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Today, we will provide detailed information about Ofev soft capsules, a medication used to treat idiopathic pulmonary fibrosis (IPF), addressing all the questions patients may have. Ofev is an important drug for maintaining lung health, and understanding its proper usage and precautions is crucial.
In this article, we will explain the efficacy, dosage, mechanism of action, pharmacokinetics, health insurance coverage status (as of April 2025), and precautions for taking Ofev soft capsules in an easy-to-understand manner.
What Are Ofev Soft Capsules?
Ofev soft capsules contain the active ingredient Nintedanib Esylate. This medication is used to treat idiopathic pulmonary fibrosis (IPF), a chronic lung disease. IPF is a condition in which lung tissue gradually hardens and develops scars (fibrosis), leading to a decline in respiratory function. Ofev helps slow this progression.
※ "Idiopathic" means the cause is not clearly identified. ※
Efficacy of Ofev Soft Capsules
- Treatment of idiopathic pulmonary fibrosis (IPF)
- Delaying lung function decline in patients with systemic sclerosis-associated interstitial lung disease
- Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype
Ofev soft capsules are primarily effective in slowing the rate of lung function decline in IPF patients. Specifically, it suppresses the lung fibrosis process, alleviating symptoms such as shortness of breath and contributing to an improved quality of life. Medically, it has been proven to reduce the rate of decline in forced vital capacity (FVC), a measure of lung function.
This plays a vital role in helping patients maintain their daily activities for a longer period.
Dosage and Administration of Ofev Soft Capsules
Ofev soft capsules are typically available in 100 mg and 150 mg strengths. The administration method is as follows:
- Recommended Dose : 150 mg twice daily, taken immediately after meals.
- Dosing Interval : Taken in the morning and evening, approximately 12 hours apart, on a regular schedule.
- Adjusted Dose : If side effects (e.g., diarrhea) are severe, consult your doctor; the dose may be reduced to 100 mg.
Mechanism of Action of Ofev Soft Capsules
The active ingredient, nintedanib, inhibits multiple tyrosine kinases. In simple terms, it prevents the excessive growth and transformation of cells that cause lung fibrosis. Specifically, it blocks the following receptors:
- Platelet-Derived Growth Factor Receptor (PDGFR) : Suppresses fibroblast proliferation.
- Fibroblast Growth Factor Receptor (FGFR) : Reduces abnormal changes in lung tissue.
- Vascular Endothelial Growth Factor Receptor (VEGFR) : Regulates blood vessel formation to alleviate inflammation.
In this process, nintedanib competes with ATP (adenosine triphosphate), the energy source of cells, to block signal transduction. As a result, it slows the progression of lung fibrosis.
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Source : Journal of Respiration, September 2022, Vol 08 (03); 178-184 |
Pharmacokinetics of Ofev Soft Capsules
Pharmacokinetics describes how a drug is absorbed, distributed, metabolized, and excreted in the body. The pharmacokinetics of Ofev are as follows:
- Absorption : Taking it with food increases drug exposure by 20%, delaying absorption.
- Distribution : Widely distributed throughout the body, with a volume of distribution (Vss) of 1,050 L. Approximately 98% binds to proteins.
- Metabolism : Broken down in the liver by esterase enzymes, followed by glucuronidation to prepare for excretion.
- Excretion : Primarily excreted in feces (93%), with less than 1% excreted in urine. The half-life (time for half the drug to leave the body) is about 9.5 hours.
- Bioavailability : Approximately 5%, meaning only a small amount is absorbed, but its effects are potent.
Thanks to these properties, Ofev maintains stable efficacy with consistent use.
Health Insurance Coverage Status of Ofev Soft Capsules (April 2025 / South Korea)
In the past, Ofev soft capsules were classified as a non-reimbursed drug under South Korea’s National Health Insurance, meaning it was not covered. This was because Pirfenidone (brand name: Pirespa), used for the same indication (IPF), had already entered the reimbursement system through a Risk-Sharing Agreement (RSA), making it difficult for Ofev, a later entrant, to gain coverage. However, this situation changed after negotiations with the National Health Insurance Service in February 2025.
According to an article in Daily Pharm, health insurance coverage for Ofev was decided in February 2025. However, as of April 4, 2025, the reimbursement price and the exact start date for coverage remain undecided. Industry experts predict that coverage could begin as early as April 2025, but this depends on the final review by the Health Insurance Review and Assessment Service (HIRA) and administrative procedures by the insurance agency.
For now, patients must await further announcements to receive Ofev with insurance benefits, and non-reimbursed prescriptions may still apply. Once coverage begins, conditions such as a specialist’s diagnosis, prescription, and submission of regular lung function test results (e.g., FVC) are likely to be required.
Precautions When Taking Ofev Soft Capsules
While Ofev is an effective medication, there are important precautions to keep in mind. Patients should remember the following:
- Managing Side Effects : Common side effects include diarrhea, nausea, and abdominal pain. If diarrhea is severe, drink plenty of water; if it significantly disrupts daily life, consult your doctor about adjusting the dose.
- Liver Function Monitoring : Regular blood tests are needed as liver enzyme levels may rise.
- Food Intake : Must be taken with food for better absorption; avoid taking on an empty stomach.
- Pregnancy and Breastfeeding : Use is prohibited during pregnancy or breastfeeding. Be sure to inform your doctor of your condition.
IPF is a condition that requires consistent management and medication. Ofev soft capsules play a significant role in protecting lung health, but adhering to the dosage and precautions is essential.
Feel free to visit our pharmacy for detailed medication guidance. Please contact Ilwon Station Exit 1 Pharmacy anytime with questions. We support your journey to a healthier life!
Prescription Dispensing for Samsung Medical Center (Samsung Seoul Hospital)
Ilwon Station Exit 1 Pharmacy
