Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
TAKHZYRO 300 mg solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lanadelumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
TAKHZYRO contains the active substance lanadelumab. What TAKHZYRO is used for TAKHZYRO is a medicine used in patients 2 years and older to prevent angioedema attacks, in patients with hereditary angioedema (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. 2.
What you need to know before you take it
e TAKHZYRO
Do not use TAKHZYRO 1
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 heartbeat, 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 2 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 no or negligible influence on the ability to drive and use machines. TAKHZYRO contains sodium The medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially 'sodium-free'. 3.
How to take it
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.
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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 For adults and adolescents 12 to less than 18 years of age: •
The recommended starting dose is 300 mg lanadelumab every 2 weeks. If you have not had an attack for a long period, your doctor may change the dose to 300 mg lanadelumab every 4 weeks, especially if you have a low body weight.
•
In patients with a body weight less than 40 kg, a starting dose of 150 mg lanadelumab every 2 weeks may also be considered. If you have not had an attack for a long period, your doctor may change the dose to 150 mg lanadelumab every 4 weeks.
For children 2 to less than 12 years of age, the recommended dose is based on body weight: Body Weight (kg)
Recommended Starting Dose
Dose Adjustment
A dose increase to 150 mg lanadelumab every 3 10 to less than 20 150 mg lanadelumab every 4 weeks may be considered kg weeks in patients with insufficient control of attacks A dose reduction to 150 mg lanadelumab every 4 20 to less than 40 150 mg lanadelumab every 2 weeks may be considered kg weeks in patients who are stably attack free on treatment A dose reduction to 300 mg lanadelumab every 4 40 kg or more 300 mg lanadelumab every 2 weeks may be considered weeks in patients who are stably attack free on treatment –
For patients with a body weight of 20 to less than 40 kg who have not had an attack for a long period, the doctor may allow your child or the child you are caring for to continue with the same dose when reaching 12 years of age.
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 for patients 12 years and over. The injection can be given by either healthcare provider or caregiver for patients 2 to less than 12 years of age.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. 3
•
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 The next dose scheduled may need to be adjusted based on the intended dosing frequency to ensure
- at least 10 days between doses for patients on every 2 weeks dosing schedule,
- at least 17 days between doses for patients on every 3 weeks dosing schedule,
- at least 24 days between doses for patients on every 4 weeks dosing schedule. 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.
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 United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
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 and on the carton 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. When one pre-filled syringe from a multi-pack is removed from refrigeration, return the remaining pre-filled syringes to the refrigerator until future use when needed. 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"
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 Marketing Authorisation Holder Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 5
50-58 Baggot Street Lower Dublin 2 D02 HW68 Ireland Tel: +44(0) 3333 000181 E-mail: [email protected] Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HW68 Ireland Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 Ireland This leaflet was last revised in 04/2025
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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, needlebased injection device intended for subcutaneous administration of the drug product by healthcare providers, caregivers, or by self-administration (for patients 12 years and older) Storing TAKHZYRO • • • • • • •
Store the TAKHZYRO pre-filled syringe 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. When one pre-filled syringe from a multi-pack is removed from refrigeration, return the remaining pre-filled syringes to the refrigerator until future use when needed. Store TAKHZYRO in the original carton to protect the pre-filled syringe from light. Throw away (discard) the TAKHZYRO pre-filled syringe if it has been kept out of the refrigerator, frozen, or not kept in the original carton protected 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).
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Figure A: TAKHZYRO pre-filled syringe STEP 1: Prepare for your injection a.
Gather an alcohol swab, cotton ball or 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
Figure B: Supplies •
b. Remove TAKHZYRO pre-filled syringe from refrigerator.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 minutes.
•
Your medicine is sensitive to warm temperatures. Do not use heat sources such as a microwave or hot water to warm your TAKHZYRO pre-filled syringe.
•
Do not remove the needle cap until you are ready to inject.
c . Open the carton. Hold the syringe barrel and remove the TAKHZYRO pre-filled syringe from the tray (Figure C). 7
Figure C: Remove pre-filled syringe d. Wash your hands with soap and water (Figure D). Dry your hands completely Check the expiration date on the label (Figure D). •
Do not touch any surface or body part after washing your hands before the injection.
