3.11 Antifibrotics

Nintedanib
  • Capsules 100mg, 150mg

Notes

  1. NICE TA347: Nintedanib (Vargatef) in combination with docetaxel is recommended, within its marketing authorisation, as an option for treating locally advanced, metastatic or locally recurrent non small cell lung cancer of adenocarcinoma histology that has progressed after first line chemotherapy (July 2015)
  2. NICE TA379: Nintedanib (Ofev) is recommended as an option for treating idiopathic pulmonary fibrosis (January 2016), only if:
    1. the person has a forced vital capacity (FVC) between 50% and 80% of predicted
    2. the company provides nintedanib with the discount agreed in the patient access scheme and
    3. treatment is stopped if disease progresses (a confirmed decline in percent predicted FVC of 10% or more) in any 12‑month period
  3. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm andartery dissection
    1. Before initiating a systemic VEGF pathwayinhibitor, carefully consider the risk of aneurysm and artery dissection inpatients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathwayinhibitor, reduce as far as possible any modifiable risk factors such assmoking and hypertension
    3. Monitor patients for and treat hypertension inaccordance with recommendations in the SPC (click here)
Pirfenidone
  • Capsule 267mg

Notes

  1. NICE TA504: Pirfenidone for treating idiopathic pulmonary fibrosis (NHS England commissioned) (February 2018)
  2. MHRA Drug Safety Update (November 2020): Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing
    1. Refer to the Drug Safety Update or the Summary of Product Characteristics for guidance on monitoring liver function
    2. Follow new guidance on testing liver function promptly in patients who report symptoms or have clinical signs that might indicate they have liver injury and adjust the dose or discontinue treatment according to new recommendations
    3. Monitor closely for signs of toxicity if pirfenidone is being used concomitantly with inhibitors of one or more other CYP isoenzymes involved in the metabolism of pirfenidone (see table in Drug Safety Update for more information)

 

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