Nintedanib

Is the active ingredient.

Treatment of idiopathic pulmonary fibrosis (IPF) in adults.

Treatment of systemic sclerosisassociated interstitial lung disease (SSc-ILD) in adults.

Nintena 100 Cap (Nintedanib) is a tyrosine kinase inhibitor that selectively inhibits the activity of fibroblast growth factor receptors (FGFRs), vascular endothelial growth factor receptors (VEGFRs), and platelet-derived growth factor receptors (PDGFRs). By blocking these receptors, nintedanib reduces the proliferation and migration of fibroblasts and other cells involved in the pathogenesis of IPF and SSc-ILD, thereby slowing disease progression.

Store below 25°C (77°F). Protect from moisture.

The recommended dose of nintedanib is 150 mg twice daily, taken with food.

The capsules should be swallowed whole with water; do not crush, chew or open them.

Dosage adjustments may be necessary based on individual patient factors such as liver and kidney function.

Diarrhea

Nausea

Vomiting

Weight loss

Fatigue

Increased liver enzymes

Decreased appetite

Hair thinning

Rash

Elevated blood pressure

Alcohol Consumption

Alcohol consumption may increase the risk of side effects. Limit or avoid alcohol while taking nintedanib.



While Driving or operating Machinery

Nintedanib may cause dizziness, fatigue or vision changes. Avoid driving or operating machinery if affected.



Pregnant & Breastfeeding Women

Nintedanib is contraindicated in pregnancy. Effective contraception is essential. It is also contraindicated during breastfeeding.



Children

The safety and efficacy of nintedanib in children have not been established.



Kidney

Dosage adjustment may be necessary for patients with impaired kidney function.



Liver

Dosage adjustment may be necessary for patients with impaired liver function. Regular liver function monitoring is recommended.

Please consult your physician or pharmacist for specific references and complete prescribing information.

The official prescribing information (package insert) for the specific nintedanib product you are taking should be reviewed.