Nintedanib Brand Name– Ofev
What is Nintedanib
Nintedanib is a kinase inhibitor that blocks multiple pathways involved in the scarring of lung tissue.
The drug is approved for the treatment of adults with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and to slow the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Based on data from animal studies and its mechanism of action, nintedanib can cause fetal harm when administered to pregnant women; therefore, women of childbearing age should undergo pregnancy testing before and during treatment.
Instruct women of reproductive potential to use highly effective contraception during therapy and for at least 3 months after the last dose.
Avoid use in patients with moderate to severe hepatic disease (Child-Pugh B and C) and in patients with severe renal impairment (CrCl 30 mL/min or less) or end-stage renal disease.
Indications
- chronic fibrosing interstitial lung disease
- pulmonary fibrosis
- scleroderma (systemic sclerosis)
For the treatment of idiopathic pulmonary fibrosis (IPF)
NOTE: The FDA has granted orphan drug status to nintedanib for this indication.
Side Effects
- abdominal pain
- alopecia
- anorexia
- back pain
- bleeding
- cardiomyopathy
- dehydration
- diarrhea
- dizziness
- elevated hepatic enzymes
- fatigue
- fever
- GI perforation
- headache
- hyperbilirubinemia
- hypertension
- hypertensive crisis
- hypothyroidism
- infection
- jaundice
- myocardial infarction
- nausea
- new primary malignancy
- pancreatitis
- pharyngitis
- pruritus
- rash
- skin ulcer
- stroke
- thrombocytopenia
- thromboembolism
- vomiting
- weight loss
Monitoring Parameters
- LFTs
- pregnancy testing
Contraindications
- acute myocardial infarction
- anticoagulant therapy
- Asian patients
- bleeding
- breast-feeding
- children
- contraception requirements
- coronary artery disease
- corticosteroid therapy
- diarrhea
- diverticulitis
- females
- geriatric
- GI perforation
- hepatic disease
- hepatotoxicity
- infants
- infertility
- jaundice
- myocardial infarction
- pregnancy
- pregnancy testing
- reproductive risk
- stroke
- surgery
- tobacco smoking
- vomiting
Interactions
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Amiodarone
- Amobarbital
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Anticoagulants
- Antithrombin III
- Apalutamide
- Apixaban
- Argatroban
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Atazanavir; Cobicistat
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Barbiturates
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Betrixaban
- Bivalirudin
- Boceprevir
- Butabarbital
- Carbamazepine
- Clarithromycin
- Cobicistat
- Conivaptan
- Cyclosporine
- Dabigatran
- Dalteparin
- Danaparoid
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Desirudin
- Dronedarone
- Edoxaban
- Elexacaftor; tezacaftor; ivacaftor
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Enoxaparin
- Erythromycin
- Erythromycin; Sulfisoxazole
- Fondaparinux
- Fosphenytoin
- Fostamatinib
- grapefruit juice
- Heparin
- Isavuconazonium
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ivacaftor
- Ketoconazole
- Lapatinib
- Lepirudin
- Lopinavir; Ritonavir
- Lumacaftor; Ivacaftor
- Mephobarbital
- Methohexital
- Mifepristone
- Nelfinavir
- Ombitasvir; Paritaprevir; Ritonavir
- Pentobarbital
- Pentosan
- Phenobarbital
- Phenytoin
- Primidone
- Ranolazine
- Rifampin
- Ritonavir
- Rivaroxaban
- Saquinavir
- Secobarbital
- Simeprevir
- St. John’s Wort, Hypericum perforatum
- Telaprevir
- Telithromycin
- Tezacaftor; Ivacaftor
- Thiopental
- Ticagrelor
- Tinzaparin
- Trandolapril; Verapamil
- Tucatinib
- Verapamil
- Warfarin
