Nintedanib Intas
Generic tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and other progressive fibrosing interstitial lung diseases
Quick Facts About Nintedanib Intas
Key Takeaways About Nintedanib Intas
- Slows progression of pulmonary fibrosis: Nintedanib reduces the annual decline in forced vital capacity (FVC) by approximately 50% in patients with IPF, as demonstrated across the INPULSIS, SENSCIS and INBUILD trials.
- Triple kinase inhibitor: It simultaneously targets VEGFR, FGFR and PDGFR receptor families — the three pathways most strongly implicated in fibroblast activation and lung scarring.
- Diarrhea is the dominant side effect: Affecting more than 60% of patients, diarrhea can usually be managed with hydration, loperamide and dose reduction from 150 mg to 100 mg twice daily.
- Liver monitoring is mandatory: Liver function tests (ALT, AST, bilirubin) must be performed before treatment, monthly during the first three months, and periodically thereafter due to the risk of drug-induced liver injury.
- Strictly contraindicated in pregnancy: Nintedanib has demonstrated embryo-fetal toxicity. Highly effective contraception is required during treatment and for at least 3 months after the last dose.
What Is Nintedanib Intas and What Is It Used For?
Nintedanib Intas is a generic tyrosine kinase inhibitor that slows the progression of pulmonary fibrosis by blocking the molecular signaling pathways that drive abnormal scar tissue formation in the lungs. It 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 Intas contains the active substance nintedanib (administered as the esylate salt), a small-molecule kinase inhibitor that belongs to the antifibrotic class of medicines. The product is manufactured by Intas Pharmaceuticals as a generic equivalent of the originator brand, and it provides the same active substance, bioavailability and clinical effect at a substantially lower acquisition cost. The medicine is supplied as 100 mg soft capsules for oral administration, designed to be taken twice daily with food.
Pulmonary fibrosis describes a heterogeneous group of lung diseases in which the alveolar interstitium becomes progressively replaced by stiff, non-functional scar tissue. As the architecture of the lung is destroyed, the ability of oxygen to reach the bloodstream falls, and patients experience increasing breathlessness, chronic dry cough, fatigue and reduced exercise tolerance. In its most aggressive form — idiopathic pulmonary fibrosis (IPF) — the underlying cause cannot be identified, the disease typically affects adults aged 50 and older, and median survival without antifibrotic therapy is approximately 3 to 5 years from diagnosis. This makes IPF prognostically comparable to many advanced cancers.
Nintedanib produces its antifibrotic effect by competitively binding to the adenosine triphosphate (ATP) binding pocket of three families of receptor tyrosine kinases that are central to the fibrotic cascade: 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 alpha and beta). By simultaneously inhibiting these three families, nintedanib reduces the proliferation, migration and transformation of fibroblasts into myofibroblasts — the effector cells responsible for excessive collagen deposition and remodeling of the extracellular matrix in fibrotic lung tissue.
The clinical efficacy of nintedanib in IPF was established in three pivotal randomized controlled trials. The Phase II TOMORROW study first signaled a clinically meaningful reduction in the annual rate of forced vital capacity (FVC) decline at the 150 mg twice-daily dose. This finding was subsequently confirmed in the two replicate Phase III INPULSIS trials, published in the New England Journal of Medicine in 2014. Across these studies, nintedanib consistently reduced the annual rate of FVC decline by approximately 50% versus placebo, establishing it as one of only two antifibrotic agents approved worldwide for the treatment of IPF (the other being pirfenidone).
Approved Indications
Nintedanib Intas is approved for the following clinical indications:
- Idiopathic Pulmonary Fibrosis (IPF): The primary licensed indication. Nintedanib slows lung function decline in adult patients with IPF and is recommended as a conditional treatment option in the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline.
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Based on the SENSCIS trial, nintedanib reduces the annual FVC decline in patients with SSc-ILD — a serious pulmonary complication of systemic sclerosis (scleroderma) that historically had no targeted therapy.
- Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype: Following the INBUILD trial, nintedanib is licensed for patients with other forms of chronic fibrosing ILD — such as chronic hypersensitivity pneumonitis or fibrotic non-specific interstitial pneumonia — who continue to show signs of disease progression despite optimized standard management.
