Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
How ANDEMBRY is given You or your caregiver must carefully read and follow the instructions in section 7, "Instructions for Use".
• Remove the pre-filled pen from the carton box and place it on a clean flat surface. • Wait 30 minutes for the medicine to reach room temperature if it was stored in the refrigerator (see Figure C). Injecting the medicine cold could
ANDEMBRY contains the active substance garadacimab. Andembry is a monoclonal antibody.
• ANDEMBRY is given as an injection under the skin ('subcutaneously'). • The injection can be given by either yourself or a caregiver • A doctor, pharmacist or nurse should show you how to inject ANDEMBRY 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. • For instructions on how to inject ANDEMBRY, see the "Instructions for use" at the end of the leaflet. If the pre-filled pen does not perform as intended, tell your doctor, pharmacist or nurse immediately.
be uncomfortable. • Do not try to speed up the warming process in any way. For example, do not warm it in a microwave, in hot water, or leave it in direct sunlight.
ANDEMBRY is a medicine used in patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.
In adolescent patients, administer ANDEMBRY under the supervision of an adult. Make sure you have been trained by your healthcare provider before you use this pre-filled pen for the first time.
What Hereditary Angioedema (HAE) is? HAE is a hereditary condition that often runs in families, but some people may not have a family history. It is a non-allergic disease that causes episodes of swelling and pain, known as HAE attacks.
30 mins
Parts of the pre-filled pen (see Figure A):
If you take more ANDEMBRY than you should Tell your doctor, pharmacist or nurse if you take too much ANDEMBRY.
These attacks can cause swelling and pain in different parts of the body including:
Continue to next sections to prepare and perform the injection.
Room temp.
expiration date (EXP)
If you miss a dose If you miss a dose of ANDEMBRY, inject your dose as soon as possible. If you are not sure when to inject ANDEMBRY after a missed dose, ask your doctor, pharmacist or nurse.
Before use:
• hands and feet • face, eyelids, lips or tongue • voice box (larynx), which may make breathing difficult • genitals • stomach and intestine
printed on label
If you stop using ANDEMBRY It is important that you keep injecting ANDEMBRY as instructed by your doctor even if you feel better. If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.
Figure C
Three types of HAE are known, based on the type of genetic defect and its effect on a protein that circulates in your blood, named C1 esterase inhibitor (C1-INH). A person can have low levels of C1-INH in the body (type I HAE), poorly functioning C1-INH (type II HAE), or HAE with normal functioning C1-INH (type III HAE). The last type is extremely rare. All three types of HAE can cause attacks. Some subcategories of normal C1-INH HAE may not respond to treatment with garadacimab. Talk to your doctor if you have any concerns about your medicine.
clear cap Do not remove until
plunger stopper viewing window (medicine visible)
ready to inject
Step 2. Check the expiry date
• Check the expiry date on the pre-filled pen label (see Figure D). • Do not use the pre-filled pen if the expiry date has passed. • Do not use the pre-filled pen if stored at room temperature for longer than 2 months. • If the expiry date has passed or if stored at room temperature for longer than 2 months, then safely dispose of the pre-filled pen and get a new one (see Step 11. Disposing of the pre-filled pen).
Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.
Do not use ANDEMBRY: If you are allegic to garadacimab or any of the other ingredients in this medicine (listed in section 6).
Read the following safety information:
• Keep the pre-filled pen in its original carton box until use, in order to protect it from light. • Do not remove the clear cap until you are ready to inject. • Do not put the clear cap back on the pre-filled pen after it has been removed because this could start the injection and cause injury. • The pre-filled pen contains 1 dose and is for single use only. Do not try to reuse the same pre-filled pen. • Do not use the pre-filled pen if the expiry date has passed. • The pre-filled pen is for subcutaneous (under the skin) injection only. • Do not use the pre-filled pen if it has been dropped, looks damaged, has cracks, or is leaking medicine. Throw away the pre-filled pen as described in Step 11 and use a new one. • Do not inject through clothing. • Do not touch or try to remove the gray needle shield at any time. • Keep ANDEMBRY and all medicines out of the sight and reach of children.
Warnings and precautions
• Talk to your doctor, pharmacist or nurse before using ANDEMBRY. • If you have a severe allergic reaction to ANDEMBRY with symptoms such as hives, tight chest, difficulty breathing, wheezing, hypotension or anaphylaxis, tell your doctor, pharmacist or nurse immediately. • Treat a hereditary angioedema attack with your regular rescue medicine without taking additional doses of ANDEMBRY.
