Bimzelx 160mg/ml Pf Syr Inj, 1ml
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
Pharmacologic Class
Interleukin-17A and Interleukin-17F Inhibitor, Monoclonal Antibody
Pregnancy Category
Not available
FDA Approved
Jul 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bimzelx is a medicine used to treat moderate to severe plaque psoriasis. It works by blocking two specific proteins in your body, IL-17A and IL-17F, that cause inflammation and lead to psoriasis symptoms. By blocking these proteins, Bimzelx helps to reduce the redness, scaling, and itching 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 visual 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 reach 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. Inspect the skin before injection and avoid areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. 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 color has changed or if the solution appears abnormal.
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.
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 resume 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.
Preparation and Handling
Before using the medication, remove it from the refrigerator and let it reach 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. Inspect the skin before injection and avoid areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. 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 color has changed or if the solution appears abnormal.
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.
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 resume 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
- Avoid live vaccines while on Bimzelx and discuss any 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 symptoms of inflammatory bowel disease (e.g., abdominal pain, diarrhea, rectal bleeding) to your doctor.
- 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 injection. Do not warm in any other way.
- Follow proper injection technique as instructed by your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
320 mg (given as two 160 mg subcutaneous injections) at Weeks 0, 4, 8, 12, and 16, then 320 mg every 8 weeks thereafter.
Dose Range:
160 - 320 mg
Condition-Specific Dosing:
plaquePsoriasis:
Initial: 320 mg (two 160 mg injections) at Weeks 0, 4, 8, 12, and 16. Maintenance: 320 mg every 8 weeks. For patients weighing <120 kg, 160 mg every 4 weeks after Week 16 may be considered if needed for continued response.
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; unlikely 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. By inhibiting these key inflammatory cytokines, bimekizumab reduces inflammation and clinical symptoms associated with plaque psoriasis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70%
Tmax:
3-4 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 11.2 L
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein bound in the conventional sense)
CnssPenetration:
Limited (large molecular weight)
Elimination:
HalfLife:
Approximately 23 days
Clearance:
Approximately 0.337 L/day
ExcretionRoute:
Reticuloendothelial system (catabolism)
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed as early as Week 2
PeakEffect:
Maximum clinical response typically observed by Week 16
DurationOfAction:
Maintained with every 8-week dosing after initial induction
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 or seek medical attention immediately:
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 was the cause. If you have concerns, discuss them with your doctor. If you experience new or worsening symptoms such as depression, nervousness, restlessness, irritability, panic attacks, or changes in mood or behavior, contact your doctor immediately. If you have suicidal thoughts or actions, seek help 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
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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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 was the cause. If you have concerns, discuss them with your doctor. If you experience new or worsening symptoms such as depression, nervousness, restlessness, irritability, panic attacks, or changes in mood or behavior, contact your doctor immediately. If you have suicidal thoughts or actions, seek help 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
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, warm/red/painful skin sores, burning during urination.
- Signs 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, 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 allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you are experiencing
Your doctor will review this information to determine if it is safe for you to take this medication and to identify any potential interactions with your other medications or health conditions. 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 been diagnosed with 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you are experiencing
Your doctor will review this information to determine if it is safe for you to take this medication and to identify any potential interactions with your other medications or health conditions. 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 health while taking this drug.
Before initiating treatment with this medication, you will need to undergo a tuberculosis (TB) test to ensure you do not have an active TB infection.
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.
Prior to starting treatment, make sure you are up to date with all recommended vaccinations. Consult your doctor to determine the optimal timing for receiving any necessary vaccines before beginning this medication.
If you have recently received a vaccine or plan to get vaccinated, discuss this with your doctor, as the use of vaccines with this medication may either increase the risk of infection or reduce the vaccine's effectiveness.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
In the event that you took this medication during pregnancy, be sure to notify your baby's doctor. This will enable you to discuss the safety and optimal timing of certain vaccinations for your child.
Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this drug.
Before initiating treatment with this medication, you will need to undergo a tuberculosis (TB) test to ensure you do not have an active TB infection.
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.
