Ixekizumab is a biological medicine called a monoclonal antibody that is used to treat certain autoimmune disorders that cause inflammation.

Ixekizumab suppresses the immune system and helps to prevent inflammation. It works by binding to a protein in your body called cytokine interleukin 17A (IL-17A), preventing it from interacting with the IL-17 receptor. This blocks the release of substances called cytokine and chemokines that cause inflammation. 

Ixekizumab was approved by the US Food and Drug Administration (FDA) in 2016. No biosimilars of ixekizumab have been approved. Biosimilars are highly similar versions of ixekizumab that are designed to have the same effect on a person, but a biosimilar is not identical to the original version of the drug.

What is ixekizumab used for?

Ixekizumab is a prescription medicine used to treat:

• people 6 years of age and older with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
• adults with active psoriatic arthritis. Ixekizumab can be used alone or with the medicine methotrexate.
• adults with active ankylosing spondylitis.
• adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

It is not known if ixekizumab is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age.

Ixekizumab is a medicine that affects your immune system. Ixekizumab may lower the ability of your immune system to fight infections and may increase your risk of infections, which can sometimes become serious.

• Your healthcare provider should check you for tuberculosis (TB) before you start treatment with ixekizumab. People with active tuberculosis should not take this medicine. Your healthcare provider may treat you for tuberculosis before you begin treatment with ixekizumab if you currently have tuberculosis or if you had tuberculosis.
• Your healthcare provider may treat you with medicine for TB before you begin treatment with ixekizumab if you have a past history of TB or have TB.
• Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ixekizumab.

Before starting ixekizumab, tell your healthcare provider if you:

• are being treated for an infection
• have an infection that does not go away or that keeps coming back
• have TB or have been in close contact with someone with TB
• think you have an infection or have symptoms of an infection such as:
  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm (mucus)
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal

After starting ixekizumab, call your healthcare provider right away if you have any of the symptoms of infection listed above.

Do not use ixekizumab if you have any symptoms of infection unless you are instructed to by your healthcare provider.

See “What are the side effects of ixekizumab?” below for more information about side effects.

See the detailed “Instructions for Use” that comes with your ixekizumab for information on how to prepare and inject a dose of ixekizumab, and how to properly throw away (dispose of) used ixekizumab autoinjectors and prefilled syringes.

• Use ixekizumab exactly as prescribed by your healthcare provider.
• For children weighing 110 pounds (50 kg) or less, ixekizumab must be given by a healthcare provider. ixekizumab will be given every 4 weeks.
• For children weighing more than 110 pounds (50 kg), if your healthcare provider decides that your caregiver may give your injections of ixekizumab at home, your caregiver should ask and receive training from the healthcare provider on the right way to prepare and inject ixekizumab. Ixekizumab will be given every 4 weeks.
• For adults, if your healthcare provider decides that you or a caregiver may give your injections of ixekizumab at home, you should receive training on the right way to prepare and inject ixekizumab. Do not try to inject ixekizumab yourself, until you or your caregiver have been shown how to inject ixekizumab.
• Ixekizumab comes in an autoinjector and a prefilled syringe that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of ixekizumab is best for you to use at home.
• Ixekizumab is given as an injection under your skin (subcutaneous injection), in your thighs or stomach area (abdomen) by you or a caregiver. A caregiver may also give you an injection of ixekizumab in the back of your arm.
• Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis.
• Each ixekizumab injection should be given at a different site. Do not use the 1 inch area around your navel (belly button).

The recommended dose of ixekizumab for different groups of patients are listed below.

• Adult Plaque Psoriasis
  • Recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.
• Pediatric Plaque Psoriasis
  • For patients weighing greater than 50 kg, recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
  • For patients weighing 25-50 kg, recommended dose is 80 mg at Week 0, followed by 40 mg every 4 weeks.
  • For patients weighing less than 25 kg, recommended dose is 40 mg at Week 0, followed by 20 mg every 4 weeks.
• Psoriatic Arthritis
  • Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
  • For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for adult plaque psoriasis.
  • Ixekizumab may be administered alone or in combination with a conventional DMARD (e.g., methotrexate).
• Ankylosing Spondylitis
  • Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
• Non-radiographic Axial Spondyloarthritis
  • Recommended dose is 80 mg by subcutaneous injection every 4 weeks.

Do not use ixekizumab if you have had a severe allergic reaction to ixekizumab or any of the other ingredients in ixekizumab.

See below for a complete list of ingredients in ixekizumab.

What should I tell my doctor before using ixekizumab?

Before using ixekizumab, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section “Important information” above
• have Crohn's disease or ulcerative colitis
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with ixekizumab.

If you forget to take your dose:

Do not miss any doses of ixekizumab unless your healthcare provider says it is okay. If you forget to take your ixekizumab dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time.

If you inject more ixekizumab than prescribed, call your healthcare provider or go to the nearest emergency room right away.

Ixekizumab may cause serious side effects, including:

• See "Important information" above
• Serious allergic reactions. If you have a severe allergic reaction, do not give another injection of ixekizumab. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
  • feel faint
  • swelling of your face, eyelids, lips, mouth, tongue, or throat
  • trouble breathing or throat tightness
  • chest tightness
  • skin rash
• Crohn's disease or ulcerative colitis (inflammatory bowel disease) can happen during treatment with ixekizumab, including worsening symptoms. Tell your healthcare provider if you have new or worsening symptoms of inflammatory bowel disease during treatment with ixekizumab, including:
  • stomach (abdomen) pain
  • diarrhea with or without blood
  • weight loss

The most common side effects of ixekizumab in adults and children include:

• injection site reactions
• upper respiratory infections
• nausea
• fungal infections

These are not all of the possible side effects of ixekizumab. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.