Nerandomilast

Nerandomilast is a prescription medicine indicated for the treatment of: 

• idiopathic pulmonary fibrosis (IPF) in adult patients
• progressive pulmonary fibrosis (PPF) in adult patients
• Nerandomilast is available under the following different brand names: Jascayd

Common side effects of Nerandomilast include:

• diarrhea
• nausea 
• vomiting
• headache
• back pain
• dizziness
• COVID-19 
• upper respiratory tract infection
• depression 
• weight loss 
• decreased appetite 

Serious side effects of Nerandomilast include:

• not available

Rare side effects of Nerandomilast include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Oral Tablet

• 9 mg
• 18 mg

Pulmonary Fibrosis

Adult dosage

• 18 mg orally twice daily; may reduce dose to 9 mg twice daily if unable to tolerate 18 mg twice daily
• In combination with pirfenidone: 18 mg orally twice daily; do not reduce to 9 mg twice daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

Drug interaction overview

• Substrate of CYP3A
• Strong CYP3A inhibitors
  • Modify dose
  • Reduce nerandomilast dose if coadministered
  • Strong inhibitors may increase the risk of nerandomilast adverse effects
• Moderate or weak CYP3A inhibitors
  • No dosage adjustment required
• Moderate or strong CYP3A inducers
  • Avoid coadministration
  • Moderate or strong inducers decrease systemic exposure of nerandomilast and may reduce efficacy
• Pirfenidone
  • Do not reduce the dose
  • Concomitant use of nerandomilast with pirfenidone decreases systemic exposure of nerandomilast (by equivalent to 50%) in patients with IPF
  • When used concomitantly during clinical trials, efficacy was not observed with nerandomilast when the dose reduced to 9 mg twice daily

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nerandomilast?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nerandomilast?”

Cautions

• None

Pregnancy and Lactation

Pregnancy

• Data are not available regarding use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
• Advise pregnant females of reproductive potential of the potential risk of fetal loss
• Consider maternal and fetal risks associated with untreated IPF and PPF during pregnancy
• Clinical considerations
  • Untreated IPF or PPF can lead to maternal respiratory failure and mortality, intrauterine growth restriction, preterm birth, fetal hypoxia, and neonatal death

Lactation

• Data are unavailable on the presence of nerandomilast or its metabolite in human milk, its effects on breastfed infants, or milk production
• Nerandomilast is present in animal milk
• Consider the developmental and health benefits of breastfeeding along with mothers’ clinical need for nerandomilast, and any potential adverse effects on breastfed infants from nerandomilast or from underlying maternal condition