Bimzelx 160mg/ml Autoinjector 1 Pen

Manufacturer UCB Active Ingredient Bimekizumab(BYE me KIZ ue mab) Pronunciation BYE-me-KIZ-oo-mab
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.
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Drug Class
Immunosuppressant, Selective
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Pharmacologic Class
Interleukin-17A and Interleukin-17F Inhibitor
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Pregnancy Category
Not available
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FDA Approved
May 2023
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DEA Schedule
Not Controlled

Overview

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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. This helps to reduce the symptoms of conditions like psoriasis and psoriatic arthritis.
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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 come to room temperature for 30 to 45 minutes. Do not heat the medication. Keep it in the 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.

Administration

Rotate the injection site with each use. If your dose requires multiple injections, administer each injection in a different area. Before use, check the solution for cloudiness, leakage, or particles. The solution should be colorless to pale brownish-yellow. Do not use the medication if the solution has changed color or 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 at a temperature between 2Β°C and 8Β°C (36Β°F and 46Β°F). Do not freeze the medication, and do not use it 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.
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Lifestyle & Tips

  • Avoid live vaccines while on Bimzelx and for a period after stopping treatment. Consult your doctor about any vaccinations.
  • Report any signs of infection (e.g., fever, chills, persistent cough, skin sores) to your doctor immediately.
  • Report any new or worsening stomach pain, diarrhea, or bloody stools to your doctor immediately, as these could be signs of inflammatory bowel disease.
  • Rotate injection sites with each dose to prevent skin reactions.
  • Store the autoinjector in the refrigerator, protected from light, and do not freeze.

Dosing & Administration

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Adult Dosing

Standard Dose: For Plaque Psoriasis: 320 mg (given as two 160 mg subcutaneous injections) at Weeks 0, 4, 8, 12, 16, then every 8 weeks thereafter. For Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic axial spondyloarthritis: 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, 16, then every 8 weeks.
Psoriatic Arthritis: 160 mg every 4 weeks.
Ankylosing Spondylitis: 160 mg every 4 weeks.
Non-radiographic axial spondyloarthritis: 160 mg every 4 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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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

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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. IL-17A and IL-17F are pro-inflammatory cytokines implicated in the pathogenesis of inflammatory diseases like plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. By inhibiting both IL-17A and IL-17F, bimekizumab reduces inflammation and clinical symptoms associated with these conditions.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70%
Tmax: 3 to 6 days
FoodEffect: Not applicable (subcutaneous administration)

Distribution:

Vd: Approximately 11.2 L
ProteinBinding: Not applicable (monoclonal antibody, not typically protein bound in the same way as small molecules)
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)
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Pharmacodynamics

OnsetOfAction: Clinical improvement observed as early as Week 2 for some indications.
PeakEffect: Peak clinical response varies by indication and patient, often seen by Week 16 or later.
DurationOfAction: Maintained with every 4 or 8-week dosing regimen.

Safety & Warnings

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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 immediate medical attention:

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
+ Difficulty 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 experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or 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, 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.
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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: persistent abdominal pain, diarrhea, weight loss, bloody stools.
  • Allergic reactions: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
  • New or worsening joint pain or swelling (for non-arthritis indications).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have inflammatory bowel disease (IBD), as this condition may affect how your body responds to the medication.
If you have an active infection, as this medication may worsen the 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
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 approach. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.

Before initiating treatment with this drug, you will need to undergo a tuberculosis (TB) test. As this medication may increase your risk of developing infections, it is vital to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.

Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication. Consult your doctor to determine the optimal timing for receiving any necessary vaccines. If you have recently received a vaccine or plan to get vaccinated, discuss this with your doctor, as the use of vaccines with this drug may either increase the risk of infection or reduce the vaccine's effectiveness.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. If you took this medication during pregnancy, be sure to notify your baby's doctor, as you will need to discuss the safety and timing of certain vaccines for your child.
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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

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Contraindicated Interactions

  • Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever)
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Moderate Interactions

  • Immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids): May increase risk of infection.

Monitoring

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Baseline Monitoring

Tuberculosis (TB) screening

Rationale: To rule out latent or active TB infection before initiating therapy, as bimekizumab may reactivate latent TB.

Timing: Prior to initiation of therapy.

Hepatitis B Virus (HBV) screening

Rationale: To rule out active or latent HBV infection, as bimekizumab may reactivate HBV.

Timing: Prior to initiation of therapy.

Inflammatory Bowel Disease (IBD) history

Rationale: To assess for pre-existing IBD, as new or worsening IBD has been reported with IL-17 inhibitors.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Signs and symptoms of infection

Frequency: Regularly throughout therapy and after discontinuation.

Target: Absence of fever, chills, cough, dysuria, skin lesions, etc.

Action Threshold: Prompt evaluation and treatment if signs/symptoms of serious infection develop. Consider interrupting therapy.

New or worsening symptoms of Inflammatory Bowel Disease (IBD)

Frequency: Regularly throughout therapy.

Target: Absence of abdominal pain, diarrhea, weight loss, bloody stools.

Action Threshold: If new or worsening IBD symptoms occur, refer to a gastroenterologist and consider discontinuing bimekizumab.

Liver enzymes (ALT, AST)

Frequency: As clinically indicated (e.g., if signs of liver injury develop).

Target: Within normal limits.

Action Threshold: Elevations warrant investigation and potential interruption of therapy.

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Symptom Monitoring

  • Signs of infection (fever, chills, persistent cough, skin warmth/redness/pain, dysuria)
  • Symptoms of inflammatory bowel disease (new or worsening abdominal pain, diarrhea, bloody stools, weight loss)
  • Hypersensitivity reactions (rash, urticaria, angioedema, dyspnea)
  • Injection site reactions (redness, swelling, pain, bruising)

Special Patient Groups

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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: Limited data; theoretical risk of immune system effects on fetal development.
Second Trimester: Limited data; increased placental transfer of IgG antibodies occurs during the second and third trimesters.
Third Trimester: Limited data; increased placental transfer of IgG antibodies occurs during the second and third trimesters.
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Lactation

It is unknown whether bimekizumab is excreted in human milk. Maternal IgG is known to be excreted 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: Low (L3) - While IgG antibodies are present in breast milk, oral absorption by the infant is generally low. Monitor breastfed infants for signs of infection or adverse reactions.
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Pediatric Use

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly subjects (β‰₯65 years) and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infections was higher in bimekizumab-treated subjects β‰₯65 years of age compared to those <65 years of age in clinical trials. Use with caution in the elderly due to the generally higher incidence of infections in this population.

Clinical Information

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Clinical Pearls

  • Bimzelx is the first IL-17 inhibitor to selectively inhibit both IL-17A and IL-17F, which may offer a more complete blockade of the IL-17 pathway.
  • Patients should be screened for tuberculosis (TB) and hepatitis B virus (HBV) prior to initiating therapy.
  • Patients should be advised to avoid live vaccines during treatment and for a period after discontinuation.
  • Instruct patients on proper subcutaneous injection technique, including rotating injection sites.
  • Monitor patients for new or worsening inflammatory bowel disease (IBD) symptoms, as IL-17 inhibitors have been associated with IBD exacerbations or new onset.
  • Consider interrupting therapy if a patient develops a serious infection.
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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)
  • PDE4 inhibitors (e.g., apremilast)
  • JAK inhibitors (e.g., tofacitinib, upadacitinib, baricitinib)
  • Conventional DMARDs (e.g., methotrexate, cyclosporine, sulfasalazine, leflunomide)
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Cost & Coverage

Average Cost: Typically >$5,000 - $10,000 per 160mg/ml autoinjector (monthly/bi-monthly supply)
Insurance Coverage: Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 provides crucial information. Please read this guide carefully and review it again each time 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 your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.