Ofev 100 mg is a prescription antifibrotic medicine containing nintedanib. This pack contains 60 soft capsules and is used under respiratory specialist supervision for defined fibrosing interstitial lung diseases.

Approved uses:
• Idiopathic pulmonary fibrosis in adults.
• Other chronic fibrosing interstitial lung diseases with a progressive phenotype in adults.
• Systemic sclerosis associated interstitial lung disease in eligible patients; age eligibility follows the local authorisation and specialist assessment.

Therapeutic role:
Nintedanib inhibits several tyrosine kinase pathways involved in the formation of fibrous lung tissue. It can slow the rate of decline in lung function; it does not remove established scarring or provide immediate relief of breathlessness.

Active ingredient and composition:
Each soft capsule contains nintedanib 100 mg as nintedanib esilate and 1.2 mg soya lecithin. Capsule contents include medium chain triglycerides and hard fat; the shell contains gelatin, glycerol, titanium dioxide and iron oxides.

How to use:
The 100 mg strength is generally used for an adult dose reduction when 150 mg twice daily is not tolerated or when clinically required; it is commonly taken twice daily approximately 12 hours apart when prescribed. Take with food and swallow whole with water. Do not chew, open or crush the capsule. Do not take an extra capsule for a missed dose. Paediatric dosing, where locally authorised, is specialist and weight based.

Important safety information:
Do not use during pregnancy or with an allergy to nintedanib, peanut or soya. Liver tests are required before treatment and periodically thereafter. Diarrhoea should be managed promptly with fluids and the treatment advised by the clinical team because severe diarrhoea may cause dehydration and electrolyte disturbance. Tell the specialist about liver disease, bleeding risk, anticoagulants, recent abdominal surgery, arterial clotting disease or severe abdominal pain. Effective pregnancy prevention is required according to the local leaflet.

Medical disclaimer:
This prescription medicine must be used only for the patient and condition for which it was prescribed. The information provided supports, but does not replace, the local package leaflet or the advice of a physician or pharmacist. Seek urgent medical care for a severe allergic reaction, breathing difficulty, fainting, uncontrolled bleeding, or rapidly worsening symptoms.