Instructions for use ANDEMBRY (garadacimab) [g-AR-ahd-ah-see-mah-b]
Pre-filled pen injection, for subcutaneous use
Preparing for an Injection
How much ANDEMBRY is given The recommended dose of ANDEMBRY is an initial loading dose of 400 mg administered subcutaneously as two 200 mg injections on the first day of treatment followed by a monthly dose of 200 mg.
Do not remove the clear pre-filled pen cap until immediately before the injection.
Important:
Step 1. Let the pre-filled pen reach room temperature
This pre-filled pen works differently than other injection devices. Read the Instructions for use carefully before using it, and each time you get a new pre-filled pen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have a severe allergic reaction to ANDEMBRY with symptoms such as hives, tight chest, difficulty breathing, wheezing, hypotension or anaphylaxis, tell your doctor, pharmacist or nurse immediately.
gray needle shield (Caution: needle inside. Do not touch)
metal part inside
How ANDEMBRY works C1-INH regulates a process in the body that controls the production of an inflammatory substance called bradykinin. Overproduction of bradykinin causes swelling and inflammation in people with HAE.
clear cap
After use:
Tell your doctor, pharmacist or nurse if you notice any of the following side effects.
The active substance in ANDEMBRY, garadacimab, blocks the activation of a protein known as factor XIIa (FXIIa), which is involved in stimulating bradykinin production. By blocking FXIIa activity, garadacimab reduces the level of bradykinin, thereby decreasing HAE attacks.
Common (may affect up to 1 in 10 people)
LOT: EXP: MMMYYYY
After use, gray needle shield will lock
• Injection site reactions including redness, bruising, and itchiness. • Headache • Abdominal pain
yellow plunger filling viewing window when injection is complete
Figure A
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 outer carton and label after EXP. The expiry date refers to the last day of that month.
Keeping a record Every time you have a dose of ANDEMBRY, write down the name and batch number of the medicine. This is so that you keep a record of the batches used.
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.
Figure D
Laboratory tests Tell your doctor if you are using ANDEMBRY before you have laboratory tests to measure how well your blood is clotting. This is because ANDEMBRY may interfere with some laboratory tests, leading to inaccurate results.
The pre-filled pen may be stored at room temperature (up to 25°C) for a single period of up to 2 months, but not beyond the expiry date.
Contact your healthcare provider if you have any questions.
How should I store ANDEMBRY?
Do not return ANDEMBRY to refrigerated storage after storage at room temperature.
Children and adolescents ANDEMBRY is not recommended for use in children under 12 years of age. This is because it has not been studied in this age group.
• Store in a refrigerator, between 2°C to 8°C in its original carton box until use, in order to protect from light. • Do not freeze. If the pre-filled pen has been frozen, do not use the pre-filled pen even if it is thawed. • Take the pre-filled pen out of the refrigerator 30 minutes before use, allowing it to reach room temperature. • If needed, for example when traveling, the pre-filled pen may be stored at room temperature, up to 25°C for up to 2 months. • If you decide to store the pre-filled pen at room temperature, you must: o Write the date you first remove the pre-filled pen from the refrigerator in the space provided on the carton box to help you keep track of how long it has been stored at room temperature. o Do not put the pre-filled pen back in the refrigerator after it has reached room temperature. o Throw away the pre-filled pen if it has been stored at room temperature for longer than 2 months (see Step 11. Disposing of the pre-filled pen).
Do not use this medicine if you notice signs of deterioration such as particles or changed colour of the solution.
Other medicines and ANDEMBRY Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. ANDEMBRY is not known to affect other medicines or be affected by other medicines.
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.
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 ANDEMBRY. There is limited information on the safety of ANDEMBRY use during pregnancy and breast-feeding. Your doctor will discuss with you the risks and benefits of taking this medicine.
What ANDEMBRY contains - The active substance is garadacimab. Each pre-filled pen contains 200 mg of garadacimab in 1.2 ml solution. - The other ingredients are L-histidine, L-arginine monohydrochloride, L-proline, polysorbate 80 and water for injections – see section 2.
