Vargatef Capsules (Soft Gelatin)
Nintedanib
100mg
Boehringer Ingelheim International GmbH
| Pack size | 60's Blister |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | GULF DRUG EST. |
| Retail Price | 8044.00 AED |
Available as:
Indications
Vargatef 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
Vargatef 100mg Capsules (Soft Gelatin) manufactured by Boehringer Ingelheim International GmbH. Its generic name is Nintedanib. Vargatef is availble in United Arab Emirates.
Farmaco UAE drug index information on Vargatef Capsules (Soft Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
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