Bimzelx 320mg/2ml Pf Syr W/ndl, 2ml
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; Interleukin Inhibitor
Pharmacologic Class
Interleukin-17A and Interleukin-17F Inhibitor
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. It works by blocking two specific proteins in your body (IL-17A and IL-17F) that cause inflammation and are involved in skin conditions like plaque psoriasis. By blocking these proteins, Bimzelx helps reduce the redness, scaling, and itching of psoriasis.
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 visual or hearing impairments, you will need assistance from another person to inject the medication.
Preparing the Medication for Use
If the medication has been stored in the refrigerator, allow it to come to room temperature for 30 to 45 minutes before use. 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.
Administration Instructions
1. Wash your hands before and after handling the medication.
2. Do not shake the medication.
3. Do not use the medication if it has been dropped or damaged.
4. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
5. Do not inject within 2 inches (5 cm) of the belly button.
6. Rotate the injection site with each use.
7. If your dose requires multiple injections, administer each injection in a different area.
Inspecting the Medication
Before use, check the medication for:
Cloudiness, leakage, or particles in the solution
A color change to anything other than pale yellow or brown-yellow
Do not use the medication if you notice any of these issues.
Using the Auto-Injector or Prefilled Syringe
1. Remove the cap or cover only when ready to use.
2. Each auto-injector and prefilled syringe is for single use only.
3. Dispose of any remaining medication after use.
4. Throw away needles in a designated needle/sharp disposal box. Do not reuse needles or other items.
Storage and Disposal
Store the medication in the refrigerator. Do not freeze. If the medication has been frozen, do not use it. When disposing of the needle/sharp disposal box, follow local regulations.
Missing a Dose
If you miss a dose, take it as soon as you remember and return to your regular schedule. Do not take two doses at the same time or extra doses. If you have any questions or concerns, consult your doctor or pharmacist.
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 visual or hearing impairments, you will need assistance from another person to inject the medication.
Preparing the Medication for Use
If the medication has been stored in the refrigerator, allow it to come to room temperature for 30 to 45 minutes before use. 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.
Administration Instructions
1. Wash your hands before and after handling the medication.
2. Do not shake the medication.
3. Do not use the medication if it has been dropped or damaged.
4. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
5. Do not inject within 2 inches (5 cm) of the belly button.
6. Rotate the injection site with each use.
7. If your dose requires multiple injections, administer each injection in a different area.
Inspecting the Medication
Before use, check the medication for:
Cloudiness, leakage, or particles in the solution
A color change to anything other than pale yellow or brown-yellow
Do not use the medication if you notice any of these issues.
Using the Auto-Injector or Prefilled Syringe
1. Remove the cap or cover only when ready to use.
2. Each auto-injector and prefilled syringe is for single use only.
3. Dispose of any remaining medication after use.
4. Throw away needles in a designated needle/sharp disposal box. Do not reuse needles or other items.
Storage and Disposal
Store the medication in the refrigerator. Do not freeze. If the medication has been frozen, do not use it. When disposing of the needle/sharp disposal box, follow local regulations.
Missing a Dose
If you miss a dose, take it as soon as you remember and return to your regular schedule. Do not take two doses at the same time or extra doses. If you have any questions or concerns, consult your doctor or pharmacist.
Lifestyle & Tips
- Store Bimzelx in the refrigerator (2°C to 8°C / 36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
- Allow the syringe to reach room temperature for 30-45 minutes before injecting. Do not warm in any other way.
- Inject the full dose under the skin in the thigh, abdomen, or upper arm. Rotate injection sites.
- Do not inject into skin that is tender, bruised, red, scaly, or hard.
- Avoid live vaccines while on Bimzelx and for at least 4 weeks before starting treatment. Discuss all vaccinations with your doctor.
- Report any signs of infection (e.g., fever, chills, persistent cough, skin sores) to your doctor immediately.
- Report any new or worsening stomach pain, diarrhea, or bloody stools to your doctor immediately, as these could be signs of inflammatory bowel disease.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
320 mg (given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.
Dose Range:
320 - 320 mg
Condition-Specific Dosing:
Plaque Psoriasis:
320 mg (two 160 mg injections) subcutaneously at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For some patients weighing ≥120 kg, a dose of 320 mg every 4 weeks after Week 16 may be considered.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and effectiveness not established in pediatric patients <18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Dialysis:
No specific recommendations; Bimekizumab is a monoclonal antibody and not renally cleared.
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 two key cytokines, interleukin 17A (IL-17A) and interleukin 17F (IL-17F). By inhibiting both IL-17A and IL-17F, Bimekizumab is thought to more completely suppress the inflammatory pathways driven by these cytokines, which are implicated in the pathogenesis of inflammatory diseases like plaque psoriasis.