It is important to understand that nintedanib does not reverse fibrosis that has already formed and is not curative. Rather, it slows the rate at which lung function declines, with the goal of preserving meaningful respiratory capacity for as long as possible. Treatment is generally continued long-term, as long as the patient tolerates the medicine and clinical benefit is maintained. The decision to start nintedanib should be taken by a physician with experience in interstitial lung disease, ideally within a multidisciplinary team setting that includes a pulmonologist, radiologist and pathologist.
Nintedanib Intas is a generic version of the originator product Ofev (Boehringer Ingelheim). To obtain marketing authorization, generic nintedanib products must demonstrate bioequivalence with the reference medicine, meaning they deliver the same amount of active substance into the bloodstream over the same period of time. Clinical efficacy, contraindications, dose adjustments and the side-effect profile are therefore equivalent to the originator.
What Should You Know Before Taking Nintedanib Intas?
Before starting Nintedanib Intas, your doctor will assess liver function, bleeding risk, cardiovascular status, and pregnancy status (in women of childbearing potential). The medicine is contraindicated during pregnancy and in patients with allergy to peanut, soya or any of the excipients. Several drug interactions and pre-existing conditions require careful evaluation.
Contraindications
Nintedanib Intas must not be used in any of the following situations:
- Hypersensitivity: Known allergy to nintedanib, peanut, soya, or to any of the excipients in the soft capsule formulation. The capsules contain soya lecithin, which may cause severe allergic reactions in sensitized individuals.
- Pregnancy: Nintedanib is strictly contraindicated during pregnancy due to demonstrated embryo-fetal toxicity in preclinical studies. Women of childbearing potential must have a negative pregnancy test before initiation and use highly effective contraception during treatment and for at least 3 months after the final dose.
- Severe hepatic impairment: Use is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Nintedanib is extensively cleared by hepatic metabolism, and exposure may be substantially increased in this population, raising the risk of serious adverse reactions.
Warnings and Precautions
Treatment with Nintedanib Intas requires active monitoring for several specific safety concerns. Your healthcare provider should be aware of the following risks before starting therapy and at every follow-up visit.
Hepatotoxicity: Nintedanib can cause drug-induced liver injury. The most commonly observed liver-related adverse reactions are reversible elevations of hepatic transaminases (alanine aminotransferase, ALT, and aspartate aminotransferase, AST) and bilirubin, but serious liver injury — including isolated cases of acute liver failure with fatal outcome — has been reported in post-marketing surveillance. Liver function tests must be performed prior to initiation, at monthly intervals during the first three months of treatment, and at regular intervals thereafter or as clinically indicated. If ALT or AST exceeds 3 times the upper limit of normal (ULN), dose reduction or treatment interruption is recommended. If elevations exceed 5 times ULN, or are accompanied by clinical signs of liver damage such as jaundice or significantly elevated bilirubin, treatment must be permanently discontinued.
Diarrhea: Diarrhea is the most frequently reported adverse reaction during nintedanib therapy and can occasionally be severe enough to cause dehydration or to require treatment discontinuation. Patients should be counseled to maintain adequate hydration, to start anti-diarrheal therapy (typically loperamide) at the first signs of diarrhea, and to contact their healthcare provider promptly if diarrhea is severe or persistent. In many patients, dose reduction from 150 mg to 100 mg twice daily significantly improves tolerability without losing therapeutic benefit. Permanent discontinuation should be considered only after optimal supportive care has failed.
Nausea and vomiting: Gastrointestinal symptoms beyond diarrhea — including nausea, vomiting, abdominal pain and decreased appetite — are common and may contribute to weight loss. Taking the capsules with food, prophylactic anti-emetic therapy and symptomatic management can mitigate these effects. Body weight should be monitored at every visit, and nutritional support involving a dietitian may be helpful for patients who lose more than 5% of body weight.
Bleeding risk: Through inhibition of VEGFR signaling, nintedanib can impair vascular homeostasis and increase the risk of bleeding events, including epistaxis, bruising, hematuria and rarely more serious hemorrhage. Patients with a known predisposition to bleeding, or those receiving full-dose anticoagulant therapy, should be treated with caution, and the anticipated benefit must be carefully weighed against the increased risk.
