Nerandomilast-Jascayd instruction manual in Chinese

1. Common names:Nerandomilast, Nerandomilast

Product name:Jascayd, Boyouwe

Other names: Nidalast, Nelalast, Namilast tablets

2. Indications:

Nerandomilast (Nerandomilast)-Jascayd is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients.

3. Usage and dosage:

1. Recommended dosage and administration instructions:

The recommended dose of namilast tablets is18mg, taken orally twice a day, about 12 hours apart, with or without food.

The recommended dose of namilast tablets when used concurrently with pirfenidone is18 mg twice daily. Do not reduce the dose to 9 mg twice daily.

For patients who cannot tolerate 18 mg twice daily, reduce Namilast tablets to 9 mg twice daily, except in patients taking Namilast tablets and pirfenidone concurrently.

2. Management instructions

Swallow the namilast tablets whole or disperse in water. If a dose of Namilast is missed, advise the patient to take the next dose at the next scheduled time. Advise patients not to make up missed doses.

3. The maximum recommended dose of Namilast tablets is 18 mg, twice daily.

4. Dosage adjustment

1) Strong CYP3A inhibitors: When used concurrently with strong CYP3A inhibitors, reduce the dose to 9 mg twice daily.

2) Moderate and weak CYP3A inhibitors: When used concurrently with moderate or weak CYP3A inhibitors, it is not recommended to adjust the dose of Namilast tablets.

5. Medication instructions for patients with dysphagia

Disperse Namilast tablets in water and administer as follows: Place approximately100 mL (3 to 4 ounces) of noncarbonated room temperature water in a glass. Do not use any other liquid. Place the Namilast tablets in the water without crushing and stir regularly for about 15 to 20 minutes until the tablets are dispersed into very small pieces (the tablets will not completely dissolve). Drink the dispersion within 2 hours of mixing. If the dispersion is not consumed 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 taken.

4. Adverse reactions:

In clinical studies of namilast tablets, common adverse reactions (≥5%) include diarrhea, COVID-19, upper respiratory tract infection, depression, weight loss, decreased appetite, nausea, fatigue, headache, vomiting, back pain and dizziness.

5. Supply and storage:

Nerandomilast tablets for oral administration contain Nerandomilast.Nerandomilast is available in 9 mg and 18 mg strengths. Each box contains 60 tablets and can be stored at 20°C to 25°C (68°F to 77°F); tolerance is 15°C to 30°C (59°F to 86°F). Store in original container protected from light.

6. Taboo:

None.

7. Mechanism of action:

According to in vitro data, namilast is an inhibitor of phosphodiesterase4 (PDE4), and its preferential inhibitory effect on the PDE4B isoenzyme is at least 9 times greater than that of PDE4A, PDE4C and PDE4D. PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP). Namilast exerts antifibrotic and immunomodulatory effects because PDE4B inhibition increases intracellular cAMP levels and reduces the expression of profibrotic growth factors and inflammatory cytokines, which are overexpressed in IPF.

8. Listing situation:

Original drug:

United States:2025-10, approved for marketing (trade name: Jascayd)

China:2025-10, approved for listing (trade name: Jascayd/Boyouwei)

Reference materials:https://www.drugs.com/jascayd.html