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.
Icatibant 30 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 Icatibant acetate 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
Icatibant contains the active substance icatibant. This medicine is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older. In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea. Icatibant blocks the activity of bradykinin and therefore ends the further progression of the symptoms. 2.
What you need to know before you take it
e Icatibant
Do not use Icatibant –
if you are allergic to icatibant or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor before taking Icatibant: if you are suffering from angina (reduced blood flow to the heart muscle) if you have recently suffered a stroke Some of the side effects connected with Icatibant are similar to the symptoms of your disease. Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received this medicine. In addition: You or your caregiver must be trained on subcutaneous (under the skin) injection technique before you self-inject or your caregiver injects you with this medicine. Immediately after you self-inject Icatibant or your caregiver injects you with this medicine while 2
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you are experiencing a laryngeal attack (obstruction of the upper airway), you must seek medical care in a medical institution. If your symptoms are not resolved following one self- or caregiver administered injection of Icatibant, ask your doctor regarding additional injections of this medicineFor adult patients, up to 2 additional injections may be given within 24 hours.
Children and adolescents This medicine is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients. Other medicines and Icatibant Tell your doctor if you are taking, have recently taken or might take any other medicines. Icatibant is not known to interact with other medicines. If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, ask your doctor before receiving this medicine. 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 before starting to use this medicine. If you are breast-feeding do not breast-feed for 12 hours after you have last received this medicine. Driving and using machines Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using this medicine. Icatibant contains sodium The injection solution contains less than 1 mmol (23 mg) of sodium, so it is essentially 'sodium-free'.
3.
How to take it
Icatibant
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. If you have never received Icatibant previously, your first dose of this medicine will always be injected by your doctor or nurse. Your doctor will tell you when it is safe for you to go home. After discussion with your doctor or nurse and after training in subcutaneous (under the skin) injection technique, you may be able to inject yourself with Icatibant or your caregiver may inject this medicine for you when you have an HAE attack. It is important that Icatibant is injected subcutaneously (under the skin) as soon as you notice an attack of angioedema. Your healthcare provider will teach you and your caregiver how to safely inject this medicine by following the instructions in the Package Leaflet.
When and how often to use Icatibant? Your doctor has determined the exact dose of this medicine and will tell you how often it should be used. Adults The recommended dose of Icatibant is one injection (3 ml, 30 mg) injected subcutaneously (under the skin) as soon as you notice the attack of angioedema (for example increased skin 3
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swelling, particularly affecting the face and neck, or increasing tummy pain). If you experience no relief of symptoms after 6 hours, ask your doctor regarding additional injections of Icatibant. For adults, up to 2 additional injections may be given within 24 hours. Do not have more than 3 injections in a 24-hour period and if you require more than 8 injections in a month, talk to your doctor.
Children and adolescents aged 2 to 17 years The recommended dose of Icatibant is one injection of 1 ml up to a maximum of 3 ml based on body weight injected subcutaneously (under the skin) as soon as you develop symptoms of an angioedema attack (for example increased skin swelling, particularly affecting the face and neck, increasing tummy pain). See section on instructions for use for the dose to inject. If you are not sure which dose to inject, ask your doctor, pharmacist or nurse. If your symptoms get worse or do not improve, you must immediately seek medical help. Icatibant administration? Icatibant is intended for subcutaneous injection (under the skin). Use each syringe only once. This medicine is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy). If you have any further questions on the use of this medicine, ask your doctor or pharmacist. The following step-by step instructions are intended for: self-administration (adults) administration by a caregiver or healthcare professional to adults, adolescents or children aged over 2 years (weighing at least 12 kg). The instructions include the following main steps: 1) General information 2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less 2b) Preparing the syringe and needle for injection (all patients) 3) Preparing the injection site 4) Injecting the solution 5) Disposal of the injection material Step-by-Step Instructions for Injection 1) General information
- Clean the work area (surface) to be used before beginning the process.
- Wash your hands with soap and water.
- Remove the pre-filled syringe from the carton.
- Remove the cap from the end of the pre-filled syringe by unscrewing the cap.
- Put down the pre-filled syringe after unscrewing the cap.