Arterial thromboembolic events: An increased incidence of myocardial infarction has been observed in some clinical studies of nintedanib. Patients with significant cardiovascular risk factors, including known coronary artery disease, should be assessed before treatment and monitored carefully thereafter. Treatment should be interrupted in any patient who develops signs or symptoms of acute myocardial ischemia.
Gastrointestinal perforation: Cases of gastrointestinal perforation, some fatal, have been reported in patients treated with nintedanib. Particular caution is warranted in patients with previous abdominal surgery, recent peptic ulcer disease, diverticular disease, or concomitant use of corticosteroids or NSAIDs. Treatment must be permanently discontinued in any patient who develops gastrointestinal perforation.
Wound healing: Based on the mechanism of action (anti-angiogenesis), nintedanib may impair wound healing. No formal studies on the effect of nintedanib on wound healing have been performed in humans. Treatment should be initiated or — in case of perioperative interruption — resumed based on clinical judgment of adequate wound healing, typically several weeks after major surgery.
Liver function tests (ALT, AST, alkaline phosphatase and bilirubin) must be performed before initiation of treatment with Nintedanib Intas, and at monthly intervals during the first three months of therapy, then at regular intervals thereafter or as clinically indicated. Severe drug-induced liver injury, including fatal cases, has been reported. Contact your doctor immediately if you experience unexplained fatigue, dark urine, pale stools, jaundice (yellowing of the skin or eyes), nausea, or persistent right upper abdominal pain.
Pregnancy and Breastfeeding
Pregnancy: Nintedanib Intas is contraindicated in pregnancy. Animal studies have shown reproductive toxicity, including embryo-fetal lethality, structural abnormalities and skeletal variations, at exposures below the maximum recommended human dose. A pregnancy test should be performed prior to treatment initiation, and women of childbearing potential must use highly effective contraception during therapy and for at least 3 months after the last dose. If a patient becomes pregnant during treatment, nintedanib must be discontinued immediately and the patient counseled regarding the potential hazard to the fetus.
Contraception: Patients should be advised that the contraceptive efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhea, both of which are common adverse reactions to nintedanib. Women using oral hormonal contraception who experience these symptoms should be advised to also use a barrier method or to consult their healthcare provider regarding alternative reliable contraceptive methods.
Breastfeeding: It is not known whether nintedanib or its metabolites are excreted in human breast milk. Nonclinical data have shown excretion of small amounts of nintedanib and its metabolites in milk of lactating animals. A risk to the breastfed infant cannot be excluded. Breastfeeding should therefore be discontinued during therapy with Nintedanib Intas.
Fertility: Based on preclinical investigations, no evidence of impaired male fertility was observed. Although there are no clinical or epidemiological data on the effects of nintedanib on female fertility, the potential cannot be excluded based on the mechanism of action (VEGFR inhibition).
Driving and operating machinery: Nintedanib has minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or operating machines during treatment, particularly if they experience fatigue or dizziness as a result of dehydration secondary to diarrhea.
How Does Nintedanib Intas Interact with Other Drugs?
Nintedanib is a substrate of P-glycoprotein (P-gp) and, to a minor extent, CYP3A4. Co-administration with potent P-gp inhibitors may increase exposure (raising the risk of side effects), while potent P-gp inducers may significantly reduce efficacy. Concomitant anticoagulant or antiplatelet therapy increases bleeding risk and warrants close clinical monitoring.
