ICOTYDE Film-coated tablet Ref.[116431] Active ingredients: Icotrokinra

2.1 Recommended Evaluation and Immunizations Prior to Treatment Initiation

• Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment [see Warnings and Precautions (5.2)].
• Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.3)].

2.2 Recommended Dosage and Administration Instructions

The recommended dosage of ICOTYDE is 200 mg administered orally once daily.

Administer ICOTYDE upon waking on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food. Swallow ICOTYDE whole. Do not crush, split, or chew tablets [see Clinical Pharmacology (12.3)].

If a patient misses a dose, instruct patients to take the missed dose as soon as possible with a return to normal dosing schedule the following day.

2.3 Alternative Preparation and Administration Instructions for Patients Who Have Difficulty Swallowing Tablets

ICOTYDE 200 mg tablet can also be dispersed in water using the following instructions:

• Place one ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water. It may take a few minutes for the tablet to disperse. The tablet may not completely disperse. The mixture may look yellow, milky, or cloudy, and small pieces may be seen in the water which are safe to swallow.
• Gently swirl the cup before drinking and swallowing the full mixture.
• Add at least 120 mL (4 ounces) of additional water to the cup and completely swallow the contents to make sure the whole dose is taken.
• Complete administration of ICOTYDE within 15 minutes of dispersion in water.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in original package to protect from moisture. Do not discard desiccant.