2a) Preparing the syringe for children and adolescents (2-17years) weighing 65 kg or less: Important information for healthcare professionals and caregivers:
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Where the dose is less than 30 mg (3 ml), the following equipment is required to extract the appropriate dose (see below): a) Icatibant pre-filled syringe (containing icatibant solution) b) Connector (adapter) c) 3 ml graduated syringe
The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe (see table below). Table 1: Dosage regimen for children and adolescents
Body Weight
Injection Volume
12 kg to 25 kg
1.0 ml
26 kg to 40 kg
1.5 ml
41 kg to 50 kg
2.0 ml
51 kg to 65 kg
2.5 ml
Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).
If you are not sure which volume of solution to extract, ask your doctor, pharmacist or nurse 1) Remove the caps on each end of the connector.
Avoid touching the ends of the connector and syringe tips, to prevent contamination 2) Screw the connector onto the pre-filled syringe. 3) Attach the graduated syringe to the other end of the connector ensuring that both connections fit securely.
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Transferring the icatibant solution to the graduated syringe: 1) To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image).
2) If the icatibant solution does not begin to transfer to the graduated syringe, pull slightly on the graduated syringe plunger until the icatibant solution starts to flow into the graduated syringe (see below image).
3) Continue to push on the pre-filled syringe plunger until the required injection volume (dose) is transferred to the graduated syringe. Refer to table 1 for dosage information.
If there is air in the graduated syringe:
- Turn the connected syringes so that the pre-filled syringe is on top (see below image).
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- Push the plunger of the graduated syringe so that any air is transferred back into the pre-filled syringe (this step may need to be repeated several times).
- Withdraw the required volume of icatibant solution.
4) Remove the pre-filled syringe and connector from the graduated syringe. 5) Discard the pre-filled syringe and connector into the sharps container. 2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children)
- Remove the needle cap from the blister.
- Remove the seal from the needle cap (the needle should be still in the needle cap).
- Grip the syringe firmly. Carefully attach the needle to the syringe containing the colourless solution.
- Screw the syringe on the needle still fixed in the needle cap.
- Remove the needle from the needle cap by pulling the syringe. Do not pull up on the plunger.
- The syringe is now ready for injection.
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3) Preparing the injection site
- Choose the injection site. The injection site should be a skin fold on your abdomen approximately 5-10 cm (2-4 inches) below your navel on either side. This area should be at least 5 cm (2 inches) away from any scars. Do not choose an area that is bruised, swollen, or painful.
- Clean the injection site with a rubbing alcohol pad and allow it to dry. 4) Injecting the solution
- Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger.
- Make sure that there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle.
- Hold the syringe between 45-90 degrees angle to the skin with needle facing the skin.
- Keeping the syringe in one hand, use your other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site. 8
- Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin fold.
- Slowly push the plunger of the syringe with a steady hand until all the fluid is injected into the skin and no liquid remains in the syringe.
- Press slowly so that this takes approximately 30 seconds.
- Release the skin fold and gently pull the needle out. 5) Disposal of the injection material
- Discard the syringe, needle and needle cap into the sharps container for throwing away waste that might hurt others if not handled properly
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Icatibant will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation). These effects are usually mild and clear up without the need for any additional treatment. Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received this medicine. Very common (may affect more than 1 in 10 people): Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth). Common (may affect up to 1 in 10 people): Feeling sick Headache Dizziness Fever Itching Rash Skin redness Abnormal liver function test Not known (frequency cannot be estimated from the available data): 9
Hives (urticaria)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at Website: http://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
Icatibant Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label and box after 'EXP'. The expiry date refers to the last day of that month. Do not store above 25○C. Do not freeze. Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed. Do not throw away any medicines via waste water 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 Icatibant contains –
The active substance is icatibant. Each pre-filled syringe contains 30 mg of icatibant (as acetate). Each mL of the solution contains 10 mg of icatibant The other ingredients are: sodium chloride, acetic acid glacial (for ph adjustment), sodium hydroxide (for ph adjustment), and water for injection(see section 2).
What Icatibant looks like and contents of the pack Icatibant is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. A hypodermic needle is included in the pack. Icatibant is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Piramal Critical Care Limited Suite 4, Ground Floor Heathrow Boulevard – East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom 10
Manufacturer Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola PLA 3000 Malta
This leaflet was last revised in 04/2022
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Frequently asked questions about Icatibant 30 mg solution for injection in pre-filled syringe
How do I take Icatibant 30 mg solution for injection in pre-filled syringe?