Understanding drug interactions is essential for the safe and effective use of Nintedanib Intas. Nintedanib is primarily eliminated by hydrolytic ester cleavage to the free acid moiety BIBF 1202, followed by glucuronidation through UGT enzymes to form the inactive glucuronide BIBF 1202 glucuronide. CYP-mediated oxidative metabolism plays only a minor role. Importantly, nintedanib and its metabolites are substrates of the efflux transporter P-glycoprotein (P-gp), which makes P-gp the most clinically relevant pathway for pharmacokinetic drug interactions.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Ketoconazole | Potent P-gp and CYP3A4 inhibitor. Increases nintedanib AUC by approximately 60% and Cmax by approximately 83% | Use with caution. Monitor closely for adverse reactions. Consider dose reduction to 100 mg twice daily if poorly tolerated. |
| Erythromycin | Moderate P-gp and CYP3A4 inhibitor. Increases nintedanib AUC by approximately 61% and Cmax by approximately 36% | Use with caution and only if benefit outweighs risk. Monitor especially for gastrointestinal adverse reactions. |
| Itraconazole / Voriconazole | Potent P-gp and CYP3A4 inhibitors. Expected to increase nintedanib exposure significantly | Use with caution. Monitor for hepatotoxicity and gastrointestinal adverse effects. Dose reduction may be required. |
| Rifampicin | Potent P-gp and CYP3A4 inducer. Decreases nintedanib AUC by approximately 50% and Cmax by approximately 60% | Avoid co-administration. Substantially reduces efficacy. Select alternative anti-mycobacterial regimens where possible. |
| Carbamazepine | Potent P-gp and CYP3A4 inducer. Expected to substantially decrease nintedanib plasma exposure | Avoid co-administration. Choose an alternative anti-epileptic without P-gp/CYP3A4 induction. |
| Phenytoin | Potent CYP3A4 and P-gp inducer. Expected to lower nintedanib plasma levels and reduce efficacy | Avoid co-administration. Select an alternative anti-epileptic medication. |
| St. John's Wort (Hypericum) | Potent P-gp and CYP3A4 inducer. Expected to significantly reduce nintedanib exposure | Avoid concomitant use. Patients should be informed not to start any herbal preparation containing St. John's Wort during treatment. |
Minor Interactions
| Interacting Drug / Class | Effect | Clinical Recommendation |
|---|---|---|
| Warfarin / direct oral anticoagulants | Inhibition of VEGFR may increase bleeding tendency, with additive anticoagulant effect | Monitor INR (for warfarin) and signs of bleeding closely. Adjust anticoagulant dose as required. |
| Antiplatelet agents (aspirin, clopidogrel) | Potential additive effect on bleeding risk via VEGFR inhibition | Use with caution and monitor for clinical signs of bleeding (epistaxis, gum bleeding, bruising, hematuria). |
| Pirfenidone | No clinically relevant pharmacokinetic interaction has been demonstrated. Both are antifibrotic agents | Combination use is not routinely recommended outside clinical studies due to overlapping toxicity (GI, hepatic). |
| Bosentan | Moderate P-gp and CYP3A4 inducer; may modestly reduce nintedanib exposure | Concurrent use is acceptable in SSc-ILD patients receiving bosentan for pulmonary arterial hypertension. Monitor treatment efficacy. |
| Hormonal oral contraceptives | No direct pharmacokinetic interaction, but absorption may be impaired by vomiting/diarrhea | Advise additional barrier contraception or alternative reliable methods if GI side effects occur. |
Nintedanib Intas should always be taken with food. Co-administration with food increases the bioavailability of nintedanib by approximately 20% relative to the fasted state and reduces inter-patient variability. This is the route used in all pivotal clinical trials and is the recommended way to take the medicine. Grapefruit and grapefruit juice should be avoided, as they may modestly affect drug-metabolizing enzymes; while the clinical impact is small, abstaining is a sensible precaution.
What Is the Correct Dosage of Nintedanib Intas?
The recommended target dose of nintedanib is 150 mg twice daily, taken approximately 12 hours apart with food. Because Nintedanib Intas is supplied as a 100 mg soft capsule, dosing is individualized to either 150 mg twice daily (using the appropriate strength) or 100 mg twice daily as the reduced-dose option for patients who do not tolerate the full dose. Capsules must be swallowed whole with water and never chewed or crushed.
Dosing of Nintedanib Intas should always be individualized based on patient tolerability. Treatment must be initiated by — or in close consultation with — a physician experienced in the diagnosis and management of interstitial lung diseases. Capsules should be swallowed whole with water. They must not be chewed, crushed or opened, because the active substance can cause local irritation of mucous membranes and may stain skin or surfaces yellow if the capsule contents leak. Taking the capsules with food is essential, as it improves absorption and reduces the incidence and severity of 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.
Reduced dose option: 100 mg twice daily — used when the full 150 mg twice-daily dose is not tolerated. If 100 mg twice daily is also not tolerated, treatment with Nintedanib Intas should be permanently discontinued.
