Nintedanib
This page gives a short overview of the drug Nintedanib, including what it’s used for, how to take it, how it works, available brand names with their strengths, safety warnings, and common side effects.
Context and Approval Date
The U.S. FDA approved Nintedanib on September 15, 2014, for treating people with certain lung diseases like idiopathic pulmonary fibrosis (IPF), a long-term lung condition that gets worse over time, and systemic sclerosis.
Mechanism of Action of Nintedanib
Nintedanib works by blocking certain enzymes called receptor tyrosine kinases (RTKs) that play a role in causing lung scarring (fibrosis). By blocking these enzymes, the drug helps slow down the buildup of scar tissue in the lungs.
All Substitutes
View All| Product | Packaging Size | Manufacturer | Price |
|---|---|---|---|
| Nindanib 150mg capsule | 10 capsules | Glenmark Pharmaceuticals | INR 950 |
| Nintib 150mg capsule | 10 capsules | CIPLA Ltd | INR 750 |
| Nintenib 150mg capsule | 10 capsules | BDR Pharmaceuticals | INR 700 |
| Nintena 150mg capsule | 10 capsules | Sun Pharmaceuticals | INR 820 |
| Cyendiv 150mg capsule | 10 capsules | Boehringer Ingelheim | INR 11960 |
Uses of Nintedanib capsule
Nintedanib is used to treat idiopathic pulmonary fibrosis (IPF) and systemic sclerosis, which are long-term lung diseases that cause scarring. The drug works by blocking the activity of cells called fibroblasts that cause lung scarring. This helps slow down further damage and stiffening of the lungs.
Nintedanib capsule administration guidelines and available dosage options
Take Nintedanib exactly as your doctor tells you. Swallow the capsule whole with a glass of water—don’t crush, chew, or open it. Your doctor will decide the right dose and how long you need to take it, based on your age, weight, and health condition. Don’t stop taking it unless your doctor says so.
Information about Nintedanib
Nintedanib Uses
Nintedanib is used to treat several types of cancer, including idiopathic pulmonary fibrosis, pancreatic cancer, small cell lung cancer, liver cancer, kidney cancer, thyroid cancer, blood cancer (chronic myeloid leukemia), gastrointestinal stromal tumor, colon and rectum cancer, non-small cell lung cancer, soft tissue sarcoma, chronic idiopathic myelofibrosis, and breast cancer.How Nintedanib Works
Nintedanib is an anti-cancer medicine. It works by blocking a protein that causes cancer cells to grow and spread. This helps slow down or stop the cancer from spreading.Side effects of nintedanib
Nausea, abdominal pain, diarrhea, Vomiting, Weight loss, Headache, Decreased appetite, Increased liver enzymes1. Nintedanib is also used to treat thyroid cancer. You can take it with or without food, but try to take it at the same time each day.
2. Common side effects may include diarrhea—drink plenty of fluids, and let your doctor know if it doesn’t stop or if you see blood in your stools.
3. Use effective birth control while taking this medicine and for at least one month after stopping it, as it can harm an unborn baby.
4. Check your blood pressure regularly while on this medication. Tell your doctor if you experience signs of high blood pressure like a severe headache, confusion, vision problems, nausea, or vomiting.
5. Nintedanib can sometimes cause serious bleeding. Contact your doctor if you have headaches, stomach pain, or notice blood in your urine or stools.
6. Do not take this medicine if you are pregnant, planning to become pregnant, or breastfeeding.
2. Common side effects may include diarrhea—drink plenty of fluids, and let your doctor know if it doesn’t stop or if you see blood in your stools.
3. Use effective birth control while taking this medicine and for at least one month after stopping it, as it can harm an unborn baby.
4. Check your blood pressure regularly while on this medication. Tell your doctor if you experience signs of high blood pressure like a severe headache, confusion, vision problems, nausea, or vomiting.
5. Nintedanib can sometimes cause serious bleeding. Contact your doctor if you have headaches, stomach pain, or notice blood in your urine or stools.
6. Do not take this medicine if you are pregnant, planning to become pregnant, or breastfeeding.
Warning, Precautions, and Side Effects Associated with Nintedanib
Warnings
Before starting nintedanib, tell your doctor if you have a history of bleeding or blood clots. This medicine can affect liver function and may harm an unborn baby, so it’s important to talk to your doctor before treatment.Do not use nintedanib if you have serious liver or heart problems. It may also cause issues like a hole in the stomach or intestine (gastrointestinal perforation) and increased liver enzyme levels.
Avoid getting pregnant while on this medicine. Talk to your doctor about safe birth control methods, as regular birth control pills may not work well during treatment.
Nintedanib can interact with other medicines, including:
1. P-glycoprotein (P-gp) and CYP3A4 inhibitors
2. Ketoconazole
3. Blood thinners (anticoagulants)
4. St. John’s Wort
5. Laxatives and others
Precautions
Before starting treatment, your doctor may check your liver function regularly during the first three months. If you notice signs like dark or brown urine, unusual bruising or bleeding, or yellowing of the skin or eyes (jaundice), contact your doctor immediately.Nintedanib can harm an unborn baby. Let your doctor know if you are pregnant or planning to get pregnant before starting the medicine. You should use contraception during treatment and for at least three months after your last dose.
Breastfeeding is not recommended while taking nintedanib, as the medicine may pass into breast milk and harm your baby.
Also, inform your doctor if you have any allergies to nintedanib or experience any allergic reactions while on the medication.
Side Effects
The most common side effects of nintedanib include nausea, vomiting, diarrhea, fever, skin sores, stomach problems (like gastrointestinal perforation), liver issues, loss of appetite, headache, weight loss, and high blood pressure.Serious side effects that may occur during treatment include bronchitis, heart attack, bleeding problems, pneumonia, high levels of protein in the urine, major bleeding, yellowing of the eyes, dark urine, pain in the upper right side of the stomach, severe stomach cramps, bloating, fever and chills, and chest pain or pressure on the left side of the body.
Word Of Advice
Before starting treatment, it’s recommended to have a liver function test.Store nintedanib at room temperature (20°C to 25°C). Keep it away from light and moisture. Keep the medicine out of reach of children and pets.
It’s unclear whether drinking alcohol is safe while taking nintedanib, so talk to your doctor before drinking.
Avoid smoking while on nintedanib, as it may lower the medicine’s effectiveness.
Tell your doctor if you have any bleeding problems, high blood pressure, heart issues, or weak blood vessels.
References
1. 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
2. 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
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/
2. 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
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/
FAQ - Nintedanib
1How does Nintedanib work in the body?
Nintedanib works by blocking certain enzymes called tyrosine kinases. These enzymes are involved in the processes that cause scarring (fibrosis) in the lungs and help cancer cells grow and spread.
By blocking these enzymes, nintedanib:
1. Slows down the buildup of scar tissue in the lungs (helpful in diseases like idiopathic pulmonary fibrosis and systemic sclerosis).
2. Reduces the growth of cancer cells by cutting off signals that make them multiply and form new blood vessels (used in some cancers like thyroid cancer).
By blocking these enzymes, nintedanib:
1. Slows down the buildup of scar tissue in the lungs (helpful in diseases like idiopathic pulmonary fibrosis and systemic sclerosis).
2. Reduces the growth of cancer cells by cutting off signals that make them multiply and form new blood vessels (used in some cancers like thyroid cancer).
2Can Nintedanib cure idiopathic pulmonary fibrosis (IPF)?
Nintedanib cannot cure idiopathic pulmonary fibrosis (IPF), but it can help slow down the progression of the disease.
IPF is a chronic, progressive lung condition that causes scarring (fibrosis) of the lung tissue, making it harder to breathe over time. While there is currently no known cure for IPF, nintedanib helps by:
1. Slowing the rate of lung function decline
2. Reducing the formation of new scar tissue
3. Possibly lowering the risk of disease flare-ups (acute exacerbations)
IPF is a chronic, progressive lung condition that causes scarring (fibrosis) of the lung tissue, making it harder to breathe over time. While there is currently no known cure for IPF, nintedanib helps by:
1. Slowing the rate of lung function decline
2. Reducing the formation of new scar tissue
3. Possibly lowering the risk of disease flare-ups (acute exacerbations)
3How can I manage diarrhea while taking Nintedanib?
Managing diarrhea while taking Nintedanib is important, as it's one of the most common side effects. Here are some helpful tips:
1. Stay Hydrated
A. Drink plenty of fluids like water, clear soups, or electrolyte solutions to prevent dehydration.
B. Avoid sugary or caffeinated drinks, as they can make diarrhea worse.
2. Eat a BRAT Diet (if needed)
A. Bananas, rice, applesauce, and toast are gentle on the stomach and may help firm up stools.
B. Avoid spicy, greasy, or high-fiber foods during episodes.
3. Take Anti-Diarrheal Medication (if prescribed)
A. Your doctor may recommend loperamide (Imodium) to help control diarrhea.
B. Only take it if your doctor approves, as not all cases should be treated this way.
4. Follow Your Doctor’s Instructions A. Your doctor might adjust the dose of nintedanib or recommend a temporary pause if diarrhea becomes severe.
5. Monitor for Severe Symptoms
A. Let your doctor know if diarrhea doesn’t improve, gets worse, or is accompanied by blood in the stool, fever, weakness, or weight loss.
1. Stay Hydrated
A. Drink plenty of fluids like water, clear soups, or electrolyte solutions to prevent dehydration.
B. Avoid sugary or caffeinated drinks, as they can make diarrhea worse.
2. Eat a BRAT Diet (if needed)
A. Bananas, rice, applesauce, and toast are gentle on the stomach and may help firm up stools.
B. Avoid spicy, greasy, or high-fiber foods during episodes.
3. Take Anti-Diarrheal Medication (if prescribed)
A. Your doctor may recommend loperamide (Imodium) to help control diarrhea.
B. Only take it if your doctor approves, as not all cases should be treated this way.
4. Follow Your Doctor’s Instructions A. Your doctor might adjust the dose of nintedanib or recommend a temporary pause if diarrhea becomes severe.
5. Monitor for Severe Symptoms
A. Let your doctor know if diarrhea doesn’t improve, gets worse, or is accompanied by blood in the stool, fever, weakness, or weight loss.
4Can Nintedanib cause liver damage?
Nintedanib can cause liver damage in some people.
It may lead to elevated liver enzymes or more serious liver problems in rare cases. That’s why doctors usually monitor your liver function with blood tests—especially during the first 3 months of treatment.
Signs of Liver Problems to Watch For:
A. Yellowing of the skin or eyes (jaundice)
B. Dark-colored urine
C. Pain in the upper right side of the abdomen
D. Unusual tiredness
E. Nausea or loss of appetite
F. Unexplained bruising or bleeding
What You Should Do:
A. Get regular liver function tests as recommended by your doctor.
B. Tell your doctor right away if you notice any of the symptoms above.
C. Avoid alcohol and other liver-harming drugs unless your doctor says it’s safe.
D. Your doctor may adjust your dose or stop the medicine if liver problems occur.
It may lead to elevated liver enzymes or more serious liver problems in rare cases. That’s why doctors usually monitor your liver function with blood tests—especially during the first 3 months of treatment.
Signs of Liver Problems to Watch For:
A. Yellowing of the skin or eyes (jaundice)
B. Dark-colored urine
C. Pain in the upper right side of the abdomen
D. Unusual tiredness
E. Nausea or loss of appetite
F. Unexplained bruising or bleeding
What You Should Do:
A. Get regular liver function tests as recommended by your doctor.
B. Tell your doctor right away if you notice any of the symptoms above.
C. Avoid alcohol and other liver-harming drugs unless your doctor says it’s safe.
D. Your doctor may adjust your dose or stop the medicine if liver problems occur.
5What dosage of Nintedanib should I take?
The usual recommended dose of nintedanib depends on the condition being treated, but here's a general guide:
For Idiopathic Pulmonary Fibrosis (IPF), Systemic Sclerosis-Associated ILD, or Other ILDs:
A. Recommended dose: 150 mg twice daily (every 12 hours)
B. Taken with food to reduce stomach upset
C. Swallow the capsule whole with water—do not crush, chew, or open
For certain cancers (like thyroid or non-small cell lung cancer, when approved):
A. Doses may vary depending on the specific cancer type and combination with other treatments
B. Your doctor will prescribe the exact dose and schedule
Your doctor may adjust the dose if you:
A. Have liver problems
B. Experience side effects like severe diarrhea, vomiting, or liver enzyme changes
C. Are elderly or underweight
D. Are taking certain other medications that may interact
Important Tips:
A. Do not change your dose or stop taking Nintedanib without your doctor's advice
B. If you miss a dose, skip it and take the next one at the usual time. Do not take a double dose.
For Idiopathic Pulmonary Fibrosis (IPF), Systemic Sclerosis-Associated ILD, or Other ILDs:
A. Recommended dose: 150 mg twice daily (every 12 hours)
B. Taken with food to reduce stomach upset
C. Swallow the capsule whole with water—do not crush, chew, or open
For certain cancers (like thyroid or non-small cell lung cancer, when approved):
A. Doses may vary depending on the specific cancer type and combination with other treatments
B. Your doctor will prescribe the exact dose and schedule
Your doctor may adjust the dose if you:
A. Have liver problems
B. Experience side effects like severe diarrhea, vomiting, or liver enzyme changes
C. Are elderly or underweight
D. Are taking certain other medications that may interact
Important Tips:
A. Do not change your dose or stop taking Nintedanib without your doctor's advice
B. If you miss a dose, skip it and take the next one at the usual time. Do not take a double dose.
6Why is liver enzyme getting elevated during treatment with Nintedanib?
Elevated liver enzymes during treatment with nintedanib can happen because the medicine is processed (metabolized) in the liver, and it can sometimes stress or irritate liver cells, leading them to release enzymes into the bloodstream.
Why Does This Happen?
A. Nintedanib affects liver metabolism: The liver breaks down the drug using certain enzymes (like CYP and P-glycoprotein pathways). This process can overwork or irritate liver cells in some people.
B. Direct liver cell damage: In rare cases, nintedanib may cause mild to moderate liver injury, which shows up as higher levels of liver enzymes (like ALT and AST).
C. Individual sensitivity: Some people’s livers are more sensitive to medications, especially if they already have liver disease or are taking other liver-stressing drugs.
D. Drug interactions: Other medicines taken with nintedanib may increase liver stress or reduce the body’s ability to clear the drug properly.
What Elevated Liver Enzymes May Indicate:
A. Mild liver irritation (often without symptoms)
B. Possible liver inflammation or damage (if enzymes are very high)
C. Need for dose adjustment or treatment pause
What You Can Do:
A. Get regular liver function tests, especially during the first 3 months
B. Avoid alcohol and unnecessary medications
C. Report any symptoms like yellowing of skin/eyes, dark urine, fatigue, or upper belly pain
D. Take the medicine exactly as prescribed and always with food
Why Does This Happen?
A. Nintedanib affects liver metabolism: The liver breaks down the drug using certain enzymes (like CYP and P-glycoprotein pathways). This process can overwork or irritate liver cells in some people.
B. Direct liver cell damage: In rare cases, nintedanib may cause mild to moderate liver injury, which shows up as higher levels of liver enzymes (like ALT and AST).
C. Individual sensitivity: Some people’s livers are more sensitive to medications, especially if they already have liver disease or are taking other liver-stressing drugs.
D. Drug interactions: Other medicines taken with nintedanib may increase liver stress or reduce the body’s ability to clear the drug properly.
What Elevated Liver Enzymes May Indicate:
A. Mild liver irritation (often without symptoms)
B. Possible liver inflammation or damage (if enzymes are very high)
C. Need for dose adjustment or treatment pause
What You Can Do:
A. Get regular liver function tests, especially during the first 3 months
B. Avoid alcohol and unnecessary medications
C. Report any symptoms like yellowing of skin/eyes, dark urine, fatigue, or upper belly pain
D. Take the medicine exactly as prescribed and always with food
