Description
Icotrokinra is used to treat moderate to severe plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is given to patients who may receive other types of treatment, including pills, injection, or phototherapy (light treatment).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of icotrokinra in children younger than 12 years of age or weighing less than 40 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of icotrokinra in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infection, history of or
- Kidney disease or
- Tuberculosis, history of—Use with caution. May make these conditions worse.
- Tuberculosis, active—Should be treated first before receiving this medicine.
Proper Use
Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine when you wake up on an empty stomach with water. Wait at least 30 minutes after taking this medicine before eating food.
Swallow the tablet whole. Do not crush, split, or chew it.
If you are unable to swallow the tablet whole:
- Place one tablet in a cup with at least 120 milliliters (mL) or 4 ounces of water.
- Wait for the tablet to disperse in the water. The tablet may not completely disperse. The mixture may look yellow, milky, or cloudy. You may see small pieces of tablet in the mixture, which are safe to swallow.
- Gently swirl the cup before swallowing the mixture.
- Add another 120 mL of water to the cup and swallow the mixture to make sure that you take the full dose.
- Take the mixture within 15 minutes of preparing it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For plaque psoriasis:
- Adults and children 12 years of age and older weighing at least 40 kilograms (kg)—200 milligrams (mg) once a day.
- Children younger than 12 years of age or weighing less than 40 kg—Use and dose must be determined by your doctor.
- For plaque psoriasis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not throw away the desiccant (drying agent).
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.
Your body's ability to fight infections may be reduced while you are using icotrokinra. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
Do not have any live vaccines (immunizations) while you are being treated with icotrokinra. Check with your doctor before having any vaccines.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Itching in genital or other skin areas
- itching of the vagina or genitals
- scaling
- sore mouth or tongue
- thick, white vaginal discharge with mild or no odor
- white patches in the mouth or tongue
Incidence not known
- Chest pain
- cough
- coughing or spitting up blood
- difficulty in breathing
- fever or chills
- lower back or side pain
- muscle aches
- night sweats
- painful or difficult urination
- sudden high fever or low-grade fever for months
- unusual tiredness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Headache
- nausea
Rare
- Burning feeling in chest or stomach
- indigestion
- stomach upset or discomfort
- tenderness in the stomach area
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80010484
