Nintedanib is an oral drug, which is given in association with taxotere/docetaxel in patients with adenocarcinoma of the lung progressing after a chemotherapeutic line with platinum.

The dose administered is 200 mg twice a day (every 12 hours). Nintedanib is taken with food.

The following are the adverse events that can be observed during nintedanib therapy. These are side effects that, in general, do not endanger patients and can be treated with well-established therapies and/or with a dose reduction, if conventional therapy is not acceptable or conclusive.

Potential side effects of Nintedanib

Very common side effects (>1 in 100 patients)

  • Diarrhea
  • Vomiting
  • Increase in liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase)
  • Neutropenia, i.e. reduction in neutrophils
  • Asthenia, i.e. fatigue
  • Loss or decrease of appetite
  • Electrolyte imbalance (sodium, potassium, calcium, magnesium), although only slightly higher than observed in the docetaxel arm
  • Peripheral neuropathy
  • Mucositis (including stomatitis), i.e. inflammation of the mucous membranes
  • Rash or change in the skin appearance.

Common side effects (≥1 patient out of 100)

  • Arterial hypertension (high blood pressure)
  • Increased bilirubin

Uncommon side effects (≥1 patient in 1000)

• Gastrointestinal perforation, especially in the case of recent abdominal surgery.

In the presence of prolonged or grade 3 toxicity, the doctor may decide to reduce the dose. You can make two dose reductions: the first 200 to 150 mg twice a day, the second 150 to 100 mg twice a day. 

The commercially available tablets are of two dosages: 100 mg and 150 mg.

Interactions with other drugs

Nintedanib is mainly metabolized by liver enzymes and eliminated by the biliary system. It is only minimally metabolized by the CYP3A4 cytochrome system. However, being a substrate of P-glycoprotein, its concentration can decrease up to 60%, when taken with P-gp inducers (such as rifampicin, carbamazepine, phenytoin or St. John’s Wort), or increase approximately 2-fold if taken with P-gp inhibitors (such as ketoconazole).