Figure D : Wash hands
e. Check the expiration date (EXP) on the syring barrel (Figure E). Do not use the TAKHZYRO pre-filled syringe if the expiration date has passed. If the TAKHZYRO pre-filled syringe is expired, throw it away (discard) in a sharps container and contact your healthcare provider.
Figure E: Location of expiration date
f.
Inspect the TAKHZYRO pre-filled syringe for any damage and make sure the medicine is colourless to slightly yellow (Figure F) •
Do not use product if syringe is damaged – e.g., cracked syringe. 8
•
Do not use the TAKHZYRO pre-filled syringe if the medicine is discoloured, cloudy or has flakes or particles in it.
•
You might see air bubbles in the TAKHZYRO pre-filled syringe. This is normal and will not affect your dose.
If you cannot use the pre-filled syringe, contact your healthcare provider.
Figure F: Inspect the pre-filled syringe
STEP 2: Select and prepare your injection site a.
The TAKHZYRO pre-filled syringe should be injected into the following sites only (Figure G): o stomach area (abdomen) o thighs o upper arms (only if healthcare provider or caregiver is giving you the injection) •
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).
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Figure G: Injection sites Important: Rotate injection sites to keep skin healthy. Each new injection should be given at least 3 cm from the last site you used. b.
Clean the injection site with an alcohol swab and allow it to dry completely (Figure H). •
Do not fan or blow on the clean site.
•
Do not touch this area again before giving your injection.
Figure H: Clean injection site
c. Firmly hold the middle of the TAKHZYRO pre-filled syringe with one hand and with the other hand, gently pull the needle cap straight off. Throw away the needle cap in your trash or in your sharps container (Figure FI). •
Do not touch or push the plunger rod until you are ready to inject.
•
Do not recap your TAKHZYRO pre-filled syringe to avoid a needle stick injury.
•
Do not use the TAKHZYRO pre-filled syringe if it has been dropped without the needle cap
•
Do not use the TAKHZYRO pre-filled syringe if the needle looks damaged or bent.
•
Do not touch the needle or allow the needle to touch anything.
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Figure I: Remove the needle cap STEP 3: Inject TAKHZYRO a.
Grip the TAKHZYRO pre-filled syringe in one hand like a pencil Figure J). Avoid touching the needle or pushing on the plunger.
Figure J: Grip pre-filled syringe b.
With your other hand, gently pinch about 3 cm fold of skin at the cleaned injection site. •
Keep pinching until the injection is complete and the needle is removed (Figure K).
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Figure K: Pinch 3 cm fold of skin c.
With one quick, short motion, push needle all the way into skin at a 45-to-90 degree angle. . Make sure to keep the needle in place (Figure L).
Important: Inject directly into the fatty layer under the skin (subcutaneous injection).
Figure L: Insert the needle d.
Slowly push the plunger rod all the way down until it stops (Figure M).
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Figure M: Push the plunger rod all the way down Important: Do not withdraw the needle until all of the medicine is injected and the syringe barrel is empty. When the injection is complete, you will see the stopper at the bottom of the syringe barrel (Figure N).
Figure N: Stopper at the bottom of the syringe barrel e. Slowly withdraw needle while maintaining the syringe at the same angle. Gently release fold of skin.). 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 (dispose) your used TAKHZYRO pre-filled syringe. • • • • •
Put your used TAKHZYRO pre-filled syringe in a sharps disposal container right away after use (Figure O) Do not recap the needle to avoid needle stick injury. Do not reuse the TAKHZYRO pre-filled syringe and any of your injection supplies Put your used TAKHZYRO pre-filled syringes in a sharps disposal container right away after use. Do not touch the needle
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Figure O: Dispose in a sharps container Important: Always keep the sharps disposal container out of the reach of children.
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Frequently asked questions about TAKHZYRO 300 mg solution for injection in pre-filled syringe
How do I take TAKHZYRO 300 mg solution for injection in pre-filled syringe?
