Nintedanib Sandoz
Triple tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and progressive fibrosing interstitial lung diseases
Quick Facts About Nintedanib Sandoz
Key Takeaways About Nintedanib Sandoz
- Slows disease progression, does not cure: Nintedanib Sandoz reduces the annual rate of forced vital capacity (FVC) decline by about 50% in patients with idiopathic pulmonary fibrosis, as demonstrated in the INPULSIS-1 and INPULSIS-2 phase III trials.
- Targets three fibrogenic pathways: As a triple kinase inhibitor it simultaneously blocks VEGFR 1-3, FGFR 1-3, and PDGFR α/β, interfering with the signaling cascades that drive fibroblast activation in the lungs.
- Diarrhea is the hallmark side effect: Occurring in more than 60% of patients, gastrointestinal diarrhea is usually manageable with early hydration, loperamide, and a dose reduction from 150 mg to 100 mg twice daily if needed.
- Liver monitoring is mandatory: Baseline and regular liver function tests (ALT, AST, bilirubin) are required because nintedanib can cause drug-induced liver injury, including rare fatal cases reported post-marketing.
- Strictly contraindicated in pregnancy: Nintedanib is teratogenic in animal models. Women of childbearing potential must use highly effective contraception during treatment and for at least 3 months after the last dose.
What Is Nintedanib Sandoz and What Is It Used For?
Nintedanib Sandoz is a prescription tyrosine kinase inhibitor used to slow the progression of pulmonary fibrosis. It blocks intracellular signaling pathways that drive the formation of scar tissue in the lungs and is approved for idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other chronic fibrosing interstitial lung diseases with a progressive phenotype.
Nintedanib Sandoz contains the active substance nintedanib (as the esylate salt), a small molecule belonging to the pharmacological class of tyrosine kinase inhibitors (TKIs). It is supplied as oral soft capsules of 100 mg strength and represents the generic equivalent of the originator product Ofev, authorised by the European Medicines Agency (EMA). Nintedanib was developed as an antifibrotic agent specifically directed at the molecular pathways responsible for the progressive lung scarring seen in several serious pulmonary conditions.
Pulmonary fibrosis is an umbrella term for a group of chronic, progressive lung diseases characterised by the gradual replacement of normal lung tissue with dense, inelastic scar tissue (fibrosis). The result is a relentless loss of lung volume and gas-exchange capacity that produces worsening breathlessness, persistent dry cough, and reduced exercise tolerance. Idiopathic pulmonary fibrosis (IPF) is the most common and severe of these conditions; its cause remains unknown, it typically affects adults over 50 years of age, and, without disease-modifying therapy, the median survival from diagnosis is only 3 to 5 years.
The pharmacological action of nintedanib is distinctive because it targets three receptor tyrosine kinase families that together orchestrate fibrogenesis. By competitively binding to the adenosine triphosphate (ATP) binding pocket of vascular endothelial growth factor receptors (VEGFR 1, 2, and 3), fibroblast growth factor receptors (FGFR 1, 2, and 3), and platelet-derived growth factor receptors (PDGFR α and β), nintedanib reduces the proliferation, migration, and transformation of fibroblasts into collagen-producing myofibroblasts. The net effect is a slowing of extracellular matrix deposition and a reduction in the rate at which lung architecture is destroyed.
The clinical evidence for nintedanib in IPF is anchored by three landmark phase III trials. The TOMORROW phase II study first demonstrated that the 150 mg twice-daily dose meaningfully reduced the annual rate of FVC decline. This observation was subsequently replicated in the two identically designed INPULSIS-1 and INPULSIS-2 trials, published in the New England Journal of Medicine in 2014. Across these pivotal studies nintedanib consistently reduced the annual rate of FVC decline by approximately 50% relative to placebo, which established it as one of only two globally approved antifibrotic therapies for IPF. Subsequent trials (SENSCIS in SSc-ILD and INBUILD in progressive fibrosing ILDs) extended its indications to other fibrotic lung diseases.
Approved Indications
Nintedanib Sandoz is approved for the following conditions in adults:
- Idiopathic Pulmonary Fibrosis (IPF): The primary indication. Nintedanib slows disease progression by reducing the rate of lung function decline and is recommended as a conditional treatment option in the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF.
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Based on the SENSCIS trial (NEJM 2019), nintedanib reduces the annual rate of FVC decline in patients with SSc-ILD, a serious pulmonary complication of systemic sclerosis (scleroderma).
- Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype: Based on the INBUILD trial (NEJM 2019), nintedanib is also indicated for patients with other forms of chronic fibrosing ILD whose disease is progressing despite appropriate management of the underlying cause.
Nintedanib Sandoz does not cure pulmonary fibrosis, reverse existing fibrotic damage, or restore lost lung function. It is an antifibrotic treatment intended to slow disease progression and preserve remaining lung function for as long as possible. Treatment should always be initiated and supervised by a physician experienced in the diagnosis and management of interstitial lung diseases.
What Should You Know Before Taking Nintedanib Sandoz?
Before starting Nintedanib Sandoz your doctor will assess your liver function, cardiovascular status, bleeding risk, and pregnancy status. The medication is contraindicated in hypersensitivity, severe hepatic impairment, and pregnancy. Pre-existing cardiovascular disease, bleeding disorders, and certain drug interactions require careful evaluation.
Contraindications
Nintedanib Sandoz must not be used in any of the following situations:
- Hypersensitivity: Known allergy to nintedanib, peanut, soya, or any of the capsule excipients. The soft-capsule formulation contains soya lecithin, which is why cross-reactive allergies are a concern.
- Pregnancy: Nintedanib is strictly contraindicated during pregnancy because preclinical reproductive-toxicity studies have demonstrated embryo-fetal lethality, malformations, and skeletal variations. Women of childbearing potential must have a negative pregnancy test before initiation and must use highly effective contraception during therapy and for at least 3 months after the last dose.
- Severe hepatic impairment: Use is contraindicated in patients with Child-Pugh class C cirrhosis, as nintedanib is extensively metabolised by the liver and systemic exposure may be substantially increased.
Warnings and Precautions
The following risks should be anticipated and monitored during treatment with Nintedanib Sandoz. Prescribers should carefully weigh the benefit-risk profile for each patient and adjust therapy accordingly.
Hepatotoxicity: Nintedanib can cause drug-induced liver injury, manifesting as elevations in hepatic transaminases (ALT, AST) and bilirubin. Rare but serious cases of acute liver failure, including fatal outcomes, have been reported in post-marketing surveillance. Liver function tests should be performed before initiation, at monthly intervals for the first three months, and periodically thereafter. If ALT or AST rises above 3 times the upper limit of normal (ULN), dose reduction or temporary interruption is recommended; elevations above 5 times ULN or those accompanied by clinical signs of hepatic damage (e.g., jaundice, hyperbilirubinaemia) should prompt permanent discontinuation.
Diarrhoea: Diarrhoea is the single most common adverse reaction to nintedanib and can be severe. Patients should be counselled to maintain adequate hydration and to report any persistent or worsening diarrhoea to their clinician. Anti-diarrhoeal therapy (e.g., loperamide) should be initiated at the first signs, and a dose reduction from 150 mg twice daily to 100 mg twice daily may be required. If severe diarrhoea persists despite best supportive care, discontinuation should be considered.
Nausea and vomiting: These gastrointestinal symptoms occur frequently and may contribute to reduced food intake, weight loss, and dehydration. Antiemetic therapy, adequate fluid intake, and supportive nutritional advice should be provided. Dose reduction may be necessary if symptoms cannot be managed symptomatically.
Bleeding risk: Because nintedanib inhibits VEGFR, which contributes to vascular integrity, treatment may increase the risk of bleeding. Patients with a known predisposition to bleeding, including those on full therapeutic doses of anticoagulants, should be treated with caution. Nintedanib should only be prescribed in such patients if the anticipated clinical benefit is judged to outweigh the potential risk.
Arterial thromboembolic events: Clinical trials have observed a slight numerical increase in the incidence of myocardial infarction in nintedanib-treated patients compared with placebo. Patients with established cardiovascular risk factors, especially known coronary artery disease, should be monitored closely. Treatment should be interrupted in patients who develop symptoms of acute myocardial ischaemia.
Gastrointestinal perforation: Cases of gastrointestinal perforation, including fatal events, have been reported. Particular vigilance is needed in patients with prior abdominal surgery, recent gastrointestinal ulceration or diverticular disease, or concurrent corticosteroid or NSAID therapy. Treatment should be permanently discontinued in any patient who develops gastrointestinal perforation.
Renal considerations: Less than 1% of an administered nintedanib dose is excreted unchanged in the urine, so no dose adjustment is needed in mild or moderate renal impairment. However, safety and efficacy in severe renal impairment and end-stage renal disease have not been established.
Liver function tests (ALT, AST, and bilirubin) must be performed prior to initiation of Nintedanib Sandoz, at regular intervals during the first three months of treatment, and periodically thereafter. Contact your doctor immediately if you experience unexplained fatigue, loss of appetite, nausea, dark-coloured urine, yellowing of the skin or whites of the eyes (jaundice), or pain in the upper right abdomen — these may indicate liver injury.
Pregnancy, Breastfeeding and Fertility
Pregnancy: Nintedanib Sandoz is contraindicated during pregnancy. Animal studies have demonstrated reproductive toxicity at systemic exposures below the maximum recommended human dose, including embryo-fetal lethality, structural abnormalities, and skeletal variations. Women of childbearing potential must use highly effective contraception during treatment and for at least 3 months after the last dose. If pregnancy occurs during therapy, nintedanib must be discontinued immediately and the patient counselled on the potential fetal risk.
Breastfeeding: It is not known whether nintedanib or its metabolites are excreted in human breast milk. Animal data suggest a small amount is transferred in milk. Because a risk to the breastfed infant cannot be excluded, a decision must be made either to discontinue breastfeeding or to discontinue nintedanib therapy, weighing the benefits of breastfeeding against the benefits of maternal treatment.
Fertility: Clinical data on the effect of nintedanib on human fertility are not available. Animal studies have not shown direct harmful effects on fertility at the exposures studied, but an impact on human fertility cannot be excluded on the basis of the drug's mechanism of action (VEGFR inhibition). Men and women should discuss family-planning considerations with their healthcare provider before starting treatment.
How Does Nintedanib Sandoz Interact with Other Drugs?
Nintedanib is a substrate of the P-glycoprotein (P-gp) efflux transporter and, to a minor extent, CYP3A4. Concomitant use with potent P-gp inhibitors (e.g., ketoconazole) may increase nintedanib exposure and toxicity; co-administration with P-gp inducers (e.g., rifampicin, St John's wort) may reduce its efficacy. Anticoagulants and antiplatelet agents may further increase the risk of bleeding.
A careful medication review is essential before starting Nintedanib Sandoz because several common drugs can alter its plasma concentrations or amplify its side effects. Nintedanib is primarily biotransformed by hydrolytic ester cleavage to the free acid moiety BIBF 1202, followed by UGT-mediated glucuronidation to BIBF 1202 glucuronide. CYP-mediated oxidation plays only a minor role in its metabolism. Nintedanib, BIBF 1202 and BIBF 1202 glucuronide are all substrates of P-glycoprotein (P-gp), which is the most clinically relevant drug-transport pathway for interactions.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Ketoconazole | Potent P-gp and CYP3A4 inhibitor. Increased nintedanib AUC by ~60% and Cmax by ~83%. | Use with caution. Monitor closely for increased side effects and consider dose reduction if poorly tolerated. |
| Erythromycin / Clarithromycin | Moderate P-gp and CYP3A4 inhibitors. Erythromycin increased nintedanib AUC by ~61% and Cmax by ~36%. | Use with caution. Monitor for gastrointestinal adverse effects and liver function changes. |
| Rifampicin | Potent P-gp and CYP3A4 inducer. Decreased nintedanib AUC by ~50% and Cmax by ~60%. | Avoid co-administration. Significantly reduces nintedanib efficacy — select an alternative antibiotic. |
| Carbamazepine | Potent P-gp and CYP3A4 inducer. Expected to substantially decrease nintedanib plasma exposure. | Avoid co-administration. Consider an alternative anti-epileptic without P-gp induction. |
| Phenytoin | Strong CYP3A4 and P-gp inducer. Expected to reduce nintedanib plasma levels. | Avoid co-administration. Select an alternative anticonvulsant regimen. |
| St John's wort (Hypericum perforatum) | Potent P-gp and CYP3A4 inducer. Expected to significantly reduce nintedanib exposure. | Avoid concomitant use. Herbal supplements should be discussed with the prescriber. |
| Itraconazole / Voriconazole | Potent P-gp and CYP3A4 inhibitors. Expected to increase nintedanib exposure. | Use with caution. Monitor for enhanced adverse effects and consider alternative antifungals. |
Minor Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Warfarin / direct oral anticoagulants | Nintedanib inhibits VEGFR signalling, potentially increasing bleeding risk. Additive anticoagulant effect. | Monitor INR (for warfarin) and clinical signs of bleeding closely. Adjust anticoagulant dose as needed. |
| Antiplatelet agents (aspirin, clopidogrel) | Potential additive effect on bleeding risk via VEGFR inhibition. | Use with caution. Monitor for epistaxis, bruising, and gastrointestinal bleeding. |
| Pirfenidone | No clinically meaningful pharmacokinetic interaction. Both drugs are antifibrotic agents for IPF. | Combination use is not routinely recommended outside clinical trials investigating combination antifibrotic therapy. |
| Bosentan | Moderate P-gp and CYP3A4 inducer. May modestly reduce nintedanib exposure. | Monitor treatment efficacy. May be used concurrently in SSc-ILD patients receiving bosentan for pulmonary arterial hypertension. |
| Hormonal contraceptives | No evidence of pharmacokinetic interaction. | Hormonal contraception alone may not be sufficient; a barrier method is recommended in combination for reliable pregnancy prevention. |
Nintedanib Sandoz should always be taken with food. Co-administration with a meal increases the bioavailability of nintedanib by approximately 20% compared with the fasted state and reduces inter-patient variability in exposure. This is the recommended method of administration and was the regimen used in all pivotal clinical trials.
What Is the Correct Dosage of Nintedanib Sandoz?
The recommended adult dose is 150 mg twice daily taken orally with food, approximately 12 hours apart. The 100 mg strength of Nintedanib Sandoz allows for a reduced dose of 100 mg twice daily in patients who do not tolerate the full dose. Capsules must be swallowed whole with water and never chewed or opened.
Dosing of Nintedanib Sandoz should be individualised on the basis of tolerability. Treatment must be initiated and supervised by a physician experienced in the diagnosis and management of interstitial lung diseases. The soft capsules must be swallowed whole with water and should not be chewed, crushed or opened, as the active substance may cause local irritation on contact with mucous membranes. Taking the capsules with a meal is strongly recommended to enhance absorption and minimise gastrointestinal side effects.
Adults
Standard Dosing for All Approved Indications
Recommended dose: 150 mg of nintedanib taken orally twice daily, approximately 12 hours apart, with food.
Dose reduction: If the full 150 mg twice-daily dose is not tolerated, the dose may be reduced to 100 mg twice daily. If the reduced dose of 100 mg twice daily is also not tolerated despite optimal supportive care, treatment should be discontinued.
Important: Nintedanib Sandoz is supplied as 100 mg soft capsules. Prescribers providing the 150 mg daily regimen may indicate an alternative formulation or specify precise capsule counts. Always follow your prescriber's written instructions and never modify the dosing schedule on your own.
| Patient Group | Dose | Frequency | Special Considerations |
|---|---|---|---|
| Adults (IPF) | 150 mg (or 100 mg if reduced) | Twice daily with food | Monitor liver function. Reduce to 100 mg if gastrointestinal side effects are intolerable. |
| Adults (SSc-ILD) | 150 mg (or 100 mg if reduced) | Twice daily with food | Same posology as IPF. May be combined with background immunosuppressive therapy such as mycophenolate mofetil. |
| Adults (progressive fibrosing ILD) | 150 mg (or 100 mg if reduced) | Twice daily with food | Indicated for patients demonstrating progression despite appropriate management of the underlying ILD. |
| Mild hepatic impairment (Child-Pugh A) | 100 mg | Twice daily with food | Reduced starting dose recommended; nintedanib exposure is approximately doubled. Close liver monitoring required. |
| Moderate hepatic impairment (Child-Pugh B) | Not recommended | — | Limited data. Use not recommended due to the potential for significantly increased exposure and toxicity. |
| Severe hepatic impairment (Child-Pugh C) | Contraindicated | — | Not to be used. |
| Mild / moderate renal impairment | No adjustment required | Standard dosing | Less than 1% of the dose is excreted renally. |
| Severe renal impairment / dialysis | Insufficient data | — | Safety and efficacy not established; use with caution. |
Children and Adolescents
The safety and efficacy of Nintedanib Sandoz in children and adolescents under 18 years of age have not been established in controlled trials for the approved adult indications. Use in the paediatric population is not recommended outside the setting of a clinical trial. Some paediatric formulations and protocols of nintedanib are under investigation for specific rare paediatric interstitial lung disorders, but these should only be considered by specialist centres.
Elderly Patients
No dose adjustment is needed based on chronological age alone. The INPULSIS and INBUILD trial populations included a substantial proportion of patients aged 65 years and older, and the safety and efficacy profiles in older patients were broadly consistent with those in the overall study population. However, elderly patients — particularly those over 75 years — may be more susceptible to gastrointestinal adverse effects, dehydration, and hepatotoxicity. A lower threshold for dose reduction and more frequent clinical review may be appropriate in this group.
Missed Dose
If you forget to take a dose of Nintedanib Sandoz, skip the missed dose and take your next dose at the scheduled time. Do not take a double dose to make up for a missed dose, as this increases the risk of gastrointestinal and hepatic side effects. The recommended interval between doses is approximately 12 hours; if the next scheduled dose is only a few hours away, simply resume your usual dosing schedule at the next planned time.
Overdose
Clinical experience with overdose of nintedanib is limited. The highest dose studied in clinical trials was 450 mg once daily over a short period, which was associated with an increased incidence of gastrointestinal adverse events (diarrhoea, nausea, vomiting) and hepatic enzyme elevations. There is no specific antidote for nintedanib, and treatment of overdose should be symptomatic and supportive. Because nintedanib is approximately 97.8% protein-bound in plasma, haemodialysis is unlikely to be an effective elimination strategy.
Contact your local poison-control centre or emergency department immediately if you suspect an overdose of Nintedanib Sandoz. Bring the medication packaging and any remaining capsules with you. Symptoms to report may include severe diarrhoea, profuse vomiting, abdominal pain, reduced urine output, fatigue, or signs of liver injury (dark urine, jaundice).
What Are the Side Effects of Nintedanib Sandoz?
The most common side effects of Nintedanib Sandoz are gastrointestinal, particularly diarrhoea (affecting over 60% of patients), nausea, vomiting, abdominal pain, and decreased appetite. Elevated liver enzymes are also common and require scheduled monitoring. Most adverse reactions are manageable with dose adjustment, supportive care, and early clinical review.
Like all medicines, Nintedanib Sandoz can cause side effects, although not everyone experiences them. The safety profile of nintedanib has been extensively characterised in clinical trials involving more than 3,000 patients across the IPF, SSc-ILD, and progressive fibrosing ILD indications. The side effects below are grouped by frequency according to international medical convention (MedDRA frequency categories).
Very Common (affects more than 1 in 10 patients)
- Diarrhoea — the most frequent adverse event (~62% in IPF trials, ~76% in SSc-ILD trials). Typically mild to moderate and manageable with hydration and loperamide
- Nausea — reported in ~24% of patients. Taking capsules with food significantly reduces nausea
- Elevated liver enzymes (ALT, AST) — reported in ~14% of patients. Usually reversible on dose reduction or temporary interruption
- Abdominal pain — including upper abdominal pain, reported in ~15% of patients
- Vomiting — reported in ~12% of patients. Antiemetic therapy may help
Common (affects 1 to 10 in every 100 patients)
- Decreased appetite — may contribute to unintentional weight loss
- Weight loss — body weight should be monitored at each visit
- Headache — generally mild and transient
- Elevated bilirubin — may signal underlying hepatic involvement
- Elevated gamma-glutamyl transferase (GGT) and alkaline phosphatase
- Hypertension — blood pressure should be measured regularly during treatment
- Bleeding events — including epistaxis (nosebleeds), gingival bleeding, bruising, and haematuria
- Rash — including pruritic skin reactions
Uncommon (affects 1 to 10 in every 1,000 patients)
- Pancreatitis — inflammation of the pancreas; severe upper abdominal pain radiating to the back should prompt urgent evaluation
- Thrombocytopenia — low platelet count which may compound bleeding risk
- Drug-induced liver injury — clinically significant hepatocellular damage requiring discontinuation
- Gastrointestinal perforation — a medical emergency requiring immediate surgical evaluation
- Hypothyroidism — rare endocrine reports
- Dehydration — usually secondary to severe diarrhoea or vomiting
Rare (affects fewer than 1 in 1,000 patients)
- Myocardial infarction — a modest numerical increase observed in some studies. Patients with cardiovascular risk factors require close monitoring
- Posterior reversible encephalopathy syndrome (PRES) — reported post-marketing; symptoms include headache, seizures, visual disturbances, and altered consciousness
- Severe anaphylactic/anaphylactoid reactions — seek emergency medical care for facial swelling, widespread urticaria, or breathing difficulty
- Hepatic failure — isolated fatal cases have been reported post-marketing
- Aneurysms and arterial dissections — class effect reported with VEGF-pathway inhibitors
Contact your healthcare provider promptly if you experience: diarrhoea that does not respond to loperamide within 24 hours; signs of liver problems (unexplained fatigue, dark urine, yellowing of skin or eyes, right-sided upper abdominal pain); unusual bleeding or bruising; severe or persistent abdominal pain; chest pain or symptoms suggestive of a heart attack; severe headache with visual changes; or any other symptom that concerns you. Most side effects can be successfully managed with early intervention and dose adjustment.
How Should You Store Nintedanib Sandoz?
Store Nintedanib Sandoz below 25°C in its original blister packaging to protect from moisture and light. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton.
Proper storage of Nintedanib Sandoz is essential to preserve the integrity of the soft-capsule formulation. The capsules are sensitive to heat and moisture, and the blister packaging is specifically designed to protect them until the moment of use. Follow the storage instructions below:
- Temperature: Store below 25°C (77°F). Do not refrigerate or freeze, as condensation can damage the soft-gelatin shell.
- Moisture protection: Keep the capsules in the original blister packaging until immediately before use. The blister pack provides a moisture barrier that protects the soft capsules.
- Light protection: Store the blisters inside the outer carton, away from direct sunlight.
- Shelf life: Do not use after the expiry date stated on the outer carton and blister foil after “EXP.” The expiry date refers to the last day of the printed month.
- Children: Keep out of the sight and reach of children. Accidental ingestion by a child requires immediate medical evaluation.
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused or expired capsules to a pharmacy for safe disposal in accordance with local regulations, as this helps protect the environment.
If you notice any change in the appearance of the capsules — such as discolouration, leakage, softening, damage to the blister foil, or suspected tampering — do not take them. Contact your pharmacist for guidance and replacement. Avoid leaving the medicine in a car, on a windowsill, or anywhere else where the temperature could rise significantly.
What Does Nintedanib Sandoz Contain?
Each Nintedanib Sandoz 100 mg soft capsule contains 100 mg of nintedanib (as the esylate salt) as the active substance, together with excipients including medium-chain triglycerides, hard fat, soya lecithin, and gelatin capsule-shell components. Patients with soya or peanut allergy must not take this medicine.
Knowing the full composition of your medication is important, especially if you have known allergies, dietary restrictions, or observe religious or ethical dietary practices. The complete composition of Nintedanib Sandoz 100 mg soft capsules is as follows:
Active substance: Each soft capsule contains nintedanib esylate corresponding to 100 mg of nintedanib (free base).
Capsule fill (excipients):
- Medium-chain triglycerides — a lipid-based vehicle used to solubilise the active substance
- Hard fat — provides structural consistency to the capsule fill
- Soya lecithin (E322) — emulsifier. Contains soya; strictly contraindicated in patients with soya or peanut allergy
Capsule shell:
- Gelatin — capsule shell material (of animal origin)
- Glycerol (85%) — plasticiser for the gelatin shell
- Titanium dioxide (E171) — opacifier
- Iron oxide red (E172) — colourant
- Iron oxide yellow (E172) — colourant
Printing ink: Shellac, iron oxide black (E172), propylene glycol — used for the identification markings imprinted on the capsule.
Nintedanib Sandoz soft capsules contain soya lecithin. Patients with a known allergy to peanut or soya must not take this medicine, as cross-reactivity can occur. The gelatin capsule shell is derived from animal sources, which may be relevant for patients with specific dietary or religious considerations. Discuss any known allergies or dietary restrictions with your pharmacist or doctor before starting treatment.
Frequently Asked Questions About Nintedanib Sandoz
References
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- Richeldi L, Costabel U, Selman M, et al. Efficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis (TOMORROW trial). N Engl J Med. 2011;365(12):1079–1087. doi:10.1056/NEJMoa1103690
- Distler O, Highland KB, Gahlemann M, et al. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease (SENSCIS trial). 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 trial). N Engl J Med. 2019;381(18):1718–1727. doi:10.1056/NEJMoa1908681
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- European Medicines Agency. Summary of Product Characteristics — Ofev (nintedanib). EMA/CHMP. Revised 2024.
- U.S. Food and Drug Administration. Ofev (nintedanib) Prescribing Information. Revised 2024.
- British National Formulary. Nintedanib. BNF. Accessed January 2026.
- Wollin L, Wex E, Pautsch A, et al. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J. 2015;45(5):1434–1445. doi:10.1183/09031936.00174914
- 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 Model List of Essential Medicines. 23rd edition, 2023.
About Our Medical Editorial Team
All content on iMedic is written and reviewed by qualified medical professionals. This article was prepared by our editorial team of specialists in pulmonology and clinical pharmacology, with expertise in the management of interstitial lung diseases and antifibrotic therapies. Every medical claim is cross-checked against current EMA and FDA product information and the most recent international treatment guidelines.
iMedic Medical Editorial Team — specialists in pulmonary medicine and pharmaceutical sciences with documented academic and clinical backgrounds in respiratory diseases and pharmacotherapy.
iMedic Medical Review Board — independent panel including board-certified pulmonologists and clinical pharmacologists who verify all content against current international guidelines (ATS, ERS, EMA, FDA).
Evidence standard: All medical claims in this article are supported by Level 1A evidence (systematic reviews and randomised controlled trials), including the INPULSIS, SENSCIS and INBUILD clinical trial programs, and the current international treatment guidelines. This article received no commercial funding and the authors and reviewers declare no conflicts of interest.