What is the recommended dosage of Nintedanib?

Nintedanib is indicated for the treatment of diseases that cause scarring and hardening of the lungs, leading to breathing difficulties. It acts by inhibiting pathological changes in lung tissue, thereby slowing down the progression of symptoms.

What is the recommended dosage of Nintedanib?

The administration is convenient: one capsule orally twice daily, which can be integrated into the patient's morning and evening daily routine. The interval between each dose should be approximately 12 hours.

No initial dose escalation is required. The recommended dosage is 150 mg orally twice daily.

The capsules should be taken with food and swallowed whole with a liquid. Do not chew, crush or open the capsules. If contact with the capsule contents occurs, wash hands thoroughly immediately.

Dose adjustment (reduction or temporary treatment interruption) of OFEV (Nintedanib) helps manage adverse reactions while sustaining clinical benefits. If the patient cannot tolerate the reduced dose, OFEV should be discontinued.

If a dose of OFEV is missed, resume dosing at the recommended dose at the next scheduled time. Patients should be advised not to take the missed dose as a supplement. The total daily dose must not exceed the maximum recommended dose of 300 mg.

For the management of adverse reactions, the dose of OFEV may be reduced, interrupted or discontinued.

Recommended Tests for Nintedanib

For all patients, liver function tests (ALT, AST and bilirubin) should be performed before the initiation of OFEV (Nintedanib) treatment, regularly during the first 3 months of treatment, and thereafter periodically or as clinically indicated.

For patients reporting symptoms that may indicate liver injury (including fatigue, anorexia, right upper abdominal discomfort, darkening of urine or jaundice), perform liver function tests promptly.

For women of childbearing potential, pregnancy testing should be conducted before the start of OFEV treatment and as appropriate during treatment.

Recommended Dosing Regimen for Patients with Hepatic Impairment

For patients with mild hepatic impairment (Child-Pugh Class A), the recommended dosage is 100 mg orally twice daily. Nintedanib is not recommended for patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.