FIBNIB
Nintedanib Soft Gelatin Capsules 100mg & 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each soft
gelatin contains 100 & 150mg of Nintedanib.
INDICATION: For the treatment of Idiopathic Pulmonary
Fibrosis (IPF); In combination with docetaxel for the treatment of adult
patients with locally advanced metastatic or recurrent non-small cell
lung cancer (NSCLC) of adenocarcinoma tumor histology after first line
chemotherapy. DOSAGE AND METHOD OF ADMINISTRATION: Dose
for IPF:150 mg taken orally twice daily approximately 12 hours apart
taken with food. In patients with mild hepatic impairment (Child Pugh
A): 100 mg taken orally twice daily approximately 12 hours apart taken
with food. CONTRAINDICATIONS:
Pregnancy; hypersensitivity to Nintedanib, and/or to peanut or soya.
WARNING AND PRECAUTION: Nintedanib treatment may cause
gastrointestinal adverse reactions like diarrhea, nausea, and vomiting,
often within the initial three months. Regular hepatic function
monitoring is necessary due to the risk of elevated liver enzymes and
drug-induced liver injury, especially in certain patient groups. Renal
impairment, neutropenia, and sepsis have been reported, requiring
ongoing monitoring. Additionally, Nintedanib may increase the risk of
arterial thromboembolic events, bleeding, gastrointestinal perforations,
and aneurysms/artery dissections, necessitating careful consideration of
patient risk factors and close monitoring. caution should be exercised
when nintedanib is administered in patients who may develop QTc
prolongation.
UNDESIRABLE EFFECTS: In IPF: Bronchitis, Myocardial infarction,
pneumonia, lung neoplasm.
Diarrhoea, Nausea, Abdominal pain, Vomiting and Liver enzyme elevation.
DRUG INTERACTIONS: Nintedanib, affected by
P-glycoprotein and CYP3A4, may have altered exposure with inhibitors or
inducers. Close monitoring and potential dose adjustments are necessary.
Additionally, it may increase bleeding risk when used with
anticoagulants. Concomitant use with pirfenidone, bosentan, or docetaxel
did not significantly alter pharmacokinetics.
USE IN SPECIAL POPULATION: Nintedanib can harm fetuses
based on animal studies. Advise pregnant women of the potential risk to
a foetus. females of reproductive potential to avoid becoming pregnant
while receiving treatment with nintedanib. Its excretion into human milk
is uncertain but may pose a risk to infants. Breastfeeding should be
stopped during treatment with Nintedanib. Adjustment of the starting
dose in patients with mild-to-moderate renal impairment is not required.
Not recommended in patients with moderate (Child-Pugh B) or severe
(Child-Pugh C) hepatic impairment. These highlights do not include all
the information needed to use FIBNIB tablets effectively and safely.
Please refer to full prescribing information [available on request].
FOR FURTHER INFORMATION, CONTACT: Medical Affairs;
Alkem House; Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra: 400
013. Prepared on 6th June 2024. Source: Prescribing Information FIBNIB
tablets