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.
Kyntheum 210 mg Solution for Injection
⚠ 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 Brodalumab 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
Kyntheum contains the active substance brodalumab. Brodalumab is a monoclonal antibody, a specialised type of protein that recognises and attaches to certain proteins in the body. Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of IL-17 proteins, which are present at increased levels in diseases such as psoriasis. Kyntheum is used to treat a skin condition called "plaque psoriasis", which causes inflammation and scaly plaque formation on the skin. Kyntheum is used in adults with moderate to severe plaque psoriasis affecting large areas of the body. Using Kyntheum will benefit you by leading to improvements of skin clearance and reducing psoriasis signs and symptoms, such as itch, redness, scaling, burning, stinging, cracking, flaking and pain.
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What you need to know before you take it
e Kyntheum
Do not use Kyntheum: • if you are allergic to brodalumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice before using Kyntheum • if you have active Crohn's disease • if you have an infection which your doctor thinks is important (for example, active tuberculosis).
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Warnings and precautions Talk to your doctor, pharmacist, or nurse before using Kyntheum: • if you have an inflammatory disease affecting the gut named Crohn's disease • if you have an inflammation of the large intestine named ulcerative colitis • if you have ever had or are having suicidal thoughts or actions, depression, anxiety, or mood problems • if you have an infection now or often get infections • if you have a long-term (chronic) infection • if you have tuberculosis (TB), have had a positive TB test, or have been in close contact with someone with TB. You may be treated with another medicine for TB before you begin treatment with Kyntheum • if you have recently received or are scheduled to receive a vaccination. You should not be given certain types of vaccines (called 'live vaccines') while being treated with Kyntheum • if you have used Kyntheum during the last three months of your pregnancy, you should talk to your doctor before vaccinating your baby • if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light. After starting Kyntheum, tell your doctor, pharmacist or nurse immediately: • if you have been told by your doctor that you have developed Crohn's disease • if you feel depressed, anxious, or have thoughts of suicide, or have unusual mood changes • if you have an infection or have any signs of infection listed in Section 4 "Possible Side Effects" • if you have been told you have tuberculosis. Inflammatory bowel disease (Crohn's disease or ulcerative colitis) Stop using Kyntheum and tell your doctor or seek medical help immediately if you notice abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (any signs of bowel problems). Look out for allergic reactions Kyntheum can potentially cause serious side effects, including allergic reactions. You must look out for signs of these conditions while you are taking Kyntheum. Stop using Kyntheum and tell your doctor or seek medical help immediately if you notice any signs indicating an allergic reaction. Such signs are listed under "Serious side effects" in section 4. Children and adolescents Kyntheum is not recommended for children and adolescents (below 18 years of age) because it has not been studied in this age group. Other medicines and Kyntheum Tell your doctor or pharmacist: • if you are taking, have recently taken or might take any other medicines • if you have recently had or you or your baby are going to have a vaccination, see "Warnings and precautions" in section 2. "What you need to know before using Kyntheum". 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 taking this medicine. Kyntheum has not been tested in pregnant women and it is not known if this medicine can harm your unborn baby. It is therefore preferable to avoid the use of Kyntheum during pregnancy. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use adequate contraception while using Kyntheum and for at least 12 weeks after the last dose of Kyntheum. It is not known whether brodalumab passes into breast milk. Tell your doctor if you are breast-feeding or plan to breast-feed. Your doctor will then help you decide whether to stop breast-feeding or stop
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using Kyntheum. Together you will consider the benefit of breast-feeding to the baby and the benefit of Kyntheum to you. Driving and using machines Kyntheum is unlikely to affect your ability to drive and use machines.
