Drug Action
Nintedanib is a tyrosine protein kinase inhibitor.
PDF page 1070
Loading InternPractice…
Drug reference
Nintedanib is a tyrosine protein kinase inhibitor.
PDF page 1070
OFEV ® Treatment of idiopathic pulmonary fibrosis ▶BY MOUTH ▶Adult: 150 mg twice daily, reduced if not tolerated to 100 mg twice daily, for dose adjustments due to side- effects, consult product literature VARGATEF ® Treatment of locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma histology after first-line chemotherapy (in combination with docetaxel) (initiated under specialist supervision) ▶BY MOUTH ▶Adult: 200 mg twice daily on days 2–21 of a standard 21 day docetaxel cycle, for treatment following discontinuation of docetaxel and for dose adjustments due to side-effects, consult product literature
PDF page 1070
History or risk factors for QT prolongation. impaired wound healing. increased risk of bleeding. patients at high risk of cardiovascular disease. previous abdominal surgery. recent history of hollow organ perforation. theoretical increased risk of gastrointestinal perforation. theoretical increased risk of venous thromboembolism
PDF page 1070
Contra-indicated in patients with peanut or soya hypersensitivity.
PDF page 1070
VARGATEF ® Not to be taken on the same day as docetaxel therapy.
PDF page 1070
NICE decisions ▶Nintedanib for previously treated locally advanced, metastatic, or locally recurrent non-small-cell lung cancer (July 2015) NICE TA347 Nintedanib (Vargatef ®), in combination with docetaxel is recommended as an option for the treatment of patients with locally advanced, metastatic, or locally recurrent non- small-cell lung cancer of adenocarcinoma histology, that has progressed after first-line chemotherapy, only if the manufacturer provides nintedanib with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta347 ▶Nintedanib for treating idiopathic pulmonary fibrosis (January 2016) NICE TA379 Nintedanib (Ofev ®) is recommended as an option for treating idiopathic pulmonary fibrosis, only if: . the patient has a forced vital capacity (FVC) between 50% and 80% of predicted, . the manufacturer provides nintedanib with the discount agreed in the patient access scheme, and, . treatment is stopped if disease progresses (a confirmed decline in percent predicted FVC of 10% or more) in any 12-month period. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta379 Scottish Medicines Consortium (SMC) decisions SMC No. 1076/15 The Scottish Medicines Consortium has advised (October 2015) that nintedanib (Ofev ®) is accepted for restricted use within NHS Scotland for the treatment of idiopathic pulmonary fibrosis in patients with a predicted forced vital capacity less than or equal to 80%.
PDF page 1070
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
PDF page 1070
→Appendix 1: nintedanib
PDF page 1070
▶Common or very common Abdominal pain. abscess. appetite decreased. dehydration. diarrhoea. electrolyte imbalance. haemorrhage. hyperbilirubinaemia. hypertension. mucositis. nausea. neutropenia. peripheral neuropathy. sepsis. skin reactions. stomatitis. thrombocytopenia. venous thromboembolism. vomiting. weight decreased ▶Uncommon Drug-induced liver injury. gastrointestinal perforation. myocardial infarction. pancreatitis. renal impairment
PDF page 1070
Manufacturer advises exclude pregnancy before treatment and ensure effective contraception (in addition to barrier method) during treatment and for at least 3 months after last dose.
PDF page 1070
Manufacturer advises avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
PDF page 1070
Manufacturer advises avoid—present in milk in animal studies.
PDF page 1070
Manufacturer advises caution in mild impairment (risk of increased exposure); avoid in moderate to severe impairment (limited information available). OFEV ® Dose adjustments Manufacturer advises dose reduction to 100 mg twice daily in mild impairment.
PDF page 1070
Manufacturer advises caution in severe impairment—no information available.
PDF page 1070
▶For Vargatef ®, manufacturer advises monitor full blood count before each treatment cycle and regularly thereafter; monitor hepatic function before each treatment cycle during combination therapy and monthly during monotherapy; monitor renal function during treatment; monitor for thromboembolic events; monitor prothrombin time, INR and for bleeding if used concomitantly with anticoagulants; monitor for cerebral bleeding in patients with stable brain metastases. ▶For Ofev ® manufacturer advises monitor hepatic function before treatment initiation and during the first month of treatment, then at regular intervals during the subsequent 2 months and as clinically indicated thereafter; monitor renal function during treatment; monitor blood pressure as clinically indicated.
PDF page 1070
There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 25 EXCIPIENTS: May contain Lecithin ▶Ofev (Boehringer Ingelheim Ltd) Nintedanib (as Nintedanib esilate) 100 mg Ofev 100mg capsules | 60 capsule P £2,151.10 (Hospital only) Nintedanib (as Nintedanib esilate) 150 mg Ofev 150mg capsules | 60 capsule P £2,151.10 (Hospital only) ▶Vargatef (Boehringer Ingelheim Ltd) Nintedanib (as Nintedanib esilate) 100 mg Vargatef 100mg capsules | 120 capsule P £2,151.10 (Hospital only) Nintedanib (as Nintedanib esilate) 150 mg Vargatef 150mg capsules | 60 capsule P £2,151.10 (Hospital only)
PDF page 1071
150 mg twice daily, reduced if not tolerated to
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1070
200 mg twice daily on days 2–21 of a standard
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1070