need:  

 

• Alcohol wipes  

• A sharps container for used vials, needles and syringes 

 

You can get supplies from your doctor, pharmacist or nurse.  

 

The injection of TAKHZYRO can be summarised in 5 steps:  

 

1. Prepare the vial of TAKHZYRO  

2. Attach blunt tip vial access needle to syringe  

3. Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle  

4. Select and prepare injection site  

5. Inject TAKHZYRO  

 

 

Step 1: Prepare the vial of TAKHZYRO  

 

a) Take the vial out of the refrigerator 

15 minutes before use to allow it to reach 

room temperature (15°C to 25°C) before 

preparing an injection.  

b) Clean your work area and wash your hands 

before preparing your dose. Do not touch any 

surface or your body, especially your face, 

after washing your hands before injection.  

c) Gather your TAKHZYRO and supplies and 

place them on your well-lit work surface.  

d) Remove the vial from the packaging. Do not 

use the vial if the cap covering the stopper is 

missing.  

 

e) Gently invert the vial 3 to 5 times to 

ensure the solution is mixed. Do not shake 

the vial as this can cause foaming.  

f) Check the solution in the vial for particles or 

a change in the colour (normally it is 

colourless to slightly yellow). Do not use if 

you see particles or a change in colour.  

 

Important: Do not shake.  



42 

 

 
 

g) Remove the plastic cap from the vial. Do not 

remove the vial rubber stopper.  

 
 

 

 

h) Place the vial on a flat surface. Clean the vial 

rubber stopper with an alcohol wipe and 

allow it to dry.  

 

Step 2: Attach blunt tip vial access needle to syringe  

 

 

a) Screw the 18 gauge blunt tip vial access needle to 

the 3 ml syringe.  

 

b) Pull back the plunger to fill the syringe with air 

equal to the amount of solution in the vial.  

Important: Do not remove the needle cap 

from the needle when attaching to the syringe.  



43 

 

c) Pull off the needle cap straight away from the 

syringe without touching the needle. Do not pull 

on the plunger.  

 

 

Step 3: Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle  

 

 

a) Insert the needle into the centre of the rubber 

stopper.  

b) Push the plunger down to inject air into the vial 

and hold the plunger down.  

 

c) Slowly turn the vial upside down with needle and 

syringe attached. Pull back on the plunger to 

withdraw the full dose in the vial.  

 

 

 

d) Remove large air bubbles by gently tapping on 

the syringe with your fingers until the bubbles 

rise to the top of the syringe.  

 

Slowly push the plunger, allowing air to go back 

into the vial, until the solution reaches the top of 

the syringe.  

 

Repeat these steps until large air bubbles are 

removed.  

Important: Be sure to keep the tip of the 

needle in the liquid to avoid drawing air in as 

you pull back the plunger.  



44 

 

 

e) Without removing the needle from the vial, 

unscrew the syringe by holding the top of the 

needle and turning the syringe counter clockwise.  

 

Return the syringe to an upright position.  

 

f) Place the 18 gauge blunt-tip vial access needle 

and the vial in a sharps container.  

 

 

g) Screw the 27 gauge x 13 mm pointed-tip 

injection needle to the syringe.  

 

 

Important: Do not remove the needle cap 

from the needle when attaching to the syringe.  

Do not use the blunt tip vial access needle to 

inject TAKHZYRO as this may cause pain 

and bleeding.  

 



45 

Step 4: Select and prepare injection site 

  
 

 
 

 

 

a) Choose an injection site on your stomach 

(abdomen), thigh, or upper arm. The 

injection should be given subcutaneously.  

b) Clean your injection site with an alcohol 

wipe and allow the skin to dry completely.  

 

Step 5: Inject TAKHZYRO 

 

 

c) Pull off the needle cap straight from the syringe 

without touching the needle. Do not pull on the 

plunger. Do not touch the needle tip or allow it to 

touch any other surface.  

 
 

 

Important: 

• It is important to use 

different injection sites to 

keep skin healthy.  

• The area you choose for 

injection should be at least 

5 cm away from any scars 

or your belly button (navel). 

Do not choose an area that 

is bruised, swollen, or 

painful.  

• The outer area of the upper 

arm is not recommended if 

you are injecting yourself.  

Important: Inject TAKHZYRO within 2 hours 

of preparing the dosing syringe at room 

temperature.  Alternatively, you can place the 

dosing syringe in a refrigerator at 2°C to 8°C 

and you must use it within 8 hours.  



46 

 
 

d) Gently pinch about 3 cm of skin at your cleaned 

injection site and insert the needle.  

 
 

 

 

e) Push the plunger slowly until all the medicine has 

been injected. Release the skin fold and gently 

remove the needle. Do not recap the needle.  

 

f) Place the 27 gauge x 13 mm pointed-tip injection 

needle and the syringe in a sharps container.  

 

Important: Be sure to inject into a 

subcutaneous space which is not too shallow 

(skin layer) or too deep (muscle).  



47 

Package leaflet: Information for the user 

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe 

lanadelumab  

This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how 

to report side effects.  

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you.  

 

• Keep this leaflet. You may need to read it again.  

• If you have any further questions, ask your doctor, pharmacist or nurse.  

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.  

 

What is in this leaflet  

 

1. What TAKHZYRO is and what it is used for  

2. What you need to know before you use TAKHZYRO  

3. How to use TAKHZYRO  

4. Possible side effects  

5. How to store TAKHZYRO  

6. Contents of the pack and other information  

7. Instructions for use  

 

 

1. What TAKHZYRO is and what it is used for  

 

TAKHZYRO contains the active substance lanadelumab.  

 

What TAKHZYRO is used for  

 

TAKHZYRO is a medicine used in adults,  and adolescents aged 12 years and older to prevent 

angioedema attacks, in patients with HAE.  

 

What hereditary angioedema (HAE) is  

 

HAE is a condition which runs in families. With this condition your blood does not have enough of a 

protein called ‘C1 inhibitor’, or C1 inhibitor does not work properly. This leads to too much ‘plasma 

kallikrein’, which in turn produces higher levels of ‘bradykinin’ in your bloodstream. Too much 

bradykinin leads to symptoms of HAE like swelling and pain on the, 

• hands and feet  

• face, eyelids, lips or tongue  

• voice-box (larynx), which may make breathing difficult  

• genitals  

 

How TAKHZYRO works  

 

TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein. This helps to reduce the 

amount of bradykinin in your bloodstream and prevents symptoms of HAE.  

 

 



48 

2. What you need to know before you use TAKHZYRO  

 

Do not use TAKHZYRO:  

 

If you are allergic to lanadelumab or any of the other ingredients of this medicine (listed in section 6).  

 

Warnings and precautions  

 

• Talk to your doctor, pharmacist or nurse before using TAKHZYRO.  

• If you have a severe allergic reaction to TAKHZYRO with symptoms such as a rash, a tight 

chest, wheezing, or a fast heart beat, tell your doctor, pharmacist or nurse immediately.  

 

Keeping a record  

 

It is strongly recommended that every time you have a dose of TAKHZYRO, you write down the 

name and batch number of the medicine. This is so that you keep a record of the batches used.  

 

Laboratory tests  

 

Tell your doctor if you are using TAKHZYRO before you have laboratory tests to measure how well 

your blood is clotting. This is because TAKHZYRO in the blood may interfere with some laboratory 

tests, leading to inaccurate results 

 

Children and adolescents  

 

TAKHZYRO is not recommended for use in children under 12 years of age. This is because it has not 

been studied in this age group.  

 

Other medicines and TAKHZYRO  

 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines.  

 

TAKHZYRO is not known to affect other medicines or be affected by other medicines.  

 

Pregnancy and breast-feeding  

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before starting to use TAKHZYRO. There is limited information 

on the safety of TAKHZYRO use during pregnancy and breast-feeding. As a precautionary measure, it 

is preferable to avoid the use of lanadelumab during pregnancy and breast-feeding. Your doctor will 

discuss with you the risks and benefits of taking this medicine.  

 

Driving and using machines  

 

This medicine has negligible influence on the ability to drive or use machines.  

 

TAKHZYRO contains sodium  

 

The medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially 

‘sodium-free’. 

 

 



49 

3. How to use TAKHZYRO  

 

TAKHZYRO is provided in single-use pre-filled syringes as ready-to-use solution. Your treatment 

will be started and managed under the supervision of a doctor experienced in the care of patients with 

HAE.  

 

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has 

told you. Check with your doctor, pharmacist or nurse if you are not sure or have any further questions 

on the use of this medicine.  

 

How much TAKHZYRO to use  

 

The recommended starting dose is 300 mg every 2 weeks. If you have not had an attack for a long 

period, your doctor may change the dose to 300 mg every 4 weeks, especially if you have a low body 

weight.  

 

How to inject TAKHZYRO  

 

If you inject TAKHZYRO yourself or if your caregiver injects it, you or your caregiver must 

carefully read and follow the instructions in section 7, “Instructions for use”.  