Practical use of the 100 mg capsule: Since Nintedanib Intas is supplied as a 100 mg soft capsule, the prescriber will specify how many capsules to take per dose to achieve the prescribed strength. Always follow your prescription label and do not adjust the dose without consulting your doctor.
| Patient Group | Dose | Frequency | Special Considerations |
|---|---|---|---|
| Adults (IPF) | 150 mg (or 100 mg if reduced) | Twice daily with food | Standard dose. Monitor liver function. Reduce to 100 mg twice daily if GI adverse effects are intolerable. |
| Adults (SSc-ILD) | 150 mg (or 100 mg if reduced) | Twice daily with food | Same dose as IPF. Compatible with background immunosuppression (e.g. mycophenolate mofetil). |
| Adults (progressive fibrosing ILD) | 150 mg (or 100 mg if reduced) | Twice daily with food | Indicated for patients with continued progression despite standard management of the underlying ILD. |
| Mild hepatic impairment (Child-Pugh A) | 100 mg | Twice daily with food | Reduced starting dose recommended. Approximate 2-fold increase in exposure expected. Close monitoring required. |
| Moderate hepatic impairment (Child-Pugh B) | Not recommended | — | Limited data; risk of significantly increased exposure and hepatotoxicity. Use only if benefit clearly outweighs risk. |
| Severe hepatic impairment (Child-Pugh C) | Contraindicated | — | Not studied. Use is contraindicated. |
| Renal impairment | No dose adjustment needed | Standard dosing | Less than 1% of the dose is excreted renally. No clinically relevant change in exposure expected up to severe renal impairment. |
| End-stage renal disease / dialysis | Insufficient data | Use with caution | Hemodialysis is unlikely to remove nintedanib due to high protein binding (~97.8%). |
Children and Adolescents
The safety and efficacy of Nintedanib Intas in children and adolescents below 18 years of age have not been established. Pulmonary fibrosis in children is uncommon and biologically distinct from adult IPF, and the risk-benefit ratio of nintedanib has not been characterized in this population. Clinical investigations of pediatric childhood interstitial lung disease (chILD) are ongoing, but at present nintedanib is not recommended in children outside the setting of a clinical trial.
Elderly Patients
No initial dose adjustment is required based on age alone. The pivotal INPULSIS, SENSCIS and INBUILD trials enrolled a substantial proportion of patients aged 65 years and older, and the safety and efficacy profile in older patients was broadly consistent with the overall study population. However, elderly patients may be more susceptible to gastrointestinal adverse reactions, dehydration, hepatotoxicity and cardiovascular events. Closer clinical monitoring and a lower threshold for dose reduction are appropriate for patients over 75 years of age, particularly those with multiple comorbidities or polypharmacy.
Missed Dose
If you forget to take a dose of Nintedanib Intas, do not take a double dose to make up for it. Skip the missed dose and resume your normal dosing schedule with the next planned dose. Aim to maintain approximately 12 hours between doses; if the next scheduled dose is only a few hours away, simply continue with your regular schedule. Doubling up can substantially increase the risk of gastrointestinal side effects and hepatotoxicity.
Overdose
Clinical experience with nintedanib overdose is limited. The highest dose evaluated in clinical studies was 450 mg taken once daily for a short period, which was associated with an increased frequency of gastrointestinal adverse events. Single doses of up to 600 mg have been administered without serious adverse effects. There is no specific antidote for nintedanib. Treatment of overdose should be symptomatic and supportive, with particular attention to hydration status, liver function and cardiovascular monitoring. Because nintedanib is approximately 97.8% protein bound, hemodialysis is unlikely to be effective in removing the drug. In the event of suspected overdose, treatment with nintedanib should be interrupted.
Contact your local poison control center or attend your nearest emergency department immediately if you suspect an overdose. Bring the medicine packaging with you so that the treating clinicians can identify the exact product and strength. Symptoms of overdose may include severe diarrhea, nausea, vomiting, abdominal pain, dehydration, or signs of liver toxicity such as yellowing of the skin or eyes.
What Are the Side Effects of Nintedanib Intas?
The most common side effects of Nintedanib Intas are gastrointestinal — particularly diarrhea (affecting more than 60% of patients), nausea, vomiting, abdominal pain and decreased appetite. Elevated liver enzymes are also common and require regular blood test monitoring. Most adverse effects can be managed with supportive care and dose adjustment. Serious side effects, although uncommon, include drug-induced liver injury, gastrointestinal perforation and major bleeding events.
