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.
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
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.
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.
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.
• 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.
• 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
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.
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.
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.
