Jascayd Nerandomilast Tablets

1. Indications and Usage
Progressive Fibrosing Interstitial Lung Diseases (PF-ILD):
Investigational indication for the treatment of adult patients with progressive fibrosing interstitial lung diseases.
Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF):
Investigational indication for the prevention or treatment of acute exacerbations in patients with IPF.
2. Dosage and Administration
Recommended Dosage:
Dose: 12 mg orally twice daily.
Administration: Take with food to reduce gastrointestinal adverse reactions. Swallow tablets whole.
Missed Dose:
If a dose is missed, it may be taken as soon as possible with food. If it is close to the next scheduled dose, skip the missed dose.
3. Mechanism of Action
PDE4B Inhibition:
Nerandomilast is a potent and selective inhibitor of phosphodiesterase 4B (PDE4B).
Physiological Effect:
By inhibiting PDE4B, it increases intracellular cyclic AMP (cAMP) levels, thereby suppressing inflammation and fibrotic processes without causing emesis (nausea/vomiting), which is a common side effect of non-selective PDE4 inhibitors.
4. Safety and Warnings
Gastrointestinal Disorders:
Nausea and diarrhea have been reported. Taking the medication with food is recommended to mitigate these risks.
Embryo-Fetal Toxicity:
May cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 1 week after the final dose.
Psychiatric Disorders:
As with other PDE4 inhibitors, monitor for psychiatric symptoms such as depression or anxiety, although the risk is considered lower with this selective agent.
5. Adverse Reactions
Most Common:
Diarrhea, nausea, vomiting, and headache.
6. Drug Interactions
CYP450 Interaction:
Nerandomilast is primarily metabolized by CYP3A4. Avoid concomitant use with strong CYP3A inhibitors or inducers.
Transporter Substrates:
Caution is advised when used with P-gp or BCRP substrates.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Nerandomilast.
Storage:
Store at room temperature. Keep in original package to protect from moisture.