Icatibant 30 mg solution for injection in pre-filled syringe comes as injection containing 30mg. 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 Icatibant 30 mg solution for injection in pre-filled syringe?
The active substance in Icatibant 30 mg solution for injection in pre-filled syringe is icatibant acetate.
Are there equivalent medicines to Icatibant 30 mg solution for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: Firazyr 30 mg solution for injection in pre-filled syringe, Icatibant 30 mg Solution for Injection in pre-filled Syringe, Icatibant 30 mg solution for injection in pre-filled syringe. In total there are 7 equivalent products. 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 Icatibant 30 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 Icatibant 30 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: icatibant acetate
- 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
Icatibant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
4.2. Posology and method of administration
Icatibant is intended for use under the guidance of a healthcare professional.
Posology
Adults
The recommended dose for adults is a single subcutaneous injection of Icatibant 30 mg.
In the majority of cases a single injection of Icatibant is sufficient to treat an attack. In case of insufficient relief or recurrence of symptoms, a second injection of Icatibant can be administered after 6 hours. If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Icatibant can be administered after a further 6 hours. No more than 3 injections of Icatibant should be administered in a 24-hour period.
In the clinical trials, not more than 8 injections of icatibant per month have been administered.
Paediatric population
The recommended dose of Icatibant based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below.
Table 1: Dosage regimen for paediatric patients
Body Weight
Dose (Injection Volume)
12 kg to 25
10 mg (1.0 ml)
26 kg to 40
15 mg (1.5 ml)
41 kg to 50
20 mg (2.0 ml)
51 kg to 65
25 mg (2.5 ml)
>65 kg
30 mg (3.0 ml)
In the clinical trial, not more than 1 injection of icatibant per HAE attack has been administered.
No dosage regimen for children aged less than 2 years or weighing less than 12 kg can be recommended as the safety and efficacy in this paediatric group has not been established.
Elderly
Limited information is available on patients older than 65 years of age.
Elderly people have been shown to have increased systemic exposure to icatibant. The relevance of this to the safety of icatibant is unknown (see section 5.2).
Hepatic impairment
No dose adjustment is required in patients with hepatic impairment.
Renal impairment
No dose adjustment is required in patients with renal impairment.
Method of administration
Icatibant is intended for subcutaneous administration preferably in the abdominal area.
Icatibant solution for injection should be injected slowly due to the volume to be administered. Each Icatibant syringe is intended for single use only.
Refer to the patient information leaflet for instructions for use.
Caregiver/self-administration
The decision on initiating caregiver or self-administration of Icatibant should only be taken by a physician experienced in the diagnosis and treatment of hereditary angioedema (see section 4.4).
Adults
Icatibant may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.
Children and adolescents aged 2-17 years
Icatibant may be administered by a caregiver only after training in 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
Laryngeal attacks
Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until the physician considers discharge to be safe.
Ischemic heart disease
Under ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2. Caution should therefore be observed in the administration of icatibant to patients with acute ischemic heart disease or unstable angina pectoris (see section 5.3).
Stroke
Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin. Accordingly, caution should be observed in the administration of icatibant to patients in the weeks following a stroke.
Caregiver/self-administration
For patients who have never received icatibant previously, the first treatment should be given in a medical institution or under the guidance of a physician.
In case of insufficient relief or recurrence of symptoms after self-treatment or administration by a caregiver, it is recommended that the patient or caregiver should seek medical advice. For adults, subsequent doses that may be required for the same attack should be administered within a medical institution (see section 4.2). There are no data on administering subsequent doses for the same attack in adolescents or children.
Patients experiencing a laryngeal attack should always seek medical advice and be observed in a medical institution also after having taken the injection at home.
Paediatric population
There is limited experience with treatment of more than one HAE attack with icatibant in the paediatric population.
Excipients
The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2).
Co-administration of icatibant with angiotensin-converting-enzyme (ACE) inhibitors has not been studied. ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels.
Paediatric population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Pregnancy
For icatibant, no clinical data on exposed pregnancies are available. Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans is unknown.
