Ixekizumab

Generic name: Ixekizumab
Brand names: Taltz
Dosage form: subcutaneous injection
Drug class: Interleukin inhibitors

Usage of Ixekizumab

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.

Ixekizumab side effects

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.

Before taking Ixekizumab

Tell your doctor if your are pregnant or plan to become pregnant. It is not known if ixekizumab can harm your unborn baby.

If you become pregnant while taking ixekizumab, you are encouraged to enroll in the pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-800-284-1695 to enroll in the registry.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if ixekizumab passes into your breast milk.

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How to use Ixekizumab

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.

Warnings

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.

What other drugs will affect Ixekizumab

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

Disclaimer

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