Ofev is a kinase inhibitor approved for use in adults for the treatment of idiopathic pulmonary fibrosis (IPF) and chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

This medication is used to treat specific types of lung diseases, including idiopathic pulmonary fibrosis (IPF) and interstitial lung disease (ILD). Both conditions cause scarring and stiffening of the lungs, which can make breathing difficult. Nintedanib may help slow the progression of these lung diseases.

Ofev capsule should be taken with food and swallowed whole with a glass of liquid. If the contents come into contact with your skin, wash your hands thoroughly right away.

If a dose of Ofev is missed, take the next dose at the scheduled time. Do not take an extra dose to make up for the missed one. Avoid exceeding the maximum recommended daily dose of 300 mg.

Before taking Nintedanib, notify your doctor or pharmacist if you are allergic to it or if you have any other allergies. This medication may contain inactive ingredients that can cause allergic reactions or other issues. Speak with your pharmacist for more information.

• Have or have had liver problems
• Have or have had kidney issues, or if increased protein levels have been found in your urine
• Have or have had bleeding disorders
• Take blood-thinning medications (such as Warfarin, Heparin, or Phenprocoumon) to prevent blood clots
• Have high blood pressure
• Are taking pirfenidone, as this may increase the risk of diarrhea, nausea, and liver issues
• Have or have had an aneurysm or a tear in a blood vessel wall
• Have or have had heart problems (such as a heart attack)
• Have recently had surgery, as Nintedanib may affect wound healing. Treatment with Ofev will usually be paused around surgery, and your doctor will determine when to resume it
• Have pulmonary hypertension

Inform your doctor immediately while taking this medication if you:

• Develop diarrhea. Early treatment of diarrhea is important.
• Experience vomiting or feel nauseous.
• Experience pain, swelling, redness, or warmth in a limb, which could indicate a blood clot in a vein.
• Have any significant bleeding.
• Notice unexplained symptoms such as yellowing of your skin or the whites of your eyes (jaundice).
• Inform your doctor if you have a history of peptic ulcers, diverticular disease, or if you are taking anti-inflammatory medications (NSAIDs) or steroids, as these could increase the risk.
• Have severe stomach pain or cramping, red blood in your stool, or diarrhea, as these could signal bowel inflammation due to poor blood supply.
• Experience symptoms such as headache, vision changes, confusion, seizures, or weakness in an arm or leg, with or without high blood pressure. These may indicate a brain condition called posterior reversible encephalopathy syndrome (PRES).
• Experience chest pain or pressure, particularly on the left side of your body, along with pain in your neck, jaw, shoulder, or arm, a rapid heartbeat, shortness of breath, nausea, or vomiting. These may be signs of a heart attack.
• Develop bruising, bleeding, fever, fatigue, or confusion, which could be symptoms of thrombotic microangiopathy (TMA), a condition that causes blood vessel damage.

Ofev is not recommended for use in children and adolescents under 18 years of age.

Does it have any side effects?
Like all medications, Ofev can cause side effects, though not everyone will experience them. It is important to pay close attention if you notice any of the following side effects while taking Ofev:

Diarrhea can cause dehydration, leading to the loss of fluids and essential electrolytes (such as sodium and potassium) from your body. At the first signs of diarrhea, drink plenty of fluids and contact your doctor right away. Begin appropriate anti-diarrheal treatment, such as loperamide, as soon as possible.

The following additional side effects were reported during treatment with this medication. Contact your doctor if you experience any side effects.

• Idiopathic pulmonary fibrosis (IPF)
• Systemic sclerosis associated interstitial lung disease (SSc-ILD)

This document does not list all possible side effects, and other effects may occur. For more information about potential side effects, consult your doctor.

Is it safe to take it with another drug?

Inform your doctor or pharmacist if you are currently taking, have recently taken, or may take any other medications, including herbal remedies and over-the-counter medicines.

IOfev can interact with certain other medications. The following examples are medications that may increase the levels of Nintedanib in your blood, potentially raising the risk of side effects.

• Medication that affects your immune system (Cyclosporine)
• Medication used to treat fungal infections (Ketoconazole)
• Medication used to treat bacterial infections (Erythromycin)
The following medications are examples that may decrease the levels of Nintedanib in your blood, potentially reducing the effectiveness of Ofev:
• An antibiotic used to treat tuberculosis (Rifampicin)
• An herbal remedy used to treat depression (St. John’s Wort)
• Medications used to treat seizures (Carbamazepine, Phenytoin)
How should I store it?

Store between 20°C and 25°C with allowable temperature fluctuations between 15°C and 30°C. Protect from high humidity and excessive heat. If repackaged, use a USP tight container.

What action should I take in case of overdose?

Seek immediate medical attention to prevent further complications.

Is it safe for pregnant or breastfeeding women?

Inform your doctor if you are pregnant or planning to become pregnant, as Nintedanib may harm an unborn baby. You should not become pregnant while taking this medication. Your doctor will likely perform a pregnancy test before starting treatment. Discuss reliable birth control methods (such as condoms) with your doctor while using Nintedanib and for at least 3 months after your last dose. If you become pregnant, contact your doctor immediately to discuss the risks and benefits of continuing the medication.

It is unclear whether Nintedanib passes into breast milk. Consult your doctor before breastfeeding to discuss the risk and benefits.

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