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How to use Kyntheum
Kyntheum should be prescribed to you by a doctor with experience in diagnosing and treating psoriasis. Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How to take it
• Your doctor will decide how much Kyntheum you need and for how long. The recommended dose is 210 mg (one injection). • After the first dose you will need to have a weekly injection at Week 1 (one week after the first dose) and Week 2 (two weeks after the first dose). After that, you will need to have an injection every two weeks. • Kyntheum is for long-term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. Tell your doctor if you think your signs and symptoms of psoriasis are not improving after using Kyntheum. How is Kyntheum given Kyntheum is given as an injection under the skin (known as a subcutaneous injection). Self-administration instructions See the detailed "Instructions for Use" that comes with this medicine for information on the right way to store, prepare, and give your injections at home. • If your doctor decides that you or a caregiver can give the injections at home, you or your caregiver should receive training on the right way to prepare and inject Kyntheum. Do not try to inject Kyntheum until you or your caregiver have been shown how to inject Kyntheum by your doctor or nurse. • Do not shake the pre-filled syringe before use. • Kyntheum is injected in your upper legs (thighs) or stomach area (abdomen) by you or a caregiver. A caregiver may also give you an injection in your upper, outer arm. • Do not inject into an area of the skin that is tender, bruised, red, hard or in an area of skin that is affected by psoriasis. If you use more Kyntheum than you should If you use more of this medicine than prescribed or take the dose sooner than required, tell your doctor. If you forget to use Kyntheum If you have forgotten to inject a dose of Kyntheum, inject the next dose as soon as you can after the missed dose. Then, talk to your doctor about when you should inject the next dose. Do not take a double dose to make up for a forgotten dose. If you stop using Kyntheum You should not stop using Kyntheum without speaking to your doctor first. If you stop treatment, symptoms of psoriasis may come back. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Stop using Kyntheum and tell your doctor or seek medical help immediately if you get any of the following side effects. Your doctor will decide if and when you may restart the treatment: Serious allergic reaction (may affect up to 1 in 1,000 people), the signs may include: • difficulty breathing or swallowing • low blood pressure, which can cause dizziness or light-headedness • swelling of the face, lips, tongue or throat • severe itching of the skin, with a red rash or raised bumps. Possible serious infections (may affect up to 1 in 100 people), the signs may include: • fever, flu-like symptoms, night sweats • feeling tired or short of breath, cough which will not go away • warm, red and painful skin, or a painful skin rash with blisters. Other side effects Common (may affect up to 1 in 10 people): • diarrhoea • feeling sick • redness, pain, itching, bruising, or bleeding at injection site • tiredness • mouth or throat pain • tinea (fungal) skin infections (including on feet and groin) • flu (influenza) • headache • joint pain • muscle pain. Uncommon (may affect up to 1 in 100 people) • candida (fungal) infection in the mouth, throat or genitals • discharge from the eye with itching, redness and swelling (conjunctivitis) • low white blood cell count. Not known (frequency cannot be estimated from the available data) • painful swelling and skin ulceration (pyoderma gangrenosum). Most of these side effects are mild to moderate. If any of these side effects becomes severe, tell your doctor, nurse, or pharmacist. Abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems) have also been reported with IL-17 inhibitors, such as Kyntheum. 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 the 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.
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5.
How to store it
Kyntheum
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 of the prefilled syringe after EXP. The expiry date refers to the last day of that month. Keep the pre-filled syringe in the outer carton in order to protect from light. Store in a refrigerator (2°C to 8°C). Do not freeze. Kyntheum can be kept at room temperature up to 25°C in the outer carton for 14 days. Throw away Kyntheum if it is not used within 14 days of storage at room temperature. Do not use this medicine if you notice the solution is cloudy or discoloured or contains lumps, flakes or particles. 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.
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Contents of the pack and other information
What Kyntheum contains The active substance is brodalumab. Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution. The other ingredients are proline, glutamate, polysorbate 20 and water for injections. What Kyntheum looks like and contents of the pack Kyntheum is a solution for injection that is a clear to slightly pearly, colourless to slightly yellow liquid, with no particles. Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks comprising 3 cartons, each containing 2 pre-filled syringes. Not all pack sizes may be marketed. Marketing Authorisation Holder LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
Manufacturers Laboratoires LEO 39 route de Chartres 28500 Vernouillet France LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
This leaflet was last revised in August 2025. 5
For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333.
