Bimzelx (bimekizumab) for Plaque Psoriasis

Bimzelx contains the active substance bimekizumab and is used in adults to treat a skin condition called plaque psoriasis. It reduces the symptoms of plaque psoriasis, including pain, itching, and scaling of the skin.

Bimekizumab, the active substance in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimekizumab works by inhibiting or reducing the activity of two proteins called IL-17A and IL-17F. These two proteins cause inflammation in the skin.

Do not use Bimzelx:

• if you are allergic to the active ingredient bimekizumab or any of the other ingredients present in this medicine.

• if you have an infection, including tuberculosis (TB).

Tell your doctor about all of your medical conditions, including if you

• you have an infection or an infection that keeps coming back.

• If you are pregnant or are planning to become pregnant. It is not known if Bimzelx will affect your unborn baby. Make sure to use contraception while using this medicine and for at least 17 weeks after your last dose of Bimzelx.

• If you are breastfeeding or are planning to breastfeed. It is not known if Bimzelx can pass into your breast milk.

• you received a vaccination or planning to have a vaccination. You shouldn’t receive live vaccines while using Bimzelx.

• you have ever had tuberculosis (TB).

• you have ever had inflammatory bowel disease (like Crohn’s disease or ulcerative colitis).

You will have to talk to your healthcare provider about how to use Bimzelx.

The recommended dose, given as injections under your skin (‘subcutaneous injections’) is as follows:

• 320 mg (given as two pre-filled pens, containing 160 mg each) at weeks 0, 4, 8, 12, and 16.

• From week 16, you will use 320 mg (two pre-filled pens, containing 160 mg each) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue your injections every 4 weeks from week 16.

• upper respiratory infections with symptoms such as sore throat and stuffy nose

• thrush in the mouth or throat with symptoms such as white or yellow patches; red or sore mouth and pain with swallowing

• fungal infection of the skin (such as athlete’s foot between the toes)

• ear infections

• cold sores (herpes simplex infections)

• stomach flu (gastroenteritis)

• inflamed hair follicles which may look like pimples

• headache

• dermatitis

• acne

• redness, pain, or swelling at the site of injection

• feeling tired

• lowered levels of white blood cells (neutropenia)

• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)

• conjunctivitis

• blood in the stool, abdominal cramps, pain, diarrhea, or weight loss (signs of bowel problems)

• Inflammatory bowel disease (Crohn’s disease or ulcerative colitis): call your doctor or get medical help immediately if you notice abdominal cramps, blood in the stool, pain, diarrhea, or weight loss. These may be signs of new or worsening inflammatory bowel disease.

• Infections and allergic reactions: Bimzelx can rarely cause serious infections like tuberculosis. Talk to your doctor right away if you notice any signs of a serious infection. it can also cause some serious allergic reactions. Talk to your doctor if you notice any signs of a serious allergic reaction. Such signs may include:
  • difficulty breathing or swallowing
  • low blood pressure (making you dizzy or light-headed)
  • swelling of the lips, face, tongue, or throat
  • severe itching of the skin, with a red rash or raised bumps.

• Vaccinations: Make sure to not receive live vaccines while using Bimzelx.

• Keep this medicine out of the reach of children.

• Store in a refrigerator (do not freeze) between 2°C and 8°C.

• Keep the pre-filled syringes in the original carton in order to protect them from light.

• Bimzelx can be kept out of the refrigerator for up to 25 days.

Active ingredients: bimekizumab
Inactive ingredients: glycine, glacial acetic acid, sodium acetate trihydrate, polysorbate 80, and water for injections.