Nintedanib Newbury (100 mg Soft Capsule)
Tyrosine kinase inhibitor containing nintedanib — prescription antifibrotic medication
Quick Facts About Nintedanib Newbury
Key Takeaways About Nintedanib Newbury
- Proven antifibrotic therapy: Nintedanib slows the decline of lung function in patients with idiopathic pulmonary fibrosis (IPF), as demonstrated in the INPULSIS clinical trials
- Multiple approved indications: Approved for IPF, systemic sclerosis-associated ILD, and chronic fibrosing ILD with a progressive phenotype
- Liver monitoring essential: Regular liver function tests are required before and during treatment due to the risk of hepatotoxicity
- Diarrhoea is the most common side effect: Occurs in up to 68% of patients but is manageable with supportive care and dose adjustments
- Take with food: Capsules should be swallowed whole with water and taken with food approximately 12 hours apart
What Is Nintedanib Newbury and What Is It Used For?
Nintedanib Newbury contains the active substance nintedanib, which belongs to a class of medications known as tyrosine kinase inhibitors (TKIs). Specifically, nintedanib is an intracellular inhibitor that simultaneously blocks three key families of receptor tyrosine kinases: platelet-derived growth factor receptors (PDGFR α and β), fibroblast growth factor receptors (FGFR 1–3), and vascular endothelial growth factor receptors (VEGFR 1–3). These receptors play central roles in the signalling pathways that drive the proliferation, migration, and transformation of fibroblasts — the cells responsible for the excessive scar tissue formation that characterises pulmonary fibrosis.
The medication is primarily used for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and ultimately fatal lung disease characterised by worsening breathlessness and irreversible loss of lung function. IPF affects approximately 3 million people worldwide, and nintedanib is one of only two approved antifibrotic therapies that has been proven to slow disease progression. The INPULSIS trials, two replicate phase III randomised controlled trials published in the New England Journal of Medicine in 2014, demonstrated that nintedanib 150 mg twice daily reduced the annual rate of decline in forced vital capacity (FVC) by approximately 50% compared to placebo.
In addition to IPF, nintedanib has received regulatory approval for systemic sclerosis-associated interstitial lung disease (SSc-ILD), based on the SENSCIS trial. This landmark trial showed that nintedanib significantly reduced the annual rate of FVC decline in patients with SSc-ILD compared to placebo. Furthermore, nintedanib is approved for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, supported by the INBUILD trial, which demonstrated consistent antifibrotic effects across a range of fibrosing ILD diagnoses.
Nintedanib does not cure pulmonary fibrosis. Rather, it slows the progression of lung function decline, which is an important therapeutic goal in managing these diseases. The long-term extension studies of the INPULSIS trials (INPULSIS-ON) have shown that the treatment effect of nintedanib is maintained over treatment periods of more than four years. The medication is available as 100 mg and 150 mg soft capsules, with the recommended dose being 150 mg twice daily. However, some patients may begin at the lower 100 mg twice daily dose depending on tolerability.
What Should You Know Before Taking Nintedanib Newbury?
Contraindications
Nintedanib Newbury must not be used if you have a known hypersensitivity to the active substance nintedanib, to peanut, to soya, or to any of the excipients in the capsule formulation. Since the soft capsules contain soya lecithin, patients with peanut or soya allergy should not use this medication. Additionally, nintedanib is contraindicated during pregnancy because animal studies have demonstrated teratogenic and embryolethal effects. Women of childbearing potential must use highly effective contraception during treatment and for at least three months after the last dose.
Warnings and Precautions
Hepatotoxicity: Nintedanib can cause drug-induced liver injury. Elevations in liver enzymes (ALT and AST) and bilirubin have been observed in clinical trials, with some cases of severe hepatotoxicity reported. Liver function tests should be performed prior to initiating treatment, monthly for the first three months, and then periodically thereafter. Patients with moderate or severe hepatic impairment (Child-Pugh B and C) should not be treated with nintedanib, and patients with mild hepatic impairment (Child-Pugh A) require close monitoring.