Like all medicines, Nintedanib Intas can cause side effects, although not every patient experiences them. The safety profile of nintedanib has been extensively characterized in randomized clinical trials and in post-marketing surveillance involving more than 3,000 patients across the IPF, SSc-ILD and progressive fibrosing ILD populations. Side effects are categorized below by frequency according to the standard MedDRA convention used in the EMA Summary of Product Characteristics and the FDA Prescribing Information.
Very Common (affects more than 1 in 10 patients)
- Diarrhea — the most frequent adverse reaction (~62% in IPF trials, up to ~76% in SSc-ILD). Usually mild to moderate; manageable with hydration, loperamide and dose reduction
- Nausea — reported in approximately 24% of patients; taking the capsules with food significantly reduces nausea
- Abdominal pain — including upper abdominal pain, reported in approximately 15% of patients
- Vomiting — approximately 12% of patients; symptomatic anti-emetic therapy may help
- Elevated liver enzymes (ALT, AST) — reported in approximately 14% of patients; usually reversible with dose reduction or temporary interruption
- Decreased appetite — may contribute to weight loss; nutritional support may be required
Common (affects 1 to 10 in every 100 patients)
- Weight loss — monitor body weight regularly during treatment
- Headache — usually mild and self-limiting
- Elevated bilirubin — may indicate hepatic involvement; review with liver function tests
- Elevated gamma-glutamyltransferase (GGT) or alkaline phosphatase
- Hypertension — blood pressure should be monitored periodically during treatment
- Bleeding events — including epistaxis (nosebleeds), bruising, hematuria and gum bleeding
- Dehydration — usually secondary to diarrhea or vomiting
- Rash and pruritus — mild skin reactions
Uncommon (affects 1 to 10 in every 1,000 patients)
- Pancreatitis — inflammation of the pancreas. Report severe abdominal pain radiating to the back
- Thrombocytopenia — low platelet count, may further increase bleeding risk
- Drug-induced liver injury — serious hepatotoxicity that may require permanent discontinuation
- Gastrointestinal perforation — a serious surgical emergency requiring immediate medical attention
- Hypersensitivity reactions — including angio-edema and anaphylactoid reactions
- Renal impairment — including acute kidney injury, often related to dehydration
Rare (affects fewer than 1 in 1,000 patients)
- Myocardial infarction (heart attack) — a higher incidence has been observed in some studies. Patients with cardiovascular risk factors require careful evaluation
- Posterior reversible encephalopathy syndrome (PRES) — reported post-marketing. Symptoms include severe headache, seizures, visual disturbances and altered consciousness
- Severe anaphylactic reactions — rare hypersensitivity reactions, particularly in patients with peanut or soya allergy. Seek emergency care
- Hepatic failure — isolated fatal cases have been reported in post-marketing surveillance
- Aneurysm and arterial dissection — reported very rarely with VEGFR pathway inhibitors
Contact your healthcare provider promptly if you experience: persistent or severe diarrhea lasting more than 24 hours; signs of dehydration (dizziness, dark urine, reduced urine output); signs of liver problems (unexplained fatigue, dark urine, pale stools, jaundice, right upper abdominal pain); unusual bleeding or bruising; severe abdominal pain; chest pain or symptoms suggestive of myocardial ischemia; severe headache with visual disturbances; or any other symptoms that are new or that concern you. Most side effects can be managed effectively with early intervention and appropriate dose adjustment.
Reporting suspected adverse reactions: Reporting suspected adverse reactions after authorization of a medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicine. Patients and healthcare professionals are encouraged to report any suspected adverse reactions through their national reporting system, such as the EMA's EudraVigilance, the FDA's MedWatch program, or the UK MHRA's Yellow Card scheme.
How Should You Store Nintedanib Intas?
Store Nintedanib Intas below 25°C in the original blister packaging to protect from moisture and light. Keep out of the sight and reach of children. Do not use the medicine after the expiry date printed on the carton and blister, and do not dispose of unused capsules via household waste — return them to your pharmacy.
Proper storage of Nintedanib Intas is essential to preserve the chemical stability and clinical efficacy of the medicine. Soft capsules contain a lipid-based fill that is particularly sensitive to heat and moisture, so storage conditions must be respected throughout the product's shelf life:
- Temperature: Store below 25°C (77°F). Do not refrigerate or freeze, as this can damage the soft gelatin shell.
