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Nindanix 150 (Nintedanib) also known as Ofev and Vargatef is used to treat certain lung disease (idiopathic pulmonary fibrosis- IPF, interstitial lung disease).

Nindanix is the alternative & generic version of Ofev / Vargatef by Boehringer Ingelheim. Nindanix is manufactured by beacon pharma Bangladesh which is the biggest pharmaceutical company in Bangladesh.

Nindanix 150 | Nintedanib also known as Ofev and Vargatef is used to treat certain types of lung disease (idiopathic pulmonary fibrosis- IPF, interstitial lung disease). Both types of lung disease scar and stiffen your lungs, making it hard to breathe. Nintedanib may help slow down the worsening of your lung disease.

Therapeutic Class

Tyrosine Kinase Inhibitor

Pharmacology

Nintedanib is a small molecule, competitive, triple angiokinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Many of these RTKs are implicated in lung fibrosis and tumour angiogenesis

so nintedanib is therefore used in the treatment of proliferative diseases such as idiopathic pulmonary fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease.

The specific RTKs that Ofev inhibits are platelet-derived growth factor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR), and Fns-Like tyrosine kinase-3 (FLT3).

Ofev binds to the ATP-binding pocket of these receptors and inhibits their activity, thereby blocking signalling cascades that result in the proliferation and migration of lung fibroblasts.

Nintedanib also inhibits kinase signalling pathways in various cells within tumour tissues, including endothelial cells, pericytes, smooth muscle cells, and cells contributing to angiogenesis, culminating in an inhibition of cell proliferation and apoptosis of affected tumour cells.

In addition to RTK inhibition, Ofev also prevents the actions of the nRTKs Lck, Lyn, and Src. The contribution of the inhibition of Lck and Lyn towards the therapeutic efficacy of Ofev is unclear, but inhibition of the Src pathway by nintedanib has been shown to reduce lung fibrosis.

Dosage

Treatment with Nintedanib should be initiated by physicians experienced in the diagnosis and treatment of IPF.

Posology: The recommended dose is 150 mg Ofev twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.

If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.

For NSCLC:

The recommended dose of Ofev is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.

Nintedanib must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose.

The individual daily doses of Ofev should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded.

Patients may continue therapy with Ofev after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.

Dose adjustments: In addition to symptomatic treatment if applicable, the management of adverse reactions to Nintedanib could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy.

Ofev treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If a patient does not tolerate 100 mg twice daily, treatment with Nintedanib should be discontinued.

Administration

Nintedanib is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.

Interaction

P-glycoprotein (P-gp): Nintedanib is a substrate of P-gp. Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to Ofev 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.

In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to Ofev decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of Nintedanib alone.

Cytochrome (CYP)-enzymes: Only a minor extent of the biotransformation of Ofev consisted of CYP pathways. Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies.

Co-administration with other medicinal products: The potential for interactions of Ofev with hormonal contraceptives was not explored.

Contraindications

Hypersensitivity to Nintedanib, to peanut or soya, or to any of the excipients.

Side Effects

Summary of the safety profile: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF. The safety data provided in the following are based on the two Phase III, randomized, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with Ofev 150 mg twice daily to placebo for 52 weeks

Pregnancy & Lactation

Women of childbearing potential/Contraception: Nintedanib may cause foetalharm in humans. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Ofev .

They should be advised to use adequate contraception during and at least 3 months after the last dose of Nintedanib. Since the effect of Nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.

Pregnancy: There is no information on the use of Ofev in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance. As Nintedanib may cause foetal harm also in humans, it must not be used during pregnancy.

Lactation: There is no information on the excretion of Ofev and its metabolites in human milk. Pre-clinical studies showed that small amounts of Nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats.

Fertility: Based on preclinical investigations there is no evidence for impairment of male fertility. From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily.

Precautions & Warnings

Diarrhoea: In the INPULSIS trials, diarrhoea was the most frequent gastro-intestinal adverse reaction reported in 62.4% versus 18.4% of patients treated with Nintedanib and placebo, respectively.

Nausea and vomiting: Nausea and vomiting were frequently reported gastrointestinal adverse reactions. In most patients with nausea and vomiting, the event was of mild to moderate intensity. Nausea led to discontinuation of Nintedanib in 2.0% of patients.

Hepatic function: The safety and efficacy of Nintedanib has not been studied  in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Therefore, treatment with Ofev is not recommended in such patients.

Renal Function: Cases of renal impairment/failure, in some cases with fatal outcome, have been reported with Nintedanib use. Patients should be monitored during Ofev therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure.

Arterial thromboembolic events: Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials. Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the Nintedanib treated group.

Venous thromboembolism: In the INPULSIS trials no increased risk of venous thromboembolism was observed in Nintedanib treated patients. Due to the mechanism of action of Ofev patients might have an increased risk of thromboembolic events.

Gastrointestinal perforations: In the INPULSIS trials, the frequency of patients with perforation was very low in both treatment groups: 0% placebo, 0.3% Nintedanib (involving two patients).

Hypertension: Administration of Ofev may increase blood pressure. Systemic blood pressure should be measured periodically and as clinically indicated.

Wound healing complication: No increased frequency of impaired wound healing was observed in the INPULSIS trials. Based on the mechanism of action Nintedanib may impair wound healing. No dedicated studies investigating the effect of Nintedanib on wound healing were performed.

Co-administration with Pirfenidone: In a dedicated pharmacokinetic study, concomitant treatment of Ofev with Pirfenidone was investigated in patients with IPF. Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between Ofev and Pirfenidone when administered in combination.

Effect on QT interval: No evidence of QT prolongation was observed for Ofev in the clinical trial programme. As some other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administered Ofev in patients who may develop QTc prolongation.

Allergic reaction: Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.

Use in Special Populations

Elderly patients (≥65 years): No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required on the basis of a patient’s age. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects.

Renal impairment: Less than 1% of a single dose of Nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required.

Paediatric population: The safety and efficacy of Ofev in children aged 0-18 years have not been established. No data are available.

Storage Conditions

Store in a cool and dry place, protected from light. Do not store above 25°C.