REG-9021-01_LFT ANDEMBRY 200MG PFP REG-9021-01_LFT ANDEMBRY 200MG PFP .01.2025 10:55:55 06.01.2025 10:55:55
Step 3. Inspect the pre-filled pen and the medicine
Step 6. Prepare the injection site
Step 9. Inject the medicine (see Figure K)
• Check the pre-filled pen for damage. • Check the medicine through the viewing window of the pre-filled pen (see Figure E). • It is normal to see air bubbles, do not try to remove the air bubbles. • The medicine should be brownish-yellow to yellow and may appear slightly opalescent to clear. • Do not use the pre-filled pen, safely dispose and a get a new one (see Step 11. Disposing of the pre-filled pen) if:
• Clean the injection site with an alcohol pad (see Figure H). • Let your skin dry on its own. Do not fan or blow on the skin area that you cleaned. • Do not touch the cleaned area before injecting.
You must read all of step 9 before injecting. The injection may take up to 15 seconds. To ensure you receive a full dose you must keep the pre-filled pen firmly pressed against your pinched skin until: – The yellow plunger has stopped moving and filled the viewing window, and – 5 seconds have passed after the 2nd "click."
o The medicine is discolored or contains particles o The pre-filled pen looks damaged or has cracks o The pre-filled pen is leaking o The pre-filled pen has been dropped on a hard surface, even if it does not look damaged
Press the gray needle shield down firmly against the pinched skin to start the injection and keep pressing down until all the steps below are complete.
Press down to start Keep pressing down Keep pressing down for 5 more seconds
Watch window turn yellow
First 'Click'
Second
'Click'
Figure H
Press down to start the injection and listen for a first 'click'.
Keep pressing the pre-filled pen down and watch the viewing window.
Keep pressing the pre-filled pen down for 5 more seconds to make sure you get the full dose.
Injecting the medicine with the pre-filled pen
Complete the injection without stopping. Read all steps first before beginning. Do not remove the clear cap until you are ready to inject.
• The first "click" means the injection has started. • The yellow plunger will start moving in the viewing window.
• The window will turn yellow and • You will hear a second 'click'.
Step 7. Remove the clear cap and dispose of the cap
Keep pressing the pre-filled pen down.
Keep pressing the pre-filled pen down.
• Hold the pre-filled pen with one hand and pull the clear cap straight off with the other hand. • Do not twist the clear cap, (see Figure I). If you cannot remove the clear cap, ask a caregiver for help or contact your healthcare provider. • The clear cap has a metal part inside, this is normal. • Do not put the clear cap back on after it has been removed, because this could start the injection and cause injury. • Dispose of the clear cap in a sharps container or closed puncture-resistant container.
Figure E
Figure K
Choose and prepare an injection site
• Do not remove the pre-filled pen until the yellow plunger has stopped moving and completely filled the viewing window, and 5 seconds has passed after the second "click." • Do not remove, tilt, or rotate the pre-filled pen during the injection.
Step 4. Clean your hands
• Wash your hands well with soap and water (see Figure F).
Important:
• Do not touch the gray needle shield of the pre-filled pen to avoid injury. • Do not put the pre-filled pen down after removing the clear cap.
Step 10. Release the pinch and remove the pre-filled pen
• Release the pinch and remove the pre-filled pen from the skin at a 90° angle (see Figure L). • As the pre-filled pen is lifted from the skin, the gray needle shield returns to the original (before use) position, and will lock into place, covering the needle.
Gray needle shield Do not touch
Figure F
Step 5. Select the injection site
• Inject into the thigh or belly (abdomen) area, but stay 2 cm away from the belly button (navel) (see Figure G) • If somebody else (caregiver) gives you the injection, they can also use the upper arm. Do not try to inject into the upper arm yourself. • Change (rotate) your injection site with each injection. Do not inject in the same place multiple times if the skin is damaged. • Do not inject into the belly button, moles, scars or bruises, or into areas where the skin is tender, red, hard, or injured.
Clear cap
Figure I
Figure L
Caregiver injection sites
Self-injection
Step 8. Pinch the skin and place the pre-filled pen on the injection site Immediately after removing the clear cap, complete the following steps without stopping:
sites
Important: if you think that you have not received the full dose contact your healthcare provider right away.
• Gently pinch the area of cleaned skin around the injection site and hold the area firmly until the injection is complete (see Figure J). • Place the pre-filled pen at a 90° angle on the cleaned injection site (see Figure J). • Make sure you can see the viewing window.
• If there is a little bleeding at the injection site, you can press a cotton ball or gauze over the injection site. • Do not rub the injection site. • If needed, you may cover the injection site with a small adhesive bandage.