- Moisture protection: Keep the capsules in the original aluminum blister packaging until immediately before taking the dose. The blister provides essential protection against atmospheric moisture, which can soften or compromise the integrity of the capsule shell.
- Light protection: Store in the outer carton to protect from direct light exposure.
- Shelf life: Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
- Children: Keep out of the sight and reach of children. Although blister packaging provides some protection, accidental ingestion by a child can have serious consequences.
- Disposal: Do not dispose of unused or expired medicines via wastewater or household waste. Return any unused capsules to your local pharmacy for safe disposal in accordance with your country's pharmaceutical waste regulations. These measures help protect the environment.
If you notice that the capsules have changed in appearance — for example showing discoloration, leakage, damage to the blister, or an unusual odor — do not take them. Contact your pharmacist for replacement. Soft capsules should never be left in direct sunlight, in a car during warm weather, or in the bathroom where humidity is high. When traveling, transport the medicine in your carry-on luggage in its original packaging to avoid exposure to extreme temperatures in cargo holds.
What Does Nintedanib Intas Contain?
Each Nintedanib Intas 100 mg soft capsule contains 100 mg of nintedanib (as the esylate salt) as the active substance, together with lipid-based excipients and a gelatin capsule shell. The fill contains soya lecithin, which means the medicine is contraindicated in patients with peanut or soya allergy.
Understanding the full composition of your medicine is important, particularly if you have known allergies or specific dietary or religious requirements. The complete composition of Nintedanib Intas 100 mg soft capsules is summarized below:
Active substance: Each soft capsule contains 120.4 mg of nintedanib esylate, equivalent to 100 mg of nintedanib (as the free base).
Capsule contents (excipients):
- Medium-chain triglycerides — lipid-based vehicle to solubilize the lipophilic active substance
- Hard fat — provides structural consistency to the liquid-filled capsule
- Soya lecithin (E322) — emulsifier of plant origin. Contains soya; the medicine is contraindicated in patients with allergy to peanut or soya
Capsule shell:
- Gelatin — capsule shell material of animal origin (typically bovine or porcine)
- Glycerol (85%) — plasticizer that maintains the flexibility of the gelatin shell
- Titanium dioxide (E171) — opacifying agent
- Iron oxide red (E172) — colorant
- Iron oxide yellow (E172) — colorant
Printing ink: Shellac, iron oxide black (E172) and propylene glycol — used to imprint identifying markings on the capsule.
Pack sizes: Nintedanib Intas is typically supplied in aluminum blister packs, with pack sizes of 60 capsules per box (a one-month supply at 100 mg twice daily). Local pack sizes may vary by market.
Nintedanib Intas soft capsules contain soya lecithin. Patients with a known allergy to peanut or soya must not take this medicine. The capsule shell contains gelatin of animal origin, which may be relevant for vegetarians, vegans, or for patients following religious dietary practices that restrict animal-derived ingredients. If you have any allergies, dietary restrictions or specific concerns about the composition, discuss them with your pharmacist or doctor before starting treatment.
Frequently Asked Questions About Nintedanib Intas
References
- 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
- 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
- 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
- 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/NICE. Accessed 2025.
- 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. Geneva: World Health Organization; latest edition.
About Our Medical Editorial Team
All content on iMedic is written and reviewed by qualified medical professionals. The editorial team responsible for this article includes specialists in pulmonology and clinical pharmacology with extensive experience in the diagnosis and management of interstitial lung diseases and antifibrotic therapy.
iMedic Medical Editorial Team — Specialists in pulmonary medicine and pharmaceutical sciences with academic and clinical backgrounds in respiratory diseases and pharmacotherapy.
iMedic Medical Review Board — Independent panel of board-certified pulmonologists and clinical pharmacologists who verify all content against current international guidelines (ATS, ERS, EMA, FDA, NICE).
Evidence standard: All medical claims in this article are based on Level 1A evidence (systematic reviews and randomized controlled trials), including the INPULSIS, SENSCIS and INBUILD clinical trial programs, and on current international treatment guidelines (ATS/ERS/JRS/ALAT 2022, EMA SmPC, FDA Prescribing Information). No commercial funding was involved in the creation of this content.