NINTEDANIB
Background and Date of Approval
The U.S. FDA approved Nintedanib on 15th September 2014 for treatment of patients with idiopathic pulmonary fibrosis (IPF), a chronic fibrosing lung disease with progressive phenotype, and systemic sclerosis-associated pulmonary fibrosis.
Uses
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.
How is it administered?
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.
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.
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. Johnâs 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.
Word of Advice
Liver function testing is recommended before starting treatment. Store at room temperature between 20°C and 25°C. Protect from light and moisture. Keep out of reach and sight of children and pets. The safety of consuming alcohol while taking Nintedanib capsules is unknown; consult your physician. Smoking may reduce the effectiveness of Nintedanib and should be avoided during treatment. Inform your physician if you have bleeding disorders, hypertension, cardiac problems, or weak blood vessels.
References
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 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 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 Lutz Wollin et al., Mode of action of Nintedanib capsule in the treatment of idiopathic pulmonary fibrosis, Eur Respir J. 2015 May; 45(5): 1434â1445. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4416110/
Frequently Asked Questions
How does Nintedanib work in the body?
Nintedanib works by inhibiting several signaling pathways that are involved in the formation of scar tissue in the lungs. It targets the activity of certain enzymes and growth factors that promote the growth of fibroblasts, which are the cells responsible for producing collagen and other proteins that form scar tissue in the lungs.
Can Nintedanib cure idiopathic pulmonary fibrosis (IPF)?
Nintedanib is not a cure for idiopathic pulmonary fibrosis (IPF). It is a medication that can help slow the progression of the disease by reducing the formation of scar tissue in the lungs. It is important to continue taking nintedanib as prescribed by your doctor, even if you start feeling better.
How can I manage diarrhea while taking Nintedanib?
If you experience diarrhea while taking Nintedanib, it is important to stay hydrated by drinking plenty of fluids. Your doctor may also recommend over-the-counter medications or prescription medications to help manage your diarrhea. If your diarrhea is severe or persistent, you should contact your doctor.
Can Nintedanib cause liver damage?
Nintedanib may cause liver function abnormalities, which may indicate liver damage. It is important to have regular blood tests to monitor your liver function while taking nintedanib. If you experience symptoms of liver damage, such as jaundice or abdominal pain, you should contact your doctor immediately.
What dosage of Nintedanib should I take?
Your doctor will decide the correct dose and duration for you based upon your age, body weight and disease condition. Do not stop taking Nintedanib unless your doctor advises you to stop. As with all medications, it is important to follow the dosage instructions provided by your healthcare provider and to consult them for any questions or concerns.
Why is liver enzyme getting elevated during treatment with Nintedanib?
The reason for this elevation is not completely understood, but it is thought to be related to the drug's effects on certain enzymes involved in liver function. The elevation in liver enzymes is generally mild and temporary, and typically resolves on its own or with dose adjustment of the Nintedanib capsules.