Nerandomilast

Nerandomilast is used to treat idiopathic pulmonary fibrosis (IPF; scarring of the lungs with an unknown cause). Nerandomilast is in a class of medications called phosphodiesterase 4 (PDE4) inhibitors. It works by blocking the action of a certain natural substance in the body that is involved in causing fibrosis.

Nerandomilast comes as a tablet to take by mouth. Take with or without food two times a day, about 12 hours apart. Take nerandomilast at around the same times every day.

Take nerandomilast exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you cannot swallow the tablets whole, place the tablets in a glass of 3 to 4 ounces (100 mL) of non-carbonated, room temperature water. Do not use any other liquids other than water. Stir until the tablets are in small pieces (about 15 to 20 minutes). Do not crush the tablets; they will not completely dissolve. Drink the mixture right away or within 2 hours of preparing. If you do not take the mixture immediately, stir again before drinking. Do not chew pieces of the tablet. Rinse the glass with an additional 3 to 4 ounces (100 mL) of water and drink to make sure that you have taken the full dose.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking nerandomilast,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking nerandomilast. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with nerandomilast: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking nerandomilast. Do not start this medication while taking nerandomilast without discussing with your healthcare provider.
• tell your doctor if you have or have ever had kidney or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nerandomilast, call your doctor.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Nerandomilast may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• weight loss
• decreased appetite
• headache
• back pain
• fatigue
• dizziness
• depression
• runny nose, cough, sore throat, fever, or chills

Nerandomilast may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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