TAKHZYRO 300 mg solution for injection in pre-filled syringe comes as injection containing 300mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in TAKHZYRO 300 mg solution for injection in pre-filled syringe?
The active substance in TAKHZYRO 300 mg solution for injection in pre-filled syringe is lanadelumab.
Are there equivalent medicines to TAKHZYRO 300 mg solution for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: TAKHZYRO 300 mg solution for injection in pre-filled pen. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for TAKHZYRO 300 mg solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get TAKHZYRO 300 mg solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: lanadelumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 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
Adults and Adolescents 12 to less than 18 years of age
The recommended starting dose is 300 mg lanadelumab every 2 weeks. In patients who are stably attack free on treatment, a dose reduction to 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.
In patients with a body weight less than 40 kg, a starting dose of 150 mg lanadelumab every 2 weeks may also be considered. In patients who are stably attack free on treatment, a dose reduction to 150 mg lanadelumab every 4 weeks may be considered.
Children 2 to less than 12 years of age
The recommended dose of lanadelumab for children 2 to less than 12 years of age is based on body weight (see table below).
Patients with a body weight of 20 to less than 40 kg who are stably attack free may continue with the same dose when reaching 12 years of age.
Table 1. Recommended dose in children 2 to less than 12 years of age
Body Weight (kg)
Recommended Starting Dose
Dose Adjustment
10 to less than 20 kg
150 mg lanadelumab every 4 weeks
A dose increase to 150 mg lanadelumab every 3 weeks may be considered in patients with insufficient control of attacks
20 to less than 40 kg
150 mg lanadelumab every 2 weeks
A dose reduction to 150 mg lanadelumab every 4 weeks may be considered in patients who are stably attack free on treatment
40 kg or more
300 mg lanadelumab every 2 weeks
A dose reduction to 300 mg lanadelumab every 4 weeks may be considered in patients who are stably attack free on treatment
Consideration should be given to discontinuing treatment in patients with HAE with normal C1 esterase inhibitor (nC1-INH) who have shown insufficient reduction in attacks after 3 months of treatment (see section 4.4 and 5.1).
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 or caregiver should be instructed to administer the dose as soon as possible. The subsequent dosing schedule may need adjustment according to the intended dosing frequency to ensure:
• at least 10 days between doses for patients on every 2 weeks dosing regimen,
• at least 17 days between doses for patients on every 3 weeks dosing regimen,
• at least 24 days between doses for patients on every 4 weeks dosing regimen.
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 2 years have not been established. No data are available.
Method of administration
TAKHZYRO is intended for subcutaneous (SC) administration only.
Each TAKHZYRO 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.
For adults and adolescents (12 to less than 18 years of age), TAKHZYRO may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional.
For children (2 to less than 12 years of age), TAKHZYRO should only be administered by a caregiver after training on subcutaneous 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
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 is limited clinical data on the use of lanadelumab in HAE patients with normal C1-INH (see section 5.1).
Patients with HAE nC1-INH having mutations that are not associated with the kallikrein-kinin system (KKS) pathway are not expected to respond to TAKHZYRO. It is recommended to perform genetic testing, if available, according to the current HAE guidelines and to discontinue the treatment if clinical response is not observed (see section 4.2 and 5.1).
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 pre-filled syringe, 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 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 no or negligible influence on the ability to drive and use machines.
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 2 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 2 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 2: 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.
Safety data available from the HELP study extension are consistent with the safety data from the HELP study (described in Table 2).
Paediatric population
The safety of TAKHZYRO 300 mg/2 ml was evaluated in a subgroup of 23 subjects 12 to less than 18 years of age in the HELP and HELP study extension. In the SPRING study, safety of TAKHZYRO was also evaluated at 150 mg/1 ml in 21 subjects 2 to less than 12 years of age (see section 5.1). No subject below the age of 3.5 years was receiving lanadelumab in the study. No new adverse reactions were identified. Safety and tolerability results for paediatric subjects were consistent with overall study results for all subjects.
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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
💬 Ask about this leaflet
Ask anything about TAKHZYRO 300 mg solution for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.