Bimzelx 160mg/ml Pf Inj, 2 Syr
It is used to treat plaque psoriasis. It is used to treat psoriatic arthritis.It is used to treat spondyloarthritis.It is used to treat ankylosing spondylitis.It is used to treat a skin problem called hidradenitis suppurativa.
Drug Class
Immunosuppressant, Anti-psoriatic
Pharmacologic Class
Interleukin-17A and Interleukin-17F inhibitor, Monoclonal antibody
Pregnancy Category
Not available
FDA Approved
Oct 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bimzelx is a medicine given by injection under the skin to treat moderate to severe plaque psoriasis in adults. It works by blocking two specific proteins in your body (IL-17A and IL-17F) that cause inflammation and lead to psoriasis symptoms. This helps to reduce the redness, scaling, and thickness of your skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is giving you the injection, it may be given in the outer area of the upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. If you have vision or hearing impairments, you will need assistance from another person to inject the medication.
Preparation and Handling
Before using the medication, remove it from the refrigerator and let it come to room temperature for 30 to 45 minutes. Do not heat the medication. Keep it in its original carton to protect it from light. Avoid warming the medication by exposing it to running water or direct sunlight.
Wash your hands before and after handling the medication. Do not shake the medication, and do not use it if it has been dropped or damaged. Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Also, do not inject within 2 inches (5 cm) of the belly button.
Injection Technique
Rotate the injection site with each use. If your dose requires multiple injections, administer each injection in a different area. Before injecting, check the solution for cloudiness, leakage, or particles. The medication should be colorless to pale brownish-yellow. Do not use it if the solution has changed to a different color.
Do not remove the cap or cover until you are ready to use the medication. Each auto-injector and prefilled syringe is for single use only. Discard any remaining medication after use, and dispose of needles in a designated sharps container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator, but do not freeze it. Do not use the medication if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember, and then resume your regular schedule. Do not take two doses at the same time or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is giving you the injection, it may be given in the outer area of the upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. If you have vision or hearing impairments, you will need assistance from another person to inject the medication.
Preparation and Handling
Before using the medication, remove it from the refrigerator and let it come to room temperature for 30 to 45 minutes. Do not heat the medication. Keep it in its original carton to protect it from light. Avoid warming the medication by exposing it to running water or direct sunlight.
Wash your hands before and after handling the medication. Do not shake the medication, and do not use it if it has been dropped or damaged. Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Also, do not inject within 2 inches (5 cm) of the belly button.
Injection Technique
Rotate the injection site with each use. If your dose requires multiple injections, administer each injection in a different area. Before injecting, check the solution for cloudiness, leakage, or particles. The medication should be colorless to pale brownish-yellow. Do not use it if the solution has changed to a different color.
Do not remove the cap or cover until you are ready to use the medication. Each auto-injector and prefilled syringe is for single use only. Discard any remaining medication after use, and dispose of needles in a designated sharps container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator, but do not freeze it. Do not use the medication if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember, and then resume your regular schedule. Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Avoid live vaccines (e.g., measles, mumps, rubella, chickenpox) while on Bimzelx and for a period after stopping treatment. Consult your doctor about any vaccinations.
- Report any signs of infection (e.g., fever, chills, persistent cough, skin sores) to your doctor immediately.
- Monitor for new or worsening symptoms of inflammatory bowel disease (e.g., persistent abdominal pain, diarrhea, bloody stools) and report them to your doctor.
- Keep all scheduled appointments for injections and follow-up monitoring.
- Store Bimzelx in the refrigerator, protected from light, and do not freeze. Allow to reach room temperature before injecting.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
320 mg (given as two 160 mg subcutaneous injections) at Week 0, 4, 8, 12, and 16, then every 8 weeks thereafter.
Dose Range:
320 - 320 mg
Condition-Specific Dosing:
Plaque Psoriasis:
For some patients weighing ≥120 kg, consider 320 mg every 4 weeks after Week 16.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No specific recommendations; not expected to be removed by dialysis due to large molecular weight.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds to and neutralizes both interleukin-17A (IL-17A) and interleukin-17F (IL-17F) cytokines. IL-17A and IL-17F are pro-inflammatory cytokines implicated in the pathogenesis of immune-mediated inflammatory diseases, including plaque psoriasis. By inhibiting both, bimekizumab reduces inflammation and clinical symptoms associated with these conditions.