Pharmacokinetics
Absorption:
Bioavailability:
70-80% (subcutaneous)
Tmax:
3-6 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
11.2 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
23 days
Clearance:
0.337 L/day
ExcretionRoute:
Not applicable (catabolized)
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed as early as Week 2
PeakEffect:
Maximum clinical response typically by Week 16
DurationOfAction:
Maintained with every 8-week dosing after initial induction
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of inflammatory bowel disease, such as:
+ Severe diarrhea
+ Stomach pain
+ Rectal bleeding or pain
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or 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 caused these thoughts and actions. If you have concerns, discuss them with your doctor. Seek medical help immediately if you experience new or worsening symptoms such as:
Depression
Nervousness
Restlessness
Irritability
Panic attacks
Changes in mood or behavior
Suicidal thoughts or actions
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical help:
Common cold symptoms
Headache
Pain, redness, or swelling at the injection site
Acne
Upset stomach 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 experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of inflammatory bowel disease, such as:
+ Severe diarrhea
+ Stomach pain
+ Rectal bleeding or pain
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or 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 caused these thoughts and actions. If you have concerns, discuss them with your doctor. Seek medical help immediately if you experience new or worsening symptoms such as:
Depression
Nervousness
Restlessness
Irritability
Panic attacks
Changes in mood or behavior
Suicidal thoughts or actions
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical help:
Common cold symptoms
Headache
Pain, redness, or swelling at the injection site
Acne
Upset stomach 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, painful urination.
- Symptoms of inflammatory bowel disease: new or worsening abdominal pain, persistent diarrhea, rectal bleeding, weight loss.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
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 symptoms you experienced.
If you have inflammatory bowel disease (IBD), an infection, or tuberculosis (TB).
If you have liver disease, as this may affect how your body processes the medication.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems, including those not mentioned here
To avoid potential interactions, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other drugs and health conditions.
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 symptoms you experienced.
If you have inflammatory bowel disease (IBD), an infection, or tuberculosis (TB).
If you have liver disease, as this may affect how your body processes the medication.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems, including those not mentioned here
To avoid potential interactions, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other drugs and health conditions.
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 health.
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 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, plan to become pregnant, or are 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 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, plan to become pregnant, or are 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. Doses up to 640 mg intravenously have been 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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, varicella, yellow fever, rotavirus, live attenuated influenza vaccine) during treatment and for at least 4 weeks prior to initiation of Bimekizumab.
Major Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids): Potential for increased risk of infection. Use with caution.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection before initiating an immunosuppressive therapy.
Timing: Prior to initiation of Bimekizumab.
Hepatitis B and C screening
Rationale: To assess for viral hepatitis, as immunosuppression may reactivate these infections.
Timing: Prior to initiation of Bimekizumab.
Inflammatory Bowel Disease (IBD) history
Rationale: To assess for pre-existing or new onset IBD, as IL-17 inhibitors have been associated with new onset or exacerbation of IBD.
Timing: Prior to initiation of Bimekizumab.
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout treatment and after discontinuation
Target: Absence of fever, chills, malaise, cough, dysuria, skin lesions, etc.
Action Threshold: Prompt evaluation and treatment if signs/symptoms of serious infection occur. Discontinue Bimekizumab if serious infection develops.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout treatment
Target: Absence of new or worsening abdominal pain, diarrhea, rectal bleeding, weight loss.
Action Threshold: Refer to a gastroenterologist if new or worsening IBD symptoms occur. Discontinue Bimekizumab if IBD is confirmed.
Vaccination status
Frequency: Periodically
Target: Up-to-date on all age-appropriate non-live vaccinations.
Action Threshold: Administer all recommended non-live vaccinations prior to or during treatment. Avoid live vaccines.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, malaise, cough, shortness of breath, skin warmth/redness/pain, dysuria)
- Symptoms of inflammatory bowel disease (e.g., new or worsening abdominal pain, diarrhea, rectal bleeding, weight loss)
- Signs of hypersensitivity reactions (e.g., rash, urticaria, angioedema, dyspnea)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Bimekizumab in pregnant women. Monoclonal antibodies are known to cross the placental barrier, particularly during the third trimester. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies did not show direct harm.
Second Trimester:
Limited human data; animal studies did not show direct harm.
Third Trimester:
Potential for increased fetal exposure to Bimekizumab due to increased placental transfer of IgG antibodies.
Lactation
It is unknown whether Bimekizumab is excreted in human milk. Maternal IgG is known to be present in human milk. Consider the developmental and health benefits of breastfeeding 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:
L3 (Moderate risk) - No human data, but large molecular weight suggests limited transfer into milk. Potential for infant exposure and effects on infant immune system are unknown. Monitor breastfed infants for signs of infection.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients less than 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The incidence of infections was similar between patients ≥65 years and those <65 years. Use with caution in elderly patients due to generally higher incidence of infections in this population.
Clinical Information
Clinical Pearls
- Bimekizumab targets both IL-17A and IL-17F, which may offer more complete blockade of the IL-17 pathway compared to agents targeting only IL-17A.
- Patients should be screened for tuberculosis (TB) and treated for latent TB prior to initiating Bimekizumab.
- Patients should be advised to avoid live vaccines during treatment and for at least 4 weeks prior to initiation.
- Monitor patients for new onset or exacerbation of inflammatory bowel disease (IBD) symptoms, as this is a known risk with IL-17 inhibitors.
- The initial induction phase requires more frequent dosing (Weeks 0, 4, 8, 12, 16) before transitioning to every 8-week maintenance dosing.
Alternative Therapies
- Other IL-17A inhibitors (e.g., Secukinumab, Ixekizumab)
- IL-23 inhibitors (e.g., Guselkumab, Risankizumab, Tildrakizumab)
- TNF-alpha inhibitors (e.g., Adalimumab, Etanercept, Infliximab)
- PDE4 inhibitors (e.g., Apremilast)
- Oral systemic agents (e.g., Methotrexate, Cyclosporine)
- Phototherapy
- Topical therapies
Cost & Coverage
Average Cost:
Highly variable, typically >$5,000 - $10,000 per dose per 320mg/2ml prefilled syringe
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.