Ofev capsules 150 mg for pulmonary fibrosis (nintedanib ethanesulfonate)

General information on Japanese Ofev capsules 150 mg for pulmonary fibrosis (nintedanib ethanesulfonate)

Package details: 28 capsules

Manufacturer: Nippon Boehringer Ingelheim Co., Ltd., Japan

Active ingredients: nintedanib ethanesulfonate (chemical formula C33H39N5O7S)

Medical effect: Ofev capsules are effective for the treatment of the following diseases and conditions:

• idiopathic pulmonary fibrosis,
• systemic sclerosis associated with interstitial lung disease,
• systemic sclerosis associated with progressive fibrosing interstitial lung disease.

Contraindications and precautions: do not use for pregnant, possibly pregnant or breastfeeding women. Do not use for patients with a history of thromboembolism and predisposition to thromboembolism or predisposition to bleeding. Do not use for patients under anticoagulative treatment or patients scheduled to have surgical operation. For patients with liver dysfunction the treatment should be performed under the strict monitoring of doctor in charge with frequent liver functions tests.

Since this medicine is susceptible to heat and moisture, store it away from heat, direct sunlight and moisture. The temperature in storage space should not exceed 25 ℃ (77 ℉). Get the capsules out from a sheet just before taking them.

Avoid taking any food or supplements containing St. John's wort while taking this medicine.

As this medicine can cause decreased platelets or liver disfunction, patient will need to undergo blood test and liver function test periodically.

Female patients shall use adequate contraception while taking this medicine and for at least three months after the last dose of this medicine. Breastfeeding is strictly prohibited while taking this medicine.

If an allergic reaction occurs, stop taking the medicine and consult with your doctor. If you’re taking any other medication or receiving any other treatment, you have to consult with your doctor before use.

Dosage and administration of Ofev capsules 150 mg from Japan for pulmonary fibrosis (nintedanib ethanesulfonate)

For adults, take 1 capsule (150 mg of nintedanib) at a time, 2 times a day, after breakfast and dinner. The doctor in charge may reduce the dosage up to 100 mg of nintedanib at a time, 2 times a day, according to the symptoms. Please note that this preparation contains 150 mg of nintedanib in a capsule.

The capsules should be taken with a cup of water without chewing.

How effective are Ofev capsules 150 mg from Japan for pulmonary fibrosis (nintedanib ethanesulfonate)?

Ofev capsules contain nintedanib ethanesulfonate, a tyrosine kinase inhibitor. It works by inhibiting intracellular signaling caused by platelet-derived growth factor and fibroblast growth factor. As the result, Ofev capsules inhibit the proliferation and migration of fibroblasts and slow the progression of fibrosis formation.

Who should use Ofev capsules 150 mg from Japan?

Ofev capsules are effective for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis associated interstitial lung disease and progressive fibrosing interstitial lung diseases. Studies evolving more than 1600 patients showed that the difference between patients taking nintedanib and placebo in adjusted annual rate of change in forced vital capacity is around 107-115 ml per year (L. Richeldi, R. M. du Bois et al. “Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis”. The New England Journal of Medicine, 2014; 370: 2071-2082; K. R. Flaherty, A. U. Wells et al. “Nintedanib in Progressive Fibrosing Interstitial Lung Diseases”. The New England Journal of Medicine, 2019; 381:1718-1727). In other words, Ofev capsules can help to slow down the progression of the disease and formation of the fibrosis.