Diarrhoea: The most frequently reported adverse effect of nintedanib is diarrhoea, which can be severe and may lead to dehydration and electrolyte imbalances. Patients should be advised to maintain adequate hydration and to start anti-diarrhoeal treatment (such as loperamide) at the first signs of diarrhoea. In some cases, dose reduction or temporary treatment interruption may be necessary. If severe diarrhoea persists despite optimal supportive care, treatment discontinuation should be considered.
Cardiovascular risk: Based on its mechanism of action as a VEGFR inhibitor, nintedanib may increase the risk of thromboembolic events, including arterial thromboembolism (myocardial infarction, stroke). Caution should be exercised in patients with known cardiovascular risk factors, and the benefit-risk balance should be carefully evaluated in patients who have had a recent arterial thromboembolic event.
Bleeding risk: Nintedanib inhibits VEGFR, which plays a role in angiogenesis and vascular homeostasis. As such, nintedanib may increase the risk of bleeding. Patients receiving concomitant anticoagulant therapy (such as warfarin or direct oral anticoagulants) or those with a known bleeding predisposition require careful monitoring.
Gastrointestinal perforation: Cases of gastrointestinal perforation have been reported in patients receiving nintedanib. Caution is required in patients with prior abdominal surgery, previous history of peptic ulcer disease, diverticular disease, or concomitant use of corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs).
Pregnancy and Breastfeeding
Nintedanib is contraindicated during pregnancy. Preclinical studies in animals have demonstrated dose-dependent teratogenic effects (malformations) and embryolethal effects at exposures below the maximum recommended human dose. There are no adequate data from the use of nintedanib in pregnant women, and the potential risk to the human foetus is unknown but considered significant based on the animal data. A pregnancy test should be performed before starting treatment, and women of childbearing potential must use at least one highly effective method of contraception during treatment and for at least three months after the last dose of nintedanib.
It is not known whether nintedanib or its metabolites are excreted in human milk. Based on the pharmacological properties and the potential for adverse effects in the nursing infant, breastfeeding should be discontinued during treatment with nintedanib. The decision to continue or discontinue breastfeeding or to continue or discontinue nintedanib therapy should take into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
How Does Nintedanib Newbury Interact with Other Drugs?
Understanding the drug interaction profile of nintedanib is essential for safe prescribing, particularly because many patients with IPF and other fibrosing ILDs may be taking multiple medications. Nintedanib is metabolised primarily by ester cleavage (hydrolysis) and is a substrate of P-glycoprotein (P-gp), a transport protein that affects the absorption and distribution of many drugs. Nintedanib is not a significant substrate, inhibitor, or inducer of cytochrome P450 (CYP) enzymes at clinically relevant concentrations, which simplifies some aspects of its interaction profile.
However, co-administration with potent P-gp inhibitors can significantly increase plasma concentrations of nintedanib. For example, concomitant use with ketoconazole (a potent P-gp inhibitor) increased the AUC (area under the curve) of nintedanib by approximately 60% and the Cmax by approximately 80% in a drug interaction study. When P-gp inhibitors must be co-administered, patients should be closely monitored for tolerability, and a dose reduction to 100 mg twice daily should be considered. Conversely, potent P-gp inducers such as rifampicin can reduce nintedanib exposure by approximately 50%, potentially decreasing its efficacy. Alternative medications that do not induce P-gp should be considered where possible.
Major Interactions
| Interacting Drug | Mechanism | Effect | Clinical Management |
|---|---|---|---|
| Ketoconazole | Potent P-gp inhibitor | Increases nintedanib AUC by ~60% | Monitor closely; consider dose reduction to 100 mg twice daily |
| Rifampicin | Potent P-gp inducer | Decreases nintedanib exposure by ~50% | Avoid co-administration; choose alternative non-P-gp inducing drugs |
| Carbamazepine | Potent P-gp inducer | May significantly reduce nintedanib levels | Avoid co-administration; use alternative anticonvulsant |
| Phenytoin | Potent P-gp inducer | May significantly reduce nintedanib levels | Avoid co-administration; use alternative anticonvulsant |
| St. John’s Wort | P-gp inducer | May decrease nintedanib efficacy | Avoid concomitant use |
| Warfarin / DOACs | Additive bleeding risk via VEGFR inhibition | Increased risk of haemorrhage | Monitor closely for signs of bleeding; regular coagulation tests |
Minor Interactions
Because nintedanib is not significantly metabolised by CYP enzymes and does not inhibit or induce them at clinical doses, the potential for CYP-mediated drug interactions is low. However, co-administration with other medications that have hepatotoxic potential (such as methotrexate, amiodarone, or certain antibiotics) should be approached cautiously, with enhanced liver function monitoring. Proton pump inhibitors (PPIs) and H2-receptor antagonists do not significantly affect the pharmacokinetics of nintedanib and can be used safely together.
