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 pen
⚠ 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 pen, that is to say essentially 'sodium-free'. 3.
How to take it
TAKHZYRO
TAKHZYRO is provided in single-use pre-filled pens 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. 2
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. However, the 150 mg pre-filled syringe must be used because the 300 mg pre-filled pen cannot be used to administer 150 mg lanadelumab. For children 2 to less than 12 years of age: The recommended dose is based on body weight and should only be administered via a prefilled syringe or vial. The pre-filled pen has not been studied in children 2 to less than 12 years of age and therefore should not be used.
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 older. 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. Administer TAKHZYRO with the pre-filled pen 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 pen 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 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. 3
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 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 statedon 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 pen Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light. Pre-filled pens 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 pen from a multi-pack is removed from refrigeration, return the remaining prefilled pens 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 pen 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. 4
6.
Contents of the pack and other information
What TAKHZYRO contains • •
The active substance is lanadelumab. Each pre-filled pen 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 pen. TAKHZYRO is available as: • a single pack containing one 2 ml pre-filled pen in a carton • a single pack containing two 2 ml pre-filled pens in a carton • in multipacks comprising 3 cartons, each carton containing two 2 ml pre-filled pens. 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 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 02/2025
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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 pen 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 (for patients 12 years and older). Storing the TAKHZYRO pre-filled pen • • • • • • •
Store the TAKHZYRO pre-filled pen in the refrigerator at 2 °C to 8 °C. Do not freeze. Store TAKHZYRO in the original carton to protect the pre-filled pen from light. Pre-filled pens removed from refrigeration should be stored below 25 °C and used within 14 days. Do not return TAKHZYRO to refrigerated storage after leaving the pen out at room temperature. After removing one pre-filled pen from a multi-pack, return the remaining pre-filled pens to the refrigerator in the original carton until future use when needed. Throw away (dispose of) the TAKHZYRO pre-filled pen if it has been kept out of the refrigerator for more than 14 days, 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.
The TAKHZYRO pre-filled pen (Figure A) is for single use only. TAKHZYRO pre-filled pen before and after use
Figure A Prepare for your injection Step 1 – Prepare your pre-filled pen Remove the TAKHZYRO pre-filled pen carton from the refrigerator 30 minutes before injecting. • Do not use if the seal on the carton is open or broken. • 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 pen.
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Step 2 – Gather supplies Gather an alcohol swab, cotton ball or gauze pad, adhesive bandage, and sharps disposal container (Figure B) and place the supplies on a clean, flat, surface in a well-lit area. These supplies are not included in the TAKHZYRO pre-filled pen carton.
Figure B Step 3 – Remove pre-filled pen Open the carton. Hold the pen body and remove the TAKHZYRO pre-filled pen from the tray (Figure C). • Do not remove the protective cap until you are ready to inject. • Do not touch or push the needle cover until you are ready to inject.
Step 4 – Wash hands
Figure C
Wash your hands with soap and water (Figure D). Dry your hands completely. • Do not touch any surface or body part after washing your hands before the injection.
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Figure D Step 5 – Check expiration date Check the expiration date (EXP) on the pen body (Figure E). •
Do not use the TAKHZYRO pre-filled pen if the expiration date has passed. If the TAKHZYRO pre-filled pen is expired throw it away (dispose of) in a sharps disposal container and contact your healthcare provider.
Figure E Step 6 – Inspect TAKHZYRO Inspect the TAKHZYRO pre-filled pen for any damage. Check the viewing window (Figure F) and make sure the medicine is colourless to slightly yellow. • Do not use the TAKHZYRO pre-filled pen if the pen is damaged or cracked. • Do not use the TAKHZYRO pre-filled pen if the medicine is discoloured, cloudy, or has flakes or particles in it. • You may see air bubbles in the TAKHZYRO pre-filled pen viewing window. This is normal and will not affect your dose. If you cannot use the pre-filled pen, contact your healthcare provider.
Figure F
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Select and prepare your injection site Step 7 – Select your injection site TAKHZYRO should be injected into the following sites only (Figure G for self-injection and Figure H for caregiver injection): stomach area (abdomen) thighs upper arms (only if a healthcare provider or caregiver is giving you the injection) • Do not inject into an area of your body where the skin is irritated, red, bruised, or infected. • The area you choose for injection should be at least 5 cm away from any scars or your belly button (navel). Important: Rotate injection sites to keep skin healthy. Each new injection should be given at least 2.5 cm from the last site you used.
