Icotyde

Icotyde (icotrokinra) is a once-daily tablet used for moderate-to-severe plaque psoriasis in adults and children 12 years and older who weigh at least 88 lbs (40 kg).

Icotyde works by blocking the IL-23 receptor, a key immune system protein that drives inflammation and the formation of plaque psoriasis. By inhibiting IL-23, Icotyde helps reduce the inflammatory activity to improve plaque psoriasis symptoms.

Icotyde is taken once daily with water on an empty stomach upon waking, and patients should wait at least 30 minutes before eating. For people who have difficulty swallowing tablets, Icotyde may be dispersed in water before taking.

Icotyde pill is the first IL-23 receptor antagonist psoriasis treatment that you can take by mouth rather than an injection.

Icotyde is FDA-approved to be used for moderate-to-severe plaque psoriasis in patients who are:

• 12 years and older who weigh at least 88 lbs (40 kg), and
• candidates for systemic therapy or phototherapy.

Icotyde was effective in the clinical trial ICONIC-ADVANCE 1, helping more patients achieve major psoriasis improvement and clearer skin than placebo or deucravacitinib.

At Week 16, Icotyde significantly improved psoriasis severity:

• 55% of Icotyde patients had a 90% improvement in psoriasis severity** compared 4% on placebo and 30% on deucravacitinib (Sotyktu).
• 68% of Icotyde patients had clear or almost clear skin* compared to 11% on placebo and 50% taking deucravacitinib.
• The responses were still strong at week 24. 74% of patients on Icotyde achieved clear or almost clear skin, vs 52% of deucravacitinib (Sotyktu) patients.

*clear or almost clear skin, with at least a 2-grade improvement = IGA 0/1 ** 90% improvement in psoriasis severity = PASI 90

Infections: Do not take Icotyde if you have an active infection that is medically important, unless the infection has gone away or has been properly treated. If you develop this type of infection while taking Icotyde, your healthcare provider may tell you to stop taking it until the infection clears up.

Tuberculosis (TB): Your healthcare provider may decide to check you for TB before you start treatment with this medicine. They should also watch for signs and symptoms of active TB during treatment and after treatment ends.

Immunizations: You should avoid receiving live vaccines while being treated with this medicine

Moderate or Severe Renal Impairment: Monitor for potential adverse reactions when this medicine is used in patients with eGFR <60 mL/min.

Before taking this medicine, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection that does not go away or that keeps coming back.
• have tuberculosis (TB) or have been in close contact with someone with TB.
• have kidney problems.

Vaccinations

Complete all age-appropriate vaccinations according to current immunization guidelines. Avoid receiving live vaccines during treatment with this medicine.

Pregnancy

Tell your healthcare providers if you are pregnant or plan to become pregnant. It is not known if this medicine can harm your unborn baby. There is a pregnancy safety study for women who take Icotyde during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with Icotyde, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com.

Breastfeeding

Tell your healthcare providers if you are breastfeeding or plan to breastfeed. It is not known if Icotyde passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine

Common Icotyde side effects included headache (4.1%), nausea (1.2%), cough (1.2%), fungal infections (1.1%), and tiredness (1%) in the clinical trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16. Stomach irritation (gastritis) or abdominal discomfort was reported in less than 1% of patients.

Serious 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.

This medicine may cause serious side effects. Call your doctor at once if you have:

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• signs of tuberculosis - fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

The recommended Icotyde dosage is 200 mg taken orally once daily.

It should be taken upon waking on an empty stomach with water, and patients should wait at least 30 minutes before eating.

Tablets should be swallowed whole and not crushed, split, or chewed.

For those who have difficulty swallowing, the Icotyde tablet may be dispersed in water before swallowing. This helps make the treatment more practical for patients who cannot easily swallow tablets.

How to take Icotyde in water

Place 1 tablet in a cup with at least 120 mL (4 ounces) of water. Wait a few minutes for the tablet to break apart in the water. It may not dissolve completely.

The mixture may look yellow, milky, or cloudy. You may also see small pieces of the tablet in the water. This is normal, and the pieces are safe to swallow.

Before drinking, gently swirl the cup. Swallow the mixture, then add at least 120 mL (4 ounces) of water to the same cup. Drink all of this second mixture to make sure you take the full dose of Icotyde.

Use the mixture within 15 minutes of preparation.

Icotyde recommended dosage: 200 mg orally once daily.

Moderate or Severe Kidney Problems: If you have moderate or severe kidney impairment (eGFR less than 60 mL/min), your healthcare provider may monitor you more closely for possible side effects while you are taking this medicine.

Tablets: 200 mg

What happens if I miss a dose?

If you miss a dose of Icotyde, take the dose as soon as you remember and go back to your regular schedule the next day.

Tell your healthcare providers about all medicines you take or use, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Store in the original bottle to protect from moisture.
• The original bottle comes with a child-resistant cap and contains a desiccant packet to keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant packet.
• Keep Icotyde and all medicines out of the reach of children.

Active ingredient: icotrokinra

Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and silicified microcrystalline cellulose.

Film coating: glyceryl monocaprylocaprate, iron oxide yellow, macrogol polyvinyl alcohol graft polymer, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.

Manufactured for: Janssen Biotech, Inc., Horsham, PA 19044, USA