Generic name: Bimekizumab
Pregnancy & Lactation: Risk data not available
What is Bimzelx Autoinjector?
Bimekizumab is used in adults to treat moderate to severe plaque psoriasis.
Bimekizumab may also be used for purposes not listed in this medication guide.
Warnings
Before you start using bimekizumab, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.
Tell your doctor if you have or have ever had:
- an active or recent infection;
- tuberculosis, been exposed to tuberculosis, or if you recently traveled;
- history of depression or mental illness;
- if you have recently received or are scheduled to receive a vaccine;
- inflammatory bowel disease such as Crohn's disease or ulcerative colitis; or
- liver disease.
Make sure you are current on all vaccines before you start using bimekizumab.
Some people have thoughts about suicide while using bimekizumab. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of bimekizumab on the baby.
Tell your doctor if you are pregnant or breastfeeding.
How should I use Bimzelx Autoinjector
Use Bimzelx Autoinjector (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Before you use bimekizumab, your doctor may test you for tuberculosis or other infections.
Bimekizumab is usually injected once every 4 weeks. Later doses are then injected once every 8 weeks. Your doctor will determine your treatment schedule.
Bimekizumab is injected under the skin. A healthcare provider may give you this injection or may teach you how to properly use this medicine by yourself.
Your dose should be given as 2 injections to receive the full dose. Your healthcare provider will show you where to inject bimekizumab. Do not inject into the same place two times in a row. Do not give an injection into a skin area with psoriasis, or skin that is red, bruised, or tender.
Do not shake the prefilled syringes or autoinjector.
Ask your doctor or pharmacist if you don't understand how to use an injection.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Each prefilled syringe or autoinjector is for one use only. Throw away after one use, even if there is still medicine left inside. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Doses are based on weight. Your dose may change if you gain or lose weight.
You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
You will need frequent blood tests to check your liver function.
Store the medicine in the original container in the refrigerator. Protect from light and do not freeze.
Take the medicine out of the refrigerator and let it reach room temperature for 30 to 45 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.
Bimekizumab may also be stored at room temperature away from moisture and heat. Do not return the medicine to the refrigerator. Throw the medicine away after 30 days if stored at room temperature.
Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.
Bimzelx Autoinjector side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worsening depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
- fever, chills, sore throat;
- mouth sores, red or swollen gums;
- pale skin, easy bruising, unusual bleeding; or
- chest discomfort, wheezing, dry cough or hack, rapid weight loss.
Call your doctor at once if you have:
- severe stomach pain, diarrhea, bloody or tarry stools; or
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Your treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- cold symptoms such as stuffy nose, sneezing, sore throat, headache;
- feeling tired;
- cold sores around your mouth;
- fungal infections;
- folliculitis (redness or crusting around your hair follicles);
- pain, bruising, swelling, or irritation where the medicine was injected;
- upset stomach, vomiting (stomach flu symptoms); or
- acne.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Bimzelx Autoinjector?
Never share an injection pen, cartridge, or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.
Do not receive a "live" vaccine while using bimekizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.