Bimzelx 160mg/ml Autoinjector, 2pen
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, Selective
Pharmacologic Class
Interleukin-17A and Interleukin-17F Inhibitor
Pregnancy Category
Not assigned (Risk Summary available)
FDA Approved
Oct 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bimzelx is a medication that helps reduce inflammation in your body. It works by blocking specific proteins (IL-17A and IL-17F) that cause inflammation in conditions like psoriasis and certain types of arthritis. This helps to clear skin plaques and reduce joint pain and stiffness.
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 also 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 sit at room temperature for 30 to 45 minutes. Do not heat the medication or expose it to direct sunlight. Keep the medication in its original carton to protect it from light. 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 you need to administer multiple injections, use a different area for each injection. 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.
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. After administering the dose, discard any remaining medication and dispose of the needle in a sharps disposal container. Do not reuse needles or other materials.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze it. Do not use the medication if it has been frozen. When disposing of the medication, follow local regulations and guidelines. If you have any questions or concerns, consult your doctor or pharmacist.
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 administer 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 also 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 sit at room temperature for 30 to 45 minutes. Do not heat the medication or expose it to direct sunlight. Keep the medication in its original carton to protect it from light. 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 you need to administer multiple injections, use a different area for each injection. 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.
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. After administering the dose, discard any remaining medication and dispose of the needle in a sharps disposal container. Do not reuse needles or other materials.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze it. Do not use the medication if it has been frozen. When disposing of the medication, follow local regulations and guidelines. If you have any questions or concerns, consult your doctor or pharmacist.
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 administer extra doses.
Lifestyle & Tips
- Avoid live vaccines while taking Bimzelx and for several months after stopping it. Discuss any vaccinations with your doctor.
- Report any signs of infection (e.g., fever, chills, persistent cough, skin sores) to your doctor immediately.
- Inform your healthcare provider if you have a history of tuberculosis or hepatitis B, or if you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Store Bimzelx in the refrigerator (2°C to 8°C / 36°F to 46°F) in its original carton to protect from light. Do not freeze. Do not shake. If needed, it can be stored at room temperature (up to 25°C / 77°F) for a maximum of 25 days, but must be discarded if not used within that time.
- Learn proper self-injection technique from your healthcare provider or nurse.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Plaque Psoriasis: 320 mg (given as two 160 mg subcutaneous injections) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis, and Ankylosing Spondyloarthritis: 160 mg (given as one 160 mg subcutaneous injection) every 4 weeks.
Dose Range:
160 - 320 mg
Condition-Specific Dosing:
Plaque Psoriasis:
320 mg (two 160 mg injections) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks.
Psoriatic Arthritis:
160 mg (one 160 mg injection) every 4 weeks.
Non-radiographic Axial Spondyloarthritis:
160 mg (one 160 mg injection) every 4 weeks.
Ankylosing Spondyloarthritis:
160 mg (one 160 mg injection) every 4 weeks.
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 studies conducted; no dose adjustment expected based on metabolism.
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 monoclonal IgG1 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 autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
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)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 23 days
Clearance:
Approximately 0.337 L/day
ExcretionRoute:
Primarily via catabolism; not renally or hepatically cleared in the traditional sense.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed as early as Week 2 for psoriasis.
PeakEffect:
Peak clinical response typically observed by Week 16 for psoriasis.
DurationOfAction:
Maintained with every 8-week dosing for psoriasis after initial loading phase; every 4-week dosing for other indications.
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 notice 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
+ Pain while urinating
+ 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, patients 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 of these thoughts and actions. If you have any concerns, discuss them with your doctor. Seek immediate medical attention if you experience:
New or worsening symptoms of 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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
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, 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 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
+ Pain while urinating
+ 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, patients 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 of these thoughts and actions. If you have any concerns, discuss them with your doctor. Seek immediate medical attention if you experience:
New or worsening symptoms of 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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
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, 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, painful urination, diarrhea.
- Signs of allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- New or worsening symptoms of inflammatory bowel disease: persistent abdominal pain, diarrhea, bloody stools, weight loss.
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 you respond to the medication.
If you have an active infection, as this medication may worsen the condition or interact with other treatments.
If you have been diagnosed with tuberculosis (TB), as this medication may reactivate the infection.
If you have liver disease, as this condition may impact the medication's metabolism and increase the risk of side effects.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. 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 supplements you use
Vitamins you take
Your doctor will assess the safety of taking this medication with your existing health conditions and medications. Do not initiate, stop, or adjust the dosage 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 you respond to the medication.
If you have an active infection, as this medication may worsen the condition or interact with other treatments.
If you have been diagnosed with tuberculosis (TB), as this medication may reactivate the infection.
If you have liver disease, as this condition may impact the medication's metabolism and increase the risk of side effects.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. 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 supplements you use
Vitamins you take
Your doctor will assess the safety of taking this medication with your existing health conditions and medications. Do not initiate, stop, or adjust the dosage 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 used 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 with them.
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 used 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 with them.
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) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, live attenuated influenza vaccine) - concurrent administration is contraindicated due to potential for infection.
Major Interactions
- Immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids) - concomitant use may increase the risk of infection. Caution advised.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, as bimekizumab may increase the risk of reactivation.
Timing: Prior to initiation of therapy.
Hepatitis B Virus (HBV) screening
Rationale: To rule out active or latent HBV infection, as bimekizumab may increase the risk of reactivation.
Timing: Prior to initiation of therapy.
Inflammatory Bowel Disease (IBD) history
Rationale: Bimekizumab has been associated with new onset or exacerbation of IBD. Assess patient history.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout therapy and for several months 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 develop. Consider interrupting therapy.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout therapy.
Target: Absence of abdominal pain, diarrhea, weight loss, bloody stools.
Action Threshold: If new onset or exacerbation of IBD occurs, discontinue bimekizumab and initiate appropriate medical management.
Symptom Monitoring
- Signs of infection (fever, chills, persistent cough, shortness of breath, skin warmth/redness/pain, painful urination)
- Symptoms of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Symptoms of inflammatory bowel disease (new or worsening abdominal pain, diarrhea, bloody stools, weight loss)
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. A pregnancy exposure registry is available.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies did not show direct harmful effects.
Second Trimester:
Limited human data; animal studies did not show direct harmful effects.
Third Trimester:
Increased placental transfer of IgG antibodies, potentially leading to fetal exposure.
Lactation
Bimekizumab is an IgG antibody and is present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant are unknown. 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:
Low to moderate risk. Potential for infant exposure, but oral absorption of intact antibodies by infants is generally low.
Pediatric Use
The safety and effectiveness of Bimzelx 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 (≥65 years) and younger patients. No dose adjustment is required for elderly patients.
Clinical Information
Clinical Pearls
- Bimzelx is the first and only approved biologic that selectively inhibits both IL-17A and IL-17F, offering a unique mechanism of action for inflammatory conditions.
- Patients should be screened for tuberculosis and hepatitis B before starting treatment.
- Patients should be advised to report any signs of infection promptly, as serious infections can occur.
- Live vaccines should not be administered concurrently with Bimzelx.
- Monitor for new onset or exacerbation of inflammatory bowel disease symptoms, and discontinue treatment if these occur.
- Proper injection technique is crucial for patient adherence and efficacy; provide thorough training.
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, tofacitinib, deucravacitinib)
- Conventional systemic agents (e.g., methotrexate, cyclosporine, acitretin)
Cost & Coverage
Average Cost:
Highly variable, typically >$5,000 per month per 160mg/ml autoinjector
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 use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.