Figure G
Material Number | Component Description:
REG-9021-01_LFT ANDEMBRY 200MG PFP UK_D6 Artwork Author: Svenja Lang Specification Number: n/a Additional comments: 755 x 456 mm Colours:
Figure J
Technical Colours (indication only – not to be printed):
Die Cut
Disposal
Step 11. Disposing of the pre-filled pen
• Do not try to reuse the pre-filled pen. • After injecting your dose, dispose of the pre-filled pen into a sharps container or closed puncture-resistant container (see Figure M).
sharps Container
Figure M
• If you do not have a sharps disposal container or a closed puncture resistant container, you may use a household container that is:
o made of heavy-duty plastic o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out o upright and stable during use o leak-resistant o properly labeled to warn of hazardous waste inside the container • When your sharps container is almost full, you will need to follow your local guidelines for its correct disposal. • Do not dispose of your used sharps container in your household trash unless your local guidelines permit this. • Do not recycle your used sharps container.
Step 12. Keep track of your treatment
• If required by your physician, record your injection in a diary to help keep track of your medicine.
REG-9021-01_LFT ANDEMBRY 200MG PFP REG-9021-01_LFT ANDEMBRY 200MG PFP .01.2025 10:55:57 06.01.2025 10:55:57
Andembry 200 mg Solution for injection in pre-filled pen comes as solution containing 200 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Andembry 200 mg Solution for injection in pre-filled pen is garadacimab.
This leaflet reproduces the patient information leaflet approved for Andembry 200 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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
ANDEMBRY is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with HAE.
Posology
The recommended dose in adults and adolescents aged 12 years and older is an initial loading dose of 400 mg ANDEMBRY administered subcutaneously as two 200 mg injections on the first day of treatment followed by a monthly dose of 200 mg garadacimab.
Consideration should be given to discontinuing treatment in patients who have shown insufficient reduction in attacks after 3 months of treatment, in particular in patients with normal C1-INH activity (nC1-INH) (see sections 4.4 and 5.1)
ANDEMBRY is not intended for treatment of acute HAE attacks (see section 4.4)
Missed doses
If a dose of ANDEMBRY is missed, the patient should be instructed to administer the dose as soon as possible.
Special populations
Elderly
No dose adjustment is required for patients above 65 years of age (see section 5.2).
Hepatic impairment
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Renal impairment
No dose adjustment is required in patients with renal impairment (see section 5.2).
Paediatric population
The safety and efficacy of garadacimab in children less than 12 years have not been established.
No data are available.
Method of administration
ANDEMBRY is intended for subcutaneous administration only.
Each ANDEMBRY pre-filled pen is intended for single use only (see section 6.6).
The injection should be restricted to the following injection sites: the abdomen, the thighs and the upper outer arms (see section 5.2). Rotation of the injection site is recommended.
ANDEMBRY may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
No dedicated drug-drug interaction studies have been conducted in humans. Garadacimab has only been studied as a monotherapy and not in combination with other products indicated for long-term prophylaxis of HAE.
Based on population pharmacokinetic analyses, the use of analgesic, antibacterial, antihistamine, anti-inflammatory and anti-rheumatic medications had no effect on the PK of garadacimab. For breakthrough HAE attacks, use of rescue medications such as plasma-derived and recombinant C1-INH or icatibant had no effect on the PK of garadacimab.
Pregnancy
There are no or limited data (less than 300 pregnancy outcomes) from the use of garadacimab in pregnant women. A pre- and postnatal development study conducted in pregnant rabbits revealed no evidence of harm to the developing fetus. The study was conducted at subcutaneous doses resulting in exposures of approximately 53 times the exposure achieved (on an AUC basis) at the recommended human dose revealed no evidence of harm to the developing fetus (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of garadacimab during pregnancy.
Breast-feeding
It is unknown whether garadacimab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, and decrease to low concentrations soon afterwards. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ANDEMBRY and any potential adverse effects on the breastfed infant from ANDEMBRY or the underlying condition.
Fertility
Effect on fertility has not been evaluated in humans. Garadacimab had no effect on male or female fertility in rabbits (see section 5.3).
ANDEMBRY has no or negligible influence on the ability to drive and use machines.
There is no available information to identify potential signs and symptoms of overdose.
If symptoms should occur, symptomatic treatment is recommended.
Ask anything about Andembry 200 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.
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