Ofev Capsules (Soft Gelatin)

Nintedanib
100mg
Boehringer Ingelheim International GmbH
Pack size 60's (10's Blister x 6)
Dispensing mode POM
Source GERMANY
AgentGULF DRUG EST.
Retail Price 15619.50 AED

Indications

Ofev Capsules (Soft Gelatin) is used for: Idiopathic pulmonary fibrosis, locally-advanced, metastatic or locally recurrent non-small cell lung cancer, chronic fibrosing interstitial lung diseases, systemic sclerosis-associated interstitial lung disease

Adult Dose

Oral Idiopathic Pulmonary Fibrosis, Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype, Systemic Sclerosis-associated Interstitial Lung Disease Adult: 150 mg bid. Max: 300 mg daily. Locally advanced non-small cell lung carcinoma, Locally recurrent non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma Adult: In combination with docetaxel: 200 mg bid on days 2 21 of a 21-day treatment cycle. Max: 400 mg daily. Hepatic impairment Mild (Child Pugh A): 100 mg PO q12hr Moderate-to-severe (Child Pugh B or C): Not recommended (not studied)

Child Dose

Renal Dose

Renal impairment Mild-to-moderate: No dosage adjustment required Severe (CrCl <30 mL/min) or ESRD: Not studied

Administration

Should be taken with food. Swallow whole w/ liqd. Do not chew/crush cap because of bitter taste.

Contra Indications

Hypersensitivity to nintedanib, peanut or soya. Pregnancy.

Precautions

Severe liver injury with fatal outcome reported; majority of hepatic events occur within first 3 months of treatment; conduct liver function tests (ALT, AST, and bilirubin) before initiating, monthly for 3 months, and then q3months thereafter and as clinically indicated Not recommended in patients with moderate or severe hepatic impairment (Child Pugh B or C); reduced dose for patients with mild hepatic impairment (Child Pugh A) Nausea, and/or vomiting may occur; treat with adequate hydration and antidiarrheal/antiemetic medications; if persists, treatment interruption and dose reduction may be needed Diarrhea may occur; treat at first signs with adequate hydration and antidiarrheal medication (eg, loperamide); consider treatment interruption if diarrhea continues; treatment may be resumed at full dosage (150 mg twice daily), or at reduced dosage (100 mg twice daily); may subsequently increase to full dosage; if severe diarrhea persists despite symptomatic treatment, discontinue treatment Arterial thromboembolic events reported, including myocardial infarction; caution when treatment patients at higher cardiovascular risk May increased risk of bleeding or gastrointestinal perforation (based on mechanism of action [VEGFR inhibition]); monitor for bleeding if on full anticoagulant therapy and adjust anticoagulation treatment as needed Smoking associated with decreased systemic exposure; encourage patients to quit smoking Can cause fetal harm; use adequate contraception during treatment and for at least 3 months after the last dose

Pregnancy-Lactation

Pregnancy Based on findings from animal studies and its mechanism of action, can cause fetal harm when administered to pregnant women; counsel patients on pregnancy prevention and planning Verify pregnancy status of females of reproductive potential prior to treatment and during treatment as appropriate Animal data In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryofetal deaths and structural abnormalities at less than (rats) and ~5 times (rabbits) the maximum recommended human dose Contraception Advise females of reproductive potential to avoid becoming pregnant while receiving nintedanib Use effective contraception during treatment, and for at least 3 months after taking the last dose Drug does not change exposure to oral contraceptive containing ethinylestradiol and levonorgestrel in patients with SSc-ILD; however, efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhea or other conditions where drug absorption may be reduced Infertility Based on animal data, may reduce fertility in females of reproductive potential Lactation There is no information on the presence of nintedanib in human milk, the effects on the breast-fed infant or the effects on milk production Nintedanib and/or its metabolites are present in the milk of lactating rats Because of the potential for serious adverse effects in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

Interactions

Increased risk of gastrointestinal adverse effect with corticosteroids and NSAIDs. Increased plasma concentration with strong P-gp inhibitors (e.g. ketoconazole, erythromycin, ciclosporine). Decreased plasma concentration with strong P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin).

Adverse Effects

Side effects of Nintedanib : >10% Idiopathic pulmonary fibrosis Diarrhea (62%) Nausea (24%) Abdominal pain (15%) Elevated liver enzymes (14%) Vomiting (12%) Decreased appetite (11%) SSc-ILD Diarrhea (76%) Nausea (32%) Vomiting (25%) Skin ulcer (18%) Abdominal pain (18%) Liver enzyme elevation (13%) Decreased weight (12%) Fatigue (11%) 1-10% Idiopathic pulmonary fibrosis Decreased weight (10%) Bleeding events (10%) Headache (8%) Hypertension (5%) Arterial thromboembolic events (2.5%) Myocardial infarction (1.5%) Bronchitis (1.5%) Hypothyroidism (1.1%) SSc-ILD Decreased appetite (9%) Headache (9%) Pyrexia (6%) Back pain (6%) Dizziness (6%) Hypertension (5%) <1% Idiopathic pulmonary fibrosis Pneumonia (0.7%) Lung neoplasm malignant (0.3%) Gastrointestinal perforation (0.3%)

Mechanism of Action

Tyrosine kinase inhibitor; targets growth factors, which have been shown to be potentially involved in pulmonary fibrosis (eg, vascular endothelial growth factor receptor [VEGFR], fibroblast growth factor receptor [FGFR], platelet-derived growth factor receptor [PDGF]) Binds competitively to the adenosine triphosphate (ATP)-binding pocket of these receptors and blocks the intracellular signaling, which is crucial for the proliferation, migration, and transformation of fibroblasts, representing essential mechanisms of the IPF pathology

Note

Ofev 100mg Capsules (Soft Gelatin) manufactured by Boehringer Ingelheim International GmbH. Its generic name is Nintedanib. Ofev is availble in United Arab Emirates. Farmaco UAE drug index information on Ofev Capsules (Soft Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Nintedanib :