 

• TAKHZYRO is for injection under the skin (‘subcutaneous injection’).  

• The injection can be given either by yourself or a caregiver.  

• A doctor, pharmacist or nurse should show you how to prepare and inject TAKHZYRO 

properly before you use it for the first time. Do not inject yourself or someone else until you 

have been trained to inject the medicine.  

• Insert the needle into the fatty tissue in the tummy (abdomen), thigh or upper arm.  

• Inject the medicine in a different place each time.  

• Use each pre-filled syringe of TAKHZYRO only once.  

 

If you use more TAKHZYRO than you should  

 

Tell your doctor, pharmacist or nurse if you take too much TAKHZYRO.  

 

If you forget to use TAKHZYRO  

 

If you miss a dose of TAKHZYRO, inject your dose as soon as possible but there must be at least 

10 days between each dose. If you are not sure when to inject TAKHZYRO after a missed dose, ask 

your doctor, pharmacist or nurse.  

 

If you stop using TAKHZYRO  

 

It is important that you keep injecting TAKHZYRO as instructed by your doctor even if you feel 

better. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or 

nurse.  

 

 

4. Possible side effects  

 

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

 

If you have a severe allergic reaction to TAKHZYRO with symptoms such as a rash, tight chest, 

wheezing, or a fast heart beat, tell your doctor, pharmacist or nurse immediately.  

 

Tell your doctor, pharmacist or nurse if you notice any of the following side effects.  

 



50 

Very common (may affect more than 1 in 10 people):  

 

• Reactions where the injection is given – symptoms include pain, skin redness, bruising, 

discomfort, swelling, bleeding, itching, hardening of skin, tingling, warmth and rash.  

 

Common (may affect up to 1 in 10 people):  

 

• Allergic reactions including itching, discomfort and tingling of the tongue  

• Dizziness, feeling faint  

• Raised skin rash  

• Muscle pain  

• Blood tests showing liver changes  

 

Reporting of side effects  

 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine.  

 

 

5. How to store TAKHZYRO  

 

Keep this medicine out of the sight and reach of children.  

 

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date 

refers to the last day of that month.  

 

TAKHZYRO 300 mg solution for injection in pre-filled syringe  

Store in a refrigerator (2C-8C). Do not freeze. Keep the pre-filled syringe in the outer carton in order 

to protect from light.  

 

Pre-filled syringes may be stored below 25°C for a single period of 14 days, but not beyond the expiry 

date.  

 

Do not return TAKHZYRO to refrigerated storage after storage at room temperature.  

 

Do not use this medicine if you notice signs of deterioration such as particles in the pre-filled syringe 

or changed colour of the injection solution.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment.  

 

 

6. Contents of the pack and other information  

 

What TAKHZYRO contains  

 

• The active substance is lanadelumab. Each pre-filled syringe contains 300 mg of lanadelumab in 

2mL solution.  

• The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, 

sodium chloride, polysorbate 80 and water for injections – see section 2 “TAKHZYRO contains 

sodium”  

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


51 

What TAKHZYRO looks like and contents of the pack  

 

TAKHZYRO is presented as a clear, colourless to slightly yellow solution for injection in a pre-filled 

syringe.  

 

TAKHZYRO is available as: 

• a single pack containing one 2 ml pre-filled syringe in a carton 

• a single pack containing two 2 ml pre-filled syringes in a carton  

• in multipacks comprising 3 cartons, each carton containing two 2 ml pre-filled syringes.  

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer  

 

Shire Pharmaceuticals Ireland Limited  

Blocks 2 & 3 Miesian Plaza  

50-58 Baggot Street Lower  

Dublin 2  

Ireland 

Tel:  +80066838470 

E-mail: medinfoEMEA@shire.com  

 

This leaflet was last revised in  

 

Other sources of information  

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

https://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments.  

 

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.  

 

 

7 Instructions for use  

 

Be sure that you read, understand, and follow the Instructions for Use before injecting TAKHZYRO. 

Contact your healthcare provider if you have any questions.  

 

Intended use  

 

The TAKHZYRO pre-filled syringe is a fixed dose (300 mg/2 mL), ready-to-use, disposable, needle-

based injection device intended for subcutaneous administration of the drug product by healthcare 

providers, caregivers, or by self-administration.  

 

Storing TAKHZYRO  

 

• Store TAKHZYRO in the refrigerator at 2°C to 8°C. Do not freeze.  

• Pre-filled syringe removed from refrigeration should be stored below 25°C and used within 

14 days. Do not return TAKHZYRO to refrigerated storage after storage at room temperature. 