Co-administration with erythromycin, a moderate P-gp inhibitor, increased nintedanib exposure by approximately 20%, which is generally considered clinically non-significant. However, in patients already at the threshold of tolerability, even modest increases in exposure may precipitate side effects, particularly diarrhoea. Clinical judgement should guide management in these situations.
What Is the Correct Dosage of Nintedanib Newbury?
Adults
The recommended dose of Nintedanib Newbury for adult patients is 150 mg twice daily, administered approximately 12 hours apart. Each dose should be taken with food (during or immediately after a meal) and swallowed whole with water. The capsules must not be opened, crushed, or chewed, as this may alter the drug’s bioavailability and increase the risk of gastrointestinal side effects.
For patients who do not tolerate the 150 mg twice daily dose due to adverse effects (most commonly diarrhoea, nausea, or liver enzyme elevations), the dose may be reduced to 100 mg twice daily. This is where the Nintedanib Newbury 100 mg soft capsule formulation is particularly useful. Treatment can subsequently be re-escalated to 150 mg twice daily once the adverse effects have resolved. If adverse effects persist at the 100 mg twice daily dose, treatment discontinuation should be considered.
Standard Adult Dosing
Recommended dose: 150 mg twice daily with food
Reduced dose: 100 mg twice daily (for tolerability)
Administration: Swallow whole with water, ~12 hours apart
Duration: Continuous treatment; no defined treatment duration
Children
Nintedanib Newbury is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of nintedanib in the paediatric population have not been established, and no data are available. The approved indications (IPF, SSc-ILD, chronic fibrosing ILDs) are primarily diseases of adulthood, and paediatric interstitial lung diseases have different aetiologies and pathophysiology.
Elderly
No dose adjustment is required in elderly patients based on age alone. In the INPULSIS trials, a substantial proportion of patients were aged 65 years and older, and the efficacy and safety profile was consistent across age groups. However, elderly patients may have reduced hepatic or renal function and may be more susceptible to adverse effects such as diarrhoea and dehydration. Close monitoring and early intervention for adverse effects are recommended in older patients.
Renal and Hepatic Impairment
Less than 1% of a single dose of nintedanib is excreted via the kidneys. No dose adjustment is required in patients with mild to moderate renal impairment. The safety and efficacy of nintedanib have not been studied in patients with severe renal impairment (creatinine clearance <30 mL/min), and caution is advised.
Nintedanib is predominantly cleared by biliary and faecal excretion. No dose adjustment is needed in patients with mild hepatic impairment (Child-Pugh A), but enhanced monitoring for adverse effects is recommended. Nintedanib is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the lack of clinical data and the risk of increased drug exposure and hepatotoxicity.
Missed Dose
If a dose of Nintedanib Newbury is missed, the next dose should be taken at the regularly scheduled time. Do not take a double dose to make up for a missed dose. The patient should continue with the regular dosing schedule. If a missed dose is remembered within a few hours, it may still be taken if there is sufficient time before the next scheduled dose (i.e., at least 6 hours before the next dose). Patients should speak to their doctor or pharmacist if they frequently forget to take their medication.
Overdose
There is limited experience with overdose of nintedanib. In clinical trials, two patients were accidentally exposed to a maximum dose of 600 mg once daily for up to 8 days. The adverse events observed were consistent with the known safety profile of nintedanib, including diarrhoea, nausea, vomiting, and elevated liver enzymes. Both patients recovered. There is no specific antidote for nintedanib overdose. In case of overdose, treatment should be symptomatic and supportive. Treatment should be interrupted and resumed at the recommended dose once appropriate.
What Are the Side Effects of Nintedanib Newbury?