Pharmacokinetics
Absorption:
Bioavailability:
70-80%
Tmax:
3-4 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 11 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 23 days
Clearance:
Approximately 0.2 L/day
ExcretionRoute:
Catabolism and elimination via reticuloendothelial system
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed within weeks (e.g., as early as Week 4 for PASI 75).
PeakEffect:
Maximum clinical response typically observed by Week 16.
DurationOfAction:
Sustained clinical response with every 8-week dosing regimen.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal
Signs of inflammatory bowel disease: severe diarrhea, stomach pain, rectal bleeding, or rectal pain
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes
Warm, red, or painful skin or sores on the body
Small red bumps on the skin
Excessive sweating
Shortness of breath
Coughing up blood
Significant weight loss
Redness or white patches in the mouth or throat
Brittle, thick, or discolored nails
In some clinical trials, people taking this medication reported suicidal thoughts and actions more frequently than those not taking the medication. It is unclear whether the medication was the cause. If you have concerns, discuss them with your doctor. Seek immediate medical attention if you experience new or worsening symptoms such as depression, nervousness, restlessness, irritability, panic attacks, or changes in mood or behavior. If you have suicidal thoughts or actions, call your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Common cold symptoms
Headache
Pain, redness, or swelling at the injection site
Acne
Stomach upset or vomiting
Fatigue or weakness
* Cold sores
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal
Signs of inflammatory bowel disease: severe diarrhea, stomach pain, rectal bleeding, or rectal pain
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes
Warm, red, or painful skin or sores on the body
Small red bumps on the skin
Excessive sweating
Shortness of breath
Coughing up blood
Significant weight loss
Redness or white patches in the mouth or throat
Brittle, thick, or discolored nails
In some clinical trials, people taking this medication reported suicidal thoughts and actions more frequently than those not taking the medication. It is unclear whether the medication was the cause. If you have concerns, discuss them with your doctor. Seek immediate medical attention if you experience new or worsening symptoms such as depression, nervousness, restlessness, irritability, panic attacks, or changes in mood or behavior. If you have suicidal thoughts or actions, call your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Common cold symptoms
Headache
Pain, redness, or swelling at the injection site
Acne
Stomach upset or vomiting
Fatigue or weakness
* Cold sores
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: fever, chills, body aches, persistent cough, shortness of breath, flu-like symptoms, warm/red/painful skin sores, diarrhea.
- New or worsening inflammatory bowel disease symptoms: persistent abdominal pain, cramping, diarrhea (especially if bloody), weight loss.
- Allergic reactions: rash, hives, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing, dizziness, feeling faint.
- Liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have inflammatory bowel disease (IBD), as this condition may affect how your body responds to the medication.
If you have an active infection, as this medication may worsen the infection or interact with other treatments you are receiving.
If you have tuberculosis (TB), a bacterial infection that requires careful management.
If you have liver disease, as this medication may be processed differently in your body and require dose adjustments.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Any vitamins you are taking
* All your health problems, including those not mentioned here
Your doctor will help you determine whether it is safe to take this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have inflammatory bowel disease (IBD), as this condition may affect how your body responds to the medication.
If you have an active infection, as this medication may worsen the infection or interact with other treatments you are receiving.
If you have tuberculosis (TB), a bacterial infection that requires careful management.
If you have liver disease, as this medication may be processed differently in your body and require dose adjustments.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Any vitamins you are taking
* All your health problems, including those not mentioned here
Your doctor will help you determine whether it is safe to take this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.
Before initiating treatment with this drug, you will need to undergo a tuberculosis (TB) test. As this medication may increase your risk of developing infections, it is vital to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication. Consult your doctor to determine the optimal timing for receiving any necessary vaccines. If you have recently received a vaccine or plan to get vaccinated, discuss this with your doctor, as the use of vaccines with this drug may either increase the risk of infection or reduce the vaccine's effectiveness.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. If you took this medication during pregnancy, be sure to notify your baby's doctor, as you will need to discuss the safety and timing of certain vaccines for your child.