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Instructions for Use: Kyntheum® 210 mg solution for injection in pre-filled syringe brodalumab For subcutaneous use Kyntheum is available as a single-use pre-filled syringe. Each syringe contains one 210 mg dose of Kyntheum. Your doctor, pharmacist or nurse will tell you how often to inject the medicine. Each Kyntheum pre-filled syringe can only be used once. If your doctor decides that you or a caregiver can give you injections at home, you should receive training on the right way to prepare and inject Kyntheum. Do not try to inject yourself until your healthcare provider has shown you the right way to give the injections. Please read all the instructions before using the Kyntheum pre-filled syringe. Call your doctor, pharmacist or nurse if you or your caregiver have any questions about the right way to inject Kyntheum. Guide to parts Before use
After use
Used plunger Plunger Finger grips Label and expiry date
Finger grips
Used syringe barrel
Label and expiry date
Syringe barrel Used needle Medicine
Needle cap on
Needle cap off
Important: Needle is inside
Before you use a Kyntheum pre-filled syringe, read this important information: Storing your Kyntheum pre-filled syringes Keep out of the sight and the reach of children. • 7
• • • •
Keep the pre-filled syringe in the original carton in order to protect from light or physical damage. Keep in the refrigerator (2°C to 8°C). If needed, you may store the Kyntheum pre-filled syringe at room temperature up to 25°C for up to 14 days. Throw away Kyntheum that has been stored at room temperature for longer than 14 days. Do not freeze.
Using your Kyntheum pre-filled syringe Do not use after the expiry date on the label. • Do not shake. • Do not remove the needle cap until you are ready to inject. • Do not use a Kyntheum pre-filled syringe if it has been dropped on a hard surface. This is in • case the syringe is broken.
Step 1: Preparing A. Remove the Kyntheum pre-filled syringe from the box Grab the syringe barrel to remove the syringe from the tray.
Place finger or thumb on edge of tray to secure it while you remove syringe.
Grab here
Put the box with any unused syringes back in the refrigerator. For safety reasons: Do not hold the plunger. • Do not grasp the needle cap. • Do not remove the needle cap until you are ready to inject. • Do not remove the finger grips. They are part of the syringe. • Leave the syringe at room temperature for at least 30 minutes before injecting. • • • •
Do not put the syringe back in the refrigerator once it has reached room temperature. Do not try to warm the syringe by using a heat source such as hot water or a microwave. Do not leave the syringe in direct sunlight. Do not shake the syringe.
Important: Always hold the pre-filled syringe by the syringe barrel. B. Check the Kyntheum pre-filled syringe
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Label and expiry date Syringe barrel
Plunger
Finger grips Medicine Needle cap on
Make sure the medicine in the syringe is clear to slightly pearly and colourless to slightly yellow. Do not use the syringe if: • the medicine is cloudy or discoloured or contains flakes or particles • any part appears cracked or broken. • C. Collect all the materials you need Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the: new syringe • alcohol wipes • cotton ball or gauze pad • plaster • sharps disposal container (colour and appearance of container may differ depending on national • requirements).
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D. Prepare and clean the area where you will inject
Upper arm Stomach area (abdomen)
Thigh
You or your caregiver can use: your thigh • your stomach area (abdomen), except for a 5-centimetre area right around your belly button • (navel). Only your caregiver can use: your outer area of upper arm. • About the injection area: Do not inject into areas where the skin is tender, bruised red, or hard. • Avoid injecting into areas with scars or stretch marks. • Avoid injecting directly into raised, thick, red or scaly skin patches or lesions. • Clean the area where you plan to inject with an alcohol wipe. Let your skin dry. • Do not touch this area again before injecting. • If you want to use the same injection area each time, make sure it is not exactly the same spot • that you used for a previous injection. Step 2: Getting ready to inject E. When you are ready to inject, pull the needle cap straight out and away from your body
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Throw the needle cap into the sharps disposal container provided. Do not twist or bend the needle cap. • Do not put the needle cap back onto the syringe. • You may notice a small air bubble in the syringe or a drop of liquid at the end of the needle. Both are normal and do not need to be removed. F. Pinch your skin to create a firm surface
Pinch the skin firmly between your thumb and fingers, creating an area about 5 centimetres wide. Important: Keep the skin pinched until after you have injected. Step 3: Injecting G. Hold the pinched skin. With the needle cap off, insert the syringe into your skin at somewhere between 45 and 90 degrees
Do not place your finger on the plunger while inserting the needle. H. Using slow and constant pressure, push the plunger all the way down until it stops moving
I. When you have finished, release your thumb. Then, gently remove the syringe from your skin
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Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your doctor, pharmacist or nurse immediately. Step 4: Finishing up J. Throw away the used syringe
• • •
Put your used pre-filled syringe in a puncture resistant sharps disposal container straight after use. Do not re-use the syringe. Do not recycle the syringe or sharps disposal container or throw them into household rubbish.
