JASCAYD Film-coated tablet Ref.[116083] Active ingredients: Nerandomilast

2.1 Recommended Dosage and Administration Instructions

The recommended dosage of JASCAYD is 18 mg twice daily, administered orally approximately 12 hours apart, with or without food.

• Recommended dosage of JASCAYD is 18 mg twice daily when used concomitantly with pirfenidone. Do not reduce dosage to 9 mg twice daily [see Drug Interactions (7.1)].
• Reduce JASCAYD to 9 mg twice daily for patients who are unable to tolerate 18 mg twice daily, except in patients who concomitantly use JASCAYD with pirfenidone.

Administration Instructions

Swallow JASCAYD tablets whole or dispersed in water [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

Missed Dose(s)

If a dose of JASCAYD is missed, advise the patient to take the next dose at the next scheduled time. Advise the patient to not make up for a missed dose.

Maximum Recommended Dosage

The maximum recommended dosage of JASCAYD is 18 mg twice daily.

2.2 Dosage Modification of JASCAYD for Concomitant Use With CYP3A Inhibitors

Strong CYP3A Inhibitors

Reduce JASCAYD dosage to 9 mg twice daily when used concomitantly with strong CYP3A inhibitors [see Drug Interactions (7.1)].

Moderate and Weak CYP3A Inhibitors

No dosage modification is recommended for JASCAYD when used concomitantly with moderate or weak CYP3A inhibitors.

2.3 Administration Instructions for Patients Who Have Difficulty Swallowing Tablets

Disperse JASCAYD tablet in water and administer as follows:

• Place approximately 100 mL (3 to 4 ounces) of non-carbonated, room temperature water in a glass. Do not use any other liquids.
• Place a JASCAYD tablet in the water, without crushing, and stir regularly for approximately 15 to 20 minutes until the tablet is dispersed into very small pieces (the tablet will not completely dissolve).
• Drink the dispersion within 2 hours of mixing.
• If the dispersion is not drunk immediately, stir again before drinking.
• Rinse the glass with approximately 100 mL (3 to 4 ounces) of water and drink to ensure the full dose is administered.

In the event of an overdosage with JASCAYD, monitor the patient for any signs or symptoms of adverse reactions and provide appropriate symptomatic treatment. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original container to protect from light.