Icatibant should be used during pregnancy only, if the potential benefit justifies the potential risk for the foetus, (e.g for treatment of potentially life-threatening laryngeal attacks).
Breast-feeding
Icatibant is excreted in the milk of lactating rats at concentrations similar to those in maternal blood. No effects were detected in the post-natal development of rat pups.
It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Icatibant, should not breastfeed for 12 hours after treatment.
Fertility
In both rats and dogs, repeated use of icatibant resulted in effects on reproductive organs. Icatibant had no effect on the fertility of male mice and rats (see section 5.3). In a study of 39 healthy adult men and women treated with 30 mg every 6 hours for 3 doses every 3 days for a total of 9 doses, there were no clinically significant changes from baseline in basal and GnRH-stimulated concentration of reproductive hormones in either females or males. There were no significant effects of icatibant on the concentration of luteal phase progesterone and luteal function, or on menstrual cycle length in females and there were no significant effects of icatibant on sperm count, motility and morphology in males.
The dosing regimen used for this study is unlikely to be sustained in the clinical setting.
4.7. Effects on ability to drive and use machines
Icatibant has minor influence on the ability to drive and use machines. Fatigue, lethargy, tiredness, somnolence, and dizziness have been reported following the use of icatibant. These symptoms may occur as a result of an attack of HAE. Patients should be advised not to drive and use machines if they feel tired or dizzy.
4.8. Undesirable effects
Summary of the safety profile
In clinical studies used for registration, a total of 999 HAE attacks have been treated with 30 mg icatibant administered subcutaneously by a healthcare professional. SC has been administered by a healthcare professional to 129 healthy subjects and 236 patients with HAE.
Almost all subjects who were treated with subcutaneous icatibant in clinical trials developed reactions at the site of injection (characterised by skin irritation, swelling, pain, itchiness, erythema, burning sensation). These reactions were generally mild to moderate in severity, transient, and resolved without further intervention.
Tabulated list of adverse reactions
The frequency of adverse reactions listed in Table 1 is defined using the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
All adverse reactions from post-marketing experience are italicised.
Table 2: Adverse reactions reported with icatibant
System organ class
Frequency
Preferred term
Nervous system disorders
Common
Dizziness Headache
Gastrointestinal disorders
Common
Nausea
Skin and subcutaneous tissue disorders
Common
Rash Erythema Pruritus
Unknown
Urticaria
General disorders and administration site conditions
Very Common
Injection site reactions*
Common
Pyrexia
Investigations
Common
Transaminases increased
* Injection site bruising, Injection site hematoma, Injection site burning, Injection site erythema, Injection site hypoesthesia, Injection site irritation, Injection site numbness, Injection site edema, Injection site pain, Injection site pressure sensation, Injection site pruritus, Injection site swelling, Injection site urticaria, and Injection site warmth.
Paediatric population
A total of 32 paediatric patients (8 children aged 2 to 11 years and 24 adolescents aged 12 to 17 years) with HAE were exposed to treatment with icatibant during clinical studies. Thirty-one patients received a single dose of icatibant and 1 patient (an adolescent) received icatibant for two HAE attacks (in total, two doses). Icatibant was administered by subcutaneous injection at a dose of 0.4 mg/kg based on body weight to a maximum dose of 30 mg.
The majority of paediatric patients who were treated with subcutaneous icatibant experienced injection site reactions such as erythema, swelling, burning sensation, skin pain and itching/pruritus; these were found to be mild to moderate in severity and consistent with reactions that have been reported in adults. Two paediatric patients experienced injection site reactions which were assessed as severe and which were completely resolved within 6 hours. These reactions were erythema, swelling, burning and warm sensation.
No clinically significant changes in reproductive hormones were observed during clinical studies.
Description of selected adverse reactions
Immunogenicity
Across repeated treatment in adults in the controlled phase III trials, transient positivity to anti-icatibant antibodies was observed in rare cases. All patients maintained efficacy. One icatibant-treated patient tested positive for anti-icatibant antibodies before and after treatment. This patient was followed for 5 months and further samples were negative for anti-icatibant antibodies. No hypersensitivity or anaphylactic reactions were reported with icatibant.
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 at Website: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No clinical information on overdose is available.
A dose of 3.2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing or hypotension in healthy subjects. No therapeutic intervention was necessary.
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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.