Information about Nintedanib

Generic Name : Nintedanib
Up-to-date prescription details regarding Nintedanib are provided here.

Pronunciation : nin-TED-a-nib

Learn the correct pronunciation of the Nintedanib, understand it's uses, recommended dosages, its indications, how to take, when to take, when not to take, side effects, special precautions, warnings and its and its storage instructions.

You will also find a list of the medication's International and Indian brand or trade names, as well as its pricing information. For verification of the information presented on this page or for additional clarifications, it's advisable to consult your doctor.

Therapeutic Classification : Chemotherapy

Trade Names/Brand Names of Nintedanib

India :

Ofev, Vargatef

Why is Nintedanib Prescribed? (Indications)

Nintedanib is prescribed to treat idiopathic pulmonary fibrosis (IPF) in adult patients. The drug can delay disease progression but may not cure the disease.

Nintedanib is used in combination with docetaxel to treat non-small cell lung cancer which may be advanced, or where the cancer cells have moved to other body parts in adults who showed treatment failure with first-line chemotherapy.

When should Nintedanib not be taken? (Contraindications)

Nintedanib should not be used in patients-

• If there is an allergy to nintedanib
• Pregnancy and breastfeeding
• Severe liver damage
• Children below 18 years of age

What is the dosage of Nintedanib?

The recommended dose of nintedanib differs according to the medical condition for which it is prescribed.

Idiopathic Pulmonary fibrosis:

The adult dose of nintedanib is 150 mg taken twice daily approximately 12 hours apart.

The dose of nintedanib can be reduced to 100 mg two times daily if any side effects occur and can be resumed to the full dose when the side effects resolve.

Discontinue the treatment with nintedanib if the patient cannot tolerate the nintedanib 100 mg twice daily dose.

The maximum daily dose of nintedanib for treating IPF is 300 mg.

Non-small cell lung cancer:

The recommended adult dose of nintedanib is 200 mg twice daily given exactly 12 hours apart from days 2 to 21 in a 21-day docetaxel treatment cycle.

The maximum daily dose of nintedanib for treating non-small cell lung cancer is 400 mg.

How should Nintedanib be taken?

Nintedanib is available in a capsule form which should be taken by mouth with food.

Take the nintedanib capsules at the same time every day which is approximately 12 hours apart.

Swallow the nintedanib capsules as a whole with a sufficient quantity of water. Do not break, open, crush, or split the capsule contents.

Missed a Dose?

If a dose of nintedanib is missed, take the following dose as per the next scheduled time.

Never take an extra dose of nintedanib to make up for the missed dose of nintedanib.

What are the warnings and precautions for Nintedanib?

• Women of reproductive potential should use effective contraceptive measures during the nintedanib treatment that must continue for at least three months after the last dose of nintedanib to avoid risk to the unborn babies.

• Stomach disturbances such as diarrhea, vomiting, and nausea can occur during nintedanib treatment, and patients with such symptoms and signs should be managed with adequate hydration, and supportive medications to stop vomiting.

• If nausea or vomiting becomes severe during the treatment, stop the treatment with nintedanib.

• Patients should be carefully monitored during nintedanib therapy as nintedanib can cause an increased risk of bleeding and ulceration of the stomach or the intestine.

• Liver function tests should be carried out regularly before initiating the treatment with nintedanib and monthly once for three months followed by once in three months.

• The dose of nintedanib may either be reduced or the treatment stopped temporarily in case of elevated liver enzyme levels.

• Heart function should be evaluated during the treatment as nintedanib can cause clotting in the blood vessels. Patients should be treated if any symptoms or signs of heart attack or chest pain develop.

What are the side effects of Nintedanib?

Gastrointestinal: Diarrhea, vomiting, nausea, stomach pain, loss of appetite
Nervous system: Headache, peripheral neuropathy, sudden numbness
Cardiovascular: Increased blood pressure, blood clots
Respiratory: Tightness of the chest, cough
Others: Abnormal levels of liver enzymes, Rashes, mucositis, itching, weight gain

What are the other precautions for Nintedanib?

Women who become pregnant during the treatment with nintedanib should inform the doctor immediately.

Extreme caution is required while giving nintedanib to patients with severe kidney damage or patients who undergo dialysis.

Patients with a smoking history are advised to stop smoking before initiating the nintedanib treatment as smoking can decrease the effectiveness of nintedanib resulting in treatment failure.

There is no specific antidote for nintedanib overdose. Therefore patients must be treated with general supportive measures appropriately.

What are the Drug Interactions of Nintedanib?

Co-administration with some drugs may result in an altered concentration of nintedanib and therefore should be avoided.

Drugs that decrease the concentration of nintedanib are-

• Rifampicin
• Carbamazepine
• Phenytoin
• St. John’s Wort

Drugs that increase the concentration of nintedanib are-

• Ketoconazole
• Erythromycin

Patients taking blood thinners are at an increased risk of bleeding and therefore taking nintedanib along with blood thinners such as warfarin should be avoided.

What are the storage conditions for Nintedanib?

Store nintedanib capsules at room temperature between 20°C and 25°C.

Protect the nintedanib capsules from excess heat and moisture.

Keep the nintedanib capsules away from the reach of children.