This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

The U.S. FDA-approved Nintedanib treated people with a lung disease such as idiopathic pulmonary fibrosis (IPF), a chronic fibrosing lung disease with a progressive phenotype, systemic sclerosis, on  15th Sept 2014. 

Mechanism of Action of undefined

Nintedanib works by inhibiting receptor multiple tyrosine kinases (RTKs) enzyme that develops and progresses lung fibrosis (scarring). Inhibiting these enzymes reduces the development of fibrous tissue in the lungs. 

Uses of undefined

Nintedanib is used to treat idiopathic pulmonary fibrosis (IPF), a chronic fibrosing lung disease with a progressive phenotype, systemic sclerosis. This interferes with the production and migration of fibroblasts responsible for lung scars and affects its signaling. This helps to reduce further scarring and stiffening of the lungs.

undefined Drug administaration and Dosage available

Take Nintedanib as advised by your physician. Swallow the medicine with a glass of water. Do not crush, chew, or open the medicine. Your doctor will decide the correct dose and duration based on your age, body weight, and disease condition. Do not stop taking Nintedanib unless your doctor advises you to stop.

Warnings, Precautions and Side Effects of undefined

Warnings

Notify your doctor if you have a history of bleeding or blood clots (arterial thromboembolic). Nintedanib may cause liver function impairment (hepatic impairment) and embryo-fetal toxicity. Hence notify your doctor before starting the treatment. This medicine should not be used if you have severe liver or heart disorders. This medicine may cause gastrointestinal perforation and elevation in liver enzymes. It is not advised to get pregnant while under this treatment. Discuss the effect of contraception because birth pills may not work properly in women. Consult your doctor for more information. Certain medications include a P-glycoprotein (P-gp), CYP3A4 inhibitor, Ketoconazole, Anticoagulants, St. John’s wort, Laxatives, and other drugs, interacting with Nintedanib may reduce effectiveness by causing undesirable side effects. Inform your doctor if you take other medicines. 

Precautions

Before starting the treatment, your doctor may conduct a liver function test at the regular interval of the first three months. Abnormalities, such as dark or brown urine, bruises, bleeding than usual, or jaundice, must be notified immediately to your doctor. Nintedanib capsules may cause harm to the unborn baby. Tell your doctor if you are pregnant or planning to get pregnant before taking this medicine. Continue to use the contraception for three months, even after receiving the final dose. Breastfeeding is not recommended while taking Nintedanib. Because the medicine can pass into breast milk, potentially harming a nursing infant. Consult the doctor for more information. Inform your physician if you experience allergic reactions to Nintedanib.

Side Effects

The most common side effects of Nintedanib are nausea, vomiting, diarrhea, fever, skin ulcer,  gastrointestinal perforation, altered liver function, decreased appetite, headache, weight loss, and hypertension.

Some serious effects are likely to occur while you are on the treatment with Nintedanib are bronchitis, myocardial infarction, bleeding problems, pneumonia, increased protein in the urine (proteinuria), major bleeding yellow eyes, dark urine, pain at the upper right side of the stomach, severe stomach cramps, bloating, fever and chills chest pressure or pain at the left side of the body.

Word Of Advice

Before starting the treatment, it is recommended to perform a liver function test. Store at room temperature of 20°C to 25°C. Protect from light and moisture. Keep out of reach and sight of children and pets. It is unknown whether consuming alcohol while taking a Nintedanib capsule is safe. Please speak with your physician. Avoid smoking while taking Nintedanib because it may reduce the effectiveness of the medicine. Inform your physician if you have bleeding problems, hypertension, heart problems, or weak blood vessels. 

Frequently Asked Question

References

  1. Boehringer Ingelheim Pharmaceuticals. Inc, [Revised on Oct 2022] [Accessed on 05th April 2023], https://content.boehringer-ingelheim.com/DAM/f0e91cee-803b-4767-8360-af1e011fc97a/ofev-us-ppi.pdf
  2. Boehringer Ingelheim, Electronics Medicines Compendium (EMC), [Revised on Aug 2021] [Accessed on 05th April 2023], https://www.medicines.org.uk/emc/files/pil.1786.pdf
  3. Boehringer Ingelheim, U.S. Food and Drug Administration, [Revised on Mar 2020], [Accessed on 05th April 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205832s013lbl.pdf
  4. Lutz Wollin et al., Mode of action of Nintedanib capsule in the treatment of idiopathic pulmonary fibrosis, Eur Respir J. 2015 May; 45(5): 1434–1445. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4416110/

Disclaimer

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you are eligible to receive this treatment.