Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Jascayd is indicated for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF).
Jascayd is indicated for the treatment of adult patients with Progressive Pulmonary Fibrosis (PPF).
Treatment should be initiated by physicians experienced in the management of diseases for which Jascayd is approved.
The recommended dose is 18 mg twice daily, administered approximately 12 hours apart.
Based on individual patient tolerability of the side effects of diarrhoea or weight decrease (see section 4.4 and section 4.8) and based on the anticipated benefit of treatment with nerandomilast (see section 5.1), the dose may be reduced to 9 mg twice daily (except in patients who concomitantly use pirfenidone or strong or moderate cytochrome P450 3A (CYP3A) inducers, see section 4.5). Once the adverse reaction has resolved or is adequately controlled, treatment may be resumed at the recommended dose of 18 mg twice daily.
If used concomitantly with strong CYP3A inhibitors, the dose must be reduced to 9 mg twice daily (see section 4.5).
If used concomitantly with strong or moderate CYP3A inducers, the recommended dose is 18 mg twice daily and must not be reduced to 9 mg twice daily (see section 4.5).
Concomitant use with pirfenidone decreased nerandomilast exposure by approximately 50% (see section 4.5). In patients using pirfenidone, the recommended dose is 18 mg twice daily and must not be reduced to 9 mg twice daily.
If a dose is missed, the next dose should be taken at the next scheduled time. The patient should not take an additional dose. The recommended maximum dose of 18 mg twice daily should not be exceeded.
No dose adjustment is required in elderly patients (see section 5.2).
No dose adjustment is necessary in patients with mild, moderate, or severe renal impairment (eGFR ≥15 and <90 mL/min, based on CKD-EPI formula) (see section 5.2).
Treatment of patients with end stage renal disease (eGFR <15 mL/min) is not recommended. The pharmacokinetics, safety and efficacy of nerandomilast in these patients have not been investigated.
No dose adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment (see section 5.2).
Treatment of patients with severe hepatic impairment (Child-Pugh class C) is not recommended. The pharmacokinetics, safety and efficacy of nerandomilast in these patients have not been investigated.
The safety and efficacy in paediatric patients have not yet been established.
No data are available.
Jascayd is for oral use. The tablets should be swallowed whole with water.
Jascayd can be taken with or without food (see section 5.2).
For patients who have difficulty swallowing the whole tablet, a tablet may be dispersed in a glass with approximately 100 mL of non-carbonated, room temperature drinking water. No other liquids should be used. The tablet should be dropped in water without crushing it and stirred regularly for approximately 15-20 min until the tablet is dispersed into very small pieces (the tablets will not completely dissolve). The resultant dispersion should be drunk within 2 hours of mixing. If the dispersion is not drunk immediately, patients must stir again before drinking. The glass should be rinsed with approximately 100 mL of water which should also be drunk to ensure the full dose is administered.
In clinical trials, single doses of up to 48 mg of nerandomilast were studied in healthy volunteers without evidence of dose limiting toxicities. Cases of accidental overdose were reported in patients who received doses up to 72 mg/day for up to 17 days.
The observed adverse reactions were consistent with the known safety profile of nerandomilast.
In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment is provided.
2 years.
Store in the original package in order to protect from light.
This medicinal product does not require any special temperature storage conditions.
PVC/aluminium perforated unit dose blisters.
Pack sizes of 10 × 1, 30 × 1, or 60 × 1 film-coated tablets.
HDPE bottle with a child-resistant closure.
Pack sizes of 60 or 180 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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