Prior to starting treatment, make sure you are up to date with all recommended vaccinations. Consult your doctor to determine the optimal timing for receiving any necessary vaccines before beginning this medication.
If you have recently received a vaccine or plan to get vaccinated, discuss this with your doctor, as the use of vaccines with this medication may either increase the risk of infection or reduce the vaccine's effectiveness.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
In the event that you took this medication during pregnancy, be sure to notify your baby's doctor. This will enable you to discuss the safety and optimal timing of certain vaccinations for your child.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 640 mg intravenously and 320 mg subcutaneously 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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, live attenuated influenza vaccine) during treatment and for a period before and after treatment.
Major Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids): Increased risk of infection. Use with caution.
Moderate Interactions
- Non-live vaccines: May reduce the immune response to vaccination. Administer all age-appropriate immunizations prior to initiating bimekizumab.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating immunosuppressive therapy.
Timing: Prior to initiation of bimekizumab.
Hepatitis B and C screening
Rationale: To assess for chronic viral infections that could be reactivated by immunosuppression.
Timing: Prior to initiation of bimekizumab.
History of inflammatory bowel disease (IBD)
Rationale: Bimekizumab may be 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
Target: Absence of fever, chills, malaise, localized pain, redness, swelling.
Action Threshold: Prompt evaluation and treatment for any suspected infection; consider temporary or permanent discontinuation 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: Prompt evaluation by a gastroenterologist if new or worsening IBD symptoms occur; consider discontinuation if IBD is confirmed or exacerbated.
Hypersensitivity reactions
Frequency: Monitor during and after injection
Target: Absence of rash, urticaria, angioedema, dyspnea, anaphylaxis.
Action Threshold: Discontinue immediately and manage appropriately if severe reaction occurs.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Skin lesions (new or worsening)
- Painful urination
- Unusual fatigue
- Abdominal pain
- Diarrhea (especially bloody)
- Rectal bleeding
- Weight loss
- Rash
- Hives
- Swelling of face/lips/tongue
- Difficulty breathing
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of bimekizumab in pregnant women. Bimekizumab is an IgG1 antibody and is known to cross the placental barrier, especially 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 data; potential for placental transfer is lower in early pregnancy.
Second Trimester:
Limited data; placental transfer increases.
Third Trimester:
Significant placental transfer of IgG antibodies occurs, potentially leading to fetal exposure.
Lactation
There are no data on the presence of bimekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. 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 bimekizumab and any potential adverse effects on the breastfed infant from bimekizumab or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk) - Large protein, likely minimal oral absorption by infant; however, potential for immunosuppression in infant is theoretical. Monitor breastfed infants for signs of infection.
Pediatric Use
The safety and effectiveness of bimekizumab in pediatric patients (under 18 years of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger adult patients. No dose adjustment is necessary in elderly patients. However, the incidence of serious infections was higher in bimekizumab-treated patients ≥65 years of age compared to those <65 years of age.
Clinical Information
Clinical Pearls
- Bimzelx is the first and only approved treatment for plaque psoriasis that selectively inhibits both IL-17A and IL-17F.
- Patients should be screened for tuberculosis (TB) and hepatitis B/C before initiating treatment.
- Advise patients to avoid live vaccines during treatment and to complete all age-appropriate immunizations prior to starting Bimzelx.
- Monitor patients for signs and symptoms of infection and inflammatory bowel disease (IBD) throughout treatment.
- Patients should be instructed on proper subcutaneous injection technique and storage of the pre-filled syringe.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, ixekizumab, brodalumab)
- TNF inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab, golimumab)
- IL-23 inhibitors (e.g., ustekinumab, guselkumab, risankizumab, tildrakizumab)
- Oral small molecules (e.g., apremilast, deucravacitinib)
- Traditional systemic agents (e.g., methotrexate, cyclosporine, acitretin)
- Phototherapy
Cost & Coverage
Average Cost:
Highly variable, typically >$5,000 - $10,000 per month/dose per 320 mg dose (two 160 mg syringes)
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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately contact 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, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately contact 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, and the time it occurred.