Safety
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Bimzelx Injection: Uses, Dosage, Side Effects, Precautions and Alternates
| Generic name | bimekizumab |
|---|---|
| Drug class | interleukin (IL) inhibitor |
| Forms | 160 mg bimekizumab in a 1 mL pre-filled syringe, 160 mg bimekizumab in a 1 mL autoinjector, 320 mg bimekizumab in a 2 mL pre-filled syringe, 320 mg bimekizumab in a 2 mL autoinjector |
Quick overview
Bimzelx Injection (bimekizumab) is an interleukin (IL) inhibitor given by injection for adults with certain long-term inflammatory conditions affecting the skin, joints, and spine. It works by blocking two inflammatory proteins, IL-17A and IL-17F, to help calm inflammation and improve symptoms. It is given as a subcutaneous injection on a schedule set by a doctor, and it carries risks such as infections and liver effects that require monitoring.
What is Bimzelx Injection
Bimzelx is an injectable prescription medicine made with a monoclonal antibody. It is used for adults with certain long-term inflammatory conditions affecting the skin, joints, and spine.
Bimzelx Injection uses
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
- Hidradenitis suppurativa
Benefits of Bimzelx Injection
- Clinical trials showed 85–91% of patients treated with Bimzelx achieved clear or almost clear skin at week 16, with 59–68% achieving complete clearance, for plaque psoriasis
- Bimzelx achieved a 50 percent or greater improvement in hidradenitis suppurativa signs and symptoms at week 16 in clinical trials
How Bimzelx Injection works
Bimzelx blocks two proteins in the immune system called IL-17A and IL-17F, which are found at higher levels in these inflammatory diseases. By reducing the activity of these proteins, it calms inflammation and helps improve symptoms.
Bimzelx Injection dosage
A healthcare provider will show you or a caregiver how to prepare and inject this medicine before you try it yourself. Do not inject yourself or someone else until you have been properly shown how.
Let the pre-filled syringe or autoinjector warm up in its original carton for 30 to 45 minutes before injecting, to help reduce discomfort. Do not microwave it, run hot water over it, or leave it in direct sunlight to warm it up. Do not shake the syringe or autoinjector.
Inject under the skin of the stomach area, thigh, or back of the upper arm; a healthcare provider or caregiver is needed to give an injection in the back of the arm. Do not inject into skin that is tender, bruised, red, scaly, or hard, or into scars or stretch marks, or within 2 inches of the belly button.
Choose a different injection site each time, and if two injections are needed for one dose, use a different site for each one or keep them at least one inch apart.
If you miss a dose, inject it as soon as you remember, then go back to your regular schedule; do not take two doses at once to make up for a missed one.
This medicine is not approved for children and adolescents under 18 years of age.
| Age group | Dose |
|---|---|
| Under 18 years | Safety and effectiveness have not been established |
| 18–64 years — plaque psoriasis | 320 mg subcutaneously at Weeks 0, 4, 8, 12, and 16, then every 8 weeks |
| 18–64 years — psoriatic arthritis / axial spondyloarthritis | 160 mg subcutaneously every 4 weeks |
Available forms and strengths
- 160 mg bimekizumab in a 1 mL pre-filled syringe
- 160 mg bimekizumab in a 1 mL autoinjector
- 320 mg bimekizumab in a 2 mL pre-filled syringe
- 320 mg bimekizumab in a 2 mL autoinjector
Side effects of Bimzelx Injection
Common
- Upper respiratory tract infections with sore throat and stuffy nose
- Fungal infections of the mouth, throat, or vagina
- Urinary tract infection
- Headache
- Injection site reactions (pain, redness or swelling)
- Acne
- Small red bumps on the skin
- Stomach ache or stomach flu
- Diarrhea or constipation
- Athlete's foot
- Feeling tired or aching
- Feeling anxious or depressed
- Cold sores
- Cough or chest cold
- Dry skin
- Itchy skin or rash
- Toothache
- High blood pressure
- Pain in mouth
- Signs of low white blood cells, such as fever, sore throat or mouth ulcers
Serious
- Serious infections (fever, sweats or chills, cough, shortness of breath, blood in phlegm, muscle aches, warm/red/painful skin or sores, weight loss, diarrhea or stomach pain, burning when urinating)
- Serious allergic reactions (feeling faint, swelling of face/eyelids/lips/mouth/tongue/throat, trouble breathing or throat tightness, skin rash)
- Inflammatory bowel disease (new or worsening stomach pain or diarrhea)
- Elevated liver enzymes/liver problems (tiredness, loss of appetite, nausea, vomiting, itchy skin, dark urine, pain on the right side of the stomach, light-colored stools, yellowing of skin or eyes)
- Suicidal thoughts or behavior, or worsening depression
Warnings and precautions
- This medicine can increase your risk of infections, including serious ones. Do not use it if you have an infection unless your doctor tells you to.
- Do not use this medicine if you have active tuberculosis (TB). If you have latent TB, you may need TB treatment before starting this medicine, and your doctor will watch you closely for signs of TB during and after treatment.
- This medicine may raise the risk of suicidal thoughts and behavior in some people. Patients, caregivers, and families should watch for new or worsening depression, suicidal thoughts, or other mood changes and get medical help right away if these occur.
- Some people have developed inflammatory bowel disease, or had flare-ups of existing Crohn's disease or ulcerative colitis, while using this medicine. People with active inflammatory bowel disease should avoid this medicine.
- Avoid receiving live vaccines while being treated with this medicine. Make sure you are up to date on recommended vaccinations before starting treatment.
- It is not known if this medicine can harm an unborn baby. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.
- Women who can become pregnant should use effective birth control while using this medicine and for at least 4 months after the last dose.
- It is not known if this medicine passes into breast milk. Tell your doctor if you are breastfeeding or plan to breastfeed.
- This medicine can raise liver enzyme levels. You will have blood tests to check your liver before and during treatment. Tell your doctor right away if you notice signs of liver problems such as feeling very tired, loss of appetite, nausea, vomiting, itchy skin, dark urine, pain on the right side of your stomach, light-colored stools, or yellowing of your skin or eyes.
- Alcohol is not known to interact with this medicine, and it is likely safe to drink alcohol during treatment. Ask your doctor if you have questions about how much is safe for you.
- This medicine is generally not expected to impair driving, but avoid driving if dizziness or other symptoms occur.
Storage
- Store Bimzelx in the refrigerator at 2 to 8°C (36 to 46°F)
- Do not freeze. Do not use Bimzelx if it has been frozen
- Store in the original carton and protect from light
- If necessary, Bimzelx may be stored at room temperature up to 25°C (77°F), protected from light, for a maximum of up to 25 days, within the expiration date of the product
- Do not store above 25°C (77°F)
- Write the date removed from the refrigerator in the space provided on the carton
- Do not place Bimzelx back in refrigerator after it has been stored at room temperature
- Throw away the product if it is not used within 25 days at room temperature
- Do not use Bimzelx after the expiration date shown on the outer carton
- Keep out of reach and sight of children
When to see a doctor
- Get immediate medical help if you have signs of a serious allergic reaction, such as feeling faint, swelling of your face, eyelids, lips, mouth, tongue or throat, trouble breathing or throat tightness, or a skin rash.
- Tell your healthcare professional if you have signs of a serious infection, such as fever, sweats or chills, cough, shortness of breath, blood in phlegm, muscle aches, warm/red/painful skin or sores different from your psoriasis, weight loss, diarrhea or stomach pain, or burning when you urinate.
- Call your doctor right away if you notice signs of liver problems, such as feeling very tired, loss of appetite, nausea and vomiting, itchy skin, dark urine, pain on the right side of your stomach, light-colored stools, or yellowing of your skin or eyes.
- Seek medical attention promptly if you or someone you care for shows signs of new or worsening depression, suicidal thoughts, or other mood changes.
Alternatives
- Skyrizi
- Tremfya
- Cosentyx
- Stelara
Watch the video
FAQs
What is Bimzelx Injection used for?
Bimzelx is used in adults for moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), and hidradenitis suppurativa.
How does Bimzelx Injection work?
Bimzelx blocks two immune system proteins, IL-17A and IL-17F, which are found at higher levels in these inflammatory diseases, helping to calm inflammation and improve symptoms.
What is the dosage of Bimzelx for plaque psoriasis?
For adults 18-64 years with plaque psoriasis, the dose is 320 mg given subcutaneously at Weeks 0, 4, 8, 12, and 16, then every 8 weeks.
What are the common side effects of Bimzelx Injection?
Common side effects include upper respiratory tract infections, fungal infections of the mouth, throat, or vagina, urinary tract infection, headache, injection site reactions, acne, stomach ache, diarrhea or constipation, and feeling tired or aching, among others.
How should Bimzelx be stored?
Bimzelx should be stored in the refrigerator at 2 to 8°C (36 to 46°F), kept in its original carton, and protected from light. If needed, it can be stored at room temperature up to 25°C (77°F) for a maximum of 25 days, but should not be placed back in the refrigerator afterward.
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Sources
Video
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