Icotrokinra

Icotrokinra is used to treat moderate-to-severe plaque psoriasis in adults and in children 12 years of age and older who weigh at least 88 pounds (40 kg). These patients may receive treatment with medicine taken by mouth, injections, or UV light therapy.

Icotrokinra may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Before you use icotrokinra, your doctor may test you for tuberculosis or other infections.

Take icotrokinra once each day when you wake up.

Take it on an empty stomach with water, at least 30 minutes before a meal.

Swallow the tablet whole and do not crush, chew, or break it.

If you are unable to swallow a tablet, read and carefully follow the instructions provided to you on how to prepare and use icotrokinra.

• Place 1 tablet in at least 4 ounces (120 mL) of water.
• Wait a few minutes (it may look cloudy or have small pieces, which are safe to swallow).
• Swirl gently and drink the full mixture. Add another 4 ounces of water, swirl, and drink to get the full dose. Use within 15 minutes of mixing.
• Ask a doctor or pharmacist if you need help or do not understand these instructions.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Icotrokinra may reduce your ability to fight infections and may raise your risk of getting an infection. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment. You will be monitored for signs of TB during and after treatment.

Before you start using icotrokinra, 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 chronic infection;
• tuberculosis (TB) or close contact with someone with TB;
• if you are scheduled to receive a vaccine; or
• kidney disease.

Tell your doctor if you've had or been exposed to tuberculosis, or if you have recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Make sure you are current on all vaccines before you start using icotrokinra.

It is not known if icotrokinra will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using icotrokinra. It is not known if icotrokinra passes into your breastmilk.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Icotrokinra may cause serious side effects. Call your doctor right away 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.

Common side effects of icotrokinra may include:

• headache;
• nausea;
• cough;
• fungal infection; or
• tiredness.

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.

Usual Adult Dose for Psoriasis:

Weight at least 40 kg: 200 mg orally once a day Comments:-Administer upon waking on an empty stomach. -Prior to therapy, consider evaluating patients for tuberculosis (TB) infection and complete all age-appropriate vaccinations. Use: For the treatment of moderate-to-severe plaque psoriasis in patients who weigh at least 40 kg and are candidates for systemic therapy or phototherapy

Usual Pediatric Dose for Psoriasis:

12 years and older and at least 40 kg: 200 mg orally once a dayComments:-Administer upon waking on an empty stomach. -Prior to therapy, consider evaluating patients for tuberculosis (TB) infection and complete all age-appropriate vaccinations. Use: For the treatment of moderate-to-severe plaque psoriasis in patients at least 12 years of age who weigh at least 40 kg and are candidates for systemic therapy or phototherapy

Take the missed dose on the same day you remember it. Take your next dose at the regular time and continue with your once-daily schedule. Do not take two doses in one day.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Other drugs may affect icotrokinra, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you take.