Important: Always keep the sharps disposal container out of the sight and the reach of children. K. Check the injection site If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Cover with plaster if needed.
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Frequently asked questions about Kyntheum 210 mg Solution for Injection
How do I take Kyntheum 210 mg Solution for Injection?
Kyntheum 210 mg Solution for Injection comes as injection containing 210mg. 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 Kyntheum 210 mg Solution for Injection?
The active substance in Kyntheum 210 mg Solution for Injection is brodalumab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Kyntheum 210 mg Solution for Injection, 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 Kyntheum 210 mg Solution for Injection 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: brodalumab
- 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
Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
4.2. Posology and method of administration
Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Posology
The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Elderly (aged 65 years and over)
No dose adjustment is recommended in elderly patients (see section 5.2).
Renal and hepatic impairment
Kyntheum has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
The safety and efficacy of Kyntheum in children and adolescents below the age of 18 years have not yet been established. No data are available.
Method of administration
Kyntheum is administered by subcutaneous injection. Each pre-filled syringe is for single use only. Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. The pre-filled syringe must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician. Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet. Detailed instructions for use are included at the end of the package leaflet.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Active Crohn's disease.
Clinically important active infections (e.g. active tuberculosis, see section 4.4).
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.
Inflammatory bowel disease (including Crohn's disease and ulcerative colitis)
Cases of new or exacerbations of inflammatory bowel disease have been reported with IL-17 inhibitors. Therefore, brodalumab is not recommended in patients with inflammatory bowel disease (see section 4.8). If a patient develops signs and symptoms of inflammatory bowel disease, or experiences an exacerbation of pre-existing inflammatory bowel disease, treatment should be discontinued and appropriate medical management should be initiated.
Suicidal ideation and behaviour
Suicidal ideation and behaviour, including completed suicide, have been reported in patients treated with brodalumab. The majority of patients with suicidal behaviour had a history of depression and/or suicidal ideation or behaviour. A causal association between treatment with brodalumab and increased risk of suicidal ideation and behaviour has not been established.
The risk and benefit of treatment with brodalumab should be carefully weighed for patients with a history of depression and/or suicidal ideation or behaviour, or for patients who develop such symptoms. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal ideation, anxiety, or other mood changes, and they should contact their healthcare provider if such events occur. If a patient suffers from new or worsening symptoms of depression and/or suicidal ideation or behaviour is identified, it is recommended to discontinue treatment.
Hypersensitivity reactions
Rare cases of anaphylactic reactions have been reported in the post-marketing setting. In the event of an anaphylactic reaction, or any other serious allergic reaction, administration of brodalumab should be discontinued and appropriate therapy initiated.
Infections
Brodalumab may increase the risk of infections.
During the 12-week placebo-controlled clinical trial period in patients with psoriasis, serious infections were observed in 0.5% of patients receiving brodalumab (see section 4.8).
Caution should be exercised when considering the use of brodalumab in patients with a chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and brodalumab should not be administered until the infection resolves.
Brodalumab should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be considered prior to initiation of treatment in patients with latent tuberculosis.
Vaccinations
It is recommended that patients be brought up-to-date with all immunisations in accordance with local immunisation guidelines prior to initiation of treatment. Live vaccines should not be given concurrently with brodalumab (see section 4.5). No data are available on the response to live vaccines or the risk of infection, or transmission of infection after the administration of live vaccines in patients receiving brodalumab.
Vaccination of infants
Vaccination of infants with live vaccines following third trimester exposure to brodalumab should be discussed with a physician (see also section 4.6).
Concomitant immunosuppressive therapy
The safety and efficacy of brodalumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
4.5. Interaction with other medicinal products and other forms of interaction
Live vaccines should not be given concurrently with brodalumab (see section 4.4).
