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.
This medicine contains the active substance icatibant.
Icatibant Injection 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 Injection blocks the activity of bradykinin and therefore ends the further progression of the symptoms.
Do not use Icatibant Injection • 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 using Icatibant Injection:
• 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 Injection or your caregiver injects you with this medicine while 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 Injection, ask your doctor regarding additional injections of this medicine. For 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 Injection Tell your doctor if you are taking, have recently taken or might take any other medicines.
Icatibant Injection 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 Injection contains sodium The injection solution contains less than 1 mmol (23 mg) of sodium per dose, so it is essentially 'sodium-free'.
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 Injection 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 Injection or your caregiver may inject this medicine for you when you have an HAE attack.
It is important that Icatibant Injection 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 Injection? 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 Injection 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 swelling, particularly affecting the face and neck, or increasing tummy pain).
• If you experience no relief of symptoms after6 hours, ask your doctor regarding additional injections of Icatibant Injection. 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 Injection 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 Injection administration Icatibant Injection 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) Preparing the pre-filled syringe
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) Preparing the pre-filled syringe
• 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.
• Next steps for children and adolescents, see 2a below. For adults, see 2b.
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less:
• Diagrams showing the pre-filled syringe, the connector, and the empty graduated syringe
• Diagram 1 shows how the pre-filled syringe, the connector and the empty graduated syringe are connected
• Diagrams 2 and 3 shows how solution is transferred from the pre-filled syringe to the graduated syringe
• Diagram 4 shows how to remove air from the now filled graduated syringe
2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children)
• Diagrams show how the needle is attached to the syringe
3) Preparing the injection site
• Diagram shows how to prepare the injection site
4) Injecting the solution
• Diagrams show how to inject icatibant
5) Disposal of the injection material
• Diagram shows how to dispose of the now empty syringe and needle
Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Icatibant Injection 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):
• 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: 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.
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.
What Icatibant Injection contains • The active substance is icatibant. Each pre-filled syringe contains 30 milligrams 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 (see section 2).
What Icatibant Injection looks like and contents of the pack Icatibant Injection 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 Injection 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 Celix Pharma Ltd
12 Constance Street
London
E16 2DQ
United Kingdom
Manufacturer Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Eurofins PROXY Laboratories (PRX)
Archimedesweg 25 2333 CM Leiden
The Netherlands
If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected] .
This leaflet was last revised in March 2022
Celix Pharma Ltd
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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.
The active substance in Icatibant 30 mg Solution for Injection in pre-filled Syringe is icatibant acetate.
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.
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.
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.
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.
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 kg 10 mg (1.0 ml) 26 kg to 40 kg 15 mg (1.5 ml) 41 kg to 50 kg 20 mg (2.0 ml) 51 kg to 65 kg 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. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
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 This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
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. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
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 injection, 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.
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.
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. Icatibant 30 mg 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 the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
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.
Ask anything about Icatibant 30 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.
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