Nerandomilast (ner-an-DOE-mi-last)

Treats idiopathic pulmonary fibrosis.

Brand Name(s):

Jascayd

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole.
• If you cannot swallow the tablet whole:
  • You may mix it with 100 milliliters (mL) of non-carbonated, room temperature water. Do not use any other liquids.
  • Place the tablet in a glass of water, without crushing the tablet, and stir it for about 15 to 20 minutes until the tablet is in small pieces. The tablet will not dissolve completely. Swallow the mixture within 2 hours of mixing.
  • If you do not drink the mixture right away, stir the mixture again before drinking. Rinse the glass with another 100 mL of water and drink to make sure you received the full dose.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how nerandomilast works. Tell your doctor if you are using itraconazole or pirfenidone.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or liver disease.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back pain
• Changes in mood, behavior, or thoughts
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, decreased appetite or weight
• Headache, dizziness
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088