Figure G
Figure H
Step 8 – Clean injection site Clean the injection site with an alcohol swab and allow it to dry completely (Figure I). • Do not fan or blow on the clean site. • Do not touch the clean site again before giving your injection.
Figure I Step 9 – Remove protective cap Firmly hold the middle of the TAKHZYRO pre-filled pen with one hand, and with the other hand, pull the protective cap straight off (Figure J). • The needle is protected by the needle cover. • You may see a few drops of liquid come out of the needle. This is normal and will not affect your dose of TAKHZYRO. • Your TAKHZYRO pre-filled pen is ready to inject after the protective cap is removed. 9
• •
Do not touch or push the needle cover until you are ready to inject. Do not recap your TAKHZYRO pre-filled pen.
Figure J Step 10 – Dispose of protective cap Throw away (dispose of) the protective cap in your trash or in your sharps disposal container (Figure K). • Do not recap the pen to avoid a needlestick injury.
Figure K Inject TAKHZYRO Step 11 – Hold the TAKHZYRO pre-filled pen and pinch the skin Hold the TAKHZYRO pre-filled pen in one hand so that you can see the viewing window while giving the injection (Figure L). With your other hand, gently pinch a 2.5 cm fold of skin at the cleaned injection site (Figure M). • Keep pinching until the injection is complete and the needle is removed. • Do not press the needle cover against your skin until you are ready to give the injection.
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Figure L
Figure M
Step 12 – Place pen on injection site Place your TAKHZYRO pre-filled pen on your skin at a 90-degree angle to the chosen injection site (Figure N). • Do not push down on the pen until you are ready to inject. • Hold your pen so you can see the viewing window.
Figure N Step 13 – Inject TAKHZYRO Firmly press your pen straight down and hold. This will insert the needle and start your injection (Figure O). Your injection may take up to 25 seconds. • You will hear a "click" sound when the injection starts. • There will be a second "click" – this is not the end of the injection. • Continue to hold down with constant pressure, until the viewing window is completely filled with the colour magenta. • Before you remove the pen from your skin, confirm that the viewing window is filled with magenta. This means you have received your full dose (Figure O). • The grey plunger is still visible in the viewing window after the injection is complete. This is normal and will not affect your dose. • If the viewing window did not fill completely with magenta, contact your healthcare provider.
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Figure O Step 14 – Remove pen Slowly lift your pen straight away from the injection site. The needle cover will be covering all of the needle (Figure P). • Release the fold of skin. • Do not rub the injection site. There may be a small amount of blood where you injected. This is normal. • Press a cotton ball or gauze pad over the injection site and cover with an adhesive bandage, if needed.
Figure P Throw away (dispose of) the TAKHZYRO pre-filled pen Step 15 – Dispose in a sharps disposal container Put your used TAKHZYRO pre-filled pen in a sharps disposal container right away after use (Figure Q). • Do not recap the pen to avoid a needle-stick injury. • Do not reuse the TAKHZYRO pre-filled pen or any of your injection supplies. • Do not throw away (dispose of) the TAKHZYRO pre-filled pen in your household trash. • Do not touch the needle. Important: Always keep the sharps disposal container out of the reach of children.
Figure Q
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Frequently asked questions about TAKHZYRO 300 mg solution for injection in pre-filled pen
How do I take TAKHZYRO 300 mg solution for injection in pre-filled pen?
TAKHZYRO 300 mg solution for injection in pre-filled pen 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 pen?
The active substance in TAKHZYRO 300 mg solution for injection in pre-filled pen is lanadelumab.
Are there equivalent medicines to TAKHZYRO 300 mg solution for injection in pre-filled pen?
Medicines with the same active substance, strength and form include: TAKHZYRO 300 mg solution for injection in pre-filled syringe. 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 pen, 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 pen 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) and should only be administered via a pre-filled syringe or vial.
The pre-filled pen has not been studied in children 2 to less than 12 years of age and therefore should not be used.
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 pen 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 pen, 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 pen. 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.