Bimzelx 320mg/2ml Pf Autoinj, 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
Interleukin Inhibitor
Pharmacologic Class
Interleukin-17A and Interleukin-17F Inhibitor
Pregnancy Category
Not available
FDA Approved
Jul 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bimzelx is an injectable medicine used to treat moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. It works by blocking two specific proteins in your body (IL-17A and IL-17F) that are involved in causing inflammation and symptoms of these conditions.
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 administered into 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. 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 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 take extra doses. If you have 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 administered into 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. 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 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 take extra doses. If you have questions or concerns, consult your doctor or pharmacist.
Lifestyle & Tips
- Avoid live vaccines (e.g., measles, mumps, rubella, chickenpox) while taking Bimzelx and for a period after stopping it. Discuss any planned vaccinations with your doctor.
- Inform your doctor if you have any signs of infection, such as fever, chills, cough, or skin sores.
- Report any new or worsening stomach pain, diarrhea, or blood in your stool, as these could be signs of inflammatory bowel disease.
- 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. Keep out of reach of children.
- Allow the autoinjector to reach room temperature for 30-45 minutes before injection. Do not warm it in any other way.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
320 mg (given as two 160 mg subcutaneous injections) at Weeks 0, 4, 8, 12, 16, then every 8 weeks thereafter.
Dose Range:
320 - 320 mg
Condition-Specific Dosing:
Psoriatic Arthritis (PsA) / Non-radiographic Axial Spondyloarthritis (nr-axSpA) / Ankylosing Spondylitis (AS):
320 mg (given as two 160 mg subcutaneous injections) at Weeks 0, 4, 8, 12, 16, then every 8 weeks thereafter. For PsA, if inadequate response, consider 320 mg 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 recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Dialysis:
No specific considerations; not expected to be removed by dialysis due to large molecular weight.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
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 both IL-17A and IL-17F, bimekizumab is thought to reduce inflammation and clinical symptoms associated with diseases like plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
Pharmacokinetics
Absorption:
Bioavailability:
70-80%
Tmax:
3-4 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 11.2 L
ProteinBinding:
Not applicable (monoclonal antibody, binds specifically to target cytokines)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 23 days
Clearance:
Approximately 0.33 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 seen by Week 16.
DurationOfAction:
Maintained with every 8-week dosing after initial loading phase.
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 discolored sputum
+ 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. Seek immediate medical attention 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 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 discolored sputum
+ 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. Seek immediate medical attention 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 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, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, painful urination.
- Symptoms of inflammatory bowel disease: persistent abdominal pain, diarrhea, rectal bleeding, weight loss.
- Signs of allergic reaction: rash, hives, swelling of your face, lips, tongue, or throat, difficulty breathing or swallowing, dizziness, feeling faint.
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have inflammatory bowel disease (IBD), as this condition may affect the use of this 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 disease.
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. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and supplements
Vitamins
Your doctor will assess potential interactions between this medication and your other health conditions or medications to determine the safest treatment plan. Never start, stop, or change the dose of any medication without consulting your doctor first.
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have inflammatory bowel disease (IBD), as this condition may affect the use of this 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 disease.
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. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and supplements
Vitamins
Your doctor will assess potential interactions between this medication and your other health conditions or medications to determine the safest treatment plan. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 vaccinations 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 vaccinations with them.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 640 mg intravenously and 640 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) - concurrent administration is contraindicated due to potential for infection.
Major Interactions
- Immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids) - increased risk of serious infections when used concomitantly. Caution advised.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection before initiating treatment, as bimekizumab may increase the risk of TB 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 HBV reactivation.
Timing: Prior to initiation of therapy.
Immunization status review
Rationale: Ensure patients are up-to-date on all age-appropriate immunizations prior to initiating therapy. Avoid live vaccines during treatment.
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, cough, shortness of breath, skin lesions, or other signs of infection.
Action Threshold: Promptly evaluate any new or worsening signs/symptoms of infection. Consider interrupting therapy if a serious infection develops.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout therapy.
Target: Absence of new or worsening abdominal pain, diarrhea, rectal bleeding, or weight loss.
Action Threshold: Evaluate patients for new onset or exacerbation of IBD symptoms. Discontinue bimekizumab if IBD is diagnosed or exacerbated.
Hypersensitivity reactions
Frequency: Monitor during and after injection.
Target: Absence of rash, urticaria, angioedema, dyspnea, or anaphylaxis.
Action Threshold: Discontinue bimekizumab immediately and initiate appropriate therapy if a serious hypersensitivity reaction occurs.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, fatigue, skin warmth/redness/pain, painful urination)
- Symptoms of inflammatory bowel disease (e.g., new or worsening abdominal pain, diarrhea, rectal bleeding, weight loss)
- Symptoms of hypersensitivity/allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing or swallowing, dizziness, feeling faint)
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. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No human data. Animal studies showed no direct or indirect harmful effects with respect to reproductive toxicity.
Second Trimester:
No human data. IgG antibodies are increasingly transferred across the placenta during the second and third trimesters.
Third Trimester:
No human data. IgG antibodies are increasingly transferred across the placenta during the second and third trimesters.
Lactation
It is not known whether bimekizumab is excreted in human milk or absorbed systemically following ingestion. Consider the benefits of breastfeeding, 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:
Unknown. Large protein molecules like monoclonal antibodies are generally poorly absorbed orally by the infant.
Pediatric Use
Safety and effectiveness 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 (âĨ65 years of age) and younger patients. No dose adjustment is required for elderly patients.
Clinical Information
Clinical Pearls
- Bimzelx is a dual IL-17A and IL-17F inhibitor, offering a distinct mechanism compared to single IL-17A inhibitors.
- Patients should be screened for tuberculosis (TB) and hepatitis B virus (HBV) before starting treatment.
- Live vaccines should not be given concurrently with Bimzelx.
- Monitor patients for signs and symptoms of infection, particularly serious infections, and inflammatory bowel disease (IBD).
- Advise patients to report any new or worsening symptoms of IBD (e.g., abdominal pain, diarrhea, rectal bleeding).
- Proper injection technique and storage are crucial for patient safety and drug efficacy.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, ixekizumab)
- TNF inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab, golimumab)
- IL-23 inhibitors (e.g., ustekinumab, guselkumab, risankizumab, tildrakizumab)
- JAK inhibitors (e.g., tofacitinib, upadacitinib, filgotinib)
- PDE4 inhibitors (e.g., apremilast)
- Conventional systemic therapies (e.g., methotrexate, cyclosporine, acitretin)
Cost & Coverage
Average Cost:
Highly variable, typically >$5,000 - $10,000 per month/dose per 320mg/2ml prefilled autoinjector (2 autoinjectors per dose)
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 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. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.