• Store TAKHZYRO in the original carton to protect the pre-filled syringe from light.  

• Do not shake TAKHZYRO.  

• Keep TAKHZYRO and all medicines out of the reach of children.  

 

Parts of Your TAKHZYRO Pre-filled Syringe Before Use (Figure A).  

mailto:medinfoEMEA@shire.com
https://www.ema.europa.eu/


52 

 

Figure A  

STEP 1: Prepare for your injection  

a. Gather an alcohol swab, cotton ball/gauze pad, adhesive bandage and a sharps disposal 

container (Figure B) and place on a clean, flat, surface in a well-lit area. These supplies are not 

included in the TAKHZYRO packaging.  

 

 

Figure B  

b. Remove TAKHZYRO from refrigerator, open the carton box and remove the TAKHZYRO pre-

filled syringe from the tray.  

• Do not use the TAKHZYRO pre-filled syringe if the tamper evident seal is open or 

broken.  

• Before you prepare your injection, allow the pre-filled syringe to reach room 

temperature for at least 15 to 30 minutes.  

• Your medicine is sensitive to warm temperatures. Do not use external heat sources 

such as hot water to warm your TAKHZYRO pre-filled syringe.  

• Do not remove the needle cap until you are ready to inject.  

c. Wash your hands with soap and water. Dry your hands completely (Figure C).  

 

Figure C  

d. Check the expiration date on the label (Figure D).  



53 

• Do not use TAKHZYRO pre-filled syringe if the expiration date has passed.  

 

Figure D  

e. Visually inspect the TAKHZYRO pre-filled syringe for any damage and make sure the 

medicine is colourless to slightly yellow.  

• Do not use product if syringe is damaged – e.g., cracked syringe.  

• Do not administer if the medicine is discoloured, cloudy or has flakes or particles in it 

and call your Healthcare Provider.  

• You might see air bubbles in the TAKHZYRO pre-filled syringe. This is normal and 

will not affect your dose.  

STEP 2: Select and prepare your injection site  

a. The TAKHZYRO pre-filled syringe should be injected into your stomach (abdomen), thigh, or 

the back of the upper arm (the outer area of the upper arm is not recommended if you are 

injecting yourself) (Figure E).  

• It is important to rotate injection sites to keep skin healthy. Each new injection should 

be given at least 3 cm from the last site you used.  

• Do not inject into an area of your body where the skin is irritated, reddened, bruised, 

or infected.  

• The area you choose for injection should be at least 5 cm away from any scars or your 

belly button (navel).  

 

Figure E  

b. Clean the injection site with an alcohol swab and allow it to dry.  

• Do not fan or blow on the clean site.  



54 

• Do not touch this area again before giving your injection.  

c. Remove needle cap from the TAKHZYRO pre-filled syringe. Gently pull the needle cap straight 

off with one hand and firmly hold the middle of the TAKHZYRO pre-filled syringe with the 

other hand. Throw away the needle cap (Figure F).  

• Do not recap your TAKHZYRO pre-filled syringe.  

• Do not use the TAKHZYRO pre-filled syringe if it has been dropped without the 

needle cap on or if the needle looks damaged or bent.  

• Do not touch the needle or allow the needle to touch anything.  

 

Figure F  

STEP 3: Inject TAKHZYRO  

a. Grip the TAKHZYRO pre-filled syringe in one hand like a pencil. Avoid touching the needle or 

pushing on the plunger (Figure G).  

 

Figure G  

b. With your other hand, gently pinch about 3 cm fold of skin at the cleaned injection site.  

c. With one quick, short motion, push needle all the way into skin.  Make sure to keep the needle 

in place (Figure H).  



55 

 

Figure H 

d. Slowly push the plunger until all of the liquid is injected and the syringe is empty, then gently 

let go of your skin.  

e. Slowly withdraw needle while maintaining the syringe at the same angle (Figure I).  

 

Figure I  

f. Press cotton ball or gauze pad over injection site if needed and hold for 10 seconds.  

• Do not rub the injection site. You may have a minor bleeding. This is normal.  

• Cover injection site with an adhesive bandage if needed.  

g. Throw away your used TAKHZYRO pre-filled syringe.  

• Do not touch the needle.  

• To avoid a needle-stick injury, do not recap the needle.  

• Put your used TAKHZYRO pre-filled syringes in a sharps disposal container right away 

after use.  

• Do not reuse the TAKHZYRO pre-filled syringe and any of your injection supplies.  

Important: Always keep the sharps disposal container out of the reach of children.  

 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET