Bimzelx 160mg/ml Autoinjector 1 Pen
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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).
Before Using This Medicine
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.
Precautions & Cautions
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.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 640 mg intravenously have been administered without dose-limiting toxicity.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever)
Moderate Interactions
- Immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids): May increase risk of infection.
Monitoring
Baseline Monitoring
Rationale: To rule out latent or active TB infection before initiating therapy, as bimekizumab may reactivate latent TB.
Timing: Prior to initiation of therapy.
Rationale: To rule out active or latent HBV infection, as bimekizumab may reactivate HBV.
Timing: Prior to initiation of therapy.
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.
Routine Monitoring
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.
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.
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.
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
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:
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 motherβs clinical need for bimekizumab and any potential adverse effects on the breastfed infant from bimekizumab or from the underlying maternal condition.
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 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
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.
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)