Ninacent 100: Each soft gel capsule contains Nintedanib Esylate INN equivalent to Nintedanib 100 mg.
Ninacent 150: Each soft gel capsule contains Nintedanib Esylate INN equivalent to Nintedanib 150 mg.
Nintedanib is a potent and selective multi-targeted receptor and non-receptor tyrosine kinase inhibitor that blocks platelet-derived growth factor receptor (PDGFR) α and β; fibroblast growth factor receptor (FGFR) 1, 2, and 3; vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3, etc
Nintedanib is a kinase inhibitor that is indicated for
• the treatment of idiopathic pulmonary fibrosis
• the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
• slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease
• 150 mg twice daily approximately 12 hours apart taken with food.
• Recommended dosage in patients with mild hepatic impairment: 100 mg twice daily approximately 12 hours apart taken with food
Most common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension.
• Hepatic impairment: Nintedanib is not recommended for use in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg twice daily approximately 12 hours apart taken with food. Consider treatment interruption, or discontinuation for management of adverse reactions in these patients. Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential.
• Gastrointestinal disorders: Diarrhea, nausea, and vomiting have occurred with Nintedanib. Treat patients at first signs with adequate hydration and antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue Nintedanib if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment.
• Embryo-Fetal toxicity: Nintedanib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use highly effective contraception. Advise women taking oral hormonal contraceptives experiencing vomiting, diarrhea, or other conditions where the drug absorption may be reduced to use alternative highly effective contraception.
• Arterial thromboembolic events have been reported. Use caution when treating patients at higher cardiovascular risk including known coronary artery disease.
• Bleeding events have been reported. Use Nintedanib in patients with known bleeding risk only if anticipated benefit outweighs the potential risk.
• Gastrointestinal perforation has been reported. Use Nintedanib with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue Nintedanib in patients who develop gastrointestinal perforation. Only use Nintedanib in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk.
Pregnancy and Lactation
Pregnancy Category D. On the basis of various animal studies, it can be said that Nintedanib can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of Nintedanib in pregnant women.
It is not known whether Nintedanib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nintedanib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and effectiveness of Nintedanib in pediatric patients have not been established.
No overall differences in safety or effectiveness of Nintedanib were observed between these patients and younger patients.
Exposure to Nintedanib increases in patients with mild hepatic impairment (Child-Pugh A). Dose must be adjusted based on the development of any adverse reactions. Nintedanib is not recommended for patients with mild hepatic impairment (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B).
No dose adjustment is recommended for patients with mild or moderate renal impairment. No proper study is available for the use of Nintedanib in patients with severe renal impairment.
Coadministration of P-gp and CYP3A4 inhibitors may increase Nintedanib exposure. Monitor patients closely for tolerability of Nintedanib
Do not store above 30 °C. Keep away from light and out of the reach of children.
Ninacent 100: Each box contains 1 blister strip of 10 soft gel capsules.
Ninacent 150: Each box contains 1 blister strip of 10 soft gel capsules