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Although a role for interleukin (IL)-17A and IL-17RA in the regulation of CYP450 enzymes has not been reported, the effect of brodalumab on CYP3A4/3A5 activity was evaluated in a disease-drug-drug interaction study.
In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increased the exposure of midazolam, a CYP3A4/3A5 substrate by 24%. Based on the magnitude of change in exposure of midazolam, no dose adjustment of CYP3A4/3A5 substrates is necessary when administered concomitantly with brodalumab.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 12 weeks after treatment.
Pregnancy
There are no or limited amount of data from the use of brodalumab in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Human IgG2 is known to cross the placental barrier and brodalumab is a human IgG2, therefore, brodalumab has the potential to be transmitted from the mother to the developing foetus. As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy.
As the metabolism of brodalumab is unknown in infants, benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician.
Breast-feeding
It is unknown whether brodalumab is excreted in human milk. Brodalumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kyntheum therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
No data are available on the effect of brodalumab on human fertility. Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology (see section 5.3).
4.7. Effects on ability to drive and use machines
Kyntheum 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 reported adverse reactions are arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal pain (2.1%).
Tabulated list of adverse reactions
Adverse reactions from clinical trials and post-marketing experience (Table 1) are listed by MedDRA system organ class (SOC). Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each adverse reaction is based on 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) and not known (cannot be estimated from the available data). Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
Table 1: List of adverse reactions in clinical trials and post-marketing experience
System Organ Class
Frequency
Adverse reaction
Infections and infestations
Common
Influenza
Tinea infections (including tinea pedis, tinea versicolor, tinea cruris)
Uncommon
Candida infections (including oral, genital, and oesophageal infections)
Blood and lymphatic system disorders
Uncommon
Neutropenia
Immune system disorders
Rare
Anaphylactic reaction
Nervous system disorders
Common
Headache
Eye disorders
Uncommon
Conjunctivitis
Respiratory, thoracic and mediastinal disorders
Common
Oropharyngeal pain
Gastrointestinal disorders
Common
Diarrhoea
Nausea
Musculoskeletal and connective tissue disorders
Common
Arthralgia
Myalgia
General disorders and administration site conditions
Common
Fatigue
Injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage)
Skin and subcutaneous tissue disorders
Not known
Pyoderma gangrenosum
Description of selected adverse reactions
Inflammatory bowel disease
Cases of new or exacerbations of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) have been reported with IL-17 inhibitors (see section 4.4).
Infections
During the 12-week placebo-controlled trial period in plaque psoriasis, infections were reported in 28.2% of patients treated with brodalumab compared with 23.4% of patients treated with placebo. The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, influenza and sinusitis, which did not necessitate treatment discontinuation. Serious infections occurred in 0.5% of patients treated with brodalumab and in 0.1% of patients treated with placebo. Higher rates of fungal infections, primarily non-serious skin and mucosal candida infections, were observed in brodalumab patients compared to placebo patients, 2.5% vs 1.0%, respectively.
Through week 52, the event rates per 100 patient-years for infections were 134.7 for patients treated with brodalumab and 124.1 for patients treated with ustekinumab. The event rates per 100 patient-years for serious infections were 2.4 for patients treated with brodalumab and 1.2 for patients treated with ustekinumab. One serious case of cryptococcal meningitis and one serious case of coccidioidies infection were observed in clinical trials (see section 4.4).
Neutropenia
During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.9% of patients treated with brodalumab compared with 0.5% of patients treated with placebo. Most of the brodalumab-associated neutropenias were mild, transient and reversible.
Neutropenia Grade 3 (<1.0 × 109/L to 0.5 × 109/L) was reported in 0.5% of patients receiving brodalumab compared to none of the patients who received ustekinumab or placebo. No Neutropenia Grade 4 (<0.5 × 109/L) was reported in patients who received either brodalumab or placebo, but in 0.2% of patients who received ustekinumab. No serious infections were associated with neutropenia.
Immunogenicity
Antibodies to brodalumab developed in 2.2% (88/3935) of patients treated with brodalumab for up to 52 weeks in psoriasis clinical trials (0.3% of the patients had anti-brodalumab antibodies at baseline). Of these patients, none had neutralising antibodies.
No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- KyntheumBrodalumabum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Kyntheum 210 mg Solution for Injection. 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.