Like all medicines, Nintedanib Newbury can cause side effects, although not everybody gets them. The safety profile of nintedanib has been extensively characterised through clinical trials in IPF (INPULSIS 1 and 2), SSc-ILD (SENSCIS), and chronic fibrosing ILD (INBUILD), as well as long-term extension studies and post-marketing surveillance. The side effects are generally consistent across the different approved indications.
Gastrointestinal adverse events are the most commonly reported side effects and represent the primary cause of dose reduction and treatment discontinuation. However, with appropriate management including hydration, anti-diarrhoeal therapy, and dose adjustment, many patients are able to continue treatment long-term. The majority of gastrointestinal adverse events occur within the first three months of treatment and tend to decrease in intensity and frequency over time.
Very Common (affects more than 1 in 10 patients)
- Diarrhoea (62–68%)
- Nausea (24–29%)
- Abdominal pain (15%)
- Vomiting (12–14%)
- Elevated liver enzymes (ALT/AST) (14%)
- Decreased appetite (11%)
Common (affects 1 in 10 to 1 in 100 patients)
- Weight loss
- Headache
- Hypertension (high blood pressure)
- Elevated bilirubin levels
- Elevated gamma-glutamyl transferase (GGT)
- Elevated alkaline phosphatase
- Bleeding events (epistaxis, bruising)
- Abdominal distension
- Gastro-oesophageal reflux disease
Uncommon (affects 1 in 100 to 1 in 1,000 patients)
- Pancreatitis
- Thrombocytopenia (low platelet count)
- Gastrointestinal perforation
- Drug-induced liver injury (serious)
- Pruritus (itching)
- Rash
- Alopecia (hair loss)
Rare (affects fewer than 1 in 1,000 patients)
- Myocardial infarction (heart attack)
- Cerebrovascular events (stroke)
- Severe hepatotoxicity with hepatic failure
- Proteinuria (protein in urine)
- Anaphylactic reactions
It is important to note that the decision to continue or discontinue nintedanib should always be made in consultation with your prescribing physician, weighing the potential benefits of slowed disease progression against the burden of side effects. Many patients successfully manage side effects with supportive care and dose adjustments. If you experience any new or worsening symptoms, report them to your healthcare provider promptly.
How Should You Store Nintedanib Newbury?
Proper storage of Nintedanib Newbury is essential to ensure the medication retains its potency and safety throughout its shelf life. The soft capsules should be stored at a temperature not exceeding 25°C (77°F). They should be kept in the original blister packaging to protect from moisture and light. Do not remove the capsules from the blister until immediately before taking them.
Do not use Nintedanib Newbury after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month. Keep the medication out of the sight and reach of children. Do not store in the bathroom or other damp areas where humidity could affect the integrity of the capsules. If you notice that the capsules appear discoloured, damaged, or otherwise altered, do not take them and consult your pharmacist.
Do not dispose of unused medications via household waste or wastewater. Ask your pharmacist about how to dispose of medicines you no longer use. These measures will help to protect the environment and reduce the risk of accidental exposure.
What Does Nintedanib Newbury Contain?
The active substance in Nintedanib Newbury is nintedanib, present in the form of nintedanib esilate (the ethanesulfonate salt). Each soft capsule contains nintedanib esilate equivalent to 100 mg of nintedanib. The salt form was selected to optimise the solubility and bioavailability of the active compound in the soft capsule formulation.
The capsule fill contains medium-chain triglycerides, hard fat, and soya lecithin (E322) as excipients. Soya lecithin serves as an emulsifier to ensure uniform distribution of the active substance within the capsule fill. The capsule shell is composed of gelatin, glycerol (as a plasticiser), titanium dioxide (E171), and iron oxide pigments (E172) for colouring. The printing ink on the capsule contains shellac, iron oxide black (E172), and propylene glycol.
The capsules do not contain lactose, gluten, or preservatives. Nintedanib Newbury does not contain any substances derived from animal sources other than gelatin (used in the capsule shell). Patients who require halal, kosher, or vegetarian alternatives should discuss options with their healthcare provider, although gelatin-free formulations may not be available.
Frequently Asked Questions About Nintedanib Newbury
Nintedanib Newbury is a tyrosine kinase inhibitor used to treat idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other chronic fibrosing interstitial lung diseases with a progressive phenotype. It works by blocking multiple growth factor receptors (PDGFR, FGFR, VEGFR) involved in the fibrotic process, thereby slowing the rate of lung function decline. It does not reverse existing scarring but helps to slow disease progression.
The most common side effect is diarrhoea, occurring in approximately 62–68% of patients. Other very common side effects include nausea (24–29%), abdominal pain (15%), vomiting (12–14%), elevated liver enzymes (14%), and decreased appetite (11%). Most gastrointestinal side effects are manageable with anti-diarrhoeal medication, adequate hydration, and dose reduction if needed. They typically improve after the first three months of treatment.
No, nintedanib does not cure pulmonary fibrosis. Currently, there is no cure for IPF or other chronic fibrosing interstitial lung diseases. However, nintedanib has been proven in multiple large clinical trials (INPULSIS, SENSCIS, INBUILD) to significantly slow the rate of lung function decline, which is the primary therapeutic goal. By reducing the annual rate of FVC decline by approximately 50%, nintedanib helps to preserve lung function for longer and may improve the overall disease trajectory.
Nintedanib Newbury 100 mg soft capsules should be swallowed whole with water and taken with food (during or immediately after a meal). Take the capsules approximately 12 hours apart — for example, one capsule in the morning with breakfast and one capsule in the evening with dinner. Do not open, crush, or chew the capsules. If you miss a dose, take your next dose at the regular time. Do not take a double dose to make up for a missed one.
Liver function tests (ALT, AST, and bilirubin) should be measured before starting treatment, monthly for the first three months, and periodically thereafter (typically every three to six months). Your doctor will review these results and may adjust your dose or discontinue treatment if significant elevations are observed. Treatment should be interrupted if liver enzymes rise above 3 times the upper limit of normal with symptoms, or above 5 times the upper limit of normal regardless of symptoms. Report any signs of liver problems (yellowing skin/eyes, dark urine, unusual tiredness, right-sided abdominal pain) to your doctor immediately.
No, nintedanib is contraindicated during pregnancy. Animal studies have shown teratogenic (birth defect-causing) and embryolethal effects. Women of childbearing potential must use effective contraception during treatment and for at least three months after the last dose. A pregnancy test should be performed before starting treatment. If you become pregnant during treatment, stop taking nintedanib and contact your doctor immediately.
References & Sources
This article is based on the following peer-reviewed sources, regulatory documents, and clinical practice guidelines:
- Richeldi L, du Bois RM, Raghu G, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2071–2082. doi:10.1056/NEJMoa1402584
- Distler O, Highland KB, Gahlemann M, et al. Nintedanib for systemic sclerosis-associated interstitial lung disease (SENSCIS). N Engl J Med. 2019;380(26):2518–2528. doi:10.1056/NEJMoa1903076
- Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in progressive fibrosing interstitial lung diseases (INBUILD). N Engl J Med. 2019;381(18):1718–1727. doi:10.1056/NEJMoa1908681
- European Medicines Agency (EMA). Ofev (nintedanib) — Summary of Product Characteristics. Available at: ema.europa.eu. Accessed December 2025.
- U.S. Food and Drug Administration (FDA). Ofev (nintedanib) — Prescribing Information. Available at: accessdata.fda.gov. Accessed December 2025.
- Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults: an official ATS/ERS/JRS/ALAT clinical practice guideline. Am J Respir Crit Care Med. 2022;205(9):e18–e47. doi:10.1164/rccm.202202-0399ST
- Crestani B, Huggins JT, Kaye M, et al. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019;7(1):60–68. doi:10.1016/S2213-2600(18)30339-4
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd list, 2023. Geneva: WHO; 2023.
- British National Formulary (BNF). Nintedanib. Available at: bnf.nice.org.uk. Accessed December 2025.
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians and specialists in pulmonology and clinical pharmacology.
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iMedic Medical Editorial Team
Specialists in Pulmonology and Clinical Pharmacology. Evidence-based content following EMA, FDA, and ATS/ERS/JRS/ALAT guidelines.
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