Before initiating treatment with this drug, you will need to undergo a tuberculosis (TB) test. As this medication may increase your risk of developing infections, it is vital to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication. Consult your doctor to determine the optimal timing for receiving any necessary vaccines. If you have recently received a vaccine or plan to get vaccinated, discuss this with your doctor, as the use of vaccines with this drug may either increase the risk of infection or reduce the vaccine's effectiveness.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. If you took this medication during pregnancy, be sure to notify your baby's doctor, as you will need to discuss the safety and timing of certain vaccines for your child.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials.
- In clinical studies, single doses up to 640 mg intravenously and 320 mg subcutaneously were administered without dose-limiting toxicity.
What to Do:
In case 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. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG)
Major Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids) - increased risk of infection
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating immunosuppressive therapy.
Timing: Prior to initiation of treatment.
Hepatitis B and C screening
Rationale: To assess for chronic viral hepatitis, which may be reactivated with immunosuppression.
Timing: Prior to initiation of treatment.
Inflammatory Bowel Disease (IBD) history
Rationale: To identify patients at higher risk for new onset or exacerbation of IBD.
Timing: Prior to initiation of treatment.
Routine Monitoring
Signs and symptoms of infection
Frequency: Throughout treatment and for several months after discontinuation.
Target: Absence of fever, chills, persistent cough, skin lesions, or other signs of infection.
Action Threshold: Prompt evaluation and treatment if signs/symptoms of serious infection develop.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Throughout treatment.
Target: Absence of new or worsening abdominal pain, diarrhea, bloody stools, or weight loss.
Action Threshold: Discontinue bimekizumab and refer to a gastroenterologist if new or worsening IBD symptoms occur.
Liver enzymes (ALT, AST)
Frequency: As clinically indicated, especially in patients with pre-existing liver conditions or those developing symptoms of liver injury.
Target: Within normal limits.
Action Threshold: Investigate significant elevations; consider discontinuation if liver injury is suspected.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Fatigue
- Skin lesions (new or worsening)
- Abdominal pain
- Diarrhea (especially bloody)
- Weight loss
- Joint pain
- Swelling
- Rash
- Hives
- Difficulty breathing (signs of hypersensitivity)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of bimekizumab in pregnant women. Human IgG antibodies are known to cross the placental barrier. Animal studies did not show direct or indirect harmful effects with respect to reproductive toxicity. Bimzelx should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data; potential for placental transfer of IgG antibodies increases later in pregnancy.
Second Trimester:
Potential for placental transfer of IgG antibodies.
Third Trimester:
Greatest potential for placental transfer of IgG antibodies, which could lead to immunosuppression in the infant.
Lactation
It is not known whether bimekizumab is excreted in human milk or absorbed systemically following ingestion. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Bimzelx and any potential adverse effects on the breastfed infant from Bimzelx or from the underlying maternal condition.
Infant Risk:
Risk is unknown. Potential for infant exposure to bimekizumab via breast milk and potential effects on the infant's immune system.
Pediatric Use
The safety and effectiveness of Bimzelx in pediatric patients (under 18 years of age) with plaque psoriasis have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger adult patients in clinical trials. No dose adjustment is required for elderly patients.
Clinical Information
Clinical Pearls
- Bimzelx is a targeted biologic therapy that inhibits both IL-17A and IL-17F, offering a distinct mechanism compared to other IL-17 inhibitors that primarily target IL-17A.
- Patients should be thoroughly screened for tuberculosis (latent and active) and Hepatitis B/C before initiating treatment due to the risk of infection.
- Educate patients on the signs and symptoms of serious infections and inflammatory bowel disease (IBD), as these are important potential adverse effects.
- Advise patients to avoid live vaccines during treatment with Bimzelx and for a period after discontinuation.
- The initial dosing regimen involves more frequent injections (every 4 weeks for the first 16 weeks) before transitioning to an every 8-week maintenance schedule.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, ixekizumab)
- IL-23 inhibitors (e.g., risankizumab, guselkumab, tildrakizumab)
- TNF-alpha inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
- Oral systemic agents (e.g., methotrexate, cyclosporine, apremilast, deucravacitinib)
- Phototherapy (e.g., UVB, PUVA)
- Topical therapies (e.g., corticosteroids, vitamin D analogs, retinoids, calcineurin inhibitors)
Cost & Coverage
Average Cost:
High (typical for biologics) per 160mg/ml pre-filled syringe
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe and effective use. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe and effective use. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.