300 mg solution for injection, solution in the vial
lanadelumab
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 over 12 years of age to prevent angioedema attacks, in patients with HAE.
What hereditary angioedema (HAE) is
HAE is a hereditary disease. In this disease, there is not enough of a protein called “C1 inhibitor” in the blood, or the C1 inhibitor does not work properly. This leads to too much plasma kallikrein, which in turn produces higher levels of bradykinin in the blood. Too much bradykinin leads to symptoms of HAE such as swelling and pain in
- hands and feet
- eyes, eyelids, lips, or tongue
- the larynx, which can make breathing difficult
- the 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 the blood and prevents the symptoms of HAE.
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 serious allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or fast heartbeat, talk to your doctor, pharmacist or nurse immediately
Note
It is strongly recommended that you write down the name of the medicine and the batch number each time you take a dose of TAKHZYRO. In this way, you can keep track of which production batches were used.
Laboratory tests
Tell your doctor if you are using TAKHZYRO before having laboratory tests to measure how well your blood clots. This is because TAKHZYRO in the blood can interfere with certain laboratory tests, leading to incorrect results.
Children and young people
TAKHZYRO is not recommended for children under 12 years of age. This is because the drug 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 does not affect other medicines and is not affected by other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you start using TAKHZYRO. There is limited information on the safety of TAKHZYRO when used during pregnancy and breastfeeding. For safety reasons, it is recommended to avoid the use of lanadelumab during pregnancy and breastfeeding. Your doctor will discuss with you the risks and benefits of taking this medicine.
Driving ability and use of machinery
This medicine has a negligible effect on the ability to drive and use machines.
TAKHZYRO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, i.e. it is almost ‘sodium-free’.
How to use TAKHZYRO
TAKHZYRO is supplied in single-use vials as a ready-to-use solution. Your treatment will be started and managed under the supervision of a doctor experienced in treating patients with HAE.
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure or if you have further questions about the use of this medicine.
How much TAKHZYRO you should use
The recommended starting dose is 300 mg every two weeks. If you have not had a seizure for a long period, your doctor may change the dose by one to 300 mg every 4 weeks, especially if you have low body weight.
How TAKHZYRO is injected
If you inject TAKHZYRO yourself or if your healthcare provider injects the medicine, you or your healthcare provider must carefully read and follow the instructions in Section 7, “Instructions for Use”.
- TAKHZYRO is intended for injection under the skin (“subcutaneous injection”).
- Injection one can either be given by yourself or your healthcare provider.
- Your doctor, pharmacist, or nurse should show you how to prepare and inject TAKHZYRO correctly 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 stomach (abdomen), thigh, or upper arm.
- Inject the medicine in a new place each time.
- Each vial of TAKHZYRO should be used only once.
If you use too much TAKHZYRO
Talk to your doctor, pharmacist, or nurse if you have used 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 doses. If you are not sure when to inject TAKHZYRO after a missed dose, ask your doctor, pharmacist, or nurse.
If you stop using TAKHZYRO
You must continue to inject TAKHZYRO as directed by your doctor, even if you feel better.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have a serious allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing or fast heartbeat, 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 users):
- Reactions where an injection is given – symptoms can be a pain, redness, bruising, discomfort, swelling, bleeding, itching, hardening of the skin, tingling, warmth, and rash.
Common (may affect up to 1 in 10 users)
- Allergic reactions with e.g. itching, discomfort, and tingling in the tongue
- Dizziness, feeling faint
- Raised skin rash
- Muscle pain
- Blood tests showing changes in the liver
How to store TAKHZYRO
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store the vial in the outer carton. Light sensitive.
Vials can be stored at a temperature below 25 °C for a single period of 14 days, but not after the expiry date. Do not return TAKHZYRO to the refrigerator after storage at room temperature.
Do not use this medicine if you see e.g. particles in the vial or a change in color of the solution in the vial.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is lanadelumab. Each vial (with 2 ml of solution) contains 300 mg of lanadelumab.
- Other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80, and water for injections – see section 2 “TAKHZYRO contains sodium”
Appearance and package sizes of the medicine
TAKHZYRO is supplied as a clear, colorless to slightly yellow solution for injection in a glass vial.
TAKHZYRO is available as a single-use pack containing a 2 ml vial and as a multipack with 2 or 6 cartons, where each carton contains 1 vial.
Not all pack sizes may be marketed.
Each pack also contains the following items:
- Empty 3 ml syringe
- 18 G needle with a blunt tip for use in the injection vial
- 27 G x 13 mm needle with sharp tip for administration ( injection )
Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
Phone: +80066838470
Email: medinfoEMEA@takeda.com
Manufacturer
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
Ireland
Shire Pharmaceuticals Ireland Limited
Blocks 2 & 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland