Nintedanib

What is Nintedanib?

Nintedanib is a prescription medication used to treat certain long-term lung diseases marked by scarring (fibrosis). It is taken by mouth.

Drug class: Nintedanib is a tyrosine kinase inhibitor. It is also described as an antifibrotic medication because it is used to slow scarring in lung tissue.

Approved uses: In the United States, nintedanib is FDA-approved for:

• Idiopathic pulmonary fibrosis (IPF) in adults
• Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults
• Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults

Uses outside these approved indications should only be considered by a specialist who has reviewed your full medical history. In some countries, nintedanib is also used in combination with chemotherapy for certain lung cancers. That is a different use with different dosing, and it is not covered in this guide.

Available formulations and strengths: Nintedanib is supplied as soft capsules in 100 mg and 150 mg strengths. Brand names and availability can vary by country.

What is the Recommended Dosage of Nintedanib?

Your dose is set by your prescriber. It depends on several factors:

• Your condition and how you respond to treatment
• Liver function. People with mild liver impairment are usually given a lower dose, and use is not recommended in moderate or severe liver impairment.
• Tolerability, meaning how well you handle side effects, especially diarrhea and nausea
• Other medications you take, since some can change nintedanib levels in the body

Nintedanib is taken twice a day, about 12 hours apart, with food. Capsules should be swallowed whole with liquid and should not be chewed or crushed. If side effects develop, your specialist may lower the dose, pause treatment for a time, or adjust how it is taken.

Always follow your prescription label. Do not change your dose or stop taking the medication without speaking to your lung specialist.

How Nintedanib Works

Nintedanib blocks certain proteins on the surface of cells (called tyrosine kinases) that send signals for scar-forming cells to grow and multiply. In simple terms, it may help slow the buildup of scar tissue in the lungs.

Nintedanib does not cure lung fibrosis and does not reverse scarring that has already happened. In clinical studies, it slowed the rate of decline in lung function in many people. Individual results vary, and it may not make you feel better day to day.

Is a Prescription Required to Buy Nintedanib Online?

Yes. Nintedanib is available by prescription only. It should be prescribed and monitored by a licensed medical specialist, most often a pulmonologist (lung specialist) with experience in interstitial lung disease. In some cases, a rheumatologist may also be involved, such as when lung disease is linked to systemic sclerosis.

Keep these safety points in mind:

• Use only licensed, verified pharmacies that require a valid prescription.
• Be cautious of websites that offer the drug without a prescription. Products from unregulated sources may be counterfeit, contaminated, incorrectly dosed, or expired.
• Nintedanib is often dispensed through specialty pharmacies, which is normal for this type of medication.
• If the packaging or capsules look unusual, ask your pharmacist before taking them.

Side Effects of Nintedanib

Common Side Effects

• Diarrhea, which is the most common side effect and is often manageable
• Nausea and vomiting
• Stomach pain
• Decreased appetite and weight loss
• Headache
• Elevated liver enzymes on blood tests
• High blood pressure

Taking the capsules with food may help with stomach symptoms. Your care team may suggest steps such as staying hydrated and using anti-diarrheal medicine. Do not start these on your own without asking your provider or pharmacist first.

Serious Side Effects

Serious reactions are less common but need prompt attention:

• Liver problems, including rare cases of serious liver injury
• Severe or persistent diarrhea, vomiting, or dehydration
• Bleeding problems
• Heart attack or stroke (arterial blood clots)
• Holes or tears in the stomach or intestines (gastrointestinal perforation)
• Blood clots in the veins
• Problems with wound healing
• Harm to an unborn baby

Seek immediate medical attention if you have chest pain or pressure, sudden weakness or numbness on one side of the body, trouble speaking, severe stomach pain, vomiting blood, black or bloody stools, or unusual bleeding that does not stop. Contact your doctor promptly if you have yellowing of the skin or eyes, dark urine, severe or lasting diarrhea, or signs of dehydration such as dizziness and very little urine.

Drug Interactions

Some substances change how the body handles nintedanib. Major categories to discuss with your specialist include:

• P-gp and CYP3A4 inhibitors, such as certain antifungals (for example, ketoconazole) and some macrolide antibiotics (for example, erythromycin). These can raise nintedanib levels and may increase side effects.
• P-gp and CYP3A4 inducers, such as rifampin, carbamazepine, phenytoin, and St. John’s wort. These can lower nintedanib levels and may reduce its effect.
• Blood thinners and other medicines that affect bleeding risk, since nintedanib may increase bleeding risk
• Medicines that affect the liver
• Over-the-counter (OTC) medications, including pain relievers
• Vitamins, supplements, and herbal products
• Tobacco and smoking. Smoking can lower nintedanib levels and may reduce its effectiveness. Ask your care team about support to quit.

Give your licensed medical specialist and pharmacist a complete, up-to-date list of everything you take, including OTC products, supplements, and herbal remedies. Update the list whenever something changes.

Safety & Important Considerations

• Liver function: Liver blood tests are done before starting treatment, then regularly during the first months, and periodically afterward. Your dose may be lowered or interrupted if liver enzymes rise.
• Diarrhea and hydration: Early treatment of diarrhea helps prevent dehydration and kidney strain.
• Heart and blood vessel health: Use with caution if you have a history of heart disease, stroke, high blood pressure, or blood clots. Blood pressure may be monitored.
• Bleeding risk: Tell your care team if you take blood thinners or have a bleeding disorder.
• Stomach and bowel history: Use caution if you have had recent abdominal surgery or a history of bowel problems, since perforation has been reported.
• Surgery: Nintedanib may slow wound healing. Your surgeon and lung specialist should decide together whether to pause treatment around a procedure.
• Pregnancy: Nintedanib can harm an unborn baby. People who can become pregnant should have a pregnancy test before starting treatment, use effective contraception during treatment and for a period after the last dose, and tell their doctor right away if they become pregnant. Your label will state the exact length of time.
• Breastfeeding: It is not known whether nintedanib passes into breast milk. Breastfeeding is generally not recommended during treatment. Discuss this with your doctor.
• Older adults: Older adults should be monitored closely for side effects.
• Children: Nintedanib is not approved for use in children in the United States.
• Handling capsules: Swallow capsules whole. Avoid contact with the contents of a damaged capsule. If contact occurs, wash the area well with soap and water.

Who This Medication Is For

Nintedanib is intended for adults who have been diagnosed with IPF, a chronic progressive fibrosing ILD, or SSc-ILD by a qualified specialist. Diagnosis usually involves a review of symptoms, lung function tests, imaging such as a high-resolution CT scan, and sometimes additional testing. Whether nintedanib is appropriate depends on your overall health, other conditions, and treatment goals.

Who Should Not Take Nintedanib

Nintedanib may not be suitable for people who:

• Have had an allergic reaction to nintedanib, peanut, soya, or any ingredient in the capsule. The capsules contain soya lecithin.
• Are pregnant, because of the risk of harm to the baby
• Have moderate or severe liver impairment, where use is not recommended

Extra precautions apply for people with mild liver impairment, heart or blood vessel disease, bleeding risks, high blood pressure, recent abdominal surgery, or a history of bowel problems. Your specialist will weigh these factors against the possible benefits.

What to Do If You Miss a Dose

• If you miss a dose, skip it and take your next dose at the regular time.
• Do not double up or take extra capsules to make up for a missed dose.
• Do not take more than the total daily dose your prescriber has set.
• If you are unsure what to do, or you miss several doses, contact your care team for guidance.

Related products to Nintedanib

Treatment choices for pulmonary fibrosis are individualized. Options your specialist may discuss include:

• Pirfenidone, another prescription antifibrotic medication approved for IPF that works through a different mechanism
• Other approved therapies, which may become available over time
• Immune-related treatments, which may be used in some ILDs, depending on the underlying cause
• Supportive and non-drug care, such as pulmonary rehabilitation, supplemental oxygen when needed, vaccinations, symptom management, and lung transplant evaluation in selected patients

Each option has its own benefits, risks, and monitoring needs. Do not switch or stop treatment without consulting your lung specialist.

Storage Instructions

• Store at room temperature, generally 68°F to 77°F (20°C to 25°C), unless your label says otherwise.
• Keep capsules in the original package until it is time to take them. Protect them from moisture and excess heat.
• Protect from light by keeping the medication in its original container or blister pack.
• Store out of the sight and reach of children and pets.
• Do not use expired medication. Ask your pharmacist about safe disposal options, since this medicine can be harmful if handled improperly.

Disclaimer:

This page is for educational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Patients must consult a licensed pulmonologist or other qualified medical specialist before starting, changing, or stopping treatment. Treatment decisions must be based on a full clinical evaluation by a qualified specialist. If you think you are having a medical emergency, call your local emergency number immediately.