SUMMARY

• The company cannot recommend any practices, procedures or usage of ICOTYDE that deviate from the approved labeling.
• Please refer to the ICOTYDE Prescribing Information for additional details.

PRESCRIBING INFORMATION

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.
• Complete all age-appropriate vaccinations according to current immunization guidelines.

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.
• 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.

Alternative Preparation and Administration Instructions

• For patients who have difficulty swallowing tablets, ICOTYDE 200 mg tablet can be dispersed in water. The following instructions should be followed:
  • Place one ICOTYDE 200 mg 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.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 17 March 2026.