Idiopathic Pulmonary Fibrosis (IPF)

Active Ingredient: Nerandomilast

Indication for Nerandomilast

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Jascayd is indicated for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF).

For this indication, competent medicine agencies globally authorize below treatments:

18 mg once every 12 h

For:

Dosage regimens

Oral, 18 milligrams nerandomilast, once every 12 hours.

Detailed description

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 and based on the anticipated benefit of treatment with nerandomilast, 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). Once the adverse reaction has resolved or is adequately controlled, treatment may be resumed at the recommended dose of 18 mg twice daily.

Concomitant use with strong CYP3A inhibitors

If used concomitantly with strong CYP3A inhibitors, the dose must be reduced to 9 mg twice daily.

Concomitant use with strong or moderate CYP3A inducers

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.

Concomitant use with pirfenidone

Concomitant use with pirfenidone decreased nerandomilast exposure by approximately 50%. In patients using pirfenidone, the recommended dose is 18 mg twice daily and must not be reduced to 9 mg twice daily.

Missed dose

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.

Active ingredient

Nerandomilast

Nerandomilast is an inhibitor of phosphodiesterase 4 (PDE4) with at least nine-fold preferential inhibition of the PDE4B isoenzyme over PDE4A, PDE4C and PDE4D based on in vitro data. PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP). Nerandomilast exerts both anti-fibrotic and immunomodulatory effects as PDE4B inhibition elevates intracellular cAMP levels and reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are overexpressed in